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. Under ICH-GCP E6(R2), the sponsor's audit differs from monitoring in that audits are: → Systematic independent evaluations to assess trial conduct
3. Which US regulation specifically governs Institutional Review Board (IRB) requirements for FDA-regulated clinical trials? → 21 CFR Part 56
4. Standard of care (SOC) is defined as. → The normal care provided per the sites guidelines
5. A 'Certificate of Analysis' (CoA) for investigational product is used primarily to verify: → Drug identity, purity, potency, and quality
6. Analysis of all trial participants who followed procedure and finished the experiment → per protocol analysis
7. 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
8. How many steps are involved in the conduct of a clinical research study? → 4
9. 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
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 does the term 'source document verification (SDV)' refer to in clinical monitoring? → Comparing CRF data to original source documents to confirm accuracy
12. 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
13. What is the name of the document that the site must sign and date before making a QV appointment? → A CDA
14. Which organization administers the CCRA certification examination in the United States? → The Association of Clinical Research Professionals (ACRP)
15. Is it necessary to obtain approval from ________ before starting a clinical research study? → Regulators and ethics committees
16. 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
17. 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
18. 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
19. Which document defines the objectives, design, methodology, statistical considerations, and organization of a clinical trial? → The clinical trial protocol
20. The 15-day reporting clock for an expedited IND safety report begins when: → The sponsor first receives minimum valid safety information about the SUSAR
21. Statistical evaluation of subject data according to the group they were placed in despite not adhering to the study protocol → Intention to treat analysis
22. Which regulation requires informed consent to be obtained in a language understandable to the subject? → 21 CFR Part 50
23. The ALCOA+ principles add which additional attributes beyond ALCOA? → Complete, Consistent, Enduring, and Available
24. 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
25. Subject medication compliance (adherence) is most commonly assessed in clinical trials by: → Pill/device counts, subject diaries, or plasma drug level measurements
26. Under FDA regulations, which document defines the sponsor's delegation of trial-related duties to a CRO? → Written Transfer of Obligations
27. Which of the following is an example of a critical process that should be prioritized during risk-based monitoring? → Informed consent process and documentation
28. Which ICH-GCP guideline governs the conduct of clinical trials to ensure data integrity and subject safety? → ICH E6(R2)
29. Conflict of interest is a risk factor for scientific misconduct in clinical research investigations. → Yes
30. When must the CRA ensure that the Trial Master File (TMF) is set up and accessible? → Before the trial begins and maintained throughout the trial