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
Under the Bayh-Dole Act, what must a contractor do if it decides not to retain title to a federally funded invention?
Answer: Notify the federal agency and allow the government to obtain title
If a contractor elects not to retain title, it must notify the funding agency, which then has the right to obtain patent rights.
Which federal regulation governs the export of controlled biological agents and select agents for research purposes?
Answer: Select Agent Program (42 CFR Part 73)
The Select Agent Program under 42 CFR Part 73 regulates possession, use, and transfer of biological select agents and toxins.
A researcher wants to conduct a clinical trial at a VA medical center. Which additional regulatory requirement applies beyond standard IRB approval?
Answer: VA Research and Development Committee approval
VA regulations require VA R&D Committee approval for all research conducted at VA facilities, in addition to IRB approval.
What is the primary purpose of the System for Award Management (SAM) registration requirement for federal grant recipients?
Answer: To establish eligibility to receive federal awards and report subaward data
SAM registration is required to receive federal awards and to comply with Federal Funding Accountability and Transparency Act (FFATA) reporting obligations.
Under 45 CFR Part 46, which category of research with children qualifies for expedited review involving greater than minimal risk but presenting the prospect of direct benefit?
Answer: 46.405
45 CFR 46.405 covers research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
A university receives a federal grant for research on a dual-use research of concern (DURC) pathogen. What additional oversight is required?
Answer: Institutional Review Entity (IRE) review and an Institutional Biosafety Committee assessment
DURC policy requires institutions to establish an Institutional Review Entity and conduct biosafety risk assessments for covered research.
Which provision of the Federal Acquisition Regulation (FAR) requires contractors to disclose and manage organizational conflicts of interest?
Answer: FAR 9.5
FAR Subpart 9.5 addresses organizational conflicts of interest and requires agencies to identify, evaluate, and mitigate such conflicts.