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

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

What is covered in the exam(s)?

Nuremberg Code

Declaration of Helsinki

Belmont Report

• Department of Health and Human Services, Title 45 Public Welfare, Code of Federal Regulations , Part 46 Protection of Human Subjects

DHHS 45 CFR Part 46 Subpart A = Common Rule *

• Protection of Human Subjects (ICF) FDA 21 CFR

50 *

• Institutional Review Boards (IRB) 56 *

• Electronic Records, Electronic Signatures (EMR) 11

• Financial Disclosure by Clinical Investigators (COI) 54

• Investigational New Drug Application (IND) 312

• Investigational Device Exemptions (IDE) 812

• Good Clinical Practice (GCP) ICH GCP Guidelines

E6 • Clinical Safety Data Management: Definitions and Standards for Expedited

Reporting E2A

• General Considerations for Clinical Trials E8

• Statistical Principles for Clinical Trials E9

Regulations and Guidance Documents

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

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 part-time) during the past two years as a Clinical Research Professional.

http://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility

SoCRA Eligibility Requirements

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

http://www.acrpnet.org/PDF/CRC_Handbook.pdf

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)

ACRP’s Eligibility Requirements

Alliance Coordinator Award Program

Send it to the CRS; SRay@nshs.edu

Preparation Tools 1. ACRP Certification Exam Preparation Package

(http://www.acrpnet.org/prepareforyourexam) – Exam Practice Exercise – ACRP's new Certification Exam Preparation eLearning Course – Exam Prep Packages

2. RAN Institute Flash Cards: http://www.raninstitute.com/flashcards.php 3. 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.

4. www.raninstitute.com ICH Guidelines: www.ich.org (Go to Work Products/ICH Guidelines/Efficacy Guidelines)

5. Declaration of Helsinki: www.wma.net/en/20activities/10ethics/10helsinki/index.html

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.

Preparation Tools

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• 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

Preparation Ideas

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