CCA CATO Associate Study Close-Out & Archiving 1 — Questions and Answers
Question 1: What is the primary purpose of a site close-out visit (COV) in a clinical trial?
- To randomize remaining subjects
- To ensure all study activities are complete, IP is reconciled and returned/destroyed, data queries resolved, and essential documents are in order for archiving (Correct answer)
- To conduct the final safety review of SAEs
- To train staff on the next study
Correct answer: To ensure all study activities are complete, IP is reconciled and returned/destroyed, data queries resolved, and essential documents are in order for archiving
The COV confirms that all trial activities have been completed, IP accounted for, data finalized, and documents are ready for archiving per sponsor and regulatory requirements.
Question 2: How long must clinical trial records typically be retained at the investigative site under FDA regulations?
- 1 year after trial completion
- 2 years after the latest marketing application is approved, or 2 years after the IND is withdrawn (per 21 CFR 312.62) (Correct answer)
- 5 years from the last subject's last visit
- Indefinitely
Correct answer: 2 years after the latest marketing application is approved, or 2 years after the IND is withdrawn (per 21 CFR 312.62)
Under 21 CFR 312.62, investigators must retain records for 2 years following the date a marketing application is approved, or 2 years after the IND is discontinued.
Question 3: What is 'database lock' in the context of clinical trial close-out?
- Encrypting the electronic CRF to prevent hacking
- The formal process of finalizing the clinical database after all data cleaning is complete, preventing further changes (Correct answer)
- Archiving all paper source documents
- Closing the randomization system
Correct answer: The formal process of finalizing the clinical database after all data cleaning is complete, preventing further changes
Database lock is the point at which all data cleaning is complete, the database is reviewed and approved, and it is formally locked against further changes prior to analysis.
Question 4: What activities must be completed BEFORE a site close-out visit can occur?
- Only the investigator's signature on the final report
- All subject visits completed or early terminated, all data queries resolved, IP reconciled, and all SAEs resolved or with final status (Correct answer)
- Site staff have been recruited for the next study
- The clinical study report has been submitted to the FDA
Correct answer: All subject visits completed or early terminated, all data queries resolved, IP reconciled, and all SAEs resolved or with final status
Before COV, all subject participation must be completed, data queries resolved, IP fully reconciled, and SAEs documented to their final status.
Question 5: What is the purpose of the 'end of trial notification' submitted to regulatory authorities?
- To request IND cancellation for all future trials
- To officially inform regulatory authorities that the clinical trial has ended in compliance with regulatory requirements (Correct answer)
- To submit the final clinical study report
- To notify the IRB that subject visits are complete
Correct answer: To officially inform regulatory authorities that the clinical trial has ended in compliance with regulatory requirements
An end of trial notification formally informs regulatory authorities that the trial has concluded, triggering applicable post-trial reporting and archiving obligations.
Question 6: What is 'data query resolution' and why is it critical before database lock?
- Correcting data entry errors in the IP accountability log
- The process of identifying, issuing, and resolving inconsistencies or missing data in the CRF before the database is finalized (Correct answer)
- Answering sponsor questions about study budget
- Obtaining IRB approval for protocol deviations
Correct answer: The process of identifying, issuing, and resolving inconsistencies or missing data in the CRF before the database is finalized
Data query resolution ensures all CRF data is accurate, consistent, and complete before database lock, protecting the integrity of the final analysis dataset.
CCA CATO Associate Study Close-Out & Archiving 1
What is the primary purpose of a site close-out visit (COV) in a clinical trial?