CCRA Cheat Sheet 2026

The 30 highest-yield CCRA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Centralized monitoring differs from on-site monitoring in that it: → Involves remote review of accumulating data to identify trends and signals
2. Which of the following is NOT typically reviewed during a Site Qualification Visit? → Final data lock and statistical analysis outputs
3. Under ICH-GCP E6(R2), the sponsor's audit differs from monitoring in that audits are: → Systematic independent evaluations to assess trial conduct
4. Which US regulation specifically governs Institutional Review Board (IRB) requirements for FDA-regulated clinical trials? → 21 CFR Part 56
5. Standard of care (SOC) is defined as. → The normal care provided per the sites guidelines
6. A 'Certificate of Analysis' (CoA) for investigational product is used primarily to verify: → Drug identity, purity, potency, and quality
7. Analysis of all trial participants who followed procedure and finished the experiment → per protocol analysis
8. Which GCP principle states that the rights, safety, and well-being of trial subjects are the most important considerations? → Ethical principle of primacy of subject protection
9. How many steps are involved in the conduct of a clinical research study? → 4
10. A Monitoring Visit Report (MVR) must be completed and submitted to the sponsor within the timeframe specified in the monitoring plan primarily to: → Document visit findings and ensure timely follow-up on issues identified
11. What is the name of the document that the site must sign and date before making a QV appointment? → A CDA
12. Is it necessary to obtain approval from ________ before starting a clinical research study? → Regulators and ethics committees
13. When a CRA finds that a site has enrolled a subject who did not meet all inclusion criteria, this is documented as: → A protocol deviation or violation
14. After the Site Initiation Visit, what document does the CRA typically produce to summarize the visit findings and outstanding action items? → Site Initiation Visit Report / Follow-Up Letter
15. The 15-day reporting clock for an expedited IND safety report begins when: → The sponsor first receives minimum valid safety information about the SUSAR
16. Statistical evaluation of subject data according to the group they were placed in despite not adhering to the study protocol → Intention to treat analysis
17. Which regulation requires informed consent to be obtained in a language understandable to the subject? → 21 CFR Part 50
18. The ALCOA+ principles add which additional attributes beyond ALCOA? → Complete, Consistent, Enduring, and Available
19. Which of the following statements about the informed consent process at site initiation is CORRECT? → Only the IRB-approved version of the ICF may be used to consent subjects
20. Subject medication compliance (adherence) is most commonly assessed in clinical trials by: → Pill/device counts, subject diaries, or plasma drug level measurements
21. Under FDA regulations, which document defines the sponsor's delegation of trial-related duties to a CRO? → Written Transfer of Obligations
22. Which of the following is an example of a critical process that should be prioritized during risk-based monitoring? → Informed consent process and documentation
23. Which ICH-GCP guideline governs the conduct of clinical trials to ensure data integrity and subject safety? → ICH E6(R2)
24. Conflict of interest is a risk factor for scientific misconduct in clinical research investigations. → Yes
25. The initial recording of data for a clinical study is called __________ and comprises notes from observations, lab results, and other relevant documents. → Source Document
26. Which document is used at site initiation to formally define the delegation of trial-related duties from the Principal Investigator to site staff? → The Delegation of Authority Log (DOA Log)
27. From 1932 until 1972, the Tuskegee Syphilis Study was conducted. → Yes
28. At a Site Closeout Visit (COV), which activity is MOST critical for the CRA to confirm? → All trial materials are accounted for and essential documents are complete and archived
29. Source Data Verification (SDV) involves comparing CRF data to: → Original source documents such as medical records and lab reports
30. A CRA discovers that a site has been using an expired version of the informed consent form. What is the MOST immediate action? → Document the finding and require re-consent using the current IRB-approved form