CRC CERTIFICATION
GUIDE
Certified Clincial Reseach Associate (CCRA)
Certified Clinical Research Coordinator (CCRC)
Certified Principal Investigator (CPI)
CERTIFICATION HANDBOOK
Academy of Clinical Research Professionals | 500 Montgomery St., Suite 800 | Alexandria, VA 22314 | www.acrpnet.org
2016 EXAMS
Academy of Clinical Research Professionals
99 Canal Center Plaza, Suite 200
Alexandria, VA 22314
www.acrpnet.org
Welcome to the Academy of Clinical Research Professionals
Certification Programs
The Academy of Clinical Research Professionals (the Academy) would like to congratulate you on your decision
to pursue Certification in your chosen field of work. As a professional in clinical research, you deserve to be
recognized and appreciated for what you do, and like most professionals, you want to become better at it. You
look for opportunities for ongoing professional development and practical ways to evaluate your own work that
will help you develop as a professional.
What is Certification?
Certification is a voluntary process to recognize individuals for meeting professional standards set by an
impartial third party. Academy Certification is the formal recognition of clinical research professionals who have
met comprehensive eligibility requirements, agreed to uphold the ACRP Code of Ethics and Professional
Conduct, demonstrated proficiency of specific knowledge and job‐related skills by passing a rigorous,
standardized exam, and continuing to maintain their certification through a range of ongoing professional
development activities.
Three Certifications are offered:
A Clinical Research Associate (CRA) monitors the administration and progress of a clinical trial on
behalf of a sponsor. A CRA must be independent of the investigative staff conducting the research at the site or
institution. The Certified Clinical Research Associate (CCRA®) credential is awarded to a CRA who has met all
eligibility criteria which demonstrate experience with the Essential Duties of a CCRA and passed the
comprehensive ACRP CRA Certification exam.
A Clinical Research Coordinator (CRC) is a professional who, regardless of job title, works at a
clinical research site directly with study subjects under the immediate direction of a principal investigator whose
research activities are conducted under Good Clinical Practice Guidelines. The Certified Clinical Research
Coordinator (CCRC®) credential is awarded to a CRC who has met all eligibility criteria which demonstrate
experience with the Essential Duties of a CCRC and passed the comprehensive ACRP CRC Certification exam.
A Principal Investigator (PI) holds a doctorate level degree and serves as the primary, sub-, or coinvestigator on a clinical trial. A PI can also serve as a medical monitor, supervise, or design trials. A PI accepts
responsibility for the safe and ethical conduct of a clinical trial. The Certified Principal Investigator (CPI®)
credential is awarded to a PI who has met all eligibility criteria which demonstrate experience with the Essential
Duties of a CPI and passed the comprehensive ACRP PI Certification exam.
ACRP holds its Certification programs to the highest standards, as established by the National Commission for
Certifying Agencies (NCCA). The CCRC, CCRA, and CPI programs are the only clinical research certification
programs accredited by the NCCA, meaning they meet the highest standards for development, administration,
and governance of certification and testing programs. NCCA accreditation assures the validity and credibility of
the Certification process. For more information on the NCCA, visit www.credentialingexcellence.org.
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About the Academy of Clinical Research Professionals
Over 30,000 clinical research professionals have become certified through the Academy of Clinical Research
Professionals since the first exams were offered in 1992 with the advent of the CCRC Exam. The CCRA exams
were first offered in 1995, while the CPI Exams were first offered in 2002. The need for ongoing support and
formal governance led to the establishment of the Academy of Clinical Research Professionals (the Academy).
Founded in 2006 as an affiliate of the Association of Clinical Research Professionals (ACRP), the Academy is the
certifying body responsible for the governance and administration of the only job role–specific, accredited
credentials available to clinical research professionals.
The Academy’s Board of Trustees, elected by current certificants in good standing, is responsible for awarding
the Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), and Certified
Principal Investigator (CPI) credentials and for establishing eligibility criteria, examination content, passing
scores, and Maintenance of Certification requirements.
The programs are open to any eligible clinical research professional, regardless of membership affiliation. Each
program consists of an assessment of an eligible candidate’s professional experience and mastery of job-specific
clinical research principles and techniques, as measured by meeting comprehensive eligibility requirements,
successfully passing a rigorous written examination and periodic demonstration of continued competence
through the Maintenance of Certification process.
The Academy adheres to the highest standards by benchmarking its practices against standards set for
certification programs. The National Commission for Certifying Agencies (NCCA) of the Institute for Credentialing
Excellence (ICE) has established criteria for certification agencies. All three of the Academy’s programs are NCCA
accredited.
As of January 2014, TransCelerate Biopharma, Inc. has recognized certification through the Certified Clinical
Research Associate (CCRA), the Certified Clinical Research Coordinator (CCRC), and Certified Principal
Investigator (CPI) programs as evidence of Good Clinical Practice (GCP) training.
This exciting development means that TransCelerate’s membership of pharmaceutical and biotechnology
companies, including 20 major firms working together to create efficiencies within the clinical trials process, will
save time and resources by not requiring CCRAs, CCRCs and CPIs involved in their trials to complete redundant
GCP training for each and every new study team they join.
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Table of Contents
Welcome to the Academy of Clinical Research Professionals ..........................................................................................1
Certification Programs ..................................................................................................................................................1
What is Certification? ................................................................................................................................................1
About the Academy of Clinical Research Professionals ........................................................................................2
Quick Reference Questions ...........................................................................................................................................5
What is Required for Certification? ................................................................................................................................7
Eligibility Requirements of Certification .........................................................................................................................7
Clinical Research Coordinator (CCRC) Program ...............................................................................................................8
CCRC Eligibility Requirements .....................................................................................................................................8
CCRC Essential Duties ................................................................................................................................................8
Required Documentation ...........................................................................................................................................9
Clinical Research Associate (CCRA) Program ................................................................................................................ 10
CCRA Eligibility Requirements .................................................................................................................................. 10
CRA Essential Duties ............................................................................................................................................... 11
Required Documentation ........................................................................................................................................ 11
Principal Investigator (CPI) Program ........................................................................................................................... 12
CPI Eligibility Requirements ..................................................................................................................................... 12
PI Essential Duties .................................................................................................................................................. 13
Required Documentation ........................................................................................................................................ 13
Clinical Research Education Programs- Substitution for ............................................................................................... 14
Work Experience Requirements ................................................................................................................................. 14
Application for Certification ................................................................................................................................. 15
Completing the Application Form ............................................................................................................................. 15
Supporting Documents ........................................................................................................................................... 16
Application and Exam Fees ...................................................................................................................................... 17
Submitting the Application ...................................................................................................................................... 18
Receipt of Application ............................................................................................................................................. 19
Application Checklist............................................................................................................................................... 19
Eligibility Review ....................................................................................................................................................... 20
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Confirmation of Eligibility ........................................................................................................................................ 20
Ineligibility Decision Appeals Process ....................................................................................................................... 20
Exam Scheduling ................................................................................................................................................... 22
Exam Appointment Scheduling ........................................................................................................................... 22
Services for People with Disabilities ......................................................................................................................... 23
Rescheduling or Canceling an Exam Appointment ..................................................................................................... 23
Emergencies .......................................................................................................................................................... 24
Transfer Application to Next Exam Window .............................................................................................................. 25
Refunds and Cancellation of Application................................................................................................................... 25
Exam Format .......................................................................................................................................................... 27
Exam Structure and Delivery ............................................................................................................................... 27
Language ............................................................................................................................................................. 27
Exam Content and Preparation ............................................................................................................................ 28
What is Covered on the Exam? ........................................................................................................................... 28
Detailed Content Outline ......................................................................................................................................... 29
Study Texts ............................................................................................................................................................ 29
Certification Exam Abbreviation List......................................................................................................................... 30
Steps to Preparing for the Exam .............................................................................................................................. 30
Preparation Support ............................................................................................................................................... 31
Further Study Tips .................................................................................................................................................. 31
Taking the Exam ........................................................................................................................................................ 32
Exam Appointment Arrival ...................................................................................................................................... 32
Required Identification............................................................................................................................................ 33
Exam Security and Test Center Guidelines................................................................................................................. 33
Resources Available at the Test Center ..................................................................................................................... 34
Test-Taking Strategies ............................................................................................................................................ 34
Exam Results .......................................................................................................................................................... 34
Re‐Examination ......................................................................................................................................................... 35
Duplicate Certificates ................................................................................................................................................. 35
Exam Scores .............................................................................................................................................................. 35
Scaled Scores and Score-Reporting FAQs .................................................................................................................. 36
How Are Certification Exams Developed? ................................................................................................................... 37
Maintenance of Certification ...................................................................................................................................... 40
Maintenance Requirements .................................................................................................................................... 40
4
Frequently Asked Questions (FAQs) ............................................................................................................................ 41
Appendices ............................................................................................................................................................... 44
Appendix I: Detailed Content Outlines (CRA, CRC, and CPI Exams)............................................................................... 44
Appendix II: Resources ............................................................................................................................................ 44
Appendix III: The Academy Certification Policy Manual .............................................................................................. 44
Appendix IV: Forms ................................................................................................................................................. 44
Quick Reference Questions
Refer to the following table for some common points of contact throughout the Certification process.
Question or Concern
Contact Whom?
Exam Registration
Contact Information
Was my Exam application received?
The Academy
I didn’t receive notification of eligibility.
The Academy
certification@acrpnet.org
The Academy
Prometric website
www.prometric.com/ACRP
What is my Prometric testing ID number?
How can I locate a test site?
Can I reschedule my appointment more
than 29 days prior to exam?
Yes, contact Prometric;
No fee
Can I reschedule my appointment from
16 to 29 days prior to exam?
Yes, contact Prometric;
$25 fee
Can I reschedule my appointment from 5
to 15 days prior to exam?
Yes, contact Prometric;
$50 fee
www.prometric.com/ACRP
OR
telephone
No. Rescheduling is not
permitted less than 5 days prior
to exam date. All fees are
nonrefundable.*
*Rescheduling needs due to emergency- view “Exam Scheduling/ Emergencies” section ; submit Emergency
Exam Cancellation Form to the Academy
*For emergencies, contact certification@acrpnet.org; see
Can I reschedule my appointment from 4
to 0 days prior to exam?
Exam Transfers/Cancellations
Can I transfer/cancel my application
more than 29 days prior to scheduled
exam?
Can I transfer/cancel my application
from 16 to 29 days prior to scheduled
exam?
*Yes. First, contact Prometric to
cancel appointment. Next, notify
the Academy via e-mail.
Prometric:
www.prometric.com/ACRP or
telephone
AND
*Yes. First, contact Prometric to
cancel appointment and pay $25
change fee. Next, notify the
Academy via e-mail.
E-mail the
Academy: certification@acrpn
et.org
(Include Exam Transfer
Request Form if transferring)
5
Can I transfer/cancel my application from
5 to 15 days prior to scheduled exam?
*Yes. First, contact Prometric to
cancel appointment and pay $50
change fee. Next, notify the
Academy via e-mail.
*Transferring all fees is
acceptable through the last day
the exam is being offered.
Cancelling is not permitted
however, less than 5 days from
the last day the exam is being
offered. All fees are
nonrefundable.
*No. When an exam appointment
For emergencies,
Can I transfer/cancel my application from is scheduled, transferring or
contact certification@acrpnet.
4 to 0 days prior to scheduled exam?
canceling is not permitted less
org; see “Exam Scheduling/
than 5 days prior to an exam
Emergencies” section
date. All fees are nonrefundable.
*Note: Transferring is a one-time only option. Current transfer candidates cannot transfer again or cancel for a
refund. Cancellation needs due to emergency- view “Exam Scheduling/ Emergencies” section ;
submit Emergency Exam Cancellation Form to the Academy
I did NOT schedule an exam
appointment? When is the last day I can
transfer my fees to the next exam period
or cancel my application for a refund?
Post Exam Questions
Change of contact information
When can I expect confirmation of my
exam results?
The Academy
Exam results are offered at the
test center, immediately
following completion of exam.
Official confirmation of these
results will be emailed and
mailed as early as two weeks
after exams close. Allow four
weeks to receive mail outside of
the US.
certification@acrpnet.org
certification@acrpnet.org
General Contact Information
Prometric Member Services
To report issues with your Prometric
experience
The Academy
Prometric
telephone Prometric
Prometric
telephone Prometric
Certification Program
Phone: 703.253.6275
certification@acrpnet.org
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STEP 1:
STEP 2:
Meet Eligibility
Requirements
Apply for Eligibility
Review and Exam
STEP 3:
Pass Exam
What is Required for Certification?
In order to achieve certification, all applicants must meet the Eligibility Requirements and pass an Exam.
Exams are administered twice annually, during a 24-day period in March and September, at over 600 testing
centers in more than 80 counties.
The purpose of the ACRP Certification Handbook is to provide detailed information for becoming ACRP
Certified, specifically, the eligibility requirements, applying, eligibility review, scheduling an exam, exam
preparation, and understanding exam results. All of the requirements are provided in this all-encompassing
document, with links to important forms, policies and webpages. Please contact us at certification@acrpnet.org
with any questions not answered here.
The applicant should determine his/her own eligibility before submitting an application to the program. Upon
submission of a complete application, an eligibility review is conducted by the Academy. The candidate is then
notified of the eligibility review outcome via e-mail. All eligible candidates must then schedule an appointment
to take the exam.
Candidates who meet the eligibility requirements and pass the exam for the CCRA, CCRC, or CPI program will be
certified as having met the Academy standards for becoming a CCRA, CCRC, or CPI respectively, as adopted by
the Academy. Maintenance of Certification of one’s certification is required every two (2) years for continuance
of the designation.
Each ACRP Certification program has a unique set of eligibility requirements, detailed in the next section.
Eligibility Requirements of Certification
For each of the three ACRP Certification programs, there are eligibility requirements which must be met prior to
applying for a program. The requirements are based on role-specific employment experience over a specified
number of hours/ years. This employment experience required by the Academy for eligibility is consistent with
the criteria used by other specialty certification boards in healthcare. The Academy believes that recent
experience in clinical research is a major source of knowledge and skills, as well as gaining an understanding of
how to apply those. The content and practice of clinical research is largely learned by doing, given that there are
a limited number of educational programs and that the clinical research professional develops specialized
knowledge and skills through practice.
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Clinical Research Coordinator (CCRC) Program
A clinical research coordinator (CRC), regardless of job title, works at a clinical research site directly with study
participants and works under the immediate direction of a principal investigator, whose research activities are
conducted under Good Clinical Practice (GCP) guidelines.
The CCRC credential is awarded to a CRC who has met comprehensive eligibility requirements, agreed to uphold
the ACRP Code of Ethics and Professional Conduct, passed a rigorous, standardized ACRP CRC Certification
exam, and agreed to continue to maintain certification through participation in ongoing professional
development activities.
CCRC Eligibility Requirements
In order to be deemed Eligible to take the CRC Certification exam, applicants for the CCRC credential must be
able to provide evidence through a job description, detailed CV or other documentation that they:
•
Perform EACH of the CCRC Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CCRC Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon one’s
educational background.
CCRC Essential Duties
As defined by the Academy, and determined through ACRP’s 2010 Job Analysis Survey, clinical research
coordinators who are eligible for CRC Certification must document cumulative performance of each of the
following Essential Duties during the dates of employment listed on the application:
•
•
•
•
•
•
•
Document adverse events;
Prepare or review documents submitted to the institutional review board (IRB);
Protocol review or study procedures planning;
Participate in conducting subject visits;
Maintain source documents;
Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
Participate in consent process.
8
CCRC Eligibility Requirements
At least one of the Eligibility Requirement options below should be met before applying for the CCRC
program.
Minimum Hours
Required Documentation of
Education
Performing
Performed Essential Duties
Essential Duties

Option 1


Option 2

Associates or Bachelor’s degree
(or higher)
or
Registered Nurse (RN)
Other, such as LPN, LVN, Medical
Assistant, Lab Technician
or
High School diploma
3,000 hours*
4,500 hours*
Detailed CV/Résumé
and
Job Description
Detailed CV/Résumé
and
Job Description
*see section for the option of substituting “Clinical Research Education Programs” for work experience
9
Clinical Research Associate (CCRA) Program
A clinical research associate (CRA), regardless of job title, supervises, monitors, and supports the administration
and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of
pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract
research organizations (CROs), or as independent consultants or contractors.
The CCRA credential is awarded to a CRA who has met comprehensive eligibility requirements, agreed to uphold
the ACRP/ACRP Uniform Code of Ethics, passed a rigorous, standardized ACRP CRA Certification exam, and
agreed to continue to maintain certification through participation in ongoing professional development
activities.
CCRA Eligibility Requirements
In order to be deemed Eligible to take the CRA Certification exam, applicants for the CCRA credential must be
able to provide evidence through a job description, detailed CV or other documentation that they:
•
•
•
Work independently of the investigative staff conducting the research at the site or institution. This
means they do not report to the PI or site manager and that they do not have the ability to change or
manipulate data, AND;
Work on behalf of the sponsor. This means that they are contracted by the “sponsor” to perform an
independent monitoring function. The “sponsor” can be a pharmaceutical or device company, a
government or granting agency, a university department, a physician, etc., AND;
Perform EACH of the CRA Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CRA Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon one’s
educational background.
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CRA Essential Duties
As defined by the Academy, and determined through ACRP’s 2010 Job Analysis Survey, clinical research
associates who are eligible for CRA Certification must document cumulative performance of each of the
following Essential Duties during the dates of employment listed on the application:

Verify that the research site personnel, including the investigators, are conducting the study according
to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;

Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;

Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents
(source data verification);

Review accuracy and completeness of site records (site study file, query resolution, and other data
collection tools);

Verify Investigational Product accountability;

Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial
management tracking system);

Conduct routine monitoring (onsite or remote) on behalf of the clinical trial sponsor.
CCRA Eligibility Requirements
At least one of the Eligibility Requirement options below should be met before applying for the CCRA program.
Education

Bachelor’s degree (or higher)
OR
Registered Nurse (RN)

Associate’s degree

Option 1
Option 2
Minimum Hours
Performing
Essential Duties
3,000 hours*
4,500 hours*
Required Documentation
of Performed
Essential Duties
Detailed CV/résumé
and
Job Description
Detailed CV/Résumé
and
Job Description
Other, such as LPN, LVN, Medical
Detailed CV/Résumé
Assistant, Lab Technician
6,000 hours*
and
Option 3
OR
Job Description
 High School diploma
*see section for the option of substituting “Clinical Research Education Programs” for work experience

11
Principal Investigator (CPI) Program
A Principal Investigator (PI) holds a doctoral-level degree (PhD, PharmD, DNP, DO, MD, MBBS, DDS, etc.) and
serves as the primary, sub-, or co-investigator on a clinical trial. A PI can also serve as a medical monitor,
supervise, or design trials. A PI accepts responsibility for the safe and ethical conduct of a clinical trial.
The CPI credential is awarded to a PI who has met comprehensive eligibility requirements, agreed to uphold
the ACRP Code of Ethics and Professional Conduct, passed a rigorous, standardized ACRP CPI Certification
exam, and agreed to continue to maintain certification through participation in ongoing professional
development activities.
2015 Update: The March 2015 CPI Exam is the first exam being offered to all investigators with a doctoral-level
degree. A license to practice medicine is no longer required.
CPI Eligibility Requirements
In order to be deemed Eligible to take the PI Certification exam, applicants for the CPI credential must be able to
provide evidence through a job description, detailed CV or other documentation that they:
•
•
•
Have proof of employment as a PI during at least two (2) of the most recent five (5) years AND;
Perform all of the Essential Duties as detailed below. AND;
Holds a doctoral level degree (PhD, PharmD, DNP, DO, MD, MBBS, DDS, etc.)
Employment
Employment is broadly defined as paid services, fellowships and internships. Employment experience must
include service as a primary, sub- or co-investigator or a medical monitor, supervisor or designer of one or more
clinical trials during at least two (2) of the most recent five (5) years. Documentation that supports this role and
employment must include the applicant’s name and be signed and dated. A least one form of acceptable
documentation will need to be provided for EACH of the two (2) years within the most recent five (5) years
supporting employment as a PI during that time.
Completion of an applicable clinical research education program can be substituted for one (1) of the required
one (1) year periods of employment. See section below for for the option of substituting “Clinical Research
Education Programs” for work experience
Applicants must submit a detailed résumé or CV (see Appendix for sample CV) and a job description with the
exam application. This must include a description of the candidate’s PI job functions and specific employment
dates. Do not include a list of study participation with your CV.
12
PI Essential Duties
As defined by the Academy, and determined through ACRP’s 2010 Job Analysis Survey, principal investigators
(PIs) who are eligible for PI Certification must document performance of the essential PI duties using a Job
Description for each relevant position held during the dates of employment listed on the application. The
Essential PI Duties are as follows:










Responsible for the safe and ethical conduct of a clinical trial;
Evaluates the study proposal and decides on participation;
Facilitates or verifies formal approvals according to regulatory requirements and International
Conference on Harmonisation (ICH) Good Clinical Practice (GCP);
Ensures that all site initiation activities are performed to start and conduct the study;
Participates in the selection of trial subjects according to the recruitment strategy;
Performs or supervises the conduct of study-related procedures and monitors the safety of the trial
subjects and investigational staff;
Collects accurate and verifiable data and other essential study documents;
Ensures compliance with regulatory requirements and ICH GCP, the protocol and the handling of the
investigational product;
Communicates with subjects, sponsor’s personnel, and Institutional Review Board
Ensures adequate close-out of the study
Requirements
Education
Required Documentation
to be Submitted
Doctorate level degree (DDS, MD, DO, MBBS or MBChB, PhD, PharmD, DNP,
licensed Physicians Assistant with Doctorate, etc.
 CV must reflect name of educational institution, location (city, country), title of
degree and date awarded.
Experience
For at least TWO (2) of the most recent five (5) years*:
 1572 / PHS 398 / QIU (or equivalent) OR
 IRB/IEC approval letter to conduct the study OR
 Protocol approval letter for the study OR
 Notarized statement from a Program Director indicating your role as the
principal or sub investigator, medical monitor or designer of a trial OR
 Signed copy of an investigator agreement/protocol signature page OR
 Other regulatory authority document verifying your role as a Principal
Investigator or sub-investigator on the clinical trial being submitted in support
of eligibility
Any proprietary details may be blocked out.
*see section below for the option of substituting “Clinical Research Education Programs” for work experience

13
Clinical Research Education Programs- Substitution for
Work Experience Requirements
The Academy considers applicants who have completed a clinical research education program that meets the
following standards to have achieved a valid substitute for 1,500 hours of professional experience for the CCRA
or CCRC program, and one (1) of the two (2) required years of employment as a principal investigator, for the
CPI program.
Acceptable programs must:
•
•
•
Be at least 216 contact hours in length (at least 15 semester credits) and;
Cover content that substantially maps to the topics found on the current for the program:
CCRA Detailed Content Outline (DCO)
CCRC Detailed Content Outline (DCO)
CPI Detailed Content Outline (DCO) and;
Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation
(CHEA) or the appropriate authorizing authority in the country in which the institution operations. A list
of recognized US accrediting agencies can be found from the CHEA website: www.chea.org/search.
The Academy provides a list of Academic clinical research programs which have been evaluated and found to
meet the current waiver requirements established by the Academy. Programs that meet the waiver
requirements allow a candidate to waive 1,500 hours of hands‐on experience performing the Essential Duties of
the program to which the candidate has made application. This list is not to be considered exhaustive and is not
designed to represent all the academic offerings. View the Accepted Academic Clinical Research Programs List.
If an applicant submits an application using an educational program as a substitute for 1,500 hours of
CRC/CRA/PI work experience, then the following information must be included on the applicant’s CV
(see sample CV) and a certificate of completion must also be submitted:
 Name of school
 City and country in which the school is located
 Program title
 Name of organization that accredits the institution providing the program
 Dates attended (From-To)
View Policy on Denial of Eligibility and Policy on Appeals
14
Application for Certification
Once an applicant has carefully determined he/she meets the eligibility requirements, the application process
can begin. Applications are submitted online or via a printable method. Early-Bird and Regular application due
dates and fees are available online at http://www.acrpnet.org/applicationandrates.
The following must be uploaded or submitted together by the due date (received, not postmarked) to be
considered for review:
Application Form (CRA, CRC, or PI) AND
2. Supporting documents—curriculum vitae (CV)/ résumé (CPI only- proof of employment) AND
3. Detailed job description(s) for positions listed on the (CV)/ résumé AND
4. Full payment
1.
The Application form, all supporting documents, and full payment must be submitted together and by the due
date in order for the candidate to be considered for the next step, which is review for eligibility. All
documentation must be provided in English. If the original documentation was translated into English, it must
also be submitted in the original language, with the certified translated document.
Completing the Application Form
Access the online or printable Application Form from the ACRP website
at www.acrpnet.org/certificationprograms. Using the online application is recommended, as it is received
immediately for eligibility review. Completed copies are not available, therefore, it is recommended for the
applicant to take a screen shot if one is needed. Have all documentation and employment information ready so
that data in the online application is captured and does not time out.
Applicants submitting a check or bank transfer must submit the printable version of the application with the
check or receipt for bank transfer. If completing the printable application, make sure the application is received
(not postmarked) by the Academy by the Early-Bird or Regular deadline.
15
Have the following information ready before applying:
Work Experience
1. Employer(s) – list only positions which support your experience performing the essential functions.
2. Supervisor Name
3. Address
4. Phone
5. Supervisor Email
6. Start and End Date of Employment (consistent with CV/résumé)
7. Average Hours Worked per Week (enter an exact number amount, i.e. “45”)
The Academy has the right to verify qualifications. By submitting an application, applicants consent to and
authorize the Academy to verify the applicant’s academic and employment records. The Academy reserves the
right to request backup documentation to substantiate the reported information at any time during the
application process and/or once the candidate has been certified.
Supporting Documents
Supporting documentation is required for the education and work experience listed in the application. A
detailed CV or résumé is required.
Education documentation includes a listing on the CV or résumé with name of educational institutions, location
(city, country), title of any degree(s) with date(s) awarded. For PI applicants only: a doctorate level degree (DDS,
MD or equivalent degree such as DO, MBBS or MBChB, PhD, PharmD or DNP, licensed Physicians Assistant, etc.)
is required.
Work experience documentation includes employers, corresponding employment dates, and a description of
the Essential Duties performed by the applicant. Only positions in which the applicant has performed the
Essential Duties and job functions are considered, regardless of the job title. No other positions or study
participation listings will be considered. See CRC and CRA Sample CV/ Résumé and Job Description.
Job Description(s)
A job description is a required document that further details the tasks performed for each relevant position. It
may be employer- or applicant-created, and should list only the specific functions and tasks performed that
support one’s eligibility. See CRC and CRA Sample CV/ Résumé and Job Description.
16
Proof of Employment (Required for CPI Only)
Required Proof of Employment documents must be included to support employment as a PI during at least
TWO (2) of the most recent five (5) years:
Regulatory filings such as 1572 / PHS 398 / QIU (or equivalent) OR
IRB/IEC approval letter to conduct the study OR
Protocol approval letter for the study OR
Notarized statement from a Program Director indicating your role as the principal or sub investigator, a
medical monitor or designer of a trial OR
 Signed copy of an investigator agreement/protocol signature page OR
 Other regulatory authority document verifying your role as a Principal Investigator or sub-investigator on
the clinical trial being submitted in support of eligibility.
Any proprietary details may be blocked out.




