PREP Workshop #31:
Preparing for Certification as a Clinical
Research Coordinator
Presented by:
Susan Ray, MS, CCRC
Supervisor Research Coordination
Clinical Research Service
CME Disclosure Statement
• The North Shore LIJ Health System adheres to the ACCME’s new Standards
for Commercial Support. Any individuals in a position to control the
content of a CME activity, including faculty, planners, and managers, are
required to disclose all financial relationships with commercial interests.
All identified potential conflicts of interest are thoroughly vetted by the
North Shore-LIJ for fair balance and scientific objectivity and to ensure
appropriateness of patient care recommendations.
• Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck,
MPH have nothing to disclose.
• Susan Ray has nothing to disclose.
Objective: Review requirements and possible preparation options
for becoming certified as a clinical research coordinator
Topics:
 Discuss SoCRA and ACRP requirements for taking
the certification exams
 Review the Alliance Coordinator Award Program
 Discuss preparation tools, courses and options
 Test current knowledge – study review questions
What is covered in the exam(s)?
SoCRA
• Ethical Principles / Informed Consent /
Safety: 20% - 25%
• Institutional Review Board / Institutional
Ethics Committee (IRB/IEC) Roles and
Responsibilities: 7% - 11%
• Clinical Trial Protocol and Protocol
Amendments: 4% - 8%
• Investigator Roles and Responsibilities: 28%
- 32%
• Sponsor Roles and Responsibilities: 31% 35%
 See Exam Outline
•FDA regulations. You will not be tested on FDA
guidance. However, some of the guidance
documents published by the FDA may be
helpful in explaining concepts.
ACRP
General knowledge of:
• Laboratory terminology, tests, and procedures
• Basic math, including adding, subtracting,
multiplying, dividing, and calculating
percentages
Proficiency in the areas of:
• Investigational Product Management
• Protocol
• Safety
• Trial Management
• Trial Oversight
 See Detailed Content Outline (DCO)
• ICH GCP Guidelines E6, E2A, E8, E9
• Declaration of Helsinki
http://www.socra.org/certification/ccrp-certification-exam/exam-outline
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
Regulations and Guidance Documents
Nuremberg Code
Declaration of Helsinki
Belmont Report
DHHS 45 CFR Part 46
Subpart A = Common Rule *
FDA 21 CFR
50 *
56 *
• Department of Health and Human Services, Title 45 Public Welfare, Code of
Federal Regulations , Part 46 Protection of Human Subjects
• Protection of Human Subjects (ICF)
• Institutional Review Boards (IRB)
11
• Electronic Records, Electronic Signatures (EMR)
54
• Financial Disclosure by Clinical Investigators (COI)
312
• Investigational New Drug Application (IND)
812
• Investigational Device Exemptions (IDE)
ICH GCP Guidelines
E6
• Good Clinical Practice (GCP)
E2A
• Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting
E8
• General Considerations for Clinical Trials
E9
• Statistical Principles for Clinical Trials
Review of SoCRA’s Exam
• CRP Certified: “CCRP”
• Exam dates: NY area (Hartford, CT) exam will be September 25, 2015
Applications due: August 13, 2015
• Exam dates: NY area (Philadelphia, PA) exam will be October 10, 2015
Applications due: August 28, 2015
Fees: examination application fee $195 + $75 membership fee
Duration: 4 hrs
•135 multiple choice and true/false questions
•Test questions are designed to be straightforward
and easily understood.
•Case studies that relate to clinical research
practice
•Current cut score is 80% and requires that the
candidate correctly completes 108 out of the 135
examination questions.
Period of Certification: 3 years
SoCRA Eligibility Requirements
1.
Member of SoCRA
1.
Working with Good Clinical Practice (GCP) guidelines under IRB approved protocols
2.
