CRA Site Initiation & Monitoring Visits 3 — Questions and Answers
Question 1: Which regulatory document must be in place before the first subject can be enrolled at a US clinical trial site?
- Signed FDA Form 1572 (Correct answer)
- Executed Clinical Trial Agreement (CTA)
- Site qualification report
- Subject recruitment advertisement
Correct answer: Signed FDA Form 1572
FDA Form 1572 is the Statement of Investigator, which must be signed before the investigator can conduct an IND-regulated study in the US.
Question 2: A CRA is reviewing the delegation of authority log during a monitoring visit. What is the most critical thing to verify?
- That the sponsor's medical monitor is listed
- That each person's delegated tasks fall within their professional qualifications and training (Correct answer)
- That the log uses the sponsor's template format
- That the site coordinator's home address is recorded
Correct answer: That each person's delegated tasks fall within their professional qualifications and training
Tasks must only be delegated to individuals whose qualifications and training allow them to perform those duties safely and in compliance with regulations.
Question 3: During a close-out visit, which action regarding the Investigational Product (IP) must be completed before the visit is considered finished?
- Transferring remaining IP to another study site
- Completing final drug accountability reconciliation and arranging destruction or return of all IP (Correct answer)
- Obtaining a new IRB waiver for retained samples
- Re-consenting subjects for long-term follow-up
Correct answer: Completing final drug accountability reconciliation and arranging destruction or return of all IP
Final drug accountability must reconcile all dispensed, returned, and remaining IP, and all unused product must be returned to the sponsor or destroyed per protocol.
Question 4: What does the term 'essential documents' refer to in clinical research monitoring?
- Only the protocol and informed consent form
- Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced (Correct answer)
- Financial contracts between the sponsor and site
- Subject diary cards and questionnaires only
Correct answer: Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced
ICH E6(R2) defines essential documents as those that permit evaluation of trial conduct and data quality, and they must be retained in both the ISF and the Trial Master File.
Question 5: A site has missed the required follow-up visit window for three subjects. As the CRA, you should:
- Immediately terminate the subjects from the study
- Document the protocol deviations and ensure the site submits reports to the IRB and sponsor per the protocol requirements (Correct answer)
- Ignore the deviations since subjects are still enrolled
- Adjust the visit window retrospectively in the CRF
Correct answer: Document the protocol deviations and ensure the site submits reports to the IRB and sponsor per the protocol requirements
Missed visit windows are protocol deviations that require documentation, reporting to the IRB and sponsor as specified in the protocol, and corrective action planning.
Question 6: What is the key difference between a monitoring visit and an audit in clinical research?
- Monitoring is conducted by the FDA; audits are conducted by the sponsor
- Monitoring is an ongoing sponsor oversight activity; an audit is a systematic, independent examination (Correct answer)
- Monitoring reviews only financial records; audits review clinical data
- There is no difference; the terms are interchangeable
Correct answer: Monitoring is an ongoing sponsor oversight activity; an audit is a systematic, independent examination
ICH E6(R2) distinguishes monitoring as sponsor quality oversight from audits as independent systematic evaluations to assess compliance.
Question 7: During a monitoring visit, the CRA finds a subject who does not meet a key inclusion criterion but was enrolled. The CRA should:
- Retroactively amend the inclusion criteria in the protocol
- Document the deviation, notify the sponsor immediately, and advise the site to report to the IRB (Correct answer)
- Remove the subject's data from the database without documentation
- Allow continued participation without reporting since the subject is already enrolled
Correct answer: Document the deviation, notify the sponsor immediately, and advise the site to report to the IRB
Enrollment of an ineligible subject is a protocol deviation requiring documentation, immediate sponsor notification, and IRB reporting per protocol requirements.
CRA Site Initiation & Monitoring Visits 3
Which regulatory document must be in place before the first subject can be enrolled at a US clinical trial site?