Certificate/Transcript
Candidates who are substituting the completion of a clinical research education program for work experience
are required to provide a Certificate of Completion or transcript. (See “Accepted Academic Clinical Research
Programs List”)
Application and Exam Fees
The cost to apply includes an Exam and Application fee. “Early- Bird” pricing applies for anyone applying early
and always applies for ACRP Members throughout the application period. The fees are as follows:
Apply Early
October 19 – December 7, 2015
(Early - Bird)*
Application Fee
(non-refundable)
Exam Fee
(refundable)
TOTAL Due at the Time of
Application
Apply
December 8, 2015 – February 1,
2016
$125
$200
$325
$325
$450
$525
*ACRP/ APCR Members always pay the Early-Bird rate. Before you apply, log on to www.acrpnet.org to verify
your ACRP or APCR Membership status and confirm the total payment due at time of application.
The $325 Exam fee is refundable should an applicant not be eligible to take the exam or need to cancel within a
reasonable time frame. The application fee is non-refundable regardless of eligibility status or
cancellation. Credit card, check, or bank transfers are acceptable forms of payment.
17
Submitting the Application
Methods of Payment and Delivery
Payment Method
Credit Card
Check or
Bank/Wire Transfer
Application Method
Online
Application
(recommended)
Documents Required to be Submitted WITH Application
1.
2.
3.
4.
CV/résumé
Job description(s)
Proof of employment (CPI only)
Educational program certificate (if using waiver option)
Printable Application
(Mailed or Faxed))
Upload documents as part of application or
Mail documents with printable application
Printable Application
(only via Mail)
1. CV/résumé
2. Job description(s)
3. Proof of Employment (CPI only)
4. Educational program certificate (if using waiver option)
Mail documents with application; include check/ bank
transfer receipt
Only applications received with required supporting documentation and full payment will be processed. Note:
File sizes must be less than five (5) megabytes for online applications.
VERY IMPORTANT: Incomplete applications, or applications submitted without the correct fee, will not be
processed. It is the candidate’s responsibility to submit all relevant documents and payment at the time of
application, by the due date. All fees must be paid in full by check, bank transfer, or credit card (American
Express, Visa, or MasterCard). Corporate checks must reference each applicant’s name.
Submission of the application constitutes agreement that the candidate has read, understood, and agrees to
abide by the ACRP Code of Ethics and Professional Conduct. Applicants are required to sign a Candidate
Statement of Authorization and Agreement (see Appendix II II) attesting to the accuracy of the information
provided as part of the application process. By submitting an application, the applicant consents to and
authorizes the Academy to verify the candidate’s academic and employment records.
Application for, and achievement of, Academy Certification is between the Academy and an individual
candidate. Therefore, application details and status, fees, eligibility status, exam appointments, and exam
results are confidential to the individual and cannot be disclosed, regardless of payer. Only the candidate is
permitted to withdraw an application or cancel an exam appointment, regardless of payer.
18
Receipt of Application
An e-mail confirmation of payment is automatically sent once payment is processed. At that point, your
application will enter the Eligibility Review process. Please allow up to 10 days to receive notification regarding
an eligibility decision.
To ensure you receive important Certification-related notifications, add @acrpnet.org to your safe senders list
(contact your IT department for instructions). Please take any necessary steps to prevent filtering of ACRP emails.
If the printable application is submitted, it is highly recommended that the applicant mail it to the Academy via
certified mail, express parcel service, or another traceable courier to ensure receipt by the application receipt
deadline. Keep fax confirmations for tracking purposes, if sending the application via fax.
The following checklist is a resource in taking the appropriate steps to begin the Certification process.
Application Checklist
CCRA, CCRC, and CPI Exams
Prepare to Apply
 Read this Certification Handbook for important application steps, eligibility requirements, exam preparation, and
Certification exam information for which you are responsible for understanding.
 Determine your eligibility before you apply. Obtain the correct application (e.g., CRC, CRA, or PI).
Complete the Application
 Apply using your full, legal name. The first and last name must match your government issued identification.
Middle names are not considered.
 When completing the “Statement of Experience” section, list all positions for which the Essential Duties were
performed. Dates of employment must match those listed on your CV/résumé.
 Include your CV/résumé.
 Include a job description with dates of employment for each position listed in the "Statement of Experience"
section to support your eligibility.
 Include a program certificate or transcript (for work experience substitution only).
 PI Applicants only— Include proof of employment documents, (i.e., IRB/IEB approval letter)
 Confirm all documentation is in English. If original documentation was translated into English, it must also be
submitted in the original language, with the certified translated document.
 Complete all sections completely and accurately.
 Sign "Authorization and Agreement" and "Payment" sections.
Submit the Application
 Submit the complete application (e.g., application, supporting documentation and full payment) together.
Incomplete submissions will result in a denial of eligibility.
 Ensure your application will be received by the due date.
 Submit your application online OR via e-mail, fax, or traceable mail (see “Payment” section for details).
 Receive e-mail confirming the date your payment is applied.
19
Eligibility Review
The Eligibility Review process includes determining completeness of the application and determining whether or
not the applicant meets the eligibility criteria for the exam. Applicants should expect to receive an update via
email within seven to ten days after the application has been received.
It is not unusual for an applicant to receive a request for additional and/or clarifying information from an
Eligibility Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond
to the request. Applicants who do not respond to the request for additional or clarifying information will
automatically have their applications determined incomplete and therefore are ineligible to take the exam.
Ineligible applicants will be refunded the exam fee ONLY, and will need to re-apply to the program and pay all
fees if they decide to pursue Certification in the future. Incomplete applications will not be returned.
Confirmation of Eligibility
If an applicant is determined to be eligible after the application has been reviewed, the candidate will be emailed an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment. A
candidate must schedule an Exam Appointment or forfeit any fees paid. Exam Appointments can only be
scheduled after eligibility is determined.
If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a
second reviewer. If the second reviewer also determines the applicant to be ineligible, the application is
automatically sent to the Director of Certification for a third review. Applicants are notified via e-mail at each
step of the review with an explanation of the deficiency identified.
If, after the three levels of review, the applicant is still determined to be ineligible, the applicant can choose to
appeal to the Academy Board of Trustees. However, after the third level of review by the Director of
Certification, applicants can no longer submit new documents to overturn an eligibility decision.
Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will
automatically be refunded the exam fee only, within two (2) weeks.
View the Academy’s Policy on Appeals.
Ineligibility Decision Appeals Process
The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and accurate
eligibility decisions based on the information provided by the applicants. An appeal procedure is available to any
applicant who has applied for certification by the Academy and who wishes to contest any adverse decision
affecting his or her application for certification status. Any individual who does not file a request for an appeal
within the required time limit shall waive the right to appeal.
Candidates are permitted to appeal an adverse certification decision on the grounds that the Academy did not
properly apply specified certification eligibility criteria or the decision was based on a factual error that affected
the outcome. Adverse certification decisions include: denial of eligibility for initial certification, denial of
maintenance of certification, suspension of certification or revocation of certification.
20
No appeal may be taken from an adverse decision based on an individual’s receipt of a failing score on an
Academy certification examination absent extraordinary circumstances, as determined solely by the Academy.
Individuals cannot appeal (1) the passing score or actions taken in setting a passing score; (2) establishment of
eligibility criteria; (3) individual test items; and (4) test content validity.
Privileged Information, including the nature, format, content and results of examinations administered by the
Academy are considered privileged information. Due to the importance of exam security and item banking,
neither exam forms nor answer keys will be disclosed or made available for review by candidates or any other
unauthorized third party.
View the Academy’s Policy on Appeals.
21
Exam Scheduling
Exam Appointment Scheduling
The Academy administers its exams during two 24-day testing windows each year, held in March and
September. Current exam dates are available at www.acrpnet.org/Certification.
The Exams are administered via a secure network of computer-based testing sites. Over 600 locations in more
than 80 countries are available at which to take the exam. All candidates who have been
determined eligible must schedule an appointment to take the exam.
Exams are scheduled through Prometric, the Academy’s testing partner, and may be taken at any of the
approximately 600 testing centers internationally. Only candidates determined to be eligible will receive an
Eligibility Notice immediately following the Eligibility Review process. Here is a sample Eligibility Notice:
This important notice includes a Prometric ID number, the Prometric web address, and instructions for
scheduling an exam appointment. The candidate must also verify that the FIRST and LAST name on the Eligibility
Notice (registered with Prometric and ACRP) is identical to the first and last names displayed on the candidate’s
current, government-issued identification (ID). The ID must also include a photo and signature to be considered
an acceptable form of ID. See Taking the Exam section.
Only when the name matches the candidate’s legal identification, should the candidate schedule an exam
appointment. The testing center, exam date, and time are available on a first-come, first-served basis.
To view testing locations, visit www.prometric.com/acrp at any time. For detailed assistance with selecting your
test center, view www.acrpnet.org/PDF/ExamSites.pdf.
22
Services for People with Disabilities
The Academy is committed to ensuring that no individual with a disability is deprived of the opportunity to take
an exam solely by reason of that disability. The Academy will provide reasonable accommodations for
candidates with disabilities pursuant to the Americans with Disabilities Act (ADA). The following reasonable
accommodations may be addressed:


Wheelchair access is available at all established test centers.
Candidates with visual, sensory, cognitive, or physical disabilities that would prevent them from taking
an exam under standard conditions may request reasonable accommodations and arrangements.
To request a reasonable accommodation, one is required to submit at the time of application:


Submit to the Academy a Special Accommodations Form, signed by a licensed health professional
approving the request as accurate and reasonable. This MUST be submitted at the time of application.
Check the designated box on the exam application.
A link to the Special Accommodations Form is available on the website and also in the online and printable
applications. Submit this form with your application to certification@acrpnet.org. Only reasonable
accommodations will be made during the available exam window.
Rescheduling or Canceling an Exam Appointment
Rescheduling or canceling an exam appointment (test center location, date, or time) is permitted by Prometric
up to five (5) days before your scheduled appointment. There may be fees associated with appointment
changes, as noted in the chart below. Rescheduling availability varies, depending on the test center location,
and number of days prior to the exam appointment date.
To reschedule or cancel an exam appointment, you must contact Prometric directly by telephone
or www.prometric.com/ACRP with your appointment confirmation number.
If you do not plan to take the exam during the current exam window, you must FIRST, cancel your exam
appointment and SECOND, submit one of the following requests:
1. Application Cancellation Request (for cancelling the application and requesting a refund only); submit
up to 5 days before scheduled appointment. Refer to the “Refunds and Cancellation of Application”
section.
OR
2. Request to Transfer Exam Application Form for transferring your application to the next exam window
only); submit by last possible exam date. Refer to the “Transfer Application to Next Exam Window”
section.
Your request must be received by the Academy at certification@acrpnet.org within the time specified or all fees
paid will be forfeited.
23
Exam Appointment Rescheduling / Cancellation
Contact Prometric directly by telephone or online at www.prometric.com/ACRP.
Time Before Appointment
More than 30 days before
scheduled appointment
Prometric Fees
No charge
29 to 16 days before scheduled
appointment
$25
15 to 5 days before scheduled
appointment
$50
Less than 5 days before
scheduled appointment
Method
Online or via phone
Online or via phone
Online or via phone
Not permitted – All fees
forfeited
Cancellations due to emergency
See policy below
Failure to appear for scheduled
exam
All fees forfeited
Emergency Exam Cancellation
Form sent to the Academy
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.
Emergencies
If a candidate will be unable to keep his/her exam appointment due to an emergency situation that arises within
five (5) days prior to his/her exam date, the candidate is required to submit an Emergency Cancellation Form
and official documentation to the Academy at certification@acrpnet.org. This information must be received up
to seven (7) calendar days after the candidate’s scheduled exam date. The following situations will be
considered with documentation:





Emergency room visit or hospitalization
Severe medical condition requiring hospitalization
Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
Call to active military duty
Jury duty
24
Transfer Application to Next Exam Window
The Academy offers a one-time transfer from the current exam offering to the next. There are two situations in
which candidates may take advantage of this:
3. If a candidate is determined ineligible for the current exam window, but will have met the eligibility
requirements by the next exam window; or
4. If an eligible candidate withdraws from taking the original exam for any reason (up to five [5] days
before a scheduled exam appointment)
Transfers are applied toward the next exam only. Transfer of eligibility and associated fees will be applied only
to the original candidate and are not transferable to another person, even if paid for by a third party. Exam fees
are transferred toward the next exam only and not toward other products or services.
If you choose to transfer to the next exam window for one of the two reasons above, you must submit
a Request to Transfer Exam Application Form before the end of the exam window for which you had originally
applied.
If you have an exam appointment scheduled, you must first cancel it directly with Prometric (see chart, section
Rescheduling or Canceling an Exam Appointment) before submitting the Request to Transfer Exam Application
Form to ACRP. Fees, payable to Prometric directly, apply for appointment cancellations made within thirty (30) to
five (5) days prior to an appointment date. Cancellations are not permitted less than five (5) days prior to an
appointment.
If a transfer candidate does not submit the request before the end of the current exam testing window, then all
funds originally submitted will be forfeited. Transferring is not an option for re-examination candidates (from
the previous exam cycle).
When a transfer request has been approved, all fees (application and exam fees) are applied automatically at
the start of the next application period. All eligible transfer candidates will receive a “Notification of Eligibility´
email when the Eligibility ID has been reactivated and an exam appointment can be scheduled.
Contact certification@acrpnet.org if you did not receive your new Eligibility notice. Candidates who are required
to submit documentation for subsequent eligibility review must do so at the start of the next application period.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination
Refunds and Cancellation of Application
Once a candidate submits an application, it cannot be withdrawn. Candidates who wish to discontinue the
Certification process may submit an Application Cancellation Request Form to obtain a refund of the Exam Fee
only. The application fee is non-refundable. If a candidate submits such a request after the candidate has
received an Eligibility ID, the ID number will be invalidated.
25
The only portion of the total amount submitted that will be refunded is the exam fee, provided that the request
is received at least five (5) calendar days prior to a scheduled exam appointment (if one is scheduled).
Cancellation requests received after that time will not be honored. Refunds are not available to candidates who
do not schedule or attend the exam.
Only the candidate may request a cancellation or refund, regardless of whether the exam fee was paid by the
candidate or another party. Employers supporting a candidate’s fees cannot request or receive a refund for fees
paid to the Academy. Any refund will be sent to the party who initially paid for the exam. If payment was made
by credit card, that card will receive the credit. If the payment was made by check, the Academy will mail a
refund check to the original payer.
Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are
ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the
final ineligibility notification.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.
26
Exam Format
Exam Structure and Delivery
The CRA, CRC, and PI Exams are each designed as practice-based exams for individuals involved in the
performance of the essential duties within their respective roles as a clinical research associate, clinical research
coordinator, or principal investigator, to assess proficiency of the five (5) core knowledge areas:
1.
2.
3.
4.
5.
Investigational Product Management
Protocol
Safety
Trial Management
Trial Oversight
The ACRP Exam consists of 125 multiple-choice questions (25 of these questions are pre-test items and do not
affect a candidate’s score. These items are not identified to candidates). Candidates are presented with a
question and are asked to choose the single best answer from the four options provided. Only one answer is
correct. The questions test knowledge at the recall, application, and analysis cognitive level, not just a recitation
of facts. Some questions use hypothetical scenarios. The exam content is based on a process of expert peer
review, performed by the Global CCRA, CCRC, and CPI Exam Committees. There are no “trick” questions on the
exam, and there is no penalty for guessing.
The ACRP Exams are administered at computer terminals at secure testing centers. The candidate is provided
with a brief tutorial on navigating the exam, prior to the official start time. Each candidate is allowed a maximum
of three (3) hours to complete the 125 questions. Questions can be skipped, marked for review, and returned to
at any time prior to submitting the Exam for scoring. Results are provided upon the conclusion of the Exam.
Details can be found in the “Taking the Exam” section.
Language
The Exam is provided in English.
Exam candidates may bring a hard-copy (Electronic dictionaries are not permitted) English-German/ Spanish/
Chinese/ Hindi/ etc. translation only (word-to-word) dictionary to the exam. Dictionaries containing any word
definitions or other extraneous markings are strictly prohibited. The dictionary will be inspected by the proctor
prior to and after the exam is completed. Any attempt to compromise the exam will be grounds for immediate
dismissal from the site, invalidation of the exam score, and possible legal action. No additional time is given to
those using a translation dictionary.
27
Exam Content and Preparation
Preparation to take the CCRA, CCRC, or CPI Examination can begin as early as one decides to pursue
Certification. It is recommended that exam candidates begin to prepare three (3) to six (6) months prior to
attempting an exam. Understanding the exam content, as well as how to apply one’s knowledge and experience
while taking the exam, is essential to successfully becoming certified.
What is Covered on the Exam?
The Examination is intended to assess your proficiency of the body of knowledge required to perform in your job
role in clinical research. The knowledge and tasks that are being tested are based on current practice in clinical
research. The research was conducted through an international job analysis to determine what content should
be tested. It is testing your knowledge of what is required to perform in your role safely and effectively, with
grounding in ICH GCP and the application of those guidelines in the conduct of your job duties and
responsibilities. The exam does not cover country-specific (FDA, EMA, etc.) regulations. It is not testing how
your employer or you personally carry out those duties.
The Examination is specific to the role that CRAs/ CRCs/ PIs play in the conduct of a clinical trial and differs
between designations. The exam content expects that you will have a basic working knowledge of general
laboratory terms, tests, and procedures, as well as how to perform basic math. It requires a general working
knowledge of the roles and responsibilities of CRAs/ CRCs/ PIs, even if your employer does not require you to
function in that role.
No two candidates come to the exam with the same knowledge base. Since experience and educational
backgrounds are unique, these differences must be taken into consideration when determining a study method.
Although some individuals may take the exam without any preparation, the majority become involved in some
form of exam preparation. Because the exams measure proficiency of the application of the knowledge required
to be an effective CRA, CRC, or PI, it is impossible to train or teach to the exam. The best preparation is to
understand the CRA/ CRC/ PI knowledge requirements (see the Detailed Content Outline specific to your
program) and their application to clinical research.
A candidate who has met the eligibility requirements to sit for the examination should have the knowledge
needed to take and pass the examination. You might want to review the Detailed Content Outline for topics or
subtopics with which you are less familiar. If you find a particular area with which you are not familiar or
comfortable, that would be an area on which to focus your study or review. Or, you may want to do a surface
review of all the content areas, even those you believe you know well.
Because of the nature of the exam, there is not one comprehensive source to go to in order to study. However,
the Academy does recommend that you review the content areas covered on the exam by using the Detailed
Content Outline, as further explained below.
To be certified, CRAs, CRCs, and PIs are expected to have general knowledge of:
 laboratory terminology, tests, and procedures
 basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
28
What is Covered on the Exam?
Detailed Content Outline
The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research coordinators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice. Each question on the exam is based on this outline. Therefore, to prepare to take
the exam, one should study this outline and especially consider the underlying knowledge, skills, and abilities
needed to perform in his/ her role as a clinical research associate, clinical research coordinator or principal
investigator. To be certified, CRAs, CRCs, and PIs are expected to have proficiency in five (5) core knowledge
areas found on the Detailed Content Outline (DCO) for their respective Exam.
Click the image below to view the full DCO content by program:
Study Texts
In order to prepare for the exam, all candidates should review and be familiar with the relevant regulations
from:


ICH Guidelines (E2A, E6, E8, E9)
Declaration of Helsinki (latest version)
The most current copy of the ICH Guidelines and other regulatory materials may be found on the following
websites:


ICH Guidelines: www.ich.org (Go to Work Products/ICH Guidelines/Efficacy Guidelines)
Declaration of Helsinki: www.wma.net/en/20activities/10ethics/10helsinki/index.html
29
Certification Exam Abbreviation List
The Abbreviations List contains abbreviations that may be used throughout the Exam and Exam Detailed Content Outline.
The Abbreviations List is accessible on each screen during the exam and can be found in the Appendix of this Handbook.
Steps to Preparing for the Exam
STEP 1: Assess your own professional experience. Read carefully through the Detailed Content Outline
(DCO) for the exam you are going to take. Compare the detailed description of knowledge and tasks,
plus the proportion of questions, to your own professional experience. Rate your relative skill level and
experience on a scale of 0–5 (0 = no experience) as an indicator of how prepared you are for each
section and where to invest more of your study focus in preparing for the exam. While you personally
may have limited experience with certain job functions due to your job description with your employer,
success on the exam requires you to demonstrate competency in all areas of the exam.
STEP 2: Start early and plan ahead. Don’t wait to receive your Eligibility Notice. You must complete and
submit your detailed application at least three (3) weeks before the exam. Don’t leave this until the last
minute! Focus some learning time on reading in every content category, but spend extra time reading in
those categories where your experience is limited. Match your study efforts in relation to the time you
have available and the specific study needs you have identified for yourself.
STEP 3: Schedule your study time. If you decide to set up a study group, you should hold weekly
meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time
into your personal schedule. The key is not to memorize what you read, but to understand concepts
behind ICH/GCP and best practices in each knowledge category area to supplement your experience. Be
sure you understand how your SOPs differ in relation to ICH/GCP.
STEP 4: Organize your study notes. It may help you to organize your study notes, articles, summaries,
etc. in a binder using either the five (5) exam categories, or your own index. Let your experience guide
you in the content areas you are most comfortable with and focus more time in your weaker areas or on
those areas with which you are least familiar. Create flashcards to use as study aids.
STEP 5: Choose the methods that are right for your study plan. Choose a mentor or colleague who has
more experience in the areas in which you are less familiar and ask him/her to review concepts with you.
As you perform your daily responsibilities, think about the underlying principles that lead you to take a
particular course of action.
STEP 6: Stick to your study group’s plan. Pick a regular night and show up on time. Each of you has the
same goal, and everyone has something to offer. Sharing reading and exchanging notes is a great way to
lighten the load. Study groups foster friendships and provide an incentive to stay focused on your
collective goal. Complete; don’t compete.
STEP 7: Don’t panic. Follow the excellent pre-exam advice that the Academy provides, and come to the exam
well-rested and prepared.
30
Preparation Support
The Academy Exam Committees periodically retire exam questions for use in an online Exam Practice Exercise.
This internet-based option, which is designation specific, provides an opportunity for candidates to become
familiar with the format of exam questions. The Exam Practice Exercise includes fifity (50) retired items and also
provides the correct answer, the ICH Guideline reference that supports the correct answer, and a narrative
explanation for the answer. This can assist candidates in becoming more comfortable with the type of items on
the exam. It is not intended to be a pre-test to determine a candidate’s future success on the actual exam.
The Academy’s affiliate, the Association of Clincial Research Professionals (ACRP) provides optional exam
preparation support which is available for purchase online, from the Exam Preparation webpage. There are
options to purchase components separately or in a package. Visit the webpage for details and pricing for each
option:




