CCA Cheat Sheet 2026

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

1. Who is ultimately responsible for the conduct of a clinical trial at an investigative site? → The Principal Investigator (PI)
2. What step follows data lock in a clinical trial? → Statistical analysis
3. What document captures the agreement between the sponsor and the investigative site regarding financial compensation and obligations? → Clinical Trial Agreement (CTA)
4. What is the primary focus of Good Clinical Practice (GCP)? → Protect participants and ensure data quality
5. What document accompanies each shipment of investigational product (IP) to a clinical site? → Drug shipment manifest / packing slip
6. Which regulatory document must be in place at the site BEFORE any subject can sign the informed consent form? → IRB/IEC approval of the consent form
7. Which document describes the preclinical and clinical data on an investigational product to guide safe use in a clinical trial? → Investigator Brochure
8. Which form must a US-based investigator complete and sign to participate in an FDA-regulated clinical investigation of an investigational drug? → FDA Form 1572 (Statement of Investigator)
9. Which ICH guideline provides the framework for clinical safety data management and expedited reporting of adverse drug reactions? → ICH E2A
10. A Phase II clinical trial is primarily designed to: → Assess preliminary efficacy and dosing in patients with the target disease
11. Who at an investigative site is responsible for assessing causality of adverse events to the investigational product? → The Principal Investigator or qualified sub-investigator
12. Why must informed consent be obtained before trial participation? → To ensure voluntary, informed participation
13. Which role is responsible for monitoring site compliance and data integrity? → Clinical Research Associate (CRA)
14. What is the Clinical Study Report (CSR)? → Clinical Study Report
15. Under GCP, what must be included in the source documentation when recording an adverse event? → Date of onset, description, severity, relationship to IP, action taken, and outcome
16. How often must IRB continuing reviews be conducted for ongoing studies? → Annually
17. In a crossover study design, what distinguishes it from a parallel group design? → Each participant receives more than one treatment in sequence
18. What is an 'IP inventory log' used for at a clinical site? → To record current stock levels of IP at the site for accountability and re-order purposes
19. What does the term 'protocol deviation' refer to in clinical trial operations? → Any departure from the approved protocol procedures or requirements
20. Which of the following is a core ethical principle in clinical research? → Respect for persons
21. What is an adaptive clinical trial design? → A design that allows pre-specified modifications to the trial based on interim data
22. What does the Declaration of Helsinki provide? → Ethical principles for medical research
23. What is the primary ethical principle that guides subject recruitment in clinical trials? → Voluntary participation based on freely given informed consent without coercion
24. What is the term for a subject who cannot be located for follow-up visits or safety assessments? → Lost to follow-up (LTFU)
25. What is the purpose of a protocol synopsis? → To provide a concise summary of the key elements of the study protocol
26. Which ICH guideline provides the foundational framework for the design, conduct, recording, and reporting of clinical trials? → ICH E6(R2)
27. What is the primary objective of Phase I in clinical trials? → Evaluate safety and dosage in healthy volunteers
28. What is a 'medication error' in the context of investigational product management? → Any unintended exposure of a subject to the wrong IP dose, route, or product
29. In the context of protocol development, what is a 'stratification factor'? → A variable used to balance randomization across subgroups to reduce confounding
30. What is the term for the organized set of essential documents that must be maintained at the investigative site throughout a clinical trial? → Investigator Site File (ISF)