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 an 'archiving plan' for a clinical trial?
Answer: A documented plan specifying what records will be archived, where, in what format, for how long, and who is responsible
An archiving plan specifies the scope, format, location, retention duration, and responsibilities for preserving all essential trial documents post-trial.
What is the Trial Master File (TMF), and what happens to it at trial close-out?
Answer: The sponsor's master collection of all essential documents for the trial; it is finalized, quality-checked, and archived at close-out
The TMF is the sponsor's collection of all essential documents that together allow reconstruction of the trial; at close-out it is finalized and transferred to long-term archive.
Under GCP, can a site destroy archived clinical trial records before the required retention period?
Answer: No, records must not be destroyed before the required retention period without written authorization from the sponsor
Archived records cannot be destroyed before the legally required retention period expires without explicit written authorization from the sponsor.
What is a 'final study report' (Clinical Study Report, CSR) and who is responsible for its preparation?
Answer: A comprehensive document prepared by the sponsor summarizing the trial's design, conduct, results, and conclusions
The CSR is a comprehensive sponsor-prepared document summarizing the complete trial—design, methods, results, and conclusions—required for regulatory submissions.
What is the significance of the 'last subject last visit' (LSLV) milestone in a clinical trial?
Answer: It is the date when the final study subject completes their final protocol-required visit, signaling the start of data cleaning and close-out
LSLV is a key milestone indicating that all subject participation is complete, after which data cleaning, query resolution, and close-out activities begin.
What type of audit may be conducted at a site after the trial is closed to verify the integrity of archived records?
Answer: A regulatory inspection or sponsor audit of the archived Investigator Site File
Post-trial regulatory inspections or sponsor audits may examine the archived ISF to verify that all required documents are complete, accurate, and properly retained.