Cert Exam Prep Self-Paced eLearning Course
Exam Review Preparation packages
Cert Exam Prep Classroom Course
ACRP ICH Flashcards Challenge App
Please note, The objectives of the these materials, developed by ACRP, are designed to match the Detailed
Content Outline for each exam with the related ICH guidelines and are developed independently from the
Academy. The Academy does not endorse, recommend, or sponsor any review course, manuals, or books for the
CCRC®, CCRA®, and CPI® Certification exams.
Further Study Tips
In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used
when first taking on your role. You can select a publication that you may already have on your bookshelf, or one
that you can borrow from a colleague. You should select books or publications that cover topics found on the
Detailed Content Outline, the ICH Guidelines, or the tenets of GCP.
If you have time, take a workshop or attend a conference session on topics in which you need to become more
familiar. Any professional development courses that cover clinical research topics will add to your knowledge
base and therefore will help you prepare for the exam.
NOTE: The Academy does not sponsor or endorse any specific educational courses—even if the course is
advertised as a “prep” or “review” course for the Exam. Courses titled this way are at the discretion of the
organization offering the course. Those creating the course have not had any inside information about the
exam. The same information that is included in this handbook to help you prepare is publicly available to those
creating educational content. Participation in these courses may help you learn or review topics covered on the
exam, but you should not expect them to directly cover exam content.
31
Taking the Exam
It is important for candidates to understand their rights and responsibilities in the secure testing environment of
the Prometric test center. It is recommended that you review the full Policy on Testing Experience Issues.
Exam Appointment Arrival
It is the candidate’s responsibility to arrive on time for the exam appointment. If the candidate is late by 15
minutes or more, the test center has the authority to turn the candidate away and not permit the candidate to
take the test. Expect the unexpected when planning your arrival:
•
•
•
•
•
•
Plan to arrive 30 minutes prior to your appointment. If you are lost, or will be late, call the test center
using the phone number on your Appointment Confirmation.
Including check-in time, pre-exam procedures (computer tutorial), exam, and post-exam evaluation, be
prepared to stay at the exam site three-and-a-half to four hours.
Candidates denied access due to lateness, must first contact ACRP and pay the $75 rescheduling fee
before being permitted to reschedule the appointment. We will attempt to have an appointment time
rescheduled at the test site within the current exam period, only if one is available. No refunds will be
given if the exam cannot be rescheduled.
If you miss or need to miss your exam appointment due to a medical emergency, illness, accident, or
death in the family, on Exam day, let us know as soon as possible at certification@acrpnet.org and
within seven (7) days of your scheduled appointment. With proper documentation, we can help you!
If you miss your scheduled exam appointment for any other reason, for example, lack of child care,
lateness due to work or traffic, your opportunity to test will be lost.
Rescheduling for any reason is permitted with a $50 fee, by contacting Prometric directly by telephone
or www.prometric.com/ACRP, if rescheduling occurs at least five (5) days prior to your exam
appointment.
TIPS: These can help you focus on the exam and not the unexpected:
• Know your travel route and traffic. Plan for a delay.
• Prepare for child care
• Bring required identification (see below)
• Get plenty of rest!
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Required Identification
To access a secure testing center you, must present proper identification (ID) containing your legal name. Your
legal name MUST match the first name and last name (middle names excluded) listed on your Eligibility Notice
(emailed from ACRP) and on the Appointment Confirmation (from Prometric). Your (ID) must meet each of the
following criteria:
 government-issued AND
 current (non-expired) AND
 photo-bearing AND
 signature-bearing identification (ID)
The photo must look like the examinee. Signature on ID must match the signature provided during the sign-in
process.
Examples of proper ID include passport, drivers’ license, state- or government-issued ID.
Exceptions will be made if:
 name discrepancies are minor
 parts of hyphenated names are missing
 for candidates with two last/family names, one of the two last names appear
 informal first names are used (James vs. Jimmy)
Any other differences will result in a candidate being denied from the testing center and result in forfeiture of all
fees paid.
Name changes (due to marriage, for example) are common, but can prevent a candidate access to the exam if
not properly presented. If a candidate is identified by a different name for the exam than that which is listed on
the ID, the candidate will be permitted to the Exam only if the ID is accompanied by a government-issued
certificate supporting the name change (e.g., a marriage certificate or divorce decree with previous and current
name).
If the name listed with ACRP and Prometric is not your legal name, you must submit a Name Change Request
to certification@acrpnet.org immediately.
Exam Security and Test Center Guidelines
The test center is serious about security. You will be presented with Prometric Test Center Regulations upon
arrival at the test site. It is imperative to read the information provided. Those who violate security will not have
their exams scored or processed, and will be required to leave the room immediately. Also, attempting to
remove exam material or content from the test center will result in severe criminal and civil legal consequences.
Once seated, you will follow a brief on-screen tutorial for navigating through the exam. Your exam will begin
after the tutorial and is three hours in length.
Exam content will be transmitted via encrypted electronic file to each exam site to ensure the security of the
exam questions. Computer-based testing allows for different versions of the exam to be offered and for changes
in the sequence of questions; this reduces the likelihood of misconduct and enhances the validity and integrity
of the exam. Each exam will be delivered via individual video-monitored testing carrels—both to provide better
privacy while the candidate is taking the exam and to prevent unethical behavior.
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Resources Available at the Test Center
You may use the following resources, issued only by the test center:
• Hand-held calculator (also an on-screen calculator is available)
• White board and dry-erase markers
• Noise cancelling head set (Keep in mind that you are sharing a room with other examinees taking tests
of varying lengths.)
• An abbreviations list for your specific exam is also available on screen
TIP: Please, please raise your hand at any time if your computer or any of the above tools are not functioning
properly!
MORE TIPS: It is recommended to leave personal items at home. Any and all personal items will be locked in a
locker. Some examples include a purse, keys, wallet, calculators, watch, dictionary (except for non-electronic
word-to-word, English translation only) cell phone, all electronic devices, tissues, outerwear (heavy coats), food,
and all books and papers. Dress in layers
Should you have any questions about the exam experience, please refer to this Handbook and
contact certification@acrpnet.org if you cannot find an answer. We want you to own your success and perform
at your best!
Test-Taking Strategies
Most adults haven’t taken a standardized exam recently. It can be helpful to be reminded of some key strategies
for how to approach a multiple-choice exam:
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Read the entire question before you look at the possible answers.
Come up with the answer in your head before looking at the possible answers; this way, the choices
given on the test won't distract you from focusing on the question.
Read all the choices before choosing your answer so that you select the best one.
Eliminate answers you know are not correct.
There is no guessing penalty, so it’s always best to take an educated guess and select an answer if you
are uncertain of the answer.
Don't keep on changing your answer; usually your first choice is the right one, unless you misread the
question.
Go through the exam and answer the questions you know first. Mark the others for review and then go
back to those you skipped over. This will ensure that you don’t lose time by focusing on one question
you aren’t sure about.
Exam Results
Computer-based testing provides participants with preliminary results immediately. You will receive printed
results before you leave the test center. Please make sure that you have this important feedback before you
leave as it is the only feedback you will receive regarding your performance on the exam. These on-site notices
are preliminary and candidates are not yet considered certified until official notification of certification status
is received from the Academy. You will not receive another copy of your detailed results but will receive official
34
confirmation of your certification status via mail, approximately 30 days following the close of the testing
window. Candidates who pass the exam will be sent an official notice of Certification, a certificate, a certification
pin, and Maintenance of Certification information.
Candidates who do not pass the exam are advised to review the content area proficiency ratings and use this
information to assist in preparing for future exams.
Final exam results will not be given out over the telephone or by fax, nor will results be sent to employers,
schools, other individuals, or organizations under any circumstances. Candidates who pass the exam will be
added to the Academy Certification registry unless this option was de-selected at the time of application. The
registry will be updated within 30 days following the close of the testing window and can be accessed
at www.avectraacrp.com/Certlist.
Re‐Examination
Candidates who do not achieve a passing score on the first certification examination attempt will be allowed to
re‐take the exam in the next available exam period only, without submitting a new application, for a reduced re‐
examination fee. A personalized “Re-Examination Form” will be included with the candidate’s official Exam
Results confirmation letter. This letter is mailed immediately following the closure of the examination window. A
sample copy of the Re-Examination Form can be found in Appendix IV.
If the candidate is not successful on this “re‐take” examination, he or she will need to complete a new
application and pay all fees in place at the time for any subsequent exams.
The Re-take option is not available for candidates who transferred the exam application to the following exam
period and were unsuccessful. If a candidate chooses to transfer his or her first exam opportunity and,
subsequently, does not pass, he or she will need to complete a new application, meet all eligibility criteria in
effect at that time, and pay all fees in place at the time for any subsequent exams.
Candidates who do not achieve a passing score on their second attempt or who are unable to test again during
the next exam period must submit a new application, together with all current fees, to continue their
pursuit of certification. Such reapplications will be subject to all eligibility criteria in effect at that time.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination
Duplicate Certificates
There is a $25 charge for a duplicate certificate if the request is made more than three months after the exam.
Requests may be made in writing by completing and sending the DuplicateCertificateRequestForm to the
Academy at certification@acrpnet.org.
Exam Scores
35
Prometric, the Academy’s professional testing partner, scores all exams. One point is granted for each correct
answer. There is no penalty assessed for an incorrect answer; points are scored only for correct answers. The
number of questions answered correctly (or total points) is a candidate’s “raw score.”
A candidate’s raw score is converted to a scaled score. The "Total Scaled Score" will determine whether a
candidate has passed the exam. This scaled score is statistically derived from the candidate's raw score and can
range from 200 to 800. The passing scaled score for each of the exams is 600. The passing score reflects the
minimum amount of knowledge a committee of experts has determined to be appropriate for Certification,
according to accepted test development guidelines.
A criterion-referenced, standard-setting procedure and expert judgment are used to identify the passing point.
The Academy uses the widely accepted Modified Angoff method. A candidate's ability to pass the exam depends
on the amount of knowledge he or she demonstrates, not on the performance of other individuals taking the
exam.
The reason for calculating scaled scores is that different forms or versions of the exam may vary in difficulty. As
new versions of the exams are introduced, a certain number of questions in each content area are replaced by
new questions. These changes may cause one version of the exam to be slightly more or less difficult than
another version.
To adjust for these differences in difficulty, a statistical procedure called "equating" is used. The goal of equating
is to ensure fairness to all candidates. In the equating process, the minimum raw score (number of correctly
answered questions) required to equal the passing scaled score is statistically adjusted (or “equated”). For
instance, if the exam is determined to be more difficult than the base form of the exam, then the minimum raw
score required to pass will be slightly lower than the passing scaled score. If the exam is a bit easier, then the
passing raw score will be slightly higher than the passing scaled score. Equating helps ensure that the passing
scaled score represents the same level of knowledge, regardless of which version of the exam a candidate takes.
A candidate scoring below the minimum scaled score has not been successful on the exam and cannot be
certified. The exam is not scored on a curve. There is no predetermined number of candidates permitted to
pass. Your score does not depend on the other candidates testing with you that day.
Note: The passing point set for the exam cannot be appealed. To score one point below the passing point is to be
unsuccessful on the exam; to score at the passing point or higher is to pass the exam. A score higher than the
passing point is not an indication of a higher proficiency in the subject matter.
Specific questions on the exam and/or answers to exam questions will not be discussed or released. Due to
the security of the item bank and because exam questions can be used on various exams, exam questions will
not be discussed with candidates and candidates may not have access to the exam or their answers.
Scaled Scores and Score-Reporting FAQs
Commonly asked questions and information about scaled scores and score reports is provided below.
1. Why are scaled scores used?
They are used to provide a consistent scale of measurement, so that from one test administration to the next,
the same scaled score represents the same level of knowledge. Each exam administration has multiple exam
36
forms in use, and some forms may be more difficult than others. A scaled score keeps the level of knowledge
required to pass constant.
2. Why not just use the number of items answered correctly?
This may provide useful information about your performance on different parts of the test, but does not take
into account the difficulty of the items.
3. Is a scaled score the same as a percentage score?
No. Calculation of a “percent correct” is a way to convert a raw score to another scale, but a scaled score is not
the same as a percent correct. You could calculate percentage scores by dividing the number correct by the
total, for example, a raw score of 9 in a category with 15 total items relates to 60% correct, but a scaled score of
600 does not relate to 60% correct.
4. How should I interpret my performance on the category scores?
When reviewing your proficiency for the major categories, bear in mind that all categories are not equally
difficult. Those areas indicating “below proficient” are areas where additional study or review would be helpful.
5. Why don’t I get a percentage score on my report?
Similar to a raw score, converting your score to a percentage score would not take the difficulty of the items into
account.
6. How is the scaled score computed?
To calculate a scaled score, the raw score required to pass is first set equal to 600. An analogous situation is with
temperature: 0 degree and 32 degrees both represent freezing on different temperature scales. Raw scores
below the passing point are converted in linear fashion to scaled scores below 600; those above the passing
point are similarly converted to scaled scores above 600.
7. Why do I need a 600 to pass the test?
The amount of knowledge required to pass the test is based on the judgments of the content experts who are
certified in the job role tested. The raw score required to pass relates to the number of correct answers that a
minimally competent (borderline) candidate would be expected to provide, and this raw score is set equal to
600 scaled score units. Different raw scores may be required of different test forms, because all examinations
are not equally difficult. The scaled score of 600 required to pass indicates that, while a different number of
correct answers may be required from one administration to the next, the passing point for all examinations
represents the same level of knowledge.
How Are Certification Exams Developed?
The intent of a certification program is to evaluate the knowledge and skills of professionals seeking a credential
to ensure a desired level of competence. For certification exams to serve their intended goal, the exam must
assess the performance that the specific job requires. A number of widely recognized organizations have
established guidelines and standards for how certification exams should be developed.
37
The Academy’s programs are accredited by the National Commission for Certifying Agencies (NCCA), which sets
internationally recognized standards for the development and operation of certification programs. The
standards assure that a program is valid, reflects current practice, and treats candidates fairly and are based on
the established processes for developing certification exams
The development of Certification examinations begins with a Job Analysis, which conducts research into the
actual work done by various individuals to create a definitive description of the tasks required to perform a job
role and the knowledge needed in order to complete those tasks. A Job Analysis is conducted via a survey and is
typically conducted every five to seven years to assure the exam is testing current practice in a job role.
In 2010, the Academy updated its CRA, CRC and PI Job Analyses with a survey sent to thousands of clinical
research professionals, 3,636 of whom responded. The results of the survey identified for the Academy what to
include on the Detailed Content Outlines (DCOs) for each job role. Each role has a different DCO that reflects
those task and knowledge statements that the majority of CRAs, CRCs, and PIs respectively said were essential
to their job role. The results of the job analysis also dictate how much of each topic is covered; those tasks
performed more frequently or deemed most critical are tested more heavily on the exam. Each designation has
an outline that reflects the particular emphasis of their job role and function. The Academy will be updating its
Job Analysis through a new survey in the Spring 2015. New exams reflecting the results of those job analysis
results are expected in late 2016.
Individuals who are already certified as a CRA, CRC, or PI are then trained to write test questions based on
current practice and conduct of clinical research. We call these volunteers “Subject Matter Experts,” or “SMEs.”
All questions must test knowledge and skills as defined by the DCO. The correct answer for each item must be
supported by at least one citation of a reference found on the resource list, currently comprised of specific
areas of ICH Guidelines, as described in our Candidate Handbook. Once the SMEs have written draft questions,
the questions go to the CCRA, CCRC, and CPI Exam Committees for review. This process is constantly in motion,
with new questions being written, current questions being reviewed, and older or nonperforming questions
being “retired” from the item bank.
One exam committee exists for each exam. The CCRA, CCRC, and CPI Exam Committees consists of a separate
group of currently practicing, certified CRAs, CRCs, or PIs who review, edit, discuss, and rewrite the draft test
questions. Many draft test questions are discarded in the process. Others are completely rewritten or heavily
edited. Each question must meet minimum standards for applicability to the job role. All Exam Committee
members must agree that the answer keyed as correct is, in fact, the only correct answer possible. The
Committee verifies the content tested falls within the appropriate DCO and that the reference(s) cited support
the correct answer.
Once a draft question is approved by an Exam Committee, it then becomes a “pre-test question.” All questions
are pre-tested before they are counted toward a candidate’s score. The exams given to candidates are 125
questions long, and 100 of them count toward the candidate’s score while 25 are pre-test questions. This means
the Academy is collecting statistical data on the pre-test items to see if they are well-constructed enough to
appear on the exam as a scored item. Hundreds of candidates answer a pre-test question before it can be
determined if it can be used toward a candidate’s score.
38
Once enough data have been collected, analyses are performed on the item statistics in conjunction with the
Academy’s professional test development partner to see if items have performed well enough to be used. If they
have not performed well (for example, if many candidates are choosing the wrong answer; or each of the four
answers is being selected equally, which indicates test-takers are guessing; or candidates who score well on the
exam overall are selecting a wrong answer), then the questions are set aside for further review and rewriting, or
they may be discarded. Only those questions that demonstrate they are fair to the test taker and identify
proficiency in a candidate are used.
Each time the exam is administered, there are multiple “exam forms” being used. This helps minimize cheating
and assures that those retesting do not receive the same exam as taken previously. All exam forms comply with
the Detailed Content Outline. All candidates must achieve a score of 600 or greater in order to have
demonstrated sufficient knowledge and skill to pass the exam and become certified.
Several diverse groups of volunteers are used to write the questions, review the questions, select questions to
be pre-tested, and select and review questions that actually appear on the exam. Each year, over 160 volunteers
from around the world participate in some aspect of test development for Academy certification exams. This
helps assure the exam represents a variety of perspectives, practice settings and types of research. The
Academy follows a process that meets international standards for test development and works with a highly
regarded testing partner.
To date, more than 30,000 clinical research professionals have been certified by the Academy. On average, 73%
of first time test takers are successful on their exam.
Reliability Measurements
After every Certification exam, the Exam Committees review the results with the assistance of Prometric, one of
the testing industry's leading firms. Each item is analyzed for appropriate psychometric characteristics. Those
items with poor statistical results are reviewed by the appropriate Exam Committee to ensure that they have
been scored properly. Participant feedback regarding the exam and its contents is also reviewed and taken into
consideration when reviewing the exam and future test items. Each year, the Academy issues an Annual Exam
Report which details validity and reliability statistics for each of its exam programs.
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Maintenance of Certification
Once a candidate has achieved Certification, it is valid for two (2) years. In order to continue to be certified and
to continue to use the designation after two (2) years, certificants will need to apply for Maintenance of
Certification.
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a credential
maintain their ongoing commitment to professional development in their selected area of practice. Through the
Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of their
knowledge of current practice.
The Academy supports this purpose by requiring appropriate and relevant continuing education activities to
enhance the professional development of certificants. The Maintenance of Certification program also serves to
encourage and recognize individuals who participate in ongoing professional development.
CCRAs, CCRCs, and CPIs must maintain every two (2) years from the time of original Certification. The two-year
Maintenance of Certification cycle is based on the frequency of change in the clinical research field.
Maintenance of Certification requires the completion of 24 documented hours (referred to as “points”). These
points can be earned through professional development and/or continuing involvement. Updated information
is available at www.acrpnet.org/Maintenance.
Maintenance Requirements
To maintain Certification successfully, certificants must:
1. Satisfy the 24 points requirements every two years (or pass the CRC/ CRA/ PI Certification exam) prior to
your Certification expiration date.
2. Document the required points (or exam results letter) on the Maintenance application.
3. Submit the completed application together with appropriate payment by the expiration date.
The 24 points requirement for CPIs is different from those required for CCRAs and CCRCs, as noted below.
CCRAs and CCRCs, 24 Points Requirements:
• At least 12 points from Research-specific topics in Continuing Education (i.e. training, coursework)
• The other 12 points can be earned through any combination of Continuing Education from Research,
Disease/Bodily Systems/Healthcare related topics OR Continuing Involvement activities (research
related involvement; learn more)
CPIs, 24 Points Requirements:
• At least 8 points from Research-related topics in Continuing Education (i.e. training, coursework)
• At least 12 points from Continuing Involvement activities (research related involvement; see chart)
• The other 4 points can be earned through any combination of Continuing Education from Research,
Disease/Bodily Systems/Healthcare related topics OR Continuing Involvement
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Maintenance requirements are outlined more specifically in the Maintenance Handbook. Also, View Policy on
Continuing Competency and Maintenance for CCRA-CCRC or Policy on Continuing Competency and
Maintenance for CPI.
Frequently Asked Questions (FAQs)
When is the Exam offered?
Every March and September, during a 24-day period; (see Exam Scheduling section)
Where are the Exams offered?
600+ designated test centers worldwide (www.prometric.com/ACRP) (Also, see Exam Scheduling section)
How are the Exams given?
Through a secure, proctored environment, in a computerized format using multiple choice questions only. (See
Exam Format section)
How will I know if my exam application was received?
An e-mail confirmation is automatically sent once payment is applied. Applicants will also be sent an e-mail that
confirms that the application has entered the eligibility review process.
NOTE: Confirmations of receipt do not confer eligibility. A separate notification will be sent regarding an
eligibility decision. Please take any necessary steps to prevent filtering of ACRP e-mails.
How will I know if I am eligible to take the exam?
An e-mail will be sent within ten (10) days after receipt of the application to notify you of your eligibility status
or any deficiencies that may exist.
What should I bring to the test center?
Bring an appropriate identification, as described in this handbook. Online and handheld calculators will be
provided.
What happens if I need to cancel the exam?
If a candidate has already scheduled an appointment with Prometric, then:
1. Contact Prometric to cancel the appointment, online at www.prometric.com/ACRP or by telephone.
2. Pay the appropriate cancellation fee to Prometric (fees apply between 30 – 5 days prior to the set
appointment).
3. Notify the Academy in writing at certification@acrpnet.org once the appointment is cancelled.
If the candidate has not yet scheduled an appointment with Prometric, then the candidate should notify the
Academy in writing at certification@acrpnet.org.
If you cancel at least five (5) days prior to the exam, you will receive a refund of the exam fee only. No refunds
are available fewer than five (5) days prior to the exam.
What if I need to retake the exam?
An exam may be attempted only once during each testing window. Candidates may reapply for the exam and
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reattempt to take it during any future testing window however candidates, who are unsuccessful at their first
attempt, are offered the opportunity to retest for the next exam period for a reduced fee. In this instance, the
candidate submits an application with the exam fee only. The application fee is waived.
What happens if I miss the application deadline?
All applications must be received by the Academy (not postmarked) by the application deadline. Faxed
applications will be accepted. If you miss the deadline, you may reapply when the applications become available
for the next scheduled exam date. Your application will not be returned to you.
What tools does ACRP have available to help me prepare for the exams?
The Detailed Content Outlines (DCOs), and therefore the content of the Exam should be used to build your
study plan. An electronic, downloadable ICH Guidelines and Declaration of Helsinki Booklet is available, online
as well.
Optional Exam Preparation options are available for purchase online at www.acrpnet.org/examprep.
When can I expect the official confirmation of my exam results?
Official confirmation of results will be mailed 30 days following the close of the testing window. Candidates who
pass the exam will be sent an official notice of Certification, a certificate, a certification pin, and Maintenance of
Certification information.
What is the Academy’s Maintenance of Certification process?
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRA, CCRC,
or CPI credential maintain their ongoing commitment to professional development in their selected area of
practice. Through the Maintenance of Certification requirements, certificants demonstrate expansion and
reinforcement of their knowledge of current practice.
Certificants must maintain every two (2) years from the time of original Certification. Maintenance of
Certification requires the completion of 24 documented continuing education and/or continuing involvement
points. For CCRAs and CCRCs, a minimum of 12 of the 24 hours completed must be from participation in
continuing education activities specific to research topics. For CPIs, a minimum of 12 of the 24 hours completed
must be from participation in continuing involvement and a minimum of 8 points must come from participation
in continuing education activities specific to research topics. For a complete listing of acceptable activities, by
program, please visit the main Maintenance of Certification web page and the following requirements
webpages:
• Maintenance of Certification Requirements for CCRA/ CCRC Designations.
• Maintenance of Certification Requirements for the CPI Designation
View the full Policy on Continuing Competency and Maintenance for CCRA-CCRC and Policy on Continuing
Competency and Maintenance for CPI
What happens if I do not maintain my Certification?
Individuals who fail to properly maintain their Certification(s) will be decertified for failure to maintain by the
specified deadline. You will receive a two-week grace period in which you may maintain with submission of the
required professional development and/or continuing involvement points. If you do not respond by the end of
the grace period, you will be decertified and will receive notification of this action.
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Can I reinstate my Certification if it has expired?
A certificant who has had a credential revoked due to not meeting the Maintenance of Certification
requirements may re-apply for Certification by examination. The individual must meet the current eligibility
requirements, pay all required fees, and successfully pass the exam.
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Appendices
Appendix I: Detailed Content Outlines (CRA, CRC, and CPI Exams)
Appendix II: Resources
Appendix III: The Academy Certification Policy Manual
Appendix IV: Forms
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Appendix I: Detailed Content Outlines (CRA, CRC, CPI Exams)
 Detailed Content Outline (DCO) for the Clinical Research Associate Exam
 Detailed Content Outline (DCO) for Certified Clinical Research Coordinator
 Detailed Content Outline (DCO) for the Certified Principal Investigator
Detailed Content Outline (DCO) for the Clinical Research Associate Exam
The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research associates. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice.
Each question on the exam is based on this outline. Therefore, to prepare to take the exam, one should study
this outline and especially consider the underlying knowledge, skills, and abilities needed to perform as a clinical
research coordinator. To be certified a CRA is expected to have proficiency in five (5) core knowledge areas
found on the Detailed Content Outline (DCO) for their respective Exam.
Note: The percentage of questions allocated to each of the five (5) core knowledge areas is noted within the
DCO.
Certified Clinical Research Associates (CCRAs) shall have proficiency in:
I.
Investigational Product Management (10%)
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Develop and update the instructions for use of investigational product
Initiate shipment of investigational product to site
Ensure adequacy of investigational product and other supplies at site
Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and
other supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Using knowledge of:
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Investigational product (e.g., package insert, report of prior investigations, Investigator's
Brochure)
Investigational product inventory
Investigational product accountability
Investigational product storage
Packaging and labelling
Product development
Supplemental/ rescue/ comparator product
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Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
Accountability records
II.
Protocol (20%)
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Review product development plan
Identify study objective/design
Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety
and efficacy parameters)
Evaluate protocol for scientific soundness
Evaluate protocol for feasibility
Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC) with the study protocol
Verify the eligibility of potential trial subjects
Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility
Review protocol during investigator’s meeting
Execute study per protocol
Recommend and Implement protocol amendments
Using knowledge of:
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III.
Protocol development
Protocol submission and approval procedures
Clinical trial phase
Study design characteristics (e.g., double-blind, crossover, randomized)
Study objective
Description of procedures
Amendment submission and approval procedures
Inclusion/exclusion criteria
Statistical plan
Safety (25%)
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Assess safety during trial participation
Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Conduct study-related procedures and monitor the safety of the trial subjects and
investigational staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Review common laboratory values and alerts
Identify expected or unexpected results associated with investigational products
Maintain follow-up to determine resolution of adverse event
Conduct safety monitoring/reporting activities
Using knowledge of:








