CCRC Cheat Sheet 2026

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

1. Under which circumstance may a site implement a protocol change BEFORE receiving formal IRB approval? → When the change is needed to eliminate an immediate hazard to participants
2. A coordinator discovers that a colleague has been entering fabricated lab values into the study database. What is the appropriate response? → Report the concern to the PI, IRB, and institutional research integrity office
3. What key factor distinguishes a 'Serious Adverse Event' (SAE) from a non-serious adverse event according to ICH GCP guidelines? → The outcome or consequence of the event meeting specific criteria.
4. What is the average starting salary for a newly certified Clinical Research Coordinator? → $40,000 - $50,000
5. A protocol deviation rises to the level of a protocol violation when it: → Affects participant safety, rights, or data integrity
6. What is the primary ethical concern when enrolling patients who have a dependent relationship with the investigator (e.g., the PI's own patients)? → Potential undue influence that may compromise voluntary participation
7. After identifying a repeated pattern of the same protocol deviation at a site, the CRC and PI should FIRST: → Conduct a root cause analysis and implement a CAPA (Corrective and Preventive Action) plan
8. What is the primary purpose of a sponsor's audit of a clinical trial site? → To independently verify that GCP and protocol requirements are being followed
9. A sponsor issues a Safety Letter describing a new serious risk identified in another study. What is the coordinator's required action? → Submit the safety information to the IRB promptly
10. What is the purpose of a Corrective and Preventive Action (CAPA) plan submitted to a sponsor after a monitoring finding? → To document and resolve protocol deviations and prevent recurrence
11. Which of the following is an example of a MAJOR protocol deviation? → Enrollment of a participant who did not meet all inclusion criteria
12. A coordinator is aware that the PI has not reported a protocol deviation to the IRB as required. What should the coordinator do? → Remind the PI of the reporting obligation and document the interaction
13. Which of the following elements is essential for a compliant Investigational Product (IP) accountability record at a clinical trial site? → Lot number, expiration date, and quantities received, dispensed, and returned.
14. Which document outlines the sponsor's expectations for site conduct and is the primary agreement between a sponsor and a clinical investigator? → Clinical Trial Agreement
15. Which of the following is the primary purpose of randomization in a clinical trial? → To prevent selection bias by creating comparable study groups.
16. Which of the following is a mandatory membership requirement for an Institutional Review Board (IRB) as specified by federal regulations (45 CFR 46)? → The IRB must have at least one member who is not affiliated with the institution.
17. An FDA investigator arrives unannounced for a study inspection. What is the first step the coordinator should take? → Notify the principal investigator and sponsor immediately
18. What does Form FDA 1572 (Statement of Investigator) legally commit the principal investigator to? → Agreeing to conduct the study according to the protocol and applicable regulations
19. When should a US clinical trial site register its study on ClinicalTrials.gov? → Before enrollment of the first participant, as required by FDAAA 801
20. A protocol amendment that changes the primary study endpoint requires: → IRB review and approval before implementation at the site
21. A study participant completed a required blood draw 5 days outside the protocol-specified visit window. This is an example of: → A protocol deviation
22. Which of the following best describes a 'close-out visit' conducted by a sponsor? → A visit to reconcile drug supplies, archive documents, and verify study completion
23. Which document is primarily used at a clinical research site to track and manage protocol deviations? → Protocol Deviation Log
24. When a sponsor sends a protocol amendment that changes inclusion/exclusion criteria, what must the site coordinator do FIRST? → Submit the amendment to the IRB for approval before implementing
25. When must a US investigational site submit a progress report to the IRB? → At least annually, or more frequently if required by the IRB
26. A sponsor asks the coordinator to change data in the EDC without a corresponding source document correction. What should the coordinator do? → Refuse and report the request to the PI and IRB as a potential GCP violation
27. Which federal regulation requires financial conflict of interest disclosure for PHS-funded research at US institutions? → 42 CFR Part 50 / 45 CFR Part 94
28. When must a protocol amendment be submitted to the IRB for review and approval? → Before implementing any change to the approved protocol
29. In a clinical trial, a p-value of <0.05 is typically interpreted as: → The observed result is statistically significant, and the null hypothesis is rejected.
30. Under the Common Rule, which of the following studies qualifies for exemption from full IRB review? → A survey study of adults involving no sensitive topics and no identifiable information