SOCRA CCRP Regulatory Compliance 2 — Questions and Answers
Question 1: Which regulatory body must approve a new drug's IND before Phase 1 clinical trials can begin in the US?
- IRB
- NIH
- FDA (Correct answer)
- DEA
Correct answer: FDA
The FDA must receive and approve (or allow 30 days to pass without clinical hold) an IND before Phase 1 trials can begin in the US.
Question 2: What is a 'clinical hold' in the context of FDA regulations?
- A pause in patient enrollment requested by the IRB
- An FDA order to delay or suspend a clinical investigation (Correct answer)
- A temporary halt due to site staffing issues
- A sponsor-initiated pause for protocol amendments
Correct answer: An FDA order to delay or suspend a clinical investigation
A clinical hold is an FDA order to delay a proposed or suspend an ongoing clinical investigation based on safety or compliance concerns.
Question 3: Under 21 CFR Part 50, which individuals are considered 'vulnerable' populations requiring additional protections?
- Employees of the sponsor
- Pregnant women, prisoners, and children (Correct answer)
- Elderly individuals over 65
- Non-English speaking participants
Correct answer: Pregnant women, prisoners, and children
21 CFR Part 50 subparts C and D provide additional protections for children and prisoners as vulnerable populations.
Question 4: What is the purpose of a Certificate of Confidentiality (CoC) in US clinical research?
- To protect sponsor proprietary data from competitors
- To protect researchers from being compelled to disclose identifiable research information (Correct answer)
- To certify that a site maintains data confidentiality standards
- To exempt the study from HIPAA requirements
Correct answer: To protect researchers from being compelled to disclose identifiable research information
A Certificate of Confidentiality protects identifiable, sensitive research information from compelled disclosure in legal, administrative, or other proceedings.
Question 5: Which section of the Code of Federal Regulations addresses IRB composition and review procedures?
- 21 CFR Part 11
- 21 CFR Part 50
- 21 CFR Part 56 (Correct answer)
- 21 CFR Part 312
Correct answer: 21 CFR Part 56
21 CFR Part 56 covers IRB regulations, including composition, functions, operations, and review criteria.
Question 6: A sponsor submits an IND to the FDA. If the FDA does not respond within how many days, the sponsor may proceed with the trial?
- 14 days
- 21 days
- 30 days (Correct answer)
- 45 days
Correct answer: 30 days
If the FDA does not place the IND on clinical hold within 30 days of receipt, the sponsor may proceed with the proposed clinical investigation.
SOCRA CCRP Regulatory Compliance 2
Which regulatory body must approve a new drug's IND before Phase 1 clinical trials can begin in the US?