IV.
Investigator’s Brochure
Safety monitoring
Safety and clinical databases
Subject safety issues (e.g., toxicity, significant lab values)
Vulnerable subject populations
Adverse events reporting
Serious adverse events reporting
Safety reporting requirement
Trial Management (30%)


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





























Verify investigator/site feasibility
Develop timelines for conducting and completing the clinical trial
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Review, clarify, and obtain data changes from sites
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., countryspecific regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Develop Case Report Forms (e.g., CRFs, eCRFs)
Develop CRF completion guidelines
Develop monitoring guidelines/plans
Develop project tools
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare and conduct interim monitoring visit(s)
Prepare and conduct close-out monitoring visit(s)
Reconcile payments to sites per contract
Document protocol deviations/violations
Reconcile safety and clinical databases
Conduct co-monitoring/training visits
Perform remote monitoring activities
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Transmit CRFs to data management
Review CRF queries from data management
Coordinate study monitoring visits
Draft study specific tools (e.g., source document, tracking tools)
Implement corrective actions plans
Maintain trial master file (e.g., regulatory binder)



Manage study supplies (e.g., lab kits, case report forms)
Comply with subject privacy regulations
Manage study issues
Using knowledge of:
Site Activities
 Contract budget negotiations and approval process
 Project feasibility
 Project timelines
 Monitoring guidelines/plan and tools
 Study project tools
 Staff qualifications
 Staff roles and responsibilities
 data management activities
 Plan for staff oversight
 Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
 Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab kits)
 Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
 Study management plan (e.g., timelines, data management)
 Communication documentation (e.g., telephone, email)
 Pre-study site visit
 Investigator's meeting
 Site initiation
 Monitoring visit
 Close-out visit
 Site monitoring visit log
 Site signature log
 Delegation listing
 Trial master file (e.g., site, sponsor)
 Data management plan
 Data query resolution
 Electronic data (e.g., electronic health records, electronic case report forms)
 Recruitment plans/strategies
 Subject compliance
 Subject visit logistics
 Protection of human subjects
 Subject selection, screening, and recruitment
 Subject retention
 Subject discontinuation
 Subject reimbursement
 Good Clinical Practice (GCP)
 Regulatory documents
 Record retention
 Subject privacy regulations
 Case Report Form (CRF/eCRF)
 Visit reports (e.g., initiation, close-out)









V.
Final report
Progress reports
Essential documentation, subject related and non-subject related (e.g., past medical records, lab
reports, protocol, IRB approvals)
Informed consent
Procedure manuals
Source documentation
Protocol deviations
Indemnification/insurance
Clinical trial registry
Trial Oversight (15%)
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Ensure consistency between the sites’ standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Oversee vendors (e.g. Contract Research Organizations (CROs)
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation
of slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file
Using knowledge of:






Issues management (e.g., escalation)
Audit preparation
Regulatory standards
Audit documents
Project monitoring guidelines
Project investigator supervision requirements
Detailed Content Outline (DCO) for Certified Clinical Research Coordinator
The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research coordinators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice.
Each question on the exam is based on this outline. Therefore, to prepare to take the exam, one should study
this outline and especially consider the underlying knowledge, skills, and abilities needed to perform as a clinical
research coordinator. To be certified a CRC is expected to have proficiency in five (5) core knowledge areas
found on the Detailed Content Outline (DCO) for their respective Exam.
Note: The percentage of questions allocated to each of the five (5) core knowledge areas is noted within the
DCO.
Certified Clinical Research Coordinators (CCRCs) shall have proficiency in:
I.
Investigational Product Management (7%)
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Ensure adequacy of investigational product and other supplies at site
Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and
other supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Prepare investigational product according to the protocol
Dispense investigational product according to the protocol
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Prepare emergency use report
Using knowledge of:
 Investigational product (e.g., package insert, report of prior investigations, Investigator's
Brochure)
 Investigational product inventory
 Investigational product accountability
 Investigational product storage
 Packaging and labelling
 Supplemental/rescue/comparator product
 Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
 Accountability records
II.
Protocol (13%)



Evaluate protocol for feasibility
Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC)) with the study protocol
Verify the eligibility of potential trial subjects






Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility
Review protocol during Investigator’s meeting
Execute study per protocol
Recommend and implement protocol amendments
Using knowledge of:
 Protocol development
 Protocol submission and approval procedures
 Clinical trial phase
 Study design characteristics (e.g., double-blind, crossover, randomized)
 Study objective
 Description of procedures
 Amendment submission and approval procedures
 Inclusion/exclusion criteria
 Statistical plan
III.
Safety (16%)






















Assess safety during trial participation
Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Report required adverse events to regulatory authorities and/or IRB/IEC
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Handle medical monitor oversight
Conduct study-related procedures and monitor the safety of the trial subjects and
investigational staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit
progress reports to the IRB/IEC per requirements
Review common laboratory values and alerts
Determine and document the causality of adverse events
Identify expected or unexpected results associated with investigational products
Implement Investigator’s plan of action for management of adverse event (e.g., stop
investigational product; call, retest, treat subject)
Maintain follow-up to determine resolution of adverse event
Report serious adverse event to Sponsor/CRO and IRB/IEC
Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
Record adverse event and relevant information on source document
Document reasons for subject discontinuation (i.e., causes, contact efforts)
Document follow-up medical care for study subjects, as applicable
Conduct safety monitoring/reporting activities
Initiate un-blinding procedures
Using knowledge of:
 Investigator’s Brochure
 Safety monitoring
 Safety and clinical databases
 Subject safety issues (e.g., toxicity, significant lab values)
 Adverse events reporting
 Serious adverse events reporting
 Safety reporting requirements
IV.
Trial Management (58%)


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
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
























Verify investigator/site feasibility
Develop timelines for conducting and completing the clinical trial
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., countryspecific regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare and conduct close-out monitoring visit(s)
Prepare study summary and/or close-out letter for IRB/IEC
Document protocol deviations/violations
Evaluate study for feasibility
Schedule subjects
Obtain informed consent and screen trial subjects
Prepare study documents for IRB/IEC and/or sponsor review/approval
Prepare study documentation (e.g., schedule of events, description of procedures)
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Select the investigational staff and assign roles and responsibilities
Develop a recruitment strategy and site study management plan
Transmit CRFs to Data Management
Review CRF queries from Data Management
Coordinate study monitoring visits
Select and manage local vendors (e.g., laboratory, x-ray, MRI)
Draft study specific tools (e.g., source document, tracking tools)
Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
Conduct subject visits according to requirements
Implement corrective actions plans












Maintain trial master file (e.g., regulatory binder)
Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
Maintain standards for handling hazardous goods (e.g., IATA)
Manage study supplies (e.g., lab kits, case report forms)
Maintain equipment (e.g., calibration and preventive maintenance)
Manage study record retention and availability
Manage financial agreements
Comply with subject privacy regulations
Pre-screen telephone calls for eligibility requirements
Maintain subject screening/enrollment log
Collect, record, and report accurate and verifiable data
Manage study issues
Using knowledge of:
Site Activities
 Contract budget negotiations and approval process
 Monitoring guidelines/plan and tools
 Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab
kits)
 Equipment and supplies (e.g., x-ray, computer, lab kits)
 Equipment and supply storage
 Pre-study site visit
 Investigator's meeting
 Site initiation
 Monitoring visit
 Close-out visit
 Site monitoring visit log
 Site signature log
 Delegation listing
 Trial master file (e.g., site, sponsor)
 Regulatory documents
 Record retention
 Visit reports (e.g., initiation, close-out)
 Final report
 Progress reports
Protocol Compliance
 Project feasibility
 Study project tools
 Sample collection, shipment, and storage
 Study management plan (e.g., timelines, data management)
 Good Clinical Practice
 Procedure manuals
 Protocol deviations
Subject Scheduling, Screening, Recruitment, and Retention
 Project timelines
 Recruitment plan/strategies
 Subject compliance
 Subject visit logistics
 Subject selection, screening, and recruitment
 Subject retention
 Subject discontinuation
 Clinical trial registry
PI Oversight/Qualifications
 Staff qualifications
 Staff roles and responsibilities
 Plan for staff oversight
 Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
 Plan for ancillary staff education
CRF/Source Documents
 Data management activities
 Communication documentation (e.g., telephone, email)
 Data management plan
 Data query resolution
 Electronic data (e.g., electronic health records, electronic case report forms)
 Case Report Form
 Essential documentation, subject related and non-subject related (e.g., past medical
records, lab reports, protocol, IRB approvals)
 Source documentation
Consent/Assent
 Vulnerable subject populations
 Communication with subjects
 Protection of human subjects
 Subject reimbursement
 Subject privacy regulations
 Informed consent
 Indemnification/insurance
V.
Trial Oversight (6%)



















Ensure consistency between the sites’ standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation
of slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file
Using knowledge of:
 Issues management (e.g., escalation)
 Audit preparation
 Regulatory standards
 Audit documents
 Project monitoring guidelines
 Project investigator supervision requirements
Detailed Content Outline (DCO) for the Certified Principal Investigator
The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
Principal Investigators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This survey is
conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to reflect any
changes in practice.
Each question on the exam is based on this outline. Therefore, to prepare to take the exam, one should study
this outline and especially consider the underlying knowledge, skills, and abilities needed to perform as a clinical
research coordinator. To be certified, a PI is expected to have proficiency in five (5) core knowledge areas
found on the Detailed Content Outline (DCO) for their respective Exam.
Note: The percentage of questions allocated to each of the five (5) core knowledge areas is noted within the
DCO.
Certified Principal Investigator (CPIs) shall have proficiency in:
I.
Investigational Product Management (5%)










Ensure adequacy of investigational product and other supplies at site
Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and
other supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Prepare investigational product according to the protocol
Dispense investigational product according to the protocol
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Prepare emergency use report
Using knowledge of:









Investigational product (e.g., package insert, report of prior investigations, Investigator's
Brochure)
Investigational product inventory
Investigational product accountability
Investigational product storage
Packaging and labelling
Product Development
Supplemental/ rescue/ comparator product
Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
Accountability records
II.
Protocol (10%)


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
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




Review product development plan
Identify study objective/design
Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety
and efficacy parameters)
Evaluate protocol for scientific soundness
Evaluate protocol for feasibility
Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC) with the study protocol
Verify the eligibility of potential trial subjects
Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility
Review protocol during Investigator’s meeting
Execute study per protocol
Recommend and Implement protocol amendments
Using knowledge of:
 Protocol development
 Protocol submission and approval procedures
 Clinical trial phase
 Study design characteristics (e.g., double-blind, crossover, randomized)
 Study objective
 Description of procedures
 Amendment submission and approval procedures
 Inclusion/exclusion criteria
 Statistical plan
III.
Safety (25%)











Assess safety during trial participation
Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Report required adverse events to regulatory authorities and/or IRB/IEC
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Handle medical monitor oversight
Ascertain the safety and expected therapeutic effects of the investigational product by verifying
the preclinical and clinical research done so far (using the investigator brochure)
Conduct study-related procedures and monitor the safety of the trial subjects and
investigational staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit
progress reports to the IRB/IEC per requirements












Review common laboratory values and alerts
Determine and document the causality of adverse events
Identify expected or unexpected results associated with investigational products
Implement Investigator’s plan of action for management of adverse event (e.g., stop
investigational product; call, retest, treat subject)
Maintain follow-up to determine resolution of adverse event
Report serious adverse event to Sponsor/CRO and IRB/IEC
Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
Record adverse event and relevant information on source document
Document reasons for subject discontinuation (i.e., causes, contact efforts)
Document follow-up medical care for study subjects, as applicable
Conduct safety monitoring/reporting activities
Initiate unblinding procedures
Using knowledge of:








IV.
Investigator’s Brochure
Safety monitoring
Safety and clinical databases
Subject safety issues (e.g., toxicity, significant lab values)
Vulnerable subject populations
Adverse events reporting
Serious adverse events reporting
Safety reporting requirements
Trial Management (50%)




















Verify investigator/site feasibility
Develop timelines for conducting and completing the clinical trial
Plan and conduct investigator’s meeting(s)
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Review, clarify, and obtain data changes from sites
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., countryspecific regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Develop Case Report Forms (e.g., CRFs, eCRFs)
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare study summary and/or close-out letter for IRB/IEC
Reconcile payments to sites per contract
































Document protocol deviations/violations
Reconcile safety and clinical databases
Arrange site/investigator indemnification/insurance
Evaluate study for feasibility
Schedule subjects
Obtain informed consent and screen trial subjects
Prepare study documents for IRB/IEC and/or sponsor review/approval
Prepare study documentation (e.g., schedule of events, description of procedures)
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Select the investigational staff and assign roles and responsibilities
Develop a recruitment strategy and site study management plan
Transmit CRFs to Data Management
Review CRF queries from Data Management
Coordinate study monitoring visits
Select and manage local vendors (e.g., laboratory, x-ray, MRI)
Draft study specific tools (e.g., source document, tracking tools)
Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
Conduct subject visits according to requirements
Implement corrective actions plans
Verify sponsor indemnification/insurance
Maintain trial master file (e.g., regulatory binder)
Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
Maintain standards for handling hazardous goods (e.g., IATA)
Maintain equipment (e.g., calibration and preventive maintenance)
Manage study supplies (e.g., lab kits, case report forms)
Manage study record retention and availability
Manage financial agreements
Pre-screen telephone calls for eligibility requirements
Maintain subject screening/enrollment log
Collect, record, and report accurate and verifiable data
Comply with subject privacy regulations
Manage study issues
Using knowledge of:











Contract budget negotiations and approval process
Project feasibility
Project timelines
Monitoring guidelines/plan and tools
Study project tools
Staff qualifications
Staff roles and responsibilities
Data management activities
Plan for staff oversight
Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
Plan for ancillary staff education

































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




V.
Sample collection, shipment and storage
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab kits)
Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
Study management plan (e.g., timelines, data management)
Communication documentation (e.g., telephone, email)
Pre-study site visit
Investigator's meeting
Site initiation
Monitoring visit
Close-out visit
Site monitoring visit log
Site signature log
Delegation listing
Trial master file (e.g., site, sponsor)
Data management plan
Data query resolution
Electronic data (e.g., electronic health records, electronic case report forms)
Recruitment plans/strategies
Subject compliance
Communication with subjects
Subject visit logistics
Protection of human subjects
Subject selection, screening, and recruitment
Subject retention
Subject discontinuation
Subject reimbursement
Good Clinical Practice
Regulatory documents
Record retention
Subject privacy regulations
Case Report Form
Visit reports (e.g., initiation, close-out)
Final report
Progress reports
Essential documentation, subject related and non-subject related (e.g., past medical records, lab
reports, protocol, IRB approvals)
Informed consent
Procedure manuals
Source documentation
Protocol deviations
Indemnification/insurance
Clinical trial registry
Trial Oversight (10%)
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
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
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





Ensure consistency between the sites’ standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Oversee vendors (e.g. Contract Research Organizations (CROs))
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation
of slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file
Using knowledge of:






Issues management (e.g., escalation)
Audit preparation
Regulatory standards
Audit documents
Project monitoring guidelines
Project investigator supervision requirements
Appendix II: Resources
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


