CCA CATO Associate Study Close-Out & Archiving 2

Question 1

What is an 'archiving plan' for a clinical trial?

Accepted Answer

A documented plan specifying what records will be archived, where, in what format, for how long, and who is responsible

Answer

An archiving plan specifies the scope, format, location, retention duration, and responsibilities for preserving all essential trial documents post-trial.

Question 2

What is the Trial Master File (TMF), and what happens to it at trial close-out?

Accepted Answer

The sponsor's master collection of all essential documents for the trial; it is finalized, quality-checked, and archived at close-out

Answer

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.

Question 3

Under GCP, can a site destroy archived clinical trial records before the required retention period?

Accepted Answer

No, records must not be destroyed before the required retention period without written authorization from the sponsor

Answer

Archived records cannot be destroyed before the legally required retention period expires without explicit written authorization from the sponsor.

Question 4

What is a 'final study report' (Clinical Study Report, CSR) and who is responsible for its preparation?

Accepted Answer

A comprehensive document prepared by the sponsor summarizing the trial's design, conduct, results, and conclusions

Answer

The CSR is a comprehensive sponsor-prepared document summarizing the complete trial—design, methods, results, and conclusions—required for