Regulatory Compliance & Licensing Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Licensing flashcards as text
A sponsor requires a Material Transfer Agreement (MTA) before shipping biological materials to a collaborating institution. Which office typically has signature authority for MTAs?
Answer: The institution's sponsored programs or technology transfer office
MTAs are institutional agreements that bind the organization to transfer terms, so authorized institutional officials — not individual PIs — must sign them.
What triggers the requirement for a Data Use Agreement (DUA) under HIPAA for research purposes?
Answer: Receiving a limited data set containing protected health information from a covered entity
HIPAA requires a DUA when a covered entity provides a limited data set (with some PHI removed but not fully de-identified) for research.
Under DOD grant regulations (2 CFR 1108), what is required before a researcher may publish research results from a DOD-funded contract?
Answer: A prepublication security review period allowing DOD to review for classified or controlled information
DOD contracts typically include a prepublication review clause giving the agency a window (often 30-90 days) to review manuscripts for security concerns.
An investigator holds $15,000 in stock in a company that makes the device being studied in their NIH-funded research. What FCOI threshold does this exceed?
Answer: $5,000 — the current PHS significant financial interest threshold
Under 42 CFR Part 50, a significant financial interest in an entity includes equity interests exceeding $5,000 for publicly traded companies.
A subrecipient institution fails to maintain required financial records for a federal subaward. Under 2 CFR 200, what is the minimum record retention period?
Answer: 3 years from the date of submission of the final expenditure report
2 CFR 200.334 requires financial records to be retained for 3 years from the date of submission of the final expenditure report.
Which of the following best describes the purpose of an Institutional Biosafety Committee (IBC) under the NIH Guidelines?
Answer: To review and oversee recombinant DNA and synthetic nucleic acid research for biosafety compliance
The IBC's primary role under NIH Guidelines is to review research involving recombinant or synthetic nucleic acid molecules for biosafety risk.
What federal regulation governs research involving prisoners as human subjects and imposes heightened protections?
Answer: 45 CFR Part 46 Subpart C
45 CFR Part 46 Subpart C provides additional protections for prisoners involved in research, limiting permissible research categories.