®
SOCIETY OF CLINICAL RESEARCH ASSOCIATES
CCRP® CERTIFICATION PROGRAM
FOR CLINICAL RESEARCH PROFESSIONALS
The Society of Clinical Research Associates proudly announces the Certification Program for Clinical
Research Professionals. This brochure contains information concerning this program, and certification
application instructions. Applicants are those individuals with two or more years of experience in
clinical research or those having completed specific degree work and/or having completed appropriate
course work. Individuals meeting all of the eligibility and application requirements will be required to
successfully complete a written examination.
STATEMENT OF PURPOSE
SoCRA established the Certification Program for Clinical Research Professionals in order to create an internationally
accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized
by the clinical research community. Those individuals so approved may use the title “Certified Clinical Research
Professional” or “CCRP®”
ELIGIBILITY
The applicant must be a current member of SoCRA, working with Good Clinical Practice (GCP) guidelines under IRB/
IEC/REB-approved (or specifically exempted) protocols. The applicant must meet one of the following criteria:
1. Have two years of experience as a full-time Clinical
Research Professional (or have 3,500 hours parttime) during the last five years OR
2. Hold a degree in “Clinical Research” from an
Associate, Undergraduate, or Graduate Degree
Program, AND have completed a minimum of
one year of full-time experience (or 1,750 hours
part-time) during the past two years as a Clinical
Research Professional OR
3. Hold an Undergraduate or Graduate Certificate in
“Clinical Research” with a curriculum of no less than
12 semester (credit) hours or totaling a minimum
of 144 credit hours from an academic institution
of higher learning (community college, college or
university) AND hold an Associate’s or Bachelor’s
Degree in a science, health science, pharmacy
or related field AND have completed a minimum
of one year of full-time experience (or 1750 hours
part-time) during the past two years as a Clinical
Research Professional.
DEFINITION of a Clinical Research PROFESSIONAL
A clinical research professional’s (CRP) practice is guided by one or more aspects of the principles of Good Clinical
Practice (GCP). A CRP may function as a clinical investigator, sub-investigator, clinical researcher, research nurse,
pharmacist, administrator, coordinator, consultant, data manager, quality assurance manager, regulatory affairs
manager or educator in clinical trial management. The duties of a CRP may include data collection, analysis, or
monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of
subjects and subjects’ rights; development of informed consent documents; preparation of adverse event experience
reports; construction or monitoring of case report forms; maintenance of drug accountability records; development
of grants and budgets; preparation of reports; educating other healthcare professionals, patients or families about
clinical trials; protocol development; program administration; or auditing research program. A CRP would not include
professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP)
regulations.
EXAMINATION CONTENT
Four major subject areas are covered in the CCRP® certification examination. The examination outline includes
examples of content that may be covered on the examination in the four major subject areas. Each major subject area
will be included in each examination, but specific questions will vary from one exam version to another. A percentage
of questions from each subject area may change slightly from one examination to another. Each question is weighted
equally. Satisfactory completion of the SoCRA certification examination indicates that the applicant has attained the
minimum level of education and experience required of a clinical research professional. To achieve a passing grade
a candidate must correctly answer a minimum of 108 questions (80%). The examination is made up of 135 multiple
choice and true/false questions. The examination contains case studies that relate to clinical research practice. The
case studies are intended to evaluate a candidate’s ability to abstract data and do not require clinical experience. The
questions are formulated to be straight-forward and easily understood. The certification examination is offered in the
English, French and Japanese languages.
SoCRA – 530 West Butler Avenue - Suite 109, Chalfont, PA 18914 U.S.A.
Phone 800-762 7292 or +1 215 822 8644 Fax +1 215 822 8633 www.socra.org
Email: socramail@aol.com
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THE SoCRA CCRP® CERTIFICATION EXAMINATION
Background Information
Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions.
Some clinical research professionals are MDs, while others are RNs; some may have a degree in medical technology,
business administration, health information management, statistics, biology, teaching, or other areas. Every one of
these backgrounds brings special areas of expertise to the field of clinical research. Each institution and discipline has
unique requirements.
Despite the varied backgrounds and job descriptions, all clinical research professionals are guided by a common
framework of regulations, guidelines and ethical principles in the conduct of clinical research. Therefore, the
examination is designed to assess the applicant’s ability to apply the U.S. Code of Federal Regulations, ICH Guidelines,
and ethical principles that guide the conduct of clinical research under the scope of GCP, highlighted in the standards
of practice.
Examination Development
The Certification Examination has been developed by the SoCRA Certification Committee and SoCRA Certified
Clinical Research Professionals (CCRPs) who have demonstrated expertise in the development, management, and
administration of clinical trials. These clinical research subject matter experts (SMEs) come from diverse backgrounds
and job descriptions to reflect the composition of SoCRA membership.
The test questions are designed to be straightforward and easily understood. The questions are reviewed by experts
in test question development and SoCRA language representatives for fairness and readability.
The Certification Examination is evaluated and updated at least annually in order to assure that it is up-to-date and
reflective of the current regulatory environment in which clinical trials are performed.
The certification exam content areas have been reviewed and validated through completion of a Job/Task Analysis. A
copy of the Job / Task Analysis summary is available by request through the SoCRA administrative office.
