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
📚 CRA Topics to Study (69)
✍️ Sample CRA Questions & Answers
1. Under ICH-GCP, which of the following constitutes an 'essential document'?
ICH E6(R2) Section 8 defines essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.
2. Which sampling method divides the population into mutually exclusive groups and randomly samples from each?
Stratified sampling segments the population into strata (e.g., age groups) and draws random samples from each to ensure representation.
3. Under the HIPAA Privacy Rule, a 'limited data set' may be used for research without individual authorization provided:
A limited data set retains some indirect identifiers but may be used for research under a data use agreement without individual authorization.
4. In quantitative research, a p-value of 0.03 means:
A p-value represents the probability of observing data as extreme as the sample, assuming the null hypothesis is true — not the probability that any hypothesis is correct.
5. Which situation best justifies performing a meta-analysis rather than a narrative synthesis in a systematic review?
Meta-analysis is appropriate when included studies are sufficiently similar in population, intervention, comparator, and outcome to justify combining their results statistically.
6. Multiple testing in a clinical trial without correction inflates the probability of:
Each additional hypothesis test at alpha=0.05 adds a 5% chance of a false positive; without correction, the family-wise Type I error rate exceeds alpha.