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The CRC Certification Exam Prep Course is designed to review the foundation of clinical research and guide Clinical Research Professionals in preparing for the certification exam. Since our time is limited and the information to cover is vast, additional preparation time will be required for individuals planning to sit for a certification exam. This series contains 4 recorded video sessions which touches on material which will be on the certification exam and includes links to additional resources.

Why should you be certified? CRC Certification is important for you because it helps to demonstrate the foundational level of knowledge you have as a clinical research professional. Sponsors and employers recognize certification as a national set of standards for the safe and ethical conduct of clinical research.

The team preparing this course is from across the state of Virginia and have 10-25+ years of experience each in Clinical Research:

• Katie Rea, MSCR, BSN, RN, CCRC-Clinical Research Manager, SOM Clinical Research Office, UVA- kaw3j@virginia.edu
• Jennifer Phillips, RN, CCRC-Clinical Research Manager, iTHRIV, UVA- jvp8a@virginia.edu
• Sandra Burks, BSN, CCRC- Associate Director, iTHRIV, UVA- sgb2c@virginia.edu
• Andrea Mohr, MHA, CCRP-Director, Clinical Trials, Carilion Clinic- abmohr@carilionclinic.org
• Medard Ng, PhD-Research Quality Manager, iTHRIV, UVA- htn3u@virginia.edu
• Bhruga Shah-MS, BSN-RN, CCRP-Sr. Clinical Research Nurse, Inova- bhruga.shah@inova.org

Session #1:

Content includes:

• History of ICH-GCP
• Principles of ICH-GCP
• Introduction to the "Players" and their roles and responsibilities (IRB, Investigator, Sponsor)
• Principles of ICH-GCP (Safety, Integrity, Quality)

Selected Links:

• ICH-GCP E6 (R2)
• Slides for Session #1

Session #2:

Content includes:

• ICH-GCP and E6(R2)
• "Players" responsible for Paperwork
• Paperwork by phases (before, during, after trial)

Selected Links:

• ICH-GCP E6 (R2)
• FDA IND
• FDA IDE
• Slides for Session #2

Session #3:

Content Includes:

• ICH E2A-Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• Practice Questions

Selected Links:

• ICH E2A

• FDA Guidance-Safety Reporting Requirements for IND's and BA/BE Studies

• Slides for Session #3

Session #4:

Content Includes:

• Ethical Principles for Medical Research-Nuremberg Code, Declaration of Helsinki and Belmont Report
• ICH E8 (R1) General Considerations for Clinical Studies
• ICH E9 Statistical Principles
• ICH E11 Clinical Studies in Pediatrics Population
• Practice Questions

Selected Links:

• Slides for Session #4
• Nuremberg Code
• Belmont Report
• Declaration of Helsinki
• ICH E8 R1 General Considerations for Clinical Studies
• ICH E9 Statistical Principles for Clinical Trials
• ICH E11 Clinical Investigation of Medicinal Products in Pediatric Population
• 21 U.S. Code of Federal Regulations: Parts 11, 50, 56, 312 and 812
• 45 U.S. Code of Federal Regulations: Part 46

Workshop #1: (this session was NOT recorded as it was intended to be interactive)

Slides for Workshop #1

Content Includes:

• IND vs. IDE
• Clinical Trial Design (IND vs. IDE)
• Dose Calculation

Selected Links:

• FDA IDE White Paper
• FDA IND
• Clinical Trial Design
• Drug Labeling
• 21 CFR Part 312-Investigational New Drug Application
• 21 CFR Part 314-Approval to Market New Drug
• 21 CFR Part 316-Orphan Drugs
• 21 CFR Part 54-Financial Disclosure
• IDE Definitions and Acronyms
• 21 CFR Part 820-Quality System Regulation
• 21 CFR 812.1
• 21 CFR 812.3

Other Resources For Certification Prep:

• SOCRA For Clinical Research Excellence

• Association for Clinical Research Professionals ACRP

• Quizlet Citi CRC Training Course

Workshop #2: (this session was NOT recorded as it was intended to be interactive)

Content Includes:

• Real World Tips for Studying and Taking the Exam
• Tip Sheet

last updated 09/01/2024