Examination Validation
The exam is statistically and psychometrically validated by an independent consultant. The Certification Committee
evaluates the results from the statistical/psychometric evaluations and updates the exam, as needed.
The examination pass/fail score, or “cut score”, is statistically validated. The current cut score is 80% and requires that
the candidate correctly completes 108 out of the 135 examination questions.
SoCRA CCRP® Examination Outline
Conduct of Clinical Trials
• Roles and responsibilities of sponsors and
investigators
• Study development, design, trial phases, blinding
• Study initiation
• Protocol development
• Protocol amendments
• Subject recruitment/enrollment
• Study visits, assessments, procedures
• Source documentation
• Develop/complete/verify case report forms (paper/
electronic)
Institutional Review Boards / Independent Ethics
Committees (IRBs / IECs) and Regulations
• Roles and responsibilities of IRB/IEC
• IRB/IEC membership
• Standard Operating Procedures
• IRB/IEC review and approval
• Vulnerable patients and children
• Record retention
• Essential documents
• Investigational product accountability
• Safety assessment, documentation and reporting
(i.e. Adverse events, serious adverse events,
unanticipated adverse device effects)
• Reporting requirements (annual reports, protocol,
protocol amendments, and adverse events)
• Monitoring and quality assurance
• Audits
• Record retention
• Study closeout
Ethical Issues
• Ethical principles with their foundation in
Nuremberg Code, Belmont Report and
Declaration of Helsinki
• Informed Consent/Assent
• Research misconduct
• Disclosure of Financial Information
Abstracting Information from Medical Records
• Abstracting data and verifying data from source documents related to investigational product accountability,
dosing, eligibility of subjects, informed consent, study related visits, clinical reports, and clinical assessments
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Certification Examination Competency Areas
SoCRA has developed a standard core series of competencies that reflects the basic knowledge required of
clinical research professionals. These core competencies are tested by the CCRP® certification examination. The
competencies are as follows:
1.Identify and differentiate the foundations and
principles of clinical research ethics.
2.Demonstrate knowledge of laws, regulations,
guidance, and standard operating procedures and
their application to regulated clinical research.
3.Distinguish and define the responsibilities of
sponsors, monitors, and investigators according to
the principles of ICH/GCP and the Code of Federal
Regulations.
4.Identify and apply the regulations and guidance
as they relate to informed consent, IRB/EICs, and
financial disclosure.
5.Identify the principles of study design, study closure,
and record retention.
6.Demonstrate knowledge and application of safety
reporting requirements.
7.Demonstrate the ability to utilize critical thinking
skills in practical applications.
Term of Certification
The CCRP® (SoCRA) is awarded for three years to continuing members of SoCRA. Renewal after three
years requires 45 hours of validated continuing education credit, completion of a self-administered open-book
recertification quiz, a recertification processing fee (which at this time is $100), and consecutive years’ membership
in SoCRA.
SoCRA Certification Examination Sample Questions (The correct answers are bolded.)
1. What is the minimum number of
Institutional Review board (IRB) members?
a. 3
b. 5
c. 6
2. The initial drug dose is 110mg/m2. Due to
toxicity, the drug needs to be decreased by
30%. The new dosage would be?
a. 91
b. 100
c. 77
3. The responsibility for ensuring that the
investigator understands a clinical trial lies
with:
a. The FDA
b. The IRB
c. The Sponsor
4. Significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk
to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or
sustaining human life and presents a potential risk to the
health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing
impairment of human health and presents a potential for
serious risk to the health, safety, or welfare of a subject.
d. All the above
5. A purpose of monitoring clinical trials is to verify that:
a. The rights, safety, and well-being of human subjects are
protected
b. Investigators receive adequate payment for their participation
in the clinical trial
c. The investigator has received annual reports from the sponsor
d. The regulatory agency has received all case history
information of subjects enrolled on the clinical trial
Certification Preparation and Review Course
This optional one-day course is offered throughout the year. Please see our web site at www.socra.org and click on
“Courses,” You may schedule a course at your facility if you can guarantee a minimum of 20 attendees. Call the office
at 1-800-762-7292 for details.
Certification Program Reference Manual
The SoCRA Certification Program Reference Manual will be included as part of your package upon registration for
the examination. The purpose of the reference manual is to be a resource to assist with preparation for the SoCRA
Certification Examination; it is not an all-inclusive resource. This guide consists of:
- 21 Code of Federal Regulations:
- The Nuremberg Code
Parts 11, 50, 56, 312, 812
- Declaration of Helsinki
- 45 Code of Federal Regulations: Part 46
- ICH GCP Guideline for Good Clinical Practice (E6)
- Sample FDA regulatory forms:
- ICH Clinical Safety Data Management: Definitions
482, 483, 1572, 3454, 3455, 3500, 3500A
and Standards for Expedited Reporting (E2A)
- The Belmont Report
- Health Canada Information (reference only- not on exam)
The reference manual is also available for purchase at a cost of $50.00 (U.S. Funds).
Applicants Having Special Needs
Applicants having special needs should contact the SoCRA office to discuss testing requirements for persons with
physical, sensory or learning disabilities.
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