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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 ACCMEs 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)

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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 SoCRAs 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 Associates or Bachelors 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 ACRPs 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

ACRPs Eligibility Requirements


One of the following:
Option 1: RN, Associates, or Bachelors 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.

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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 groups plan.
STEP 7: Dont 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

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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