Regulatory Compliance Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulatory Compliance flashcards as text
Which regulatory body must approve a new drug's IND before Phase 1 clinical trials can begin in the US?
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.
What is a 'clinical hold' in the context of FDA regulations?
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.
Under 21 CFR Part 50, which individuals are considered 'vulnerable' populations requiring additional protections?
Answer: Pregnant women, prisoners, and children
21 CFR Part 50 subparts C and D provide additional protections for children and prisoners as vulnerable populations.
What is the purpose of a Certificate of Confidentiality (CoC) in US clinical research?
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.
Which section of the Code of Federal Regulations addresses IRB composition and review procedures?
Answer: 21 CFR Part 56
21 CFR Part 56 covers IRB regulations, including composition, functions, operations, and review criteria.
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?
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.