CATO Associate Study Close-Out & Archiving Flashcards
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Read the first 6 CATO Associate Study Close-Out & Archiving flashcards as text
What is 'electronic archiving' of clinical trial documents, and what are its regulatory requirements?
Answer: Storing validated electronic copies of trial documents in a system that ensures security, traceability, retrievability, and protection against unauthorized changes
Electronic archiving requires a validated system that ensures documents are secure, traceable, retrievable, and protected from unauthorized alterations per regulatory standards (e.g., 21 CFR Part 11).
What is the purpose of a 'site decommissioning checklist' at the end of a clinical trial?
Answer: To ensure all close-out tasks—IP return, document archiving, equipment return, and staff notifications—are completed systematically
A site decommissioning checklist provides a systematic guide to ensure every close-out requirement is fulfilled before the site is formally closed.
After a clinical trial is closed, for how long should informed consent forms be retained under FDA regulations?
Answer: Per the general record retention timeline—2 years after marketing approval or IND discontinuation (or longer per sponsor instructions)
Informed consent forms follow the same FDA retention timeline as other trial records—at minimum 2 years post-marketing approval or IND discontinuation, unless the sponsor specifies longer.
What is the role of the CRA during site close-out activities?
Answer: To verify that all study activities are complete, IP is reconciled, documents are in order, and the site is prepared for archiving and potential audit
During close-out, the CRA verifies completion of all study activities, IP reconciliation, document organization, and readiness for archiving and regulatory inspection.
What is a 'protocol deviation log' and why is it important during close-out?
Answer: A record of all instances where the study protocol was not followed, which must be reviewed and documented before close-out to ensure completeness
The protocol deviation log must be reviewed and finalized at close-out to ensure all deviations are documented, assessed for impact, and reported per sponsor and regulatory requirements.
If a sponsor transfers a trial to a new CRO during the close-out phase, what must happen to the Trial Master File?
Answer: The TMF must be formally transferred to the new CRO with documented handover, ensuring continuity and completeness of essential documents
When a CRO changes, the TMF must be formally and completely transferred with full documentation of the handover to ensure no gaps in the essential document collection.