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. How long after its occurrence must a sponsor report a suspected unexpected serious adverse reaction (SUSAR) to the FDA for fatal or life-threatening events? → Within 7 calendar days
11. 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
12. What does the term 'source document verification (SDV)' refer to in clinical monitoring? → Comparing CRF data to original source documents to confirm accuracy
13. Under ICH E6(R2), what is the minimum content required in a monitoring visit report? → Date of visit, site visited, CRA name, findings, deviations, and follow-up actions
14. What is the name of the document that the site must sign and date before making a QV appointment? → A CDA
15. Which organization administers the CCRA certification examination in the United States? → The Association of Clinical Research Professionals (ACRP)
16. Is it necessary to obtain approval from ________ before starting a clinical research study? → Regulators and ethics committees
17. 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
18. 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
19. What is the main distinction between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR) in clinical trial terminology? → An ADR implies a causal relationship to the investigational product, while an AE does not
20. In the context of a clinical trial, what does 'randomization' achieve? → It reduces selection bias by ensuring subjects are assigned to treatment groups by chance
21. Which document defines the objectives, design, methodology, statistical considerations, and organization of a clinical trial? → The clinical trial protocol
22. The 15-day reporting clock for an expedited IND safety report begins when: → The sponsor first receives minimum valid safety information about the SUSAR
23. A CRA is conducting a pre-study site selection visit. Which factor would be the STRONGEST disqualifier for site selection? → The PI is currently under FDA investigation for GCP non-compliance
24. Statistical evaluation of subject data according to the group they were placed in despite not adhering to the study protocol → Intention to treat analysis
25. Which regulation requires informed consent to be obtained in a language understandable to the subject? → 21 CFR Part 50
26. The ALCOA+ principles add which additional attributes beyond ALCOA? → Complete, Consistent, Enduring, and Available
27. 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
28. What is the role of a Central IRB (cIRB) in a multi-site clinical trial? → To provide a single ethics review that can cover multiple sites, streamlining oversight
29. Subject medication compliance (adherence) is most commonly assessed in clinical trials by: → Pill/device counts, subject diaries, or plasma drug level measurements
30. Under FDA regulations, which document defines the sponsor's delegation of trial-related duties to a CRO? → Written Transfer of Obligations