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. Which document ensures a participant’s agreement to take part in a study? → Informed Consent Form
2. What is the purpose of the Trial Master File (TMF)? → To maintain essential trial documentation
3. According to GCP, how frequently should a clinical monitor verify IP accountability records at the site? → During each monitoring visit throughout the study
4. 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
5. Which standard of practice is MOST important for ensuring quality in Study Startup & Feasibility? → Following evidence-based protocols while adapting to specific circumstances
6. 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
7. 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
8. Why must adverse events be reported to regulatory authorities? → To maintain FDA approval
9. What is the PRIMARY purpose of continuing education requirements in Informed Consent Process for CTA professionals? → Maintaining current knowledge and competency as the field evolves
10. What is the primary purpose of an Investigational Product (IP) accountability log in clinical trials? → To track receipt, dispensing, return, and destruction of all IP at the site
11. What is the correct action when investigational product at a site reaches its expiration date? → Quarantine the expired product, notify the sponsor, and arrange disposal per protocol
12. What is a protocol deviation? → Any departure from the approved protocol
13. What is the purpose of an audit in clinical research? → To verify compliance and data accuracy
14. When a conflict arises between standard procedures and a unique situation in Adverse Event Reporting, what should a CTA professional prioritize? → Safety and ethical obligations while seeking expert consultation
15. What is a primary endpoint in a clinical trial? → The main outcome measure used to assess the treatment's effect
16. Who must authorize any changes to investigational product storage conditions at a clinical trial site? → The sponsor or designee, typically in writing before implementation
17. When a conflict arises between standard procedures and a unique situation in Study Startup & Feasibility, what should a CTA professional prioritize? → Safety and ethical obligations while seeking expert consultation
18. What does 21 CFR Part 11 regulate? → Electronic records and signatures
19. Which study design follows a group of participants over time to assess outcomes? → Cohort study
20. What is the main purpose of FDA Form 1572? → To document investigator responsibilities
21. Who is typically responsible for dispensing investigational products to study participants at a clinical site? → A qualified pharmacist or authorized designee as specified in the protocol
22. What is required before initiating a clinical trial under GCP? → IRB approval and informed consent
23. Which regulatory body oversees drug approval in the United States? → FDA
24. According to GCP guidelines, where should investigational products be stored at a clinical trial site? → In a designated, secure area under conditions specified by the sponsor protocol
25. Which guideline defines the standard for clinical trials globally? → ICH E6 (R2)
26. Which of the following is essential for trial monitoring? → Regular site visits and data verification
27. What does the term 'placebo-controlled' mean in a clinical trial? → A control group receives an inactive substance identical in appearance to the treatment
28. In Good Clinical Practice & ICH Guidelines, 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
29. Why is it important to follow standard operating procedures (SOPs)? → To ensure consistent and compliant trial conduct
30. What is the timeframe for reporting a fatal or life-threatening unexpected SUSAR to the FDA under IND regulations? → 7 calendar days