Candidate Non-Disclosure Agreement
Sample Curriculum Vitae (CV) and Job Description
Abbreviations List
Prometric Testing Center Regulations
Candidate Non-Disclosure Agreement Included in All Applications for
Initial Certification and Maintenance of Certification
By submitting this Certification application, I acknowledge and affirm that the information I have provided herein is
true and correct to the best of my knowledge, I understand and agree that the Academy of Clinical Research
Professionals (the Academy) may require documentation of any information included in my application - including my
academic, continuing education, licensing, regulatory, and employment records - and may determine that I am
ineligible for Certification if I fail to provide that documentation, and I authorize the Academy, Association of Clinical
Research Professionals (ACRP), and Academy of Physicians in Clinical Research (APCR) to access, obtain, and review
my academic, continuing education, licensing, criminal, regulatory, and employment records without limitation. I
hereby authorize all institutions in possession of my academic, continuing education, licensing, criminal, regulatory,
and employment records to release those records and report the contents of those records to the Academy, ACRP, and
APCR. This authorization shall automatically expire three years after this application is submitted, or three years after
the expiration of my Academy Certification following my final Maintenance of Certification cycle, whichever is later.
Further, I agree to hold harmless, waive any and all legal claims against, and indemnify the Academy, ACRP, and APCR,
and their employees, officers, directors, consultants, agents, volunteer members, and vendors, and the institutions
releasing records or reporting their contents to the Academy, ACRP, or APCR.
I hereby authorize the Academy of Clinical Research Professionals (the Academy), Association of Clinical Research
Professionals (ACRP), and the agents, exam delivery providers, vendors, and consultants of the Academy and ACRP, to
make any and all inquiries or investigations to verify my credentials, employment and work experience, criminal
records, academic records, licenses, and professional standing, and by my signature herein I authorize the release of
that confidential information to the Academy, ACRP, its agents, exam delivery providers, vendors, and consultants. I
authorize the Academy and ACRP to use information from my application, demographic information, and subsequent
Certification examination performance, professional development activities, and Maintenance of Certification activities
for any lawful purpose, provided that my personal identification will not be made public. I have read and understand
all of the information provided in the CRA Certification Handbook.
The Academy may suspend or permanently revoke Certification in the event that I do not adhere to or am in violation
of the ACRP/APCR code of ethics. I understand and agree that submitting false, misleading, or incomplete information
may result in denial, suspension, or permanent revocation of Academy Certification, and/or civil or criminal legal
action. I understand that I can be disqualified from taking or completing the examination, or from receiving
examination scores, and may be reported to appropriate legal authorities, if the Academy determines through either
proctor observation or statistical analysis that I was engaged in collaborative, disruptive, or other inappropriate
behavior during administration of the examination. In the event of disqualification, suspension, or permanent
revocation of Certification, I release ACRP, APCR, and the Academy from any liability.
Applicant's Signature:
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
March 11, 2012
DATE MODIFIED
Date:
SAMPLE CRA CV
Sharon H. Johnson, BS, MS
123 Main Street
Capital City, VA 00000
Phone: 434-555-1234
Email: shjohnson@email.com
Education:
Masters of Science, Healthcare Administration, Capital City University, 2001.
Bachelors of Science, Nutrition, The University of Hometown, 1998.
Professional Experience:
Clinical Research Associate
PharmaBuild
Capital City, VA
December 2008 to Present
Responsible for monitoring sponsor initiated and federally funded clinical research studies for normal volunteers and
subjects diagnosed with Endocrinology Diseases.
Specific responsibilities include:
• Lead monitor (CRA) mentoring and supervising other monitor(s).
• Assist in investigator study site selection and study start-up.
• Create clinical project documents according to the protocol, including, but not limited to, source documentation
forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.
• Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with
applicable local requirements and FDA and ICH guidelines.
• Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good
Clinical Practice”, and conduct close-out visits.
• Identify site issues and initiates correction plans based on monitoring reports.
• Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential
documents and reviews them for content, consistency with other documents, and compliance with appropriate
local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor
requirements.
• Verify data in source documents are in agreement with source, initiate data query resolution and confirm
resolution in timely manner.
• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.
• Verify drug accountability logs and storage requirements.
• Responds to requests from investigative sites in a timely fashion.
• Provide study status updates to team members and project management, including interaction to resolve site
issues and facilitate project timelines.
Clinical Research Manager
Bigcity Hospital Research Center
Bigcity, VA
July 2004 to July 2008
Clinical Research Manager for the hospital’s several large multi-center, randomized, double-blind, placebocontrolled clinical trials
Specific duties include:
•
•
•
•
•
•
•
•
•
Assist with the preparation of IRB applications, including protocol and informed consents and obtain
approval to conduct the study.
Maintain appropriate correspondence with the IRB, including adverse events, annual renewals and protocol
amendments.
Create Standard Operating Procedures for each study or clinical trial.
Conduct telephone interviews to determine subject eligibility. Schedule intake appointment to recruit subjects
to study. Obtain informed consent and HIPAA authorization, conduct intake interview, and enroll subjects.
Maintain source documents and regulatory documentation of clinical trial. Ensure quality of data on CRFs.
Monitor health and safety of subjects with frequent contact and ensure subject compliance with the study
protocol.
Present adverse event documentation to Principal Investigator and sponsor where appropriate.
Train, supervise and evaluate clinical research coordinators and research assistant in the performance of their
duties. Update training module and retrain study staff as required.
Create and maintains database of subject information and generates reports and shipments of data to
coordinating center, as needed.
Clinical Research Assistant
General Clinical Research Center
Hometown, VA
August 2001 to May 1994
Assist investigators in the development of the nutrition component of research protocols and in the evaluation of
results; confer with principal investigators and the Advisory Committee regarding dietary aspects of individual
aspects of the specific research diet; provides information of food composition data and balance diet procedures to
physicians, and others involved. Calculate various types of research diets according to the research protocol and
patient's preferences; develops new recipes for highly restrictive and/or specialized diets.
SAMPLE CRA JOB DESCRIPTION
PharmaBuild, LLC
Clinical Research Associate – Lead Monitor
Job Description: Responsible for monitoring the progress of clinical studies at investigator sites and ensuring that
studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs),
ICH-GCP, and all applicable regulatory requirements.
Directly accountable to: Director of Study Management, PharmaBuild
Responsibilities include:
•
•
•
•
•
•
•
•
•
Proactively leading project success, including communicating and working closely with project leaders,
site coordinators, investigators, monitors, data management staff, and data analysts
Participating in the site selection process so as to assure adequate qualifications, training and resources
for the investigative sites
Creating, maintaining, and reviewing monitoring standard operating procedures, monitoring tools for
conducting monitoring tasks including: monitoring plans, monitoring reports, corrective and preventive
action plans
Assigning, coordinating and supervising day-to-day activities of clinical study monitors
Training investigative site personnel on study protocols
Reviewing and approving monitoring reports, tracks ongoing issues and query resolution
Escalating compliance and study issues to Director, Study Management
Working with coordination and data management teams to identify, capture, document and resolve
problems in subject enrollment, study data and study progress
Conducting monitoring visits, as needed, to: assess protocol adherence; conduct source verification;
verify drug accountability and storage requirements; and ensure compliance with regulatory
requirements and AE reporting requirements.
Travel: 20% at study initiation; as needed during study; total employment not to exceed 2100 hours per year.
Skills and Experiences:
•
•
•
•
•
•
•
Undergraduate degree in a clinical, scientific, or related field required
Advanced degree (M.S., M.B.A., PharmD, etc.) preferred
Clinical project management experience required
Monitoring experience required: minimum 2 years
Supervisory experience as monitor – preferred
Substantial experience using computerized information systems, Outlook, Word, Excel, PowerPoint,
CTMS required
Through knowledge of ICH-GCP and awareness of local regulatory regulations regarding drug research is
required
SAMPLE CRC CV
Sharon H. Johnson
99 Canal Center Plaza, #200
Alexandria, VA 22314
Education
(703) 555-1234 (mobile)
shjohnson@email.com
•
University of Hometown, B.S. in Genetics and Cell Biology, May 2005
Research Experience
Hometown Research Center
Hometown, VA
Hometown Community
Clinical Research Center
Clinical Research Coordinator
May 2012 – Present
•
•
•
Clinical Research Assistant
February 2010 – April 2012
•
•
•
•
Bigcity Hospital Center
Washington, DC 00000
Giant Medical Laboratory
Research Intern
June 2008 - January 2010
•
•
•
Conducted day-to-day execution of clinical research protocols including
obtaining informed consent, completing study procedures, and
dispensing, accounting for study drug, and documenting drug
compliance.
Responsible for recruiting prospective research subjects for clinical
trials.
Responsible for clinical communication with central and local IRBs and
maintaining ethical approval for studies, from initial study approval
through study amendments, annual continuations, and finally
termination.
Documented and conducted appropriate correspondence regarding
adverse events, including multiple severe adverse events.
Responsible for clinical tasks including venipuncture, vital signs, body
measurements and ECG.
Working with contracts and budgets with study Sponsors from study
start-up through study close-out.
Assisted with diabetes management tasks insulin dose adjustment,
home blood glucose monitoring, and diet and exercise counseling.
Produced kits for research sample collection and storage in
environments without refrigeration, computers or Internet access.
Responsible for 20,000+ entry database of human tissue samples
including daily intake, processing, diagnostics and sample retrieval.
Worked with other interns in extensive data-mining operation to create
a complete and accurate computer database of all extant research
patients and samples since 1988.
SAMPLE CRC JOB DESCRIPTION
Hometown Research Center
Clinical Research Coordinator
Job Description: Responsible for safe and effective implementation of clinical trial protocols and ensuring that protocols
are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP,
and all applicable regulatory requirements.
Directly accountable to: Research Manager, Hometown Research Center
Responsibilities include:
•
Assist with the preparation of IRB applications, including protocol and informed consents and obtain
approval to conduct the study.
•
Maintain appropriate correspondence with the IRB, including adverse events, annual renewals and
protocol amendments.
•
Create Standard Operating Procedures for each study or clinical trial.
•
Conduct telephone interviews to determine subject eligibility. Schedule intake appointment to recruit
subjects to study. Obtain informed consent and HIPAA authorization, conduct intake interview, and
enroll subjects.
•
Maintain source documents and regulatory documentation of clinical trial. Ensure quality of data on
CRFs.
•
Monitor health and safety of subjects with frequent contact and ensure subject compliance with the
study protocol.
•
Present adverse event documentation to Principal Investigator and sponsor where appropriate.
•
Create and maintains database of subject information and generates reports and shipments of data to
coordinating center, as needed.
•
Prepares documents for review by sponsors, monitors and regulatory authorities, as necessary
•
Participates in meetings with sponsors, monitors and regulatory authorities, as necessary.
Skills and Experiences:
•
•
•
•
•
Undergraduate degree in nursing preferred
Clinical trial experience minimum 1 year
Supervisory experience desirable
Substantial experience using computerized information systems, Outlook, Word, Excel, PowerPoint,
CTMS required
Through knowledge of ICH-GCP and awareness of local regulatory regulations regarding drug research is
required
Certification Exam Abbreviation List Revised and approved October 14, 2014 ADR
Adverse Drug Reaction
AE
Adverse Event
ALT
Alanine transaminase (liver enzyme)
AST
Aspartate transaminase (liver enzyme)
BMI
Body Mass Index
BP
Blood Pressure
BUN
Blood Urea Nitrogen (kidney function test)
C
Celsius
CAPA
Corrective and Preventive Action
CIOMS
Council for International Organizations of Medical Sciences
CK
Creatinine Kinase (muscle enzyme)
CRA
Clinical Research Associate
CRC
Clinical Research Coordinator
CRF
Case Report Form
CRO
Contract Research Organization
CTMS
Clinical Trial Management System
CV
Curriculum Vitae
DCF
ECG
Data Clarification Form
Independent Data Monitoring Committee / Data and Safety
Monitoring Board
Electrocardiogram
eCRF
Electronic Case Report Form
ePRO
Electronic Patient Reported Outcomes
eTMF
Electronic Trial Master File
EDC
Electronic Data Capture
EKG
Electrocardiogram
EMR/EHR
Electronic Medical Record/Electronic Health Record
F
Fahrenheit
FEV1
Forced Expiratory Volume in 1 Second
GCP
Good Clinical Practices
IDMC/DSMB
GI
Gastrointestinal
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
hCG
Human Chorionic Gonadotrophin
HMO
Health Maintenance Organization
IB
Investigator's Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IP
Investigational Product
IRB/IEC
IVRS /
IWRS
LAR
Institutional Review Board/Independent Ethics Committee
Interactive Voice Response System/ Interactive Web Response System
MAOI
Monoamine Oxidase Inhibitor
Revised and approved October 14, 2014 Legally Acceptable Representative
mcg
mmHg
microgram
Millimeters of mercury
NSAID(s)
Non-Steroidal Anti-Inflammatory Drug(s)
PI
Principal Investigator
PK
Pharmacokinetics
PRO
Patient Reported Outcomes
p.r.n.
as needed
QA
Quality Assurance
QC
Quality Control
QTc
ECG / EKG QT interval corrected for heart rate
RBCs
Red Blood Cells
RBM
Risk Based Monitoring
SAE
Serious Adverse Event
SDV
Source Document Verification
SMO
Site Management Organization
SOP
Standard Operating Procedure
SUSAR
Suspected Unexpected Serious Adverse Reaction
TMF
Trial Master File
WBCs
White Blood Cells, or leukocytes
Revised and approved October 14, 2014 Prometric Test Center Regulations
Candidates are required to be professional, civil and respectful at all times while on the premises of the test center. All exams
are continuously monitored by video and audio recording, physical walk-throughs, and through the observation window. The
Test Center Administrator (TCA) is authorized to dismiss you from the test session for a violation of any of the Test Center
Regulations, including exhibiting abusive behavior towards the TCAs or other candidates. If you are found to have violated any
of the regulations during your exam, the TCA is required to notify Prometric and your test sponsor. Prometric, alone or in
conjunction with your test sponsor, shall then take any further action necessary to sanction your conduct, up to and including
invalidation of your test score and/or pursuit of civil or criminal charges.
CONFIDENTIALITY OF EXAM CONTENT/SYSTEMS
 The computer-based test delivery system, tutorial, exam content, and survey are the unpublished, confidential, and proprietary
materials of Prometric and/or your test sponsor.
 Communicating, publishing, reproducing, or transmitting any part of an exam, in any form or by any means (e.g. verbal,
electronic, written, etc.) for any purpose is strictly prohibited.
 ANY reproduction or disclosure will result in the immediate filing of civil and/or criminal charges against you and anyone
directing or conspiring with you.
TEST CENTER PROCESSES
Check-In Procedures/Breaks
 Original, valid (unexpired), government issued photo & signature bearing identification is required in order to take an exam.
Validity and the number of acceptable IDs are predetermined by your test sponsor.
 You will be scanned with a metal detector wand prior to every entry into the test room.
 You will be required to raise your pants legs above your ankles, empty and turn all pockets inside-out and raise shirt sleeves
above your wrists prior to every entry into the test room.
 Exams may have scheduled or unscheduled breaks, as determined by your test sponsor. Each time you leave the test room you
must sign-out.
 The TCA will inform you what is permitted during exam breaks, specifically regarding whether access to your locker, and access
to cell phones and notes within it, is permitted or not. All candidates must inform the TCA before accessing a stored item
during a break, including medicine. Repeated or lengthy departures from the test room will be reported to the test sponsor.
 Upon return from a break, without exception, you must go through all security checks, present valid ID, sign-in and, if required
by the test sponsor, provide a fingerprint to be re-admitted to the test room.
 You must return to your assigned, original seat after any break.
Prohibited Items and Examinee Conduct in the Test Center
 Weapons are not allowed in any Prometric Test Center.
 Unauthorized personal items may not be brought into the test room. Such items include, but are not limited to: outerwear,
hats, food, drinks, purses, briefcases, notebooks, pagers, watches, cell phones, recording devices and photographic equipment.
 Written notes, published materials and other testing aids are strictly prohibited, except where allowed by your test sponsor.
Test center staff will refer to the applicable Client Practices for allowances.
 Only soft ear plugs (with no wires/cords attached) and center-supplied tissues are permitted in the test room.
 Clothing or jewelry items allowed to be worn in the test room must continue to be worn at all times. Removed clothing or
jewelry items must be stored in the locker provided during check-in.
 All materials issued by the TCA must be returned at the conclusion of testing. Used scratch paper must be returned before new
scratch paper will be issued by the TCA during your exam.
 Talking to other candidates in the test room, referring to their screens, testing materials or written notes is strictly prohibited.
Note: Client/test sponsor practice policies shall supersede these regulations if a conflict exists.
Academy of Clinical Research Professionals
Certification Program
Policies Manual
Updated September 2015
Contents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
ACRP/APCR Uniform Code of Ethics & Professional Conduct
Non-Discrimination Policy
Special Accommodations
Eligibility for the Certified Clinical Research Associate (CCRA) Program
Eligibility for the Certified Clinical Research Coordinator (CCRC) Program
Eligibility for the Certified Principal Investigator (CPI) Program
Denial of Eligibility
Grandfathering
Appeals
Exam Administration
Testing Experience Issues
Transfers, Cancellation, No Shows, Refunds and Re‐Examination
Use of the Certification Mark
Discipline and Complaints
Continuing Competency and Maintenance for the CCRC, CCRA and CCTI Program
Continuing Competency and Maintenance for the CPI Program
Name Change
Name Change Request Form
Release of Certificant Information
ACRP/APCR Uniform Code of Ethics & Professional Conduct
The Association of Clinical Research Professionals (ACRP) and the Academy of Physicians in Clinical Research
(APCR) are global organizations committed to promoting excellence and professionalism in clinical research and
pharmaceutical medicine. ACRP and APCR members are engaged in all aspects of discovery, testing,
development and application of drugs, devices and biologics. The scope of their activities encompasses research
and medical practice as well as diverse business activities, regulatory affairs, advocacy, education and other
professional endeavors.
Members and certificants, those who receive certification from the Academy of Clinical Research Professionals
(Academy), affirm their commitment to upholding the highest standards of personal and professional behavior in
the conduct of their endeavors. To file a complaint against a Member or certificant, please email
ethics@acrpnet.org. Complaints will be addressed according to the Discipline and Complaints Policy developed
by the ACRP Ethics Committee.
While pursuing their professional endeavors, all members and certificants shall:
•
•
•
•
•
•
•
•
•
•
•
Be mindful and respectful of the important distinctions between medical practice and research.
Accept ensuring the safety and welfare of human subjects and patients as their highest goal.
Execute their work in accordance with standards of scientific objectivity, accountability and
professionalism.
Continue to advance their knowledge and understanding of the profession through education and
training.
Safeguard the quality and credibility of their professional judgment from inappropriate influence.
Ensure that the principles of respect for persons and the practice of obtaining informed consent are
honored at all times, both in spirit and in practice.
Observe both in spirit and in practice all legal, ethical and regulatory requirements pertaining to
confidentiality of identifiable personal information, relevant records and communications.
Avoid conflicts of interest in their affairs and make full disclosure before undertaking any matter that
may be perceived as a conflict of interest.
Adhere to all relevant ethical standards and practices for responsible conduct of research and medical
practice.
Abide by all applicable laws, regulations and official directives applicable to their professional activities
in the legal jurisdiction(s) in which they work and reside, and respect the prevailing ethical and
community standards.
Abide by the laws and ethical codes of their respective disciplines.
In observance of these principles, ACRP and APCR members and certificants shall be mindful of the following
explanations and guidelines as may be applicable to specific circumstances and practices:
1
Distinctions between Medical Practice and Research
Medical practice seeks to benefit individual patients and public health through prevention, diagnosis and
treatment of disease. Research seeks to advance knowledge through application of the tools of science and
technology. Clinical research depends upon individuals who volunteer to participate as subjects of research
studies. Society can benefit from both research and medical practice when conducted responsibly through the
acquisition of knowledge and the testing and marketing of new as well as older products. Clinical research is an
endeavor in which roles can be easily confused. Treatment is not the same as investigation. The relationship
established between patients and those providing clinical care to them is distinct from that established between
a research participant (or subject) and a member of the clinical research team. Accordingly, the terms patient
and research participant should not be used indiscriminately or interchangeably. Similarly, steps shall be taken
to ensure that the roles and responsibilities of physicians and investigators, especially when they may overlap,
remain clear.
Beneficence and Nonmaleficence
Members and certificants shall strive to benefit those with, for and on whose behalf they work, and take care to
do no harm. Members and certificants shall respect and safeguard the welfare and rights of all individuals with
whom they interact professionally, including but not limited to research subjects. Members and certificants shall
act in the best interest of research subjects, patients and society. When conducting research, members and
certificants shall ensure that potential risks to research participants are minimized and that these risks are fully
evaluated against potential benefits prior to and throughout the research. Members and certificants engaged in
the practice of pharmaceutical medicine shall place the interests, safety and well-being of their patients above
all other considerations.
Research Standards and Objectivity
Members and certificants shall educate themselves, their students and their colleagues about responsible
research practices. Members and certificants shall apply sound ethical values, scientific principles and judgment
in the design, conduct and analysis of clinical studies, and in interpretation of their results. Members and
certificants shall report research findings accurately and shall not misrepresent, fabricate or falsify results. They
shall conduct research in accordance with an approved research protocol. Members and certificants shall make
all research data available for verification in accordance with established standards of the profession. Members
and certificants shall ensure the dissemination only of scientifically sound information from clinical trials and
other investigations, without regard to study outcomes, and shall not withhold information relevant to full
evaluation of the safety, efficacy or utility of agents or devices under investigation for the benefit of medicine,
patients, science and society.
Competence and Advancement of Knowledge
Clinical research professionals and pharmaceutical physicians are committed to being competent in all of their
professional activities, and members and certificants shall strive to achieve the highest level of knowledge, skill
and ability within their capacity. Members and certificants shall maintain knowledge of new developments in
emerging areas of practice and ethical interpretations through professional education and training, including
such activities as reading, courses, professional meetings, peer consultations, supervision and other continuing
education opportunities.
2
Integrity
Members and certificants shall exhibit the highest standards of integrity and be honest, open, objective and
accurate in all of their professional activities. Members and certificants shall not lie, steal, cheat or engage in
fraud, subterfuge, misrepresentation of fact, or partial or delayed disclosure of information in a misleading
manner. Members and certificants shall act honestly and openly in all professional relationships and shall not
participate in, condone or be associated with dishonesty, fraud or misrepresentation. Members and certificants
shall accurately represent their own and their associates’ qualifications, education, experience, competence and
affiliations in all spoken, written or printed communications. Members and certificants shall not fabricate data,
withhold meaningful relevant data, leave significant errors in published data uncorrected, or present portions of
others’ work or data as their own.
Informed Consent
Members and certificants shall, as appropriate for the approved research, obtain informed consent from
individuals who are research subjects using language that is reasonably understandable and clear, informing
research subjects of the purpose of the research, risks and discomforts related to the research, potential
benefits of the research to the subject and/or society, the subjects’ right to refuse or withdraw consent, the
duration of participation and any other information relevant to making an informed decision regarding
participation in a study. Members and certificants also shall provide subjects with an opportunity to ask
questions, which shall be answered completely and truthfully. When potential subjects are not literate or have
difficulty understanding the primary language used, members and certificants shall take steps to ensure
subjects’ comprehension, such as providing subjects with a detailed verbal explanation or arranging for a
qualified interpreter or translator. Individuals who do not comprehend the information provided and voluntarily
agree to participation shall not be enrolled in a study. For persons who are legally incapable of giving informed
consent, members and certificants shall nevertheless provide an appropriate explanation, obtain the individual’s
assent, and obtain appropriate permission from a legally authorized person. When a physician is both researcher
and clinician, he/she shall ensure that any patient understands this dual role and is free from coercion or other
undue pressure to participate in the research endeavors. Consent must be not only fully informed, but also
freely given without restriction.
Privacy and Confidentiality
Members and certificants shall not solicit private information from research participants or patients unless
justifiable and appropriate. Members and certificants engaged in the practice of medicine shall recognize that
information obtained by caregivers from patients is privileged and they shall respect the privacy of their
patients. In medical practice research and business activities, if private information is shared, standards of
confidentiality apply. Members and certificants must take reasonable precautions to protect confidential
information obtained through or stored in any medium, recognizing that the extent of limits of confidentiality
may be regulated by law or established by institutional rules or professional or scientific relationship. Members
and certificants may disclose confidential information, when appropriate, only with valid consent or
authorization, or if otherwise required by law. In all instances, members and certificants shall disclose the least
amount of confidential information necessary to achieve the desired purpose. To the extent that confidential
information is disclosed inappropriate scientific or professional circumstances, it shall be disclosed with
appropriate protections and only to persons clearly concerned with such matters. Written and electronic
3
records and other sensitive information shall be stored in secure locations and shall not be made available to
those who are not authorized to have access.
Conflicts of Interest
At all times, members and certificants shall safeguard the quality and credibility of their professional judgment
from inappropriate influence. Members and certificants shall not exploit any professional relationship to further
personal, political or business interest at the expense of the best interest of clients, research participants,
employers, patients or others. Members and certificants shall avoid dual relationships that could impair
professional judgment or increase the risk of harm to others, such as relationships that are familial, social,
financial, business or close personal relationships with employees, supervisees, students or research assistants.
Members and certificants shall take precautions to avoid conflicts of interests and, when a conflict of interest or
the perception of a conflict cannot be eliminated or avoided, take further steps to protect the affected
individuals and the clinical research enterprise.
Ethics and Responsible Conduct
Members and certificants are committed to involvement in professional endeavors that enhance knowledge,
skill, judgment and intellectual development for the benefit of society. Members and certificants shall be
personally committed to and encourage others to engage in safe, sound research practices consistent with the
relevant ethical and scientific standards. Members and certificants shall cooperate with other professionals as
appropriate and ethical. Members and certificants should consult and advise each other regarding medical,
scientific and ethical concerns, and seek external opinions, as appropriate, in the best interests of clinical study
participants and patients. Members and certificants shall assist those who enter the profession by helping them
to acquire a full understanding of the ethics, responsibilities and needed competencies of their chosen area of
research and practice.
Duties to Society and Compliance with the Law
Clinical research professionals and pharmaceutical physicians have a duty to society as a whole. Members and
certificants should be aware of their place in society and develop ways to help the profession contribute to the
betterment of society. ACRP members and certificants must uphold the profession’s responsibility to society by
promoting the highest ethical and practice standards in the profession and by supporting measures to maintain
accountability. Members and certificants should strive to understand and respect differences in values across
cultures and to appropriately adapt behaviors while maintaining ethical principles. Members and certificants
shall not participate in criminal or fraudulent activities. If faced with an apparent conflict between abiding by a
law or regulation and following an ethical principle, unless in an emergency, members and certificants shall
consult with colleagues and seek consensus as to the most ethical course of action in the most responsible,
knowledgeable, effective and respectful way to carry it out. Members and certificants shall not advocate,
sanction, participate in or cause to be accomplished, or condone any act that is prohibited by this Code of Ethics,
unless doing so would be seriously detrimental to the rights and well-being of others.
4
Duties to Professional Discipline and Beneficiaries of Practice
Whenever members and certificants maintain a medical or clinical license, or otherwise participate in clinical
practice, additional laws and ethics that do not pertain to research apply. Members and certificants shall, in
addition to adhering to this Code of Ethics, abide by their respective discipline’s laws and ethical standards
pertaining to their practice so that first priority is always given to the well-being of patients or other
beneficiaries who use pharmaceutical products or medical devices, or who receive any other clinical services in a
practice setting. Additionally, members and certificants whose efforts indirectly aid the practice of medicine
shall ensure that all contributory information is fair, balanced, accurate, comprehensive and easily accessible to
all so that well-informed decisions about the use of pharmaceuticals, medical devices or other clinical services
can be made by their beneficiaries and their providers.
©2012 Association of Clinical Research Professionals and the Academy of Physicians in Clinical Research
5
Non-Discrimination Policy
Approved June 2012
PURPOSE:
To state the ACRP policy against discrimination of members, certificants, and applicants for
membership or certification.
SCOPE:
This policy is applicable to ACRP and its affiliates—Academy of Physicians in Clinical Research (APCR)
and the Academy of Clinical Research Professionals (Academy).
POLICY:
ACRP, APCR, and the Academy shall not discriminate against any member, certificant, or individual
applying for membership or certification on the basis of gender, race, color, national origin, sex, age,
religion, marital status, sexual orientation, political affiliation, citizenship status, physical challenge,
disability, veteran status or any other status or condition that is protected by applicable law.
DEFINITIONS:
None.
MONITORING AND REVIEW SCHEDULE:
Monitor as needed and review every three years by the applicable Boards of Trustees.
DATE APPROVED:
DATE LAST MODIFIED:
6
PolicyonSpecialAccommodations
In compliance with the provisions of the Americans with Disabilities Act (1990) and Title VII of the Civil Rights Act, as amended (42 USCG 2000e, et.seq.), the Academy of Clinical Research Professionals (ACRP) provides qualified candidates with a disability, who supply appropriate documentation, reasonable and appropriate accommodations in order for the candidate to take the CCRC, CCRA or CPI exam. The Academy follows the Principles of Fairness set forth by the Institute for Credentialing Excellence. Under the ADA, a disability is defined as “a physical or mental impairment that substantially limits one or more major life activities.” Examples of major life activities include: 






