CTA Cheat Sheet 2026

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

1. What is the primary purpose of the Trial Master File (TMF)? → To serve as the comprehensive repository of all essential trial documents
2. When must an investigator notify the sponsor of a protocol deviation? → Within the timeframe specified in the protocol or monitoring plan
3. In a GCP-compliant trial, source document verification (SDV) by a CRA primarily serves to: → Confirm that CRF data accurately reflect the source data
4. Which document ensures a participant’s agreement to take part in a study? → Informed Consent Form
5. What is the purpose of the Trial Master File (TMF)? → To maintain essential trial documentation
6. A protocol requires fasting blood samples but a site collected samples from non-fasting subjects. This represents which type of protocol issue? → A major protocol deviation
7. In a double-blind randomized controlled trial protocol, what mechanism ensures that neither the investigator nor the subject knows the treatment assignment? → Blinding and allocation concealment procedures
8. Which document defines the responsibilities and procedures for transferring sponsor obligations to a Contract Research Organization (CRO)? → Sponsor-CRO Agreement
9. In clinical trial monitoring, what does 'source data verification (SDV)' specifically confirm? → That data entered in the CRF matches the original source records
10. Under ICH E6(R2), which of the following is NOT considered an essential document that must be in the Trial Master File before the trial begins? → Completed Case Report Forms (CRFs)
11. What is the appropriate action when a subject reports an adverse event that occurred between two scheduled visits? → Document it in the AE CRF page immediately with onset date and details
12. What is the primary purpose of a Pre-Study Site Visit (PSV)? → To evaluate the site's suitability and capabilities before trial initiation
13. Which federal regulation specifically governs informed consent requirements for FDA-regulated clinical investigations in the United States? → 21 CFR Part 50
14. Which GCP principle applies when a monitor discovers that source documents have been altered without an audit trail? → Reporting the finding in the monitoring visit report and escalating to the sponsor
15. When a sponsor transfers trial-related duties to a CRO, ICH E6(R2) requires that: → A written agreement clearly specifying transferred duties is established
16. Which of the following is an example of a serious adverse event (SAE) as defined by ICH E6? → Hospitalization for a condition unrelated to the study drug
17. What is the difference between an Adverse Event (AE) and a Treatment-Emergent Adverse Event (TEAE)? → A TEAE is an AE that was absent at baseline or worsened after study treatment began
18. According to GCP, how frequently should a clinical monitor verify IP accountability records at the site? → During each monitoring visit throughout the study
19. What does 'FPFV' stand for in clinical trial startup timelines? → First Patient First Visit
20. Which GCP principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate? → The ALCOA principle
21. Which document at the site level serves as the primary source for tracking and reconciling all reported adverse events? → The Adverse Event Log (AE Log)
22. In Site Management & Monitoring, what is the FIRST step a CTA professional should take when encountering a new case or situation? → Conduct a comprehensive assessment and gather all relevant information
23. Which standard of practice is MOST important for ensuring quality in Study Startup & Feasibility? → Following evidence-based protocols while adapting to specific circumstances
24. In Protocol Development & Review, what is the FIRST step a CTA professional should take when encountering a new case or situation? → Conduct a comprehensive assessment and gather all relevant information
25. Which of the following is NOT typically included in a site feasibility questionnaire? → Subject randomization allocation ratios
26. In clinical trials, what does 'per protocol' (PP) analysis refer to? → Analyzing only subjects who completed the trial without major protocol deviations
27. Which document serves as the master reference for the rights and responsibilities of the sponsor, investigator, and institution at a clinical trial site? → The Clinical Trial Agreement (CTA)
28. When a conflict arises between standard procedures and a unique situation in Good Clinical Practice & ICH Guidelines, what should a CTA professional prioritize? → Safety and ethical obligations while seeking expert consultation
29. A subject misses a scheduled visit. How should the missed visit data be recorded in the CRF? → Document 'not done' or 'missed visit' with the reason in the appropriate CRF fields
30. Under 21 CFR Part 312, which type of IND is designed for studies to be conducted by investigators who are NOT the IND sponsor? → Investigator IND