CCA CATO Associate Study Close-Out & Archiving

Question 1

What is the primary purpose of a site close-out visit (COV) in a clinical trial?

Accepted 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

Answer

To randomize remaining subjects

Answer

To conduct the final safety review of SAEs

Answer

To train staff on the next study

Question 2

How long must clinical trial records typically be retained at the investigative site under FDA regulations?

Accepted Answer

2 years after the latest marketing application is approved, or 2 years after the IND is withdrawn (per 21 CFR 312.62)

Answer

1 year after trial completion

Answer

5 years from the last subject's last visit

Answer

Indefinitely

Question 3

What is 'database lock' in the context of clinical trial close-out?

Accepted Answer

The formal process of finalizing the clinical database after all data cleaning is complete, preventing further changes

Answer

Encrypting the electronic CRF to prevent hacking

Answer

Archiving all paper source documents

Answer

Closing the randomization system

Question 4

What activities must be completed BEFORE a site close-out visit can occur?

Accepted Answer

All subject visits completed or early terminated, all data queries resolved, IP reconciled, and all SAEs resolved or with final status

Answer

Only the investigator's signature on the final report

Answer

Site staff have been recruited for the next study

Answer

The clinical study report has been submitted to the FDA

Question 5

What is the purpose of the 'end of trial notification' submitted to regulatory authorities?

Accepted Answer

To officially inform regulatory authorities that the clinical trial has ended in compliance with regulatory requirements

Answer

To request IND cancellation for all future trials

Answer

To submit the final clinical study report

Answer

To notify the IRB that subject visits are complete

Question 6

What is 'data query resolution' and why is it critical before database lock?

Accepted Answer

The process of identifying, issuing, and resolving inconsistencies or missing data in the CRF before the database is finalized

Answer

Correcting data entry errors in the IP accountability log

Answer

Answering sponsor questions about study budget

Answer

Obtaining IRB approval for protocol deviations