Caring for one’s self
Performing manual tasks
Walking
Seeing
Breathing
Learning
Working
Qualified Candidates with a Disability A "qualified individual with a disability" is one who has a disability and satisfies all the requisite skill, experience, education and other requirements for certification and, with or without accommodations, can perform the essential duties required of his/her job role. A person must be a "qualified individual with a disability" to be protected under the ADA. Reasonable Accommodation Reasonable accommodations provide a candidate with a disability a fair and equal opportunity to demonstrate his/her knowledge and skill in the essential duties being measured by the exam. Reasonable accommodations are decided upon based on the individual's specific request, disability and documentation submitted as well as the appropriateness of the request. Reasonable accommodations do not include steps that fundamentally alter the purpose or nature of the exam. Proper Documentation The candidate must submit documentation provided by an appropriate licensed professional or certified specialist who diagnosed the disability and is recommending reasonable accommodations. The documentation must be submitted on the professional's letterhead. The documentation must provide a diagnosis of the disability and the test(s) used to determine the disability. The professional must also recommend specific accommodations. These recommendations should be based on testing that is not older than 4 years prior to the application. The confidentiality of all documentation submitted by the candidate is protected. Approved10/31/2011
7
Procedure A candidate requesting special accommodations must do so in writing by completing the Request for Special Accommodations Form – Parts 1 and 2 and the request must accompany a completed application for certification. The request must include proper documentation from a licensed professional or certified specialist who diagnosed the disability condition AND the specific testing aids or modifications being requested. Accommodations, if approved, will be provided at no additional charge. The Academy will review the request and provide a response in writing to the candidate along with his/her eligibility determination. If the candidate has been deemed eligible to take the exam, the Eligibility Notice will include the accommodations that have been approved. All special accommodation forms and related documentation are confidential and will not be released without the written consent of the candidate. Documentation Requirements It is the responsibility of the candidate to ensure that all required forms and supporting documentation are submitted to the Academy. A request for special testing accommodations will not be reviewed until all documentation is received. Required documentation includes:  A completed Request for Special Accommodations form. This form consists of two sections—one to be completed by the candidate, and one to be completed by the healthcare professional.  Evaluation of the candidate’s disability, to be completed by the healthcare professional. Note: The healthcare professional must be a licensed or otherwise qualified practitioner whose credentials are appropriate to diagnose and evaluate the specific disability. Candidates requesting accommodations for learning disorders or mental disabilities must be diagnosed by a psychiatrist, psychologist, or other professional with a minimum of a Masters degree, with credentials recognized as competent to diagnose a mental disorder or learning disability.  If the candidate did not receive special accommodations during his/her years of higher education, a written explanation of why accommodations are being requested now is required. This is completed by the healthcare professional. Approved10/31/2011
8
Request for Special Accommodations Form ‐ Part 1 Name: _____________________________________________________________________________ Title: ______________________________________________________________________________ Organization: _______________________________________________________________________ Address: ___________________________________________________________________________ City: ________________________________ State:_________________ Zip/Postal Code: ___________ Country: ____________________________________________ Phone: _____________________________________________ Email Address: _______________________________________ Requests for Special Accommodations MUST be received WITH an application to take the exam – and NO LESS THAN 30 days in advance of the start of the testing window. Please describe your disability: ___________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________ Date disability was diagnosed: ______________________________ Please list any previous accommodations received: Date of Type of Accommodation Received
Accommodation Name of Institution / Organization
Providing Accommodation I understand that the Academy of Clinical Research Professionals (the Academy) will use the information obtained by this authorization to determine eligibility for a reasonable accommodation in regard to the CCRC, CCRA or CPI Examination, by reason of my disability. I understand that the Academy reserves the right to make additional inquiries regarding my disability and previous accommodations before making a determination as to whether to provide the accommodations I have requested above. Under penalty of perjury, I declare that the foregoing statements, and those in any required accompanying documents or statements, are true. I understand that false information may be cause for denial or revocation of certification. I hereby certify that I personally completed the above form, and that I may be asked to verify this information at any time. Candidate Signature: _____________________________________ Date: ____________________ I hereby authorize and request the health care professional identified below to release the information requested by the Academy relating to my disability and the accommodation appropriate to my disability to sit for the CCRC, CCRA or CPI examination. CandidateSignature:_____________________________________Date:____________________
Approved10/31/2011
9
Request for Special Accommodations Form ‐ Part 2 Dear Healthcare Professional: The individual identified above is requesting accommodation to sit for the Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Administrator (CCRA) or Certified Physician Investigator (CPI) Examination. The Academy of Clinical Research Professionals (the Academy) policy requires that candidates requesting special testing accommodation submit current documentation of the disability from an individual qualified to assess the disability. The individual listed above is requesting that you provide such documentation. The following must be completed by you: 1) The remainder of this form (Part 2) 2) An evaluation, on professional letterhead, that includes the following information (if submitting an existing report, it must have been written within the past 4 years): a. Confirmation of diagnosis and functional impairment o Date (month/day/year) of first consultation o Date (month/day/year) the individual was last seen by you o Diagnosis, summary history, and course of the disability o Individual’s current functioning and limitations in major life activities o For learning disabilities or mental disorders, the DSM classification of the diagnosis (Diagnostic and Statistical Manual of Mental Disorders–IV TR). Notes: DSM classification does not guarantee classification as a disability under ADA, and therefore, does not guarantee accommodation by CFRE International; CFRE International will not accept a diagnosis of Learning Disorder that was made before the individual was 18 years old, if the last diagnosis date is more than 3 years old. o Diagnostic tests administered, scores, and interpretation of scores. o Confirmation of treatment o Name and title of the professional o Duration of treatment o Outcomes of treatment o Recommended Accommodation b. The healthcare provider’s specific recommendation for accommodation(s) that directly relates to the impairment, and is supported by functional information in the evaluation. The file is considered incomplete if this specific recommendation is not included. c. If the individual did not receive any special accommodations during years of higher education, please provide a written explanation for why accommodation is now being requested for this examination. This should be on a separate page and attached to this form. Approved10/31/2011
10
Academy of Clinical Research Professionals
Policy on Eligibility for the Certified Clinical Research Associate (CCRA) Program
POLICY
All applicants for the Certified Clinical Research Associate (CCRA) program must meet all of the eligibility
requirements stated in the CCRA Candidate Handbook and on the application form itself in order to be approved
to take the CCRA examination.
Applicants are required to submit both
1) a copy of a current curriculum vitae (CV) or resume and
2) a copy of job descriptions for each of those positions used to demonstrate eligibility
with enough detail so as to sufficiently document and demonstrate achievement of the required minimum
number of hours of employment performing the Essential Duties of a Certified Clinical Research Associate.
The CCRA Essential Duties are defined as:
 Verify that the research site personnel, including the investigators, are conducting the study according
to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;

Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;

Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents
(source data verification);

Review accuracy and completeness of site records (site study file, query resolution, and other data
collection tools);

Verify Investigational Product accountability;

Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial
management tracking system);

Conduct routine monitoring visits on behalf of the clinical trial sponsor.

In addition, the CRA must operate independently from the investigative site staff.
Applicants must document a cumulative, minimum of number of hours of employment performing the Essential
Duties, based on his/her highest level of education completed. If the applicant’s experience is within 120 hours
of the requirement, by the first day of the exam window, full consideration will be given toward eligibility.
11
Highest Level of Education Completed
Minimum Hours Performing Essential Duties


Bachelor’s degree (or higher) OR
Registered Nurse (RN)
3,000 hours

Associate’s degree
4,500 hours

Other, such as LPN, LVN, Medical Assistant, Lab
Technician
OR
High School diploma

6,000 hours
The Academy considers applicants who have completed a formal clinical research education program that meets
the following standards to have achieved a valid substitute for 1,500 hours of the required professional
experience performing the Essential Duties.
Acceptable programs must:
 Be at least 216 hours in length and
 Cover content that substantially maps to the topics found on the current CCRA Detailed Content Outline
(DCO) and
 Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation
(CHEA) or be authorized by the appropriate regulatory authority in the country in which the program
operates.
If an applicant submits an application using an educational program as a substitute for 1,500 hours of work
experience performing the Essential Duties, then the following information must be included on the applicant’s
CV and a certificate of completion/transcript must also be submitted:
 Name of school
 City and country in which the school is located
 Program title
 Name of organization that accredits the institution providing the program
 Dates attended (From-To)
The Academy reserves the right to verify any and all employment information submitted on an applicant’s CV
or job description at any time during the process of certification or thereafter. If an applicant is found to have
falsified or misrepresented his/her documentation, it is grounds for revocation of eligibility and/or certification
status.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
12
DATE APPROVED
May 21, 2013
DATES REVIEWED
DATES MODIFIED
May 19, 2015
13
Academy of Clinical Research Professionals
Policy on Eligibility for the Certified Clinical Research Coordinator (CCRC) Program
POLICY
All applicants for the Certified Clinical Research Coordinator (CCRC) program must meet all of the eligibility
requirements stated in the CRCC Candidate Handbook and on the application form itself in order to be approved
to take the CCRC examination.
Applicants are required to submit both
1) a copy of a current curriculum vitae (CV) or resume and
2) a copy of job descriptions for each of those positions used to demonstrate eligibility
with enough detail so as to sufficiently document and demonstrate achievement of the required minimum
number of hours of employment performing the Essential Duties of a Certified Clinical Research Coordinator.
The CCRC Essential Duties are defined as:
• Document adverse events;
• Prepare or review documents submitted to the institutional review board (IRB);
• Protocol review or study procedures planning;
• Participate in conducting subject visits;
• Maintain source documents;
• Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
• Participate in consent process.
Applicants must document a cumulative, minimum of number of hours of employment performing the Essential
Duties, based on his/her highest level of education completed. If the applicant’s experience is within 120 hours
of the requirement, by the first day of the exam window, full consideration will be given toward eligibility.
Highest Level of Education Completed




Minimum Hours Performing Essential Duties
Associates or Bachelor’s degree (or
higher) OR
Registered Nurse (RN)
Other, such as LPN, LVN, Medical
Assistant, Lab Technician
OR
High School diploma
3,000 hours
4,500 hours
The Academy considers applicants who have completed a formal clinical research education program that meets
the following standards to have achieved a valid substitute for 1,500 hours of the required professional
experience performing the Essential Duties.
Acceptable programs must:
 Be at least 216 hours in length and
 Cover content that substantially maps to the topics found on the current CCRC Detailed Content Outline
(DCO) and
14

Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation
(CHEA) or be authorized by the appropriate regulatory authority in the country in which the program
operates.
If an applicant submits an application using an educational program as a substitute for 1,500 hours of work
experience performing the Essential Duties, then the following information must be included on the applicant’s
CV and a certificate of completion/transcript must also be submitted:
 Name of school
 City and country in which the school is located
 Program title
 Name of organization that accredits the institution providing the program
 Dates attended (From-To)
The Academy reserves the right to verify any and all employment information submitted on an applicant’s CV or
job description at any time during the process of certification or thereafter. If an applicant is found to have
falsified or misrepresented his/her documentation, it is grounds for revocation of eligibility and/or certification
status.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
May 21, 2013
DATES REVIEWED
DATES MODIFIED
May 19, 2015
15
Academy of Clinical Research Professionals
Policy on Eligibility for the Certified Principal Investigator (CPI) Program
POLICY
All applicants for the Certified Principal Investigator (CPI) program must meet all of the eligibility requirements
stated in the CPI Candidate Handbook and on the application form itself in order to be approved to take the CPI
examination.
Applicants are required to submit documents, as outlined below, to demonstrate that he/she has served as a
Principal Investigator or sub-investigator for clinical trials for at least two (2) years of the past five (5) years with
enough detail so as to sufficiently document and demonstrate achievement of the required minimum
experience performing the Essential Duties of a Certified Principal Investigator.
The CPI Essential Duties are defined as:
 Responsible for the safe and ethical conduct of a clinical trial;
 Evaluates the study proposal and decides on participation;
 Facilitates or verifies formal approvals according to regulatory requirements and International
Conference on Harmonisation (ICH) Good Clinical Practice (GCP);
 Ensures that all site initiation activities are performed to start and conduct the study;
 Participates in the selection of trial subjects according to the recruitment strategy;
 Performs or supervises the conduct of study-related procedures and monitors the safety of the trial
subjects and investigational staff;
 Collects accurate and verifiable data and other essential study documents;
 Ensures compliance with regulatory requirements and ICH GCP, the protocol and the handling of the
investigational product;
 Communicates with subjects, sponsor’s personnel, and Institutional Review Board
 Ensures adequate close-out of the study
Applicants must document experience performing the Essential Duties during at least two (2) out of the
most recent five (5) years by submitting copies of at least one (1) of the following documents for two (2)
separate twelve-month periods out of the most recent five (5) years.
Requirements
Education
Experience
Documentation to be Submitted
 Doctorate level degree (DDS, MD or equivalent degree such as DO, MBBS or
MBChB, PhD, PharmD) OR DNP, licensed Physicians Assistant, etc.)
 CV must reflect name of educational institution, location (city, country), title
of degree and date awarded.
For at least TWO (2) of the most recent five (5) years:
 1572 / PHS 398 / QIU (or equivalent) OR
 IRB/IEC approval letter to conduct the study OR
 Protocol approval letter for the study OR
 Notarized statement from a Program Director indicating your role as the
principal or sub investigator, medical monitor or designer of a trial OR
 Signed copy of an investigator agreement/protocol signature page OR
 Other regulatory authority document verifying your role as a Principal
Investigator or sub-investigator on the clinical trial being submitted in support
16
of eligibility
Any proprietary details may be blocked out.
The Academy considers applicants who have completed a formal clinical research education program that meets
the following standards to have achieved a valid substitute for one (1) of the required two (2) years of
professional experience performing the Essential Duties.
Acceptable programs must:
 Be at least 216 hours in length and
 Cover content that substantially maps to the topics found on the current CPI Detailed Content Outline
(DCO) and
 Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation
(CHEA) or be authorized by the appropriate regulatory authority in the country in which the program
operates.
If an applicant submits an application using an educational program as a one (1) of the required two (2) years of
professional experience performing the Essential Duties, then the following information must be included on the
applicant’s CV and a certificate of completion/transcript must also be submitted:
 Name of school
 City and country in which the school is located
 Program title
 Name of organization that accredits the institution providing the program
 Dates attended (From-To)
The Academy reserves the right to verify any and all employment information submitted on an applicant’s CV or
job description at any time during the process of certification or thereafter. If an applicant is found to have
falsified or misrepresented his/her documentation, it is grounds for revocation of eligibility and/or certification
status.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
May 14, 2013
DATE APPROVED
June 30, 2014
17
Policy on Denial of Eligibility
(Approved March 2012)
All applicants who seek eligibility to take one of the Academy’s certification exams, the Certified
Clinical Research Coordinator (CCRC®), Certified Clinical Research Associate (CCRA®), or the
Certified Physician Investigator (CPI®), must satisfy the minimum eligibility requirements as
outlined in the appropriate candidate handbook for each designation. Applicant eligibility is
reviewed individually. Each applicant is automatically afforded review by three separate
reviewers, if necessary, during the eligibility review process.
Eligibility for approval to take an Academy certification exam may be denied when any part of the
application and/or disclosure statement is incomplete, illegible or does not contain the correct
fees.
Eligibility for approval to take an Academy certification exam may also be denied when an
application purporting to represent and demonstrate how the applicant meets the established
eligibility requirements is found to be incomplete, and/or does not substantiate or properly
demonstrate the applicant’s achievement of the minimum eligibility requirements.
When any application for eligibility to take an Academy certification exam is denied, the applicant
will be notified in writing, typically via email, and given seven (7) business days to correct and
submit that which is necessary to properly complete the application process and verify minimum
eligibility requirements as outlined in the Academy’s certification handbooks.
If time permits and all documentation is in order, the candidate’s application will be processed
and eligibility granted for the examination window originally requested by the candidate. Should
this process take the applicant within three (3) business days of the start of the examination
window he/she requested, the candidate will be granted eligibility for the next available
examination window.
Regardless of the items the candidate must supply, or the time line in which materials are
submitted, the candidate’s application may only be transferred forward to the next examination
window once, based on the examination window for which the candidate originally applied.
If the applicant cannot supply appropriate and sufficient eligibility documentation or an eligible
candidate does not take the examination by the start of the next examination window, he/she will
forfeit all fees. The applicant will need to reapply and submit all current fees in order to be
consider again for eligibility.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
18
March 11, 2012
DATE MODIFIED
19
Policy on Grandfathering As is often common practice, when the Academy certification programs were established in the mid 1990’s, a cadre of dedicated volunteers participated in the development and creation of the first certification exams. Because they had created the first sets of questions, these volunteers would have had an unfair advantage if they had taken the exam they helped developed. In recognition their work, these individuals were granted certification status on the basis of the work they did. This grandfathering process was permitted one time only at the start of each of the Academy’s programs (CRC, CRA, PI) and has not occurred since. After a period of time after having been grandfathered into the certification program, each individual was given the option of surrendering their designation or proceeding forward by maintaining their certification in accordance with applicable policies and requirements. All individuals permitted to carry the designation through grandfathering have since complied with all applicable maintenance of certification requirements. The Academy does not permit the grandfathering of certification designations for any purpose. All candidates must meet the same eligibility criteria and pass the same exam to earn the credential applicable to their job role, clinical research coordinator (CRC), clinical research associate (CRA) or principal investigator (PI). DATE APPROVED December 20, 2014 DATES REVIEWED DATES MODIFIED
Policy on Appeals
The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and accurate
decisions based on the information provided by the applicants and certificants. An appeal procedure is available
to those who wish to contest any adverse decision affecting his or her application or certification status. Any
individual who does not file a request for an appeal within the required time limit shall waive the right to appeal.
The Academy will review appeals of adverse certification decisions from Academy certified individuals
(“certificants”) and applicants for Academy certification (“applicants”).
Candidates are permitted to appeal an adverse certification decision on the grounds that the Academy did not
properly apply specified certification eligibility criteria or the decision was based on a factual error that affected
the outcome. Adverse certification decisions include: denial of eligibility for initial certification, denial of
maintenance of certification, suspension of certification or revocation of certification.
No appeal may be taken from an adverse decision based on an individual’s receipt of a failing score on an
Academy certification examination absent extraordinary circumstances, as determined solely by the Academy.
Individuals cannot appeal (1) the passing score or actions taken in setting a passing score; (2) establishment of
eligibility criteria; (3) individual test items; and (4) test content validity.
Privileged Information, including the nature, format, content and results of examinations administered by the
Academy are considered privileged information. Due to the importance of exam security and item banking,
neither exam forms nor answer keys will be disclosed or made available for review by candidates or any other
unauthorized third party.
Appeal Process
Upon receipt of the notice of an adverse decision, the applicant or certificant has the option to submit a written
notice of appeal to the Academy no more than fifteen (15) days following notice of the adverse decision.
In the written appeal, the applicant or certificants shall detail the nature of the request for appeal and the
specific facts and circumstances supporting the request, and, all reasons why the action or decision should be
changed or modified. The applicant or certificant must provide additional written, factual documentation to
support his/her appeal. The applicant shall bear the burden of proving the adverse decision was based on
erroneous factual determination. There is no appeal on the basis of an incomplete application.
Applicants or certificants submitting a request for review to the Academy shall receive notification of the results
within fifteen (15) days of receipt of the request. Should the candidate not be satisfied with the decision
rendered, the candidate may submit a written appeal to the Academy within fourteen (14) days.
The Academy will review the appeal submission and accompanying documents and make a determination.
Candidates will be notified of the Academy’s decision within forty five days (45) of receipt of the request. The
Academy’s decision is final.
This policy does not apply to certificants who have had their certification or recertification denied, suspended or
revoked for fraud, misrepresentation, violation of testing procedures or other conduct in violation of the ACRP
Uniform Code of Ethics and Professional Conduct. Such candidates may have their case processed through the
appeal rights described in the Discipline and Complaints Policy.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
October 31, 2011
DATE MODIFIED
October 14, 2014
Policy on Exam Administration
PURPOSE:
Establish consistent, standardized procedures for exam administration to ensure fairness to candidates and to
protect the integrity of the certification exams.
SCOPE:
All Academy exams are offered via a secure, computer-based testing network of testing centers through a
contract with a testing provider. Test centers must provide a secure and standardized testing environment, as
well as secure encrypted delivery of exams. All exam administrations shall be conducted in accordance with
policies and procedures established by the contracted testing vendor to ensure the security of the exam,
fairness in the testing environment, and to minimize potential for misconduct during the exam.
Information for applicants regarding what to expect during the examination process will be published and easily
accessible.
LANGUAGE:
Academy certification exams are provided in the English language.
Exam candidates whose first language is not English may bring into the testing center an English‐
German/Spanish/Dutch/Italian/etc. strict translation (word-to-word) dictionary to the exam. The dictionary will
be inspected by the proctor prior to and after the exam is completed. Any attempt to compromise the exam will
be grounds for immediate dismissal from the site, invalidation of the exam score, and possible legal action.
ACCOMMODATIONS:
The Academy is committed to ensuring that no individual with special needs or a disability is deprived of the
opportunity to take an exam solely by reason of that disability. The Academy will provide reasonable
accommodations for candidates with disabilities in accordance with its Policy on Special Accommodations.
Procedures and forms for requesting special accommodations will be published and available to all applicants.
SCORE REPORTING
Candidates will receive a score report immediately following the examination. Information on how the score
should be interpreted will be published and available to all applicants.
Candidates will receive proficiency indications for each main content area of the exam. This information is
intended to assist candidates in directing their study should they need to retake the test.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
October 14, 2014
DATE MODIFIED
Academy of Clinical Research Professionals Policy on Testing Experience Issues POLICY All of the Academy’s certification exams are administered via a network of computer‐based testing centers. These centers are administered by the Academy’s contracted testing partner and administer a wide variety of tests. Very rarely do any issues arise at the test center that may be perceived as having a negative effect on a candidate’s performance. However, the Academy takes these issues very seriously. In order for the Academy to be able to investigate any problems thoroughly, all issues must be reported to the Testing Center Administrator (TCA) before leaving the test center. Issues can be reported on the exam exit survey but must be brought to the attention of the TCA during the exam/before leaving the test center. Problems reported later than the day of testing will not be considered. Technical Issues The Academy expects a candidate to be responsible for immediately notifying the proctor at the testing center should the candidate believe there to be a technical problem with the computer or related equipment during their exam. It may be possible for the TCA to resolve the program and restart the candidate’s exam or reschedule the candidate for later the same day. Any complaints regarding technical issues should be reported immediately and must be reported to the Testing Center Administrator (TCA) before leaving the testing center. The candidate must also report the issue to the Academy the same day. If it is over a weekend, a voice mail or email message must be sent to the Academy on same day the candidate tested. The Academy will investigate all reported technical issues and report back to the candidate within two (2) weeks of receiving the report. Based on the results of the investigation of the reported issue, the Academy may choose to offer a subsequent opportunity to retest. Disruptive Issues Candidate should expect an environment suitable to testing but should also understand that they will be testing with other individuals who may be taking exams of varying length or requiring use of the keyboard. Noise cancelling headphones are available to each candidate, upon request, at the testing center. Should there be a disruption that the candidate believes is affecting his or her performance on the exam, the situation should be reported to the TCA immediately. Should the candidate believe that his or her performance is hindered by the disruption, the candidate may choose to end the test and inform the TCA of the reason. The candidate must also report the issue to the Academy the same day. If it is over a weekend, a voice mail or email message must be sent to the Academy on same day the candidate tested. The Academy will investigate all reported disruption issues and report back to the candidate within two (2) weeks of receiving the report. Based on the results of the investigation of the reported issue, the Academy may choose to offer a subsequent opportunity to retest. 22
Candidate requests for a review of the fairness or accuracy of an exam due to equipment or software failure, or disruptive conditions in a testing center, shall result in the Academy working with its testing vendor to review relevant incident or discrepancy reports, technical data and analyses. Exam Content Candidates who have an issue with a particular test question are welcome to put their concerns in writing to the Academy. Such information will be shared with the appropriate exam committee. However, given the security of the exam, the candidate will not receive any response regarding the content of the question, the correct answer, or the rationale for the item. Candidates are permitted to appeal the appropriateness of content on the exam through its Policy on the Appeal of Denial of Eligibility but cannot be granted access to test questions or an answer key. MONITORING AND REVIEW SCHEDULE Monitor as needed and review every three years. DATE APPROVED December 17, 2013 DATES REVIEWED DATES MODIFIED 23
Academy of Clinical Research Professionals Policy on Transfers, Cancellation, No Shows, Refunds and Re‐Examination POLICY When an applicant is granted eligibility to take an Academy certification exam, that eligibility is granted for the exam period for which application was made. All eligible candidates are expected to schedule an exam appointment for, and take the examination during, the exam period for which eligibility was granted. The Academy does recognize that occasionally circumstances may prevent a candidate from testing in the originally scheduled exam period, or may require the candidate to retake the examination. Under certain circumstances, the Academy will grant eligibility for one additional exam period beyond the original period for which the candidate has applied. Transfers If a candidate is unable to test during the exam period for which he or she was originally approved, the candidate may request a one‐time transfer to the next available exam period at no additional cost. Transfer will only be made to the next available exam period. The transfer request can be made at any time between the time of initial approval and the last day of the exam period. The candidate must request a transfer by completing the Exam Transfer Request form. The candidate must cancel any previously scheduled appointments with the testing agency in order to take advantage of this option. Candidates are allowed one transfer only. If a candidate has already transferred the exam one time, the candidate will not be able to do so again. Transfer of eligibility and associated fees will be applied only to the original candidate and are not transferable to another person, even if paid for by a third party. Exam fees transferred may be used only toward the next exam and not toward other products or services. No Testing Appointment Scheduled If a candidate does not schedule an appointment for, or take, the exam in the original exam period for which he or she was approved, and the candidate does not request a transfer before the close of the original exam period for which he or she was approved, the candidate will not be refunded the exam fee. Candidates will need to submit a new application, together with all current fees, to continue their pursuit of certification. Such reapplications will be subject to all eligibility criteria in effect at that time. Exam Cancellations Occasionally, a candidate intends to test but circumstances prevent him or her from doing so. Candidates are permitted to cancel a scheduled exam up to five (5) days before the scheduled appointment by contacting the testing agency directly. Based on how far in advance the candidate cancels the scheduled appointed, there may be fees associated the appointment cancellation. It is mandatory that the candidate cancel their exam with both the testing agency and with the Academy. Candidates are to contact the testing agency directly first and then must contact the Academy. Only the candidate may request a cancellation, regardless of whether the exam fee was paid by the candidate or another party. 24
Cancellation requests received fewer than five (5) calendar days prior to a scheduled exam appointment will not be honored. Once an exam appointment is cancelled, a candidate may be eligible to request a Transfer to the next exam period. No Shows If a candidate schedules an exam appointment and fails to take the exam, he or she forfeits all fees. If a candidate arrives late for a scheduled exam appointment, entrance to the testing area is at the discretion of the Test Center Administrator. A candidate may not be allowed to test and will not be eligible for a refund. Refunds will not be given for exams that are missed because a candidate was not able to locate the testing center or arrived late. Emergencies If a candidate is unable to keep his or her exam appointment due to an emergency situation that arises within the five (5) days prior to his or her exam appointment, the candidate is required to submit an Emergency Cancellation Form and official documentation to the Academy in order to avoid forfeiting fees. This information must be received by the Academy within seven (7) calendar days after the candidate’s scheduled exam appointment. The following situations will be considered with documentation:  Emergency room visit or hospitalization  Severe medical condition requiring hospitalization (e.g., spouse, child/dependent, parent, grandparent, sibling)  Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)  Jury duty  Call to active military duty Refunds If a candidate must cancel an exam appointment and is eligible to transfer his or her eligibility to the next exam period, the candidate may instead elect to receive a refund of exam fees. The only portion of the total amount submitted that will be refunded is the exam fee, provided that the request for cancellation is received at least five (5) calendar days prior to a scheduled exam appointment and the exam appointment has been cancelled . Application fees are non‐refundable. Refunds are not available to candidates who do not schedule an exam and fail to request a transfer, who cancel within five (5) days of the exam and do not provide sufficient documentation of an acceptable emergency, or who fail to show up for a scheduled exam appointment. Refund requests will be considered only if made by the candidate. Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the final ineligibility notification. Refund requests can be made by the candidate only. Employers supporting a candidate’s fees cannot request a refund for fees paid to the Academy. Any refund will be sent to the party who initially made payment to the 25
Academy. If payment was made by credit card, that card will receive the credit. If the payment was made by check, the Academy will mail a refund check to the original payer. Re‐Examination Candidates who do not achieve a passing score on the certification examination will be allowed to re‐take the exam in the next available exam period only without submitting a new application for a reduced re‐examination fee. If the candidate is not successful on this “re‐take” examination, he or she will need to complete a new application and pay all fees in place at the time for any subsequent exams. If a candidate chooses to transfer his or her first exam opportunity and, subsequently, does not pass, he or she will need to complete a new application, meet all eligibility criteria in effect at that time, and pay all fees in place at the time for any subsequent exams. Candidates who do not achieve a passing score on their second attempt or who are unable to test again during the next exam period must submit a new application, together with all current fees, to continue their pursuit of certification. Such reapplications will be subject to all eligibility criteria in effect at that time. MONITORING AND REVIEW SCHEDULE Monitor as needed and review every three years. DATE APPROVED December 17, 2013 DATES REVIEWED DATES MODIFIED 26
Policy on Use of the Certification Mark
Approved March 2014
PURPOSE:
To state the Academy policy regarding appropriate use of the certification designations awarded by the
Academy of Clinical Research Professionals (Academy).
SCOPE:
This policy is applicable to all individuals certified by the Academy of Clinical Research Professionals
(Academy).
POLICY:
The Association of Clinical Research Professionals (ACRP), and its affiliate the Academy of Clinical
Research Professionals (Academy), offer four (4) programs to certify various job roles within the clinical
research industry. They are:
• Certified Clinical Research Associate (CCRA®)
• Certified Clinical Research Coordinator (CCRC®)
• Certified Clinical Trial Investigator (CCTI®)
• Certified Physician Investigator (CPI®)
ACRP and the Academy, grant limited permission to individuals who have met all of the Certification
eligibility criteria, passed the applicable exam(s), or maintained their certification per the Academy’s
maintenance requirements, and received notification of certification from the Academy to use the
CCRA®, CCRC®, CCTI®, or CPI® designations that have been granted to them.
The CCRA®, CCRC®, CCTI®, or CPI® designations are registered trademarks in the United States, Canada,
and India (CPI® only) and their use is protected by applicable trademark law.
This limited permission allows only individuals who are currently in good standing with the Academy to
use the designations as part of one’s professional title. Proper uses of the designations include:
o Signatures
o Business cards
o Letterhead
o Directory listings
o Marketing materials (e.g. press releases, ads, etc.)
Acceptable examples:
Jane J. Smith, CCRA
John R. Smith, CCRC®
Jane D. Doe, CCRC, RN
John Doe, MD, CPI®
27
Use of the CCRA®, CCRC®, CCTI® , or CPI® designations by individuals who are not currently in good
standing with the Academy (e.g. have not been granted certification, have failed to properly maintain
certification), is prohibited. Improper use of the designations or certification trademarks may result in
disciplinary or legal action.
An Academy credential holder has the responsibility to report the unauthorized use, misuse, or other
violation of this Policy to the Academy in a timely manner. This reporting responsibility includes any
circumstance where the use of an Academy granted certification mark is related to an individual or
organization that is not an Academy credential holder, or where a certification mark is used improperly
by an Academy credential holder.
Suspected improper use of the CCRA®, CCRC®, CCTI®, or CPI® designations should be reported in
writing via e-mail to the Academy of Clinical Research Professionals at: certification@acrpnet.org . A
report of improper use must include a copy of the materials showing the misuse (i.e., copy of a CV,
email signature line, business card, online profile, etc.). The complainant must include his or her name
and contact details when lodging a complaint. However, such information will be held as confidential.
Within seven (7) business days upon receipt of a report of suspected misuse, the Academy will verify
the certification status of the individual reported to have been misusing the designation. If the
individual is currently in good standing with the Academy, the complainant will be notified as such.
If the individual purportedly misusing the designation is not currently certified in good standing with
the Academy, the Academy shall contact the individual through a written letter, via a traceable
method. The letter shall inquire regarding the use of credential and a request made that the
respondent forward any evidence of current certification (copy of certificate or award of certification
letter) to the Academy within 15 days of receipt of the notification. The respondent may also reply
acknowledging the improper use with evidence that corrective action has been taken (i.e., removal of
the designation from business cards, website, CV, etc.). or with an application to take the appropriate
examination to achieve the designation
If no response is received within the stipulated time frame, the Academy shall then request legal
counsel to send a cease and desist letter to the individual, demanding a response and applicable
mandatory corrective action.
If the individual is a current ACRP member, a copy of the cease and desist letter shall be forwarded to
the ACRP Ethics Committee for review regarding possible further action. The ACRP Ethics Committee
will coordinate its review in accordance with the ACRP Discipline and Complaints Policy.
If the individual is not a current ACRP member and does not respond to the letter from legal counsel,
the Academy Board shall receive notice of the failure to respond to legal counsel to determine what
further action is warranted.
DEFINITIONS:
28
None.
MONITORING AND REVIEW SCHEDULE:
Monitor as needed and review every three years by the applicable Boards of Trustees.
DATE APPROVED:
March 9, 2014
DATE LAST MODIFIED:
29
ACRP DISCIPLINE AND COMPLAINTS POLICY
Approved by the ACRP Board of Trustees on December 12, 2011
Endorsed by the Academy Board of Trustees March 2012
Purpose:
Maintain and enforce standards of professional conduct and ethics within the Association of Clinical Research
Professionals (ACRP) for ACRP members and individuals certified by or seeking certification from the Academy of
Clinical Research Professionals (Academy).
Scope:
The Ethics Committee has the responsibility to maintain and enforce standards of professional conduct and
ethics within ACRP and draft position statements on behalf of the Association (see “Ethics Committee” policy in
the ACRP Policy Manual). The committee will review and respond to cases of possible or actual misconduct by
members or certificants and those seeking membership or certification.
The Ethics Committee will investigate violations of the Uniform Code of Ethics and Professional Conduct.
Complaints regarding alleged violations should be reported to ACRP in writing, and should include a detailed
description of factual allegations supporting the charges, and any relevant supporting documentation.
The Ethics Committee will make every effort to follow the time requirements established in this policy.
However, failure to do so will not prevent the resolution of any investigation or action, and discipline may be
imposed at the conclusion of the process even if the timelines set forth herein are not met. Complainants and
individuals who are the subject of the complaint are required to comply with established time requirements.
Time extensions or postponements may be granted for good cause by ACRP.
Information submitted during the complaint investigation and any hearing process is considered confidential,
and will be addressed in a discreet and professional manner by the ACRP staff and volunteers. At the
conclusion of the proceedings, submittals will not be returned.
Procedure:
Initial Complaint Review
Each complaint must contain the following information:
a. The name, address and contact information of the complainant;
b. The name of the individual against whom the complaint is being made, and his or her contact
information, if known;
c. The nature of the complaint, including the factual background and time period involved;
d. The name of other individuals or organizations who may have information regarding the facts set forth
in the complaint; and
e. Any documentary information supporting the complaint.
Complaints will be received and reviewed by ACRP to determine if the complaint will be forwarded to the Ethics
Committee for investigation. Each complaint will be evaluated based on the following:
1) Whether the subject of the complaint is an ACRP member, applicant for membership, certificant or an
applicant for certification.
30
2) Whether the alleged misconduct, if proven, would be a violation of the Uniform Code of Ethics and
Professional Conduct.
3) Whether relevant information concerning the charge is available.
4) Whether the charge appears to be justified considering the proof available.
If it is determined that a complaint should not receive further investigation, the individual submitting the
complaint and the individual who is the subject of the complaint will be notified by letter within 30 days of the
rejection decision, and provided the reason(s) for the determination in writing.
This decision may be appealed to the Ethics Committee. The written request for an appeal must be submitted
within 30 days of the mailing of the rejection letter and must state the reason the rejection decision was
incorrect and specific information in support of the acceptance of the charges. The Ethics Committee will
consider and decide any appeal at the next scheduled Committee meeting. The decision of the Ethics Committee
cannot be appealed.
Review by Ethics Committee
Once a complaint, or appeal of a denial, is accepted:
1) A written notice will be issued to the individual who is the subject of the complaint. The notice will
include:
1) the factual basis of the complaint,
2) a copy of the Discipline and Complaints and Appeal policy,
3) a request to submit a response to the Ethics , and
4) a deadline for the response to be received.
2) The Ethics Committee will investigate the complaint.
Investigation Procedure
The Ethics Committee will review the complaint, any response received by the subject of the complaint, and any
additional relevant information. The subject of the complaint may be present at the hearing to discuss the
allegations directly with the sub‐committee/committee or may be present by telephone.
A hearing date will be scheduled in consultation with all involved parties. The hearing, and any meetings of the
sub‐committee/committee, may be conducted in person or by teleconference, or any other manner in which all
participants can hear each other. Hearing proceedings are not open to the public; however, testimony shall be
recorded, either electronically or via transcription.
If practical, the hearing will be held within 60 days of the acceptance of the complaint. If any parties involved in
the complaint wish to have an attorney or witnesses present at the hearing they must notify ACRP at least 10
days in advance of the meeting date.
Following the hearing, the Ethics Committee will make a decision regarding the complaint. The decision will be
based upon a review of the applicable evidence, the rules and regulations of ACRP, any applicable statues or
regulations promulgated by any state or federal entity or administrative body, the governing documents and
policies of ACRP, and the best interests of ACRP.
31
The complainant and the individual who is the subject of the complaint will be notified of the decision and the
appeals process in writing within 30 days following the hearing.
Disciplinary Actions
Disciplinary actions imposed by the Ethics Committee may include any of the following actions:
1) Decision that the member/certificant/applicant be ineligible for membership, certification or
recertification and/or that an application for membership and/or certification be denied.
2) Requirement that corrective actions be taken by the subject of the investigation.
3) Decision to issue a public or private reprimand.
4) Suspension of membership and/or certification for a period determined by the committee.
5) Revocation of certification and/or membership.
A final decision which imposes discipline shall be published in The Monitor magazine and on the website of
ACRP. This will include a Publication of Decision for Public Reprimands, Suspension and Revocation.
In addition to the foregoing, ACRP may notify appropriate government or professional bodies of any final
disciplinary action taken.
Appeals
Within four (4) weeks from the receipt of notice of a sanction, the affected member/certificant/applicant may
appeal, in writing, any such revocation or decision via certified, return receipt mail or via other traceable carrier
to the ACRP Board of Trustees.
In the appeal, the Member/certificant/applicant shall clearly state the reasons of the appeal. The following are
appropriate grounds for appeal of the decision of the Ethics Committee:
1) There were errors of facts or omissions in the consideration process that would have
significantly changed the outcome of the investigation;
2) The Committee failed to conform to published criteria, policies, or procedures which significantly
changed the likely outcome of the investigation.
Within thirty (30) days of receipt of the appeal, the ACRP Board shall constitute an Appeal Committee to review
the complete record. Within six (6) weeks of its initial constitution, the Appeal Committee will seek to review the
appeal, and issue a recommendation and a report to the ACRP Board regarding the appeal. Within four (4)
weeks of receipt of the Appeal Committee’s recommendation and report, the ACRP Board shall render a
decision, and notification to the appellant, the complainant, if there is one, and all other appropriate parties, as
determined by the Appeal Committee of the ACRP Board, shall be sent via certified, return receipt mail or other
traceable carrier.
The Appeal Committee may only review whether the determination of a violation of the Uniform Code of Ethics
and Professional Conduct , was inappropriate because of the stated reasons in #1 and #2 above.
The appellant may consult with legal or other counsel at any time during the appeal process. The Appeal
Committee may consult legal counsel at any time during the appeal process. The Appeal Committee may, at its
32
sole discretion, permit the appellant to make an oral or a written presentation. The appellant may be asked to
appear in person before the Committee.
The decision of the Appeal Committee shall either affirm or overrule the determination of the Ethics Committee,
but shall not address a sanction imposed by the Ethics Committee. The Appeal Committee can comment on
irregularities in the process (i.e. facts not considered or policies not followed) but they cannot change the
sanction determined by the Ethics Committee.
The decision of the Appeal Committee is binding upon ACRP and the Academy, the
member/certificant/applicant who is subject to the determination, and all other persons. The Appeal Committee
may decide to take one or more of the following actions:
1) Upholding the process and decision carried out by the original Ethics Committee;
2) Overturn the decision of the Ethics Committee and initiating a process to re-investigate the violation;
3) Establishing a new Ethics Committee or discharging certain members.
If the Appeal Committee determines that errors were made in the process that could have significantly changed
the outcome, it may require the investigative procedures to be re-opened and order the process to be modified
to focus on the aspect that was performed incorrectly or incompletely. A new Committee may be established or
Committee members may be discharged depending on the approved recommendations of the Appeal
Committee.
Admission of Guilt
At any point in the investigative or hearing process or appeals period, investigative procedures shall be stopped
and the Ethics Committee shall recommend a sanction to the ACRP Board for approval and notification, if a
member/certificant/appellant who is the subject of a disciplinary investigation admits to having violated the
Uniform Code of Ethics and Professional Conduct. By admission of guilt, the member/certificant/appellant
waives his or her right to a hearing or appeals process.
Voluntary Resignation
If at any point in the investigative or hearing process, the subject of the individual who is the subject of the
complaint voluntarily resigns his or her membership, certification, or application for membership or
certification, the Ethics Committee may choose to continue until it completes the discipline and complaints
process. A voluntary resignation will also be reported publicly, with a statement of the complaint made, and
may be reported to a governmental agency as set forth herein. The individual surrendering his or her
membership, certification, or application shall not be eligible for future membership or certification with ACRP.
33
Academy of Clinical Research Professionals
Policy on Continuing Competency and Maintenance for the CCRC, CCRA and CCTI Program
POLICY
The goal of the Certification process is to ensure, as much as possible, the continuing competence of each
certificant and maintain the professional standard of those engaged in clinical research. There are a number of
professional activities that can contribute to that goal.
The purposes of the Continuing Competency requirements established by the Academy are that CCRCs, CCRAs,
and CCTIs continue to:
• obtain current professional development information;
• explore new knowledge in specific content areas;
• master new clinical research-related skills and techniques;
• enhance approaches to effective clinical research, both within their specified job role and beyond;
• further develop professional judgment;
• conduct clinical research in a safe and ethical manner.
The Academy expects that clinical research professionals engage in lifelong development to maintain and
improve knowledge and skills for competent practice. This includes continuous self-assessment to identify
professional strengths and learning needs, establishment of short- and long-term goals for individual
professional development, and selection of appropriate professional development to meet these goals.
Candidates for Maintenance should choose those professional development activities that provide them with
the most benefit, keeping in mind that the length and rigor of a program contribute to its value. Advance
planning for Professional Development enables candidates to choose more appropriate courses and also to
control expenses more effectively. Professional development programs provide one of the main methods for
keeping up with professional practice.
Maintenance of Certification is required every two (2) years. Each candidate for Maintenance must
demonstrate that he/she meets the current requirements in order to successfully recertify and be permitted to
continue to use the designation.
To successfully maintain Certification, each candidate must submit 24 points as part of the Maintenance
application. At least twelve (12) of those 24 points must come from participation in research-related
professional development programs.
REPORTING PERIOD FOR POINTS
Applicable activities to satisfy the Maintenance requirements must fall within the appropriate timeframe for a
candidate’s maintenance period.
Certification Expiration Date
May 31
November 30
24 Month Reporting Period
June 1 (year 1) – May 15 (year 2)
December 1 (year 1) – November 15 (year 2)
PROFESSIONAL DEVELOPMENT PROGRAM TOPIC AREAS
Candidates for Maintenance can take professional development offerings in two (2) areas:
• Research Topics
• Disease/Bodily System/other Healthcare Topics
RESEARCH PROGRAM TOPICS
For Maintenance purposes, Research Topics are defined those that cover the actual “practice” of clinical
research and follow topics covered on the Detailed Content Outline (DCO) for your designation. These topics
should cover transferrable knowledge and skills, not those specific to your workplace, such as company SOPs or
specific software. Examples of Research Topics include, but are not limited to:
• Trial Management
• Investigational Product Management
• Protocol Development
• Safety
• Human Subject Protection
• Document Management
• Trial Oversight
• Ethics
• Adverse Events
• Informed Consent
• Good Clinical Practice (GCP)
• ICH Guidelines
• Regulatory Issues
• Monitoring
• Statistics
DISEASE/BODILY SYSTEM/HEALTHCARE PROGRAM TOPICS
Disease/Bodily System/Healthcare Topics are those that deal with the prevention, treatment, and management
of illness and the preservation of physical well-being. Training to gain access or query a specific database or
software, even if healthcare related, is not acceptable. Consideration is also given to specific skills that, while not
clinical research or healthcare related, are acknowledged as an advanced set of skills invaluable to the work of
clinical research. These specifically include: project management, grant writing and medical writing.
Courses pertaining to a particular disease are generally considered to be Disease/Bodily System/Healthcare
Topic hours. Examples include, but are not limited to:
• Pharmacology
• Medical devices
• Palliative / Hospice care
• Psychiatry
• Oncology
• Endocrinology
• Cystic Fibrosis
• Results of clinical trial studies
• Advanced Cardiac Life Support (ACLS) (This course is only acceptable once during the lifetime of the
certificant’s Certification tenure.)
For general participation in workshops, seminars, conferences and in-service trainings, points are awarded
according to the actual amount of time spent under instruction at a ratio of 1:1. Forty-five (45) – sixty (60)
minutes of instruction = one (1) education point; one (1) semester credit = fifteen (15) points.
Points are not awarded for sessions that are fewer than forty-five (45) minutes in length but can be pro-rated for
sessions exceeding sixty (60) minutes (i.e., a session one hour and fifteen minutes in length = 1.25 points)
All web-based training to be applied to the requirements must result in a certificate that indicates the number
of hours awarded for successful completion. The Academy cannot determine the number of points for webbased training for a candidate. The Academy reserves the right to request certificates of attendance and/or
transcripts from any and all courses.
Time Spent
Contact Hours
Points on Maintenance
Application
< 45 minutes
No points awarded
0 points
45-60 minutes
1 contact hour
1 contact hour = 1 point
90 minutes
1.5 contact hours
1.5 contact hour = 1.5 points
Activity Awarding CMEs
60 minutes
1 CME
1 CME = 1 point
Course Awarding CEUs
60 minutes
1 CEU
1 CEU = 1 point
University Course
1 semester
1 semester credit
1 semester credit =
15 points
Activity
Professional Development
Session
(non-accredited programs)
ACCREDITED PROFESSIONAL DEVELOPMENT PROGRAMS
It is anticipated that the majority of programs that a candidate for Maintenance of Certification will submit in
support of his/her application will come from programs that have some sort of accreditation. If the program
does not have accreditation from a known accrediting body, the applicant should submit the program for
approval prior to submitting it as part of the Maintenance Application process.
EXAMPLES OF ACCEPTABLE PROVIDERS OF ACCREDITED PROFESSIONAL DEVELOPMENT CONTACT HOURS:
• ACRP
• All state and national nursing associations (e.g. ANCC, CBRN)
• Accreditation Council for Pharmacy Education (ACPE)
• Accreditation Council for Continuing Medical Education (ACCME) (e.g. CME and AMA Category I credits)
• Other national healthcare-related associations offering professional development contact hours
• College/university courses in healthcare and clinical research
• Regulator-sponsored educational programs
• In-company training on research topics with specific learning objectives awarding a certificate/proof of
attendance and specifying the number of hours (SOP training is not acceptable.)
CONTINUING INVOLVEMENT
Continuing Involvement is another area in which a candidate for Maintenance can earn points toward the stated
Maintenance requirements. These are activities other than attending a professional development educational
activity.
Continuing Involvement Activities
CCRC /CCRA/ CCTI applicants may document up to 12 points in this category
from activities listed below. These points DO NOT satisfy the
required points form participation in research-related professional development programs
Continuing Involvement (CI)
Activity
Number of
Points Awarded
Per Activity
Maximum
Points
Allowed in
this Category
Examples of Documentation Required
for Verification
(CI activities are required to be included
on the online Contact History Report or
the Academy’s Activity form)
Professional development
developer or presenter in
clinical research or related
topic (to both research and
non-research audiences)
2
8
Copy of program with
speakers and objectives or presentation
abstract including organization, location
and dates (this is not required for
speakers at ACRP’s Global Conference)
Authorship of journal paper
on clinical research (cannot be
self-published)
2
8
Journal citation including
Authors
Participate in or present at
investigator meeting (inperson or virtual) or an
initiation visit, if in lieu of an
investigator meeting
2
4
Documentation of meeting date, time
and proof of participation/presentation
Active Participation in a
Regulatory Meeting (does not
include an audit)
2
4
Proof of attendance
Involvement in a New
Marketing Application Process
(specifically compiling a
specific section or writing a
clinical study report)
2
4
Supervisor documentation of role in
specifically compiling a specific section
or writing a clinical study report
Authorship of protocol (sole or
co-authorship)
2
4
Supervisor documentation of role
Inclusion on 1572 or
equivalent regulatory
authority document as an
active investigator or sub-I
2
4
Copy of 1572 (both sides) or equivalent
regulatory authority document
Service as a peer reviewer of
scientific articles
4 per 12months of
service
8
Confirmation of appointment as a peer
reviewer that includes dates
Service as a peer reviewer of
clinical-research related papers
or of clinical research grants
4 per 12months of
service
8
Confirmation of appointment as a peer
reviewer that includes dates
Service on IDMC/DSMB or
equivalent
4 per 12months of
service
8
Letter from DSMB/IDMC chair outlining
level of participation and # of mtgs
attended
Volunteer Service on IRB/IEC
4 per 12months of
service
8
Letter from IRB chair outlining level of
participation and # of mtgs attended
Service on healthcare-related
exam committee
4 per 12months of
service
8
Proof of participation
Service as a clinical research
exam item writer
0.5 points per
question
submitted
12
Proof of participation
Service on an association’s
clinical research-related
committee (editorial board,
conference session review,
regulatory affairs are
permitted. Membership,
nominating, general board
service not permitted)
4 per 12months of
service
8
Proof of participation
Other activities may be approved on a case-by-case basis by the Academy Board.
•
Presentation Development and Delivery: A single presentation can be claimed only once per year. The
same presentation can be counted a second time the following year only if the presentation required
significant updates prior to being presented again.
Certificants are permitted to include presentations they were paid to develop and present to the
extent allowed by the above chart. Certificants cannot claim participation points for programs
that they present.
• Authorship of an article pertaining to Clinical Research
o Certificants are not required to be the primary author to be able to claim points for a published
article.
o An article must be published within the appropriate time frame for the current Maintenance
cycle.
Presentations and articles must be in clinical research-related topics in order to be considered for points.
o
TAKING THE EXAM FOR MAINTENANCE
Taking and passing the current form of the exam for a specific designation’s Maintenance is acceptable and
satisfies all point requirements (all 24 points). The exam must be taken and passed BEFORE the candidate’s
Certification expires. A candidate must then submit a copy of their score report with their Maintenance
application. This would include taking another Academy Certification exam to obtain an additional credential
(i.e., a CCRC taking the CCRA exam in order to also achieve the CCRA designation.)
When being used for Maintenance, candidates are expected to apply for the exam, using the Examination for
Maintenance Form in accordance with the regular exam window deadlines. Once they are successful on the
exam, a candidate must then apply for Maintenance in accordance with the regular process and deadlines and
submit a copy of his/her score report.
If a candidate wishes to use the exam for another Academy designation, as in the example above, for
Maintenance he or she must still apply for and be deemed eligible for that program. In this instance, the
Examination for Maintenance Form cannot be used.
If a candidate is unsuccessful on the examination, he or she may still submit the necessary 24 points to satisfy
the Maintenance requirements.
NON-COMPLIANCE OF THE MAINTENANCE REQUIREMENTS
Candidates for Maintenance are expected to submit an application for Maintenance that fulfills all the necessary
requirements no later than his/her certification expiration date. A candidate will be considered non-compliant
if:
• no application for Maintenance was submitted;
• if the application submitted does not meet the stipulated requirements and the candidate has not
rectified any deficiencies; or
• if randomly selected, the candidate has not satisfied the requirements of the Document Verification
Process.
If compliance is not achieved within the stipulated timeframe, the candidate’s certification will expire and the
designation will be permanently removed from his/her record. The individual must stop using the designation
and/or representing him or herself as certified.
Once a candidate’s certification has been removed from his/her record, the only way to regain use of the
credential is to apply to the program as a candidate for initial certification and to take and pass the current form
of the examination.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
July 08, 2013
DATES REVIEWED
DATES MODIFIED
July 15, 2015
Academy of Clinical Research Professionals
Policy on Continuing Competency and Maintenance for the CPI Program
POLICY
The goal of the Certification process is to ensure, as much as possible, the continuing competence of each
certificant and maintain the professional standard of those engaged in clinical research. There are a number of
professional activities that can contribute to that goal.
The purposes of the Continuing Competency requirements established by the Academy are that CPIs continue
to:
• obtain current professional development information;
• explore new knowledge in specific content areas;
• master new clinical research-related skills and techniques;
• enhances approaches to effective clinical research, both within their specified job role and beyond;
• further develop professional judgment;
• conduct clinical research in a safe and ethical manner.
The Academy expects that clinical research professionals engage in lifelong development to maintain and
improve knowledge and skills for competent practice. This includes continuous self-assessment to identify
professional strengths and learning needs, establishment of short- and long-term goals for individual
professional development, and selection of appropriate professional development to meet these goals.
Candidates for Maintenance should choose those professional development activities that provide them with
the most benefit, keeping in mind that the length and rigor of a program contribute to its value. Advance
planning for Professional development enables candidates to choose more appropriate courses and also to
control expenses more effectively. Professional development programs provide one of the main methods for
keeping up with professional practice.
Maintenance of Certification is required every two (2) years. Each candidate for Maintenance must
demonstrate that he/she meets the current requirements in order to successfully recertify and be permitted to
continue to use the designation.
To successfully maintain Certification, each candidate for CPI Maintenance must submit 24 points as part of the
Maintenance application. The point requirements are broken down below. At least eight (8) of those 24 points
must come from participation in research-related professional development programs AND at least twelve (12)
of those 24 points must come from Continuing Involvement activities.
Maintenance of Certification– Two Options
Participation in Professional
Development
Continuing
Involvement Points
(see chart)
Total Points
Required
At least 12 points total
24
At least 12 points total
Option 1 Points
At least 8 points from Research
topics
No more than 4 points from
Disease/Bodily Systems/Other
Healthcare topics
OR
Option 2 Examination
Pass the current form of the CPI exam prior
to your Certification expiration date
CPIs must submit at least eight (8) points of research-related professional development program.
REPORTING PERIOD FOR POINTS
Applicable activities to satisfy the Maintenance requirements must fall within the appropriate timeframe for a
candidate’s maintenance period.
Certification Expiration Date
May 31
November 30
24 Month Reporting Period
June 1 (year 1) – May 15 (year 2)
December 1 (year 1) – November 15 (year 2)
PROFESSIONAL DEVELOPMENT PROGRAM TOPIC AREAS
Candidates for Maintenance can take professional development offerings in two (2) areas:
• Research Topics
• Disease/Bodily System/other Healthcare Topics
RESEARCH PROGRAM TOPICS
For Maintenance purposes, Research Topics are defined those that cover the actual “practice” of clinical
research and follow topics covered on the Detailed Content Outline (DCO) for your designation. These topics
should cover transferrable knowledge and skills, not those specific to your workplace, such as company SOPs or
specific software. Examples of Research Topics include, but are not limited to:
• Trial Management
• Investigational Product Management
• Protocol Development
•
•
•
•
•
•
•
•
•
•
•
•
Safety
Human Subject Protection
Document Management
Trial Oversight
Ethics
Adverse Events
Informed Consent
Good Clinical Practice (GCP)
ICH Guidelines
Regulatory Issues
Monitoring
Statistics
DISEASE/BODILY SYSTEM/HEALTHCARE PROGRAM TOPICS
Disease/Bodily System/Healthcare Topics are those that deal with the prevention, treatment, and management
of illness and the preservation of physical well-being. Training to gain access or query a specific database or
software, even if healthcare related, is not acceptable. Consideration is also given to specific skills that, while not
clinical research or healthcare related, are acknowledged as an advanced set of skills invaluable to the work of
clinical research. These specifically include: project management, grant writing and medical writing.
Courses pertaining to a particular disease are generally considered to be Disease/Bodily System/Healthcare
Topic hours. Examples include, but are not limited to:
• Pharmacology
• Medical devices
• Palliative / Hospice care
• Psychiatry
• Oncology
• Endocrinology
• Cystic Fibrosis
• Results of clinical trial studies
• Advanced Cardiac Life Support (ACLS) (This course is only acceptable once during the lifetime of the
certificant’s Certification tenure
For general participation in workshops, seminars, conferences and in-service trainings, points are awarded
according to the actual amount of time spent under instruction at a ratio of 1:1. Forty-five (45) – sixty (60)
minutes of instruction = one (1) education point; one (1) semester credit = fifteen (15) points.
Points are not awarded for sessions that are fewer than forty-five (45) minutes in length but can be pro-rated for
sessions exceeding sixty (60) minutes (i.e., a session one hour and fifteen minutes in length = 1.25 points)
All web-based training to be applied to the requirements must result in a certificate that indicates the number
of hours awarded for successful completion. The Academy cannot determine the number of points for webbased training for a candidate. The Academy reserves the right to request certificates of attendance and/or
transcripts from any and all courses.
Professional Development Activities
All applicants MUST document 12 points in this category from activities listed below
Time Spent
Contact Hours
Points on Maintenance
Application
< 45 minutes
No points awarded
0 points
45-60 minutes
1 contact hour
1 contact hour = 1 point
90 minutes
1.5 contact hours
1.5 contact hour = 1.5 points
Activity Awarding CMEs
60 minutes
1 CME
1 CME = 1 point
Course Awarding CEUs
60 minutes
1 CEU
1 CEU = 1 point
University Course
1 semester
1 semester credit
1 semester credit =
15 points
Activity
Professional
Development Session
(non-accredited
programs)
ACCREDITED PROFESSIONAL DEVELOPMENT PROGRAMS
It is anticipated that the majority of programs that a candidate for Maintenance of Certification will submit in
support of his/her application will come from programs that have some sort of accreditation. If the program
does not have accreditation from a known accrediting body, the applicant should submit the program for
approval prior to submitting it as part of the Maintenance Application process.
Examples of Acceptable Providers of Accredited Professional Development Contact Hours:
• ACRP
• All state and national nursing associations (e.g. ANCC, CBRN)
• Accreditation Council for Pharmacy Education (ACPE)
• Accreditation Council for Continuing Medical Education (ACCME) (e.g. CME and AMA Category I
credits)
• Other national healthcare-related associations offering professional development contact hours
• College/university courses in healthcare and clinical research
• Regulator-sponsored educational programs
• In-company training on research topics with specific learning objectives awarding a certificate/proof
of attendance and specifying the number of hours (SOP training is not acceptable.)
CONTINUING INVOLVEMENT
In addition, CPIs MUST submit at least 12 points from the Continuing Involvement Chart. This is because some
PIs do not do research full-time. Requiring the Continuing Involvement points is a way of making sure that they
are still involved in clinical research in a meaningful way. These are activities other than attending a professional
development educational activity.
Continuing Involvement Activities
All applicants MUST document 12 points in this category from activities listed below
Continuing Involvement (CI)
Activity
Number of
Points
Awarded
Per Activity
Maximum
Points
Allowed in
this Category
Examples of Documentation Required
for Verification
(CI activities are required to be included
on the online Contact History Report or
the Academy’s Activity form)
Copy of program with
speakers and objectives or presentation
abstract including organization, location
and dates (this is not required for
speakers at ACRP’s Global Conference)
Professional development
developer or presenter in clinical
research or related topic (to both
research and non-research
audiences)
2
8
Participate in or present at
investigator meeting (in-person
or virtual) or an initiation visit if
attended in lieu of an
investigator meeting
2
4
Documentation of meeting date, time
and proof of participation/presentation
1
3
Report signature page
2
4
Proof of Attendance
Authorship of journal paper on
clinical research
(cannot be self-published)
2
8
Journal citation including
authors
Authorship of journal paper on a
therapeutic topic
(cannot be self-published)
2
8
Journal citation including
authors
Authorship of protocol
(sole or co-authorship)
2
4
Supervisor documentation of role
Authorship/review of
clinical study report
(sole or co-authorship)
2
4
Report signature page that includes
protocol # or study name
Inclusion on 1572 or equivalent
regulatory authority document as
active investigator or sub-I
2
6
Copy of 1572 (both sides) or equivalent
regulatory authority document
Participate in a close out visit
Active Participation in a
Regulatory Authority meeting
(does not include an audit)
Medical monitor for clinical
research trial
1
3
Name listed on protocol title page
(sponsor)
Clinical research compliance
officer for institution
12 per year
12
Copy of appointment letter
12
Copy of appointment letter
Director of research center
12 per year
Involvement in a New Marketing
Application process (specifically
compiling a section or writing a
clinical study report
2
4
Supervisor documentation of specifically
compiling a specific section or writing a
clinical study report (signature page or
supervisor letter confirming role)
Investigational New Drug or
Device Application / Clinical Trial
Exemption Application
2
4
Supervisor documentation of authoring
the application (signature page;
supervisor letter confirming role)
8
Confirmation of appointment as a peer
reviewer that includes dates
8
Confirmation of appointment as a peer
reviewer that includes dates
8
Letter from DSMB/IDMC chair outlining
level of participation and # of mtgs
attended
8
Letter from IRB/IEC chair outlining level
of participation and # of mtgs attended
8
Copy of certificate/proof of participation
12
Proof of participation
Service as a peer reviewer of
scientific articles
Service as a peer reviewer of
clinical research-related papers or
clinical research grants
Service on DSMB/IDMC or
equivalent
Volunteer Service on IRB/IEC
Service on healthcare-related
exam committee
Service as a clinical research
exam item writing writer
4 per 12months of
service
4 per 12months of
service
4 per 12months of
service
4 per 12months of
service
4 per year of
service
0.5 points per
question
submitted
Service on an association’s clinical
research-related committee
(Editorial Advisory Board,
4 per year of
conference session review,
8
Proof of participation
service
regulatory affairs committee is
permitted. Membership,
nominating or general board
service not permitted)
Other activities may be approved by the Academy Board on a case-by-case basis
• Professional Development Presentation Development and Delivery: A single presentation can be
claimed only once per year. The same presentation can be counted a second time the following
year only if the presentation required significant updates prior to being presented again.
Certificants are permitted to include presentations they were paid to develop and present to the
extent allowed by the above chart. Certificants cannot claim participation points for programs
that they present.
Authorship of an article pertaining to Clinical Research:
o Certificants are not required to be the primary author to be able to claim points for a published
article.
o An article must be published within the appropriate time frame for the current Maintenance
cycle.
Presentations and articles must be in clinical research-related topics in order to be considered for
points.
o
•
•
TAKING THE EXAM FOR MAINTENANCE
Taking and passing the current form of the exam for a specific designation’s Maintenance is acceptable and
satisfies all point requirements (all 24 points). The exam must be taken and passed BEFORE the candidate’s
Certification expires. A candidate must then submit a copy of their score report with their Maintenance
application. This would include taking another Academy Certification exam to obtain an additional credential
(i.e., a CCRC taking the CCRA exam in order to also achieve the CCRA designation.)
When being used for Maintenance, candidates are expected to apply for the exam, using the Examination for
Maintenance Form in accordance with the regular exam window deadlines. Once they are successful on the
exam, a candidate must then apply for Maintenance in accordance with the regular process and deadlines and
submit a copy of his/her score report.
If a candidate wishes to use the exam for another Academy designation, as in the example above, for
Maintenance he or she must still apply for and be deemed eligible for that program. In this instance, the
Examination for Maintenance Form cannot be used.
If a candidate is unsuccessful on the examination, he or she may still submit the necessary 24 points to satisfy
the Maintenance requirements.
NON-COMPLIANCE OF THE MAINTENANCE REQUIREMENTS
Candidates for Maintenance are expected to submit an application for Maintenance that fulfills all the necessary
requirements no later than his/her certification expiration date. A candidate will be considered non-compliant
if:
• no application for Maintenance was submitted;
• if the application submitted does not meet the stipulated requirements and the candidate has not
rectified any deficiencies; or
• if randomly selected, the candidate has not satisfied the requirements of the Document Verification
Process.
If compliance is not achieved within the stipulated timeframe, the candidate’s certification will expire and the
designation will be permanently removed from his/her record. The individual must stop using the designation
and/or representing him or herself as certified.
Once a candidate’s certification has been removed from his/her record, the only way to regain use of the
credential is to apply to the program as a candidate for initial certification and to take and pass the current form
of the examination.
MONITORING AND REVIEW SCHEDULE
Monitor as needed and review every three years.
DATE APPROVED
July 08, 2013
DATES REVIEWED
DATES MODIFIED
July 15, 2015
Name Change Policy
Approved June 2012
In order to avoid the potential for confusion or misrepresentation, a certificant should apply for and hold
certification in his/her legal name.
An individual wishing to change his/her name on their eligibility notice, certificate, or database record may do so
with proper legal documentation.
The Academy will make a name change only if the individual provides the following:
• Written request for name change (via email or letter)
• Copy of the legal document showing the name change (marriage certificate, divorce decree, court order,
etc.)
• Copy of a current government issued identification showing new or former name
The above named documents do not need to be notarized copies. Copies of these documents will be attached
to the individual’s electronic database record.
If a current certificant wishes a new certificate reflecting the name change, he/she must also submit the
Duplicate Certificate Form and the appropriate fee.
Name Change Request Form
In order to ensure an accurate representation of those individuals currently certified with the
Academy of Clinical Research Professionals (the Academy), we require that the following
documentation be supplied to complete an individual’s name change in our records:
• Copy of an official court document ordering the name change.
This includes: marriage certificate, divorce decree, or court order for a name
change. This document does not need to be notarized.
AND
• A copy of a government-issued ID (i.e. driver’s license) showing either the old name
or new name
Upon receiving this documentation, the name will be updated in the database. An updated
certificate will ONLY be sent upon request.
Check all that apply:
⎕I would like a new copy of my certificate mailed to me ($25 fee)
⎕I would like a new electronic copy of my certificate emailed to me (no charge)
⎕Please only change my name in the ACRP records. I do not need a new certificate at this time.
By submitting this Name Change Request Form and documentation, I acknowledge and affirm that
the information I have provided herein is true and correct to the best of my knowledge.
Former Certificant Name (printed):
New Certificant Name (printed):
Certificant Signature:
Date: __
Email or fax this form to certification@acrpnet.org or 703-254-8101
Policy on Release of Certificant Information Approved June 2012 Certification is a voluntary credentialing process with the goal of protecting the public. The purpose of certification is to ensure the public that Academy certificants have met all eligibility criteria and mastered particular knowledge to provide so as to perform the duties essential to their role in clinical trials safely and effectively. Names of individuals holding Academy certifications, which have not opted out, shall be available to the public via the Academy’s online Certification Registry or inquiry to Academy staff. This publically available information shall be limited to confirming an individual is “currently certified” or individual is “not certified”. No contact information or employer details will be released. Any further details regarding an individual’s certification status will only be released upon receipt of a signed released signed by the individual about whom information is being sought. Upon receipt of the signed release the Academy will release the following information only:  Name of the individual  Name of the certification program  Initial certification date  Certification expiration date  Certification number Confidential information that will not be released, even if a signed release is provided, includes: names of candidates for certification; names of individuals who are not successful on the examination; and individual test scores. Based on certification status, the following information will be released following receipt of a signed release form: Never Certified: “Individual is not currently certified.” Applicant/Candidate for Certification: “Individual is not currently certified.” No other information, including confirmation of the individual’s status as an application or candidate, will be released. Currently Certified: Name of the certification program (CCRC, etc.) Initial certification date Certification expiration date Certification number Expired/Decertified Name of the certification program (CCRC, etc.) Initial certification date Certification expiration date 51
Certification number 52
Appendix IV: Forms





