CRA Study Guide 2026

Everything you need to pass the CRA exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.

📋 CRA Exam Format at a Glance

250
Questions
240 min
Time Limit
70%
Passing Score

📚 CRA Topics to Study (71)

✍️ Sample CRA Questions & Answers

1. Under 45 CFR Part 46, which category of research qualifies for exemption from full IRB review when involving educational tests, surveys, or interviews with adults?
Research involving only benign behavioral interventions with no identifiable data

Exemption Category 3 covers benign behavioral interventions with no reasonably anticipated risks, where data is not identifiable or disclosure would not harm subjects.

2. A university discovers it has been acting as the lead institution on a multi-site study but never executed formal subaward agreements with participating sites. The primary compliance risk is:
Failure to comply with 2 CFR 200.332 pass-through entity obligations

Without executed subawards, the prime recipient has failed its mandatory pass-through entity obligations under 2 CFR 200.332, including communicating award terms and monitoring subrecipients.

3. Under 21 CFR Part 312, which of the following is NOT an investigator obligation related to investigational drugs?
Manufacturing the drug at the clinical site

Investigators are not responsible for manufacturing investigational drugs; that obligation falls on the sponsor under GMP requirements.

4. A research administrator notices that a subrecipient is consistently late submitting technical reports. Which monitoring tool under Uniform Guidance is most appropriate to formalize risk mitigation?
Implementing specific conditions or enhanced oversight per 2 CFR 200.208

2 CFR 200.208 authorizes pass-through entities to impose specific conditions on subrecipients identified as higher-risk to improve performance.

5. Why include a timeline in the proposal?
It helps demonstrate project feasibility

Including a detailed timeline in a research proposal demonstrates the project's feasibility and shows reviewers that the researcher has a realistic plan for completing the work within the proposed timeframe. It breaks down the project into manageable phases, assigning specific durations to each task. This provides confidence that the project can be successfully executed and managed.

6. Under FAR 52.227-11, what must a contractor do when electing to retain title to a subject invention made under a federal contract?
File a patent application within 12 months of disclosure

FAR 52.227-11 (Patent Rights – Ownership by Contractor) requires a patent application to be filed within 12 months of the invention disclosure.

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1. Learn with Flashcards → 2. Drill Practice Tests → 3. Take the Full Exam Simulation
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