One of the following :
 Category 1: 2 yrs FT Clinical Research Professional (or have 3,500 hours part-time) within 5
years
 Category 2: degree in "Clinical Research" + 1 yr. year FT (or 1,750 hours part-time) within 2
years in Clinical Research Professional
 Category 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 parttime) during the past two years as a Clinical Research Professional.
http://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility
Review of ACRP’s Exam
•
CRC Certified: “CCRC”
•
Fall 2015 Exam dates: September 9 – October 3, 2015
Applications Open: May 1, 2015
Applications Due: August 15, 2015
Fees: $450 for ACRP members and nonmembers by July 1 2015
$525 for nonmembers July 2 through August 15 2015
•
Spring 2016 Exam dates: February 25 – March 21, 2016
Applications Open: October 1, 2015
Applications Due: February 1, 2016
Fees: $450 for ACRP members and nonmembers by December 1 2015
$525 for nonmembers December 2, 2015 through February 1 2016
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
Duration: 3 hrs
•125 multiple choice questions
•Practice based exam with hypothetical scenarios,
no trick questions
•Approximately 74% of candidates are successful
on their first exam attempt.
•Scaled score of 600 (800 max.) 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.
Period of Certification: 2 years
ACRP’s Eligibility Requirements
One of the following:
Option 1: RN, Associates, or Bachelor’s or higher, 3000 hrs,
documentation of performed essential duties (CV and Job
Description)
Option 2: Other such as LPN, LVN, Med. Assistant, Lab Technician
OR HS diploma, 4500 hrs, documentation of performed essential
duties (CV and Job Description)
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
Alliance Coordinator Award Program
Send it to the CRS;
SRay@nshs.edu
Preparation Tools
1.
2.
3.
4.
5.
ACRP Certification Exam Preparation Package
(http://www.acrpnet.org/prepareforyourexam)
– Exam Practice Exercise
– ACRP's new Certification Exam Preparation eLearning Course
– Exam Prep Packages
RAN Institute Flash Cards: http://www.raninstitute.com/flashcards.php
www.mobilizepress.com - 1-2 hour reviews on other ICH
documents. Tip: You can purchase these and have unlimited access to
use to prepare for the exams.
www.raninstitute.com
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
Preparation Tools
 Pharmaschool (free): http://www.pharmaschool.co/resources.asp.
Under the general resources there is a “jargonbuster” with key
definitions
“GCP and Clinical Research Tests” there are various multiple choice
quizzes
Registered Users can go to “My GCP Zone” to score your quizzes
and tell you how you compare to the average user.
*The website is based out of the UK there are some specific questions
regarding EU regulations, but overall was found to be extremely
helpful.
15
Preparation Ideas
• STEP 1: Assess your own professional experience
• STEP 2: Start early and plan ahead.
• STEP 3: Schedule your study time. 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 in
answering questions on the exam.
• STEP 4: Assemble your study notes in a binder.
• 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.
• STEP 6: Stick to your study group’s plan.
• STEP 7: Don’t panic! Follow the excellent pre-exam advice that the
Academy provides, and come to the exam well-rested and prepared.
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
Exam Preparation – CRS Study Groups?
• Additional prep sessions using RAN Institute
Flash Cards
• Contact your Regional CRS
• Electronic GCP
• Hard-copy box of flash cards
17
Test Current Knowledge
Pre-Exam Assessment
Test current knowledge by completing the
questionnaires


Code of Federal Regulation – Slides on screen
 CFR questions -Broader
Good Clinical Practice – The RAN Institute's On Line Training
Campus
<http://raninstitute.trainingcampus.net>
 GCP -More specific
Final Tips
Certification Prep from Coordinators:
• When you apply to take the certification exam: be prepared to literally justify why and how
you meet all of the qualification requirements
– detail your experience and make sure it adds up to the specific requirements indicated.
They will reject your application if you do not show how you meet eligibility.
• Concentrate on the big picture: ICH guidelines E6, E8, Declaration of Helsinki.
• Make sure you understand the difference between your local guidelines/requirements and
the international/ federal regulations for clinical research
• Noticed emphasis on “phases of clinical drug development” and “statistical principles for
clinical trials”
• Take the practice exam: dissect each question as there's some truth or reason to all the
answers listed.
• Be able to critically asses various situations that could happen in research - especially those
you are not familiar with because you will most likely come across that and slow you down
during the exam
• Be prepared for math/calculation questions for drug accountability/subject compliance, etc.
• Understand the process of the testing center and taking a test on a computer
Special Thanks
Contributors
Division/Department/Facility
This presentation was primarily created
by Cerdi Beltre, CIP, CCRP.
Clinical Research Service, Feinstein
Institute for Medical Research, NSLIJHS