Request to Transfer Exam Application
Application Cancellation Form
Emergency Exam Cancellation Form
Name Change Request Form
Re-Examination Form (Sample)
Request to Transfer Exam Application to September 2016
Must be received by the Academy by March 21, 2016.
The Academy offers a one-time transfer of the exam application from one exam cycle to the next. This
transfers the application and all fees to the next exam only. All fees become non-refundable upon
transfer. If, for any reason the next exam is not taken, all fees are forfeited. Transferring is not an
option for re-examination candidates (from the previous exam cycle).
There are two (2) situations in which applicants may take advantage of the transfer option:
1) An applicant is determined Ineligible for the current exam, but have met the eligibility
requirements by the next exam period.
2) An applicant is determined Eligible, but must withdraw from the exam at least five (5) days
before the scheduled exam appointment*.
*If an appointment is scheduled, you must first cancel it directly with Prometric (see below) before
submitting this request to ACRP. Note: Fees, payable to Prometric directly, apply for cancellations
within thirty (30) to five (5) days prior to an appointment date. Cancellations are not permitted less
than five (5) days prior to an appointment.
 I have canceled my exam appointment by contacting Prometric online or by telephone.
(Applicable only if an appointment was scheduled)
By signing below, you attest that you have read and understand the Policy on Transfers,
Cancellation, No Shows, Refunds and Re-Examination.
Candidate Signature:
_____ Date:
Candidate Name (printed):
You should receive an emailed confirmation that your request to transfer was received and accepted.
Contact certification@acrpnet.org if you have not received confirmation within seven (7) days.
E-mail this form to certification@acrpnet.org or fax it to +1.703.254.8102 by March 21, 2016.
Application Cancellation Request Form
Must be received by the Academy five (5) days prior to a scheduled or cancelled Exam
appointment, or by the end of the current exam offering.
Candidates who wish to discontinue the Certification process may submit this form to request a
refund of the Exam fee only. The Academy does not refund fees for cancellation requests
received less than 5 days prior to the scheduled exam, or the end of the current exam
offering.
You must cancel your Exam appointment, if one was made, prior to submitting this request.
Cancellations are permitted by up to 5 days prior to your Exam appointment by contacting
Prometric Online or By Telephone. There is a charge for cancellations made within 29 to 5 days
of your Exam appointment. Refer to the Certification Handbook's Cancellations section.
This request may only be made by the applicant, regardless of whether the exam fee was paid
by the candidate or another party.
Candidate Name (printed): ________________________________________________
Name of Exam: __________________________________________________________
 I have canceled my exam appointment with Prometric at 800-853-6769.
 I did not schedule an exam appointment.
Candidate Signature: _______________________________________
Date:_____________
E-mail this form to certification@acrpnet.org, or fax it to 703-254-8102.
Emergency Exam Cancellation Form
Usually, if a candidate does not cancel his/her scheduled exam appointment at least five (5) days prior
to the scheduled date, or does not appear for the exam as scheduled, he/she forfeits all fees. However,
if a candidate will be unable to keep their exam appointment due to an emergency situation that arises
within less than five (5) days prior or the day of the scheduled exam appointment date, the Academy
may consider waiving the forfeited fee.
In order to be considered for such a waiver, the candidate is required to submit the Emergency Exam
Cancellation Form along with official supporting documentation of the emergency, to the Academy at
certification@acrpnet.org. This information should be received by the Academy before the candidate’s
scheduled exam date, OR as soon as the emergency has passed, but NO LATER than seven (7) days after
the scheduled exam date.
The following situations will be considered:





Emergency room visit or hospitalization
Severe medical condition requiring hospitalization
Death of an immediate family member (spouse, child/dependent, parent, grandparent, sibling)
Jury duty
Call to active military duty
The above situations apply to a spouse, child/dependent, parent, grandparent, or sibling as acceptable
absences for severe medical conditions requiring hospitalization. Notification and documentation of the
emergency must be submitted by the candidate to the Academy no later than seven (7) calendar days
past the scheduled exam date.
Candidate Name:
Date of Missed Exam:
Reason:
Supporting Document Type Attached (e.g. Emergency room release, death certificate):
Email this form and corresponding documentation to the Academy at certification@acrpnet.org
NO LATER THAN SEVEN (7) DAYS AFTER THE SCHEDULED EXAM DATE.
Fax is also accepted - 703.254.8102.
Name Change Request Form
In order to ensure an accurate representation of those individuals currently certified with the Academy
of Clinical Research Professionals (the Academy), we require that the following documentation be
supplied to complete an individual’s name change in our records:
•
Copy of an official court document ordering the name change (e.g., marriage certificate,
divorce decree, or court order for a name change, etc.; the document does not need to be
notarized).
AND
•
A copy of a government-issued ID (i.e., driver’s license) showing either the old name or
new name
Upon receiving this documentation, the name will be updated in the database. An updated certificate
will only be sent upon request.
Check all that apply:
I would like a new copy of my certificate mailed to me ($25 fee)
I would like a new electronic copy of my certificate e-mailed to me (no charge)
Please only change my name in the ACRP records. I do not need a new certificate at this time.
By submitting this Name Change Request Form and documentation, I acknowledge and affirm that the
information I have provided herein is true and correct to the best of my knowledge.
Former Certificant Name (printed):
New Certificant Name (printed):
Certificant Signature:
Date:
E-mail or fax this form to certification@acrpnet.org or +1.703.254.8101.
__
Clinical Research Coordinator (CRC) Re-Examination Form
Must be completed prior to receiving a new Eligibility ID#.
The Academy is allowing the candidate listed below to re-test during the next immediate testing
cycle only, without having to pay the Application Fee or submit a full application. Candidates
need only to submit the Exam fee and this form by August 14, 20XX. This opportunity cannot be
transferred to another exam or another applicant.
The candidate is responsible for the applicable exam fee: $325. Please provide payment information
below and correct the following contact information if necessary.
pl
Michael X Anderson
1234 Any Street
Any Town, VA 12344
e
CANDIDATE’S LEGAL NAME: Michael X Anderson
Be sure that your first and last names , as listed above, are identical to your name on your government
issued Identification.
Sa
m
PAYMENT METHOD (circle one): [MasterCard] [Visa] [AMEX] [Check]
Credit Card Number:
Name on Card:
Expiration Date:
TOTAL AMOUNT DUE $325 Exam Fee
I understand that the opportunity to re-take the exam without submitting a complete application is
provided for the next immediate exam period only. I understand that if I fail to make an examination
appointment or fail to show up for a scheduled exam appointment, that I forfeit all fees. I understand
that I will be required to submit a full application and all necessary fees to take any subsequent
examinations. I understand and agree that the Authorizations and Agreements of my original
application for Academy Certification are still in force.
Candidate Signature: ______________________________________
Date: ________________
Email this form to certification@acrpnet.org or fax to: +1 703.254.8102. Your Eligibility Notice is your
confirmation. Please allow seven (7) days to receive this important email.
Mail Checks to:
Academy of Clinical Research Professionals
Certification Program
99 Canal Center Plaza, Suite 200
Alexandria, VA 22314