SOCRA CCRP Regulatory Compliance 1 — Questions and Answers
Question 1: Which US federal regulation governs the protection of human subjects in research conducted or supported by federal departments?
- 21 CFR Part 50
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 164
Correct answer: 45 CFR Part 46
45 CFR Part 46, known as the Common Rule, is the federal regulation governing protection of human subjects in federally funded research.
Question 2: What is the primary purpose of 21 CFR Part 312 in clinical research?
- To regulate laboratory testing standards
- To establish requirements for Investigational New Drug (IND) applications (Correct answer)
- To govern IRB operations
- To define Good Laboratory Practice
Correct answer: To establish requirements for Investigational New Drug (IND) applications
21 CFR Part 312 establishes FDA requirements for IND applications, including sponsor and investigator responsibilities.
Question 3: Which ICH guideline defines Good Clinical Practice (GCP) standards internationally?
- ICH E3
- ICH E6 (Correct answer)
- ICH E9
- ICH E10
Correct answer: ICH E6
ICH E6 (R2) is the international GCP guideline that establishes standards for the design, conduct, and reporting of clinical trials.
Question 4: A Form FDA 1572 is required to be signed by which individual?
- The IRB Chairperson
- The Sponsor's Medical Monitor
- The Principal Investigator (Correct answer)
- The CRO Project Manager
Correct answer: The Principal Investigator
Form FDA 1572 is the Statement of Investigator that must be signed by the Principal Investigator, committing to GCP compliance.
Question 5: Under FDA regulations, how long must an investigator retain clinical trial records after the investigation is discontinued or completed?
- 2 years
- 3 years (Correct answer)
- 5 years
- 7 years
Correct answer: 3 years
Per 21 CFR Part 312.62, records must be retained for 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued.
Question 6: What does 'regulatory binder' typically contain at a clinical research site?
- Lab results and patient diaries
- Essential documents required by ICH GCP and FDA regulations (Correct answer)
- Sponsor invoices and budget agreements
- Patient enrollment logs only
Correct answer: Essential documents required by ICH GCP and FDA regulations
The regulatory binder contains essential documents such as the protocol, IND, IRB approvals, CVs, lab certifications, and FDA 1572 required by GCP.
SOCRA CCRP Regulatory Compliance 1
Which US federal regulation governs the protection of human subjects in research conducted or supported by federal departments?