Practice Test Geeks(CRA) Certified Research Administrator Practice Test
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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

  1. A foreign national researcher joins a federally funded project involving export-controlled technology. What must the research administrator assess first?

    Answer: Whether a deemed export license is required

    Sharing export-controlled technology with a foreign national in the U.S. is a 'deemed export' and may require an EAR or ITAR license.

  2. Under the NIH Grants Policy Statement, what is the maximum allowable indirect cost rate on training grants (T and F series)?

    Answer: 8% of modified total direct costs

    NIH caps indirect costs on training grants at 8% of modified total direct costs, regardless of the institution's negotiated rate.

  3. Which federal law established the requirement for research institutions receiving PHS funding to have written policies on research misconduct?

    Answer: The Public Health Service Act as amended (42 CFR Part 93)

    42 CFR Part 93 implements PHS research misconduct regulations requiring institutions to have policies, procedures, and reporting requirements.

  4. What does 'assurance' refer to in the context of human subjects research compliance at a federally funded institution?

    Answer: A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46

    A Federalwide Assurance is a formal institutional commitment to OHRP to follow federal human subjects protections for all research.

  5. An institution discovers a significant financial conflict of interest (FCOI) on an active NIH grant mid-project. What is the required timeline for reporting to NIH?

    Answer: Within 60 days of identification

    Under 42 CFR Part 50 Subpart F, institutions must report identified FCOIs to NIH within 60 days and implement a management plan.

  6. Which of the following activities is specifically exempt from IACUC review under the Animal Welfare Act?

    Answer: Field studies of free-living wild animals that do not involve harm, deprivation, or stress

    The Animal Welfare Act exempts field studies of free-living wild animals where the research does not involve invasive procedures or captivity.

  7. Under Uniform Guidance 2 CFR 200, what is the threshold above which a non-Federal entity must have a single audit conducted?

    Answer: $750,000 in federal expenditures

    2 CFR 200.501 requires a single audit for non-Federal entities that expend $750,000 or more in federal awards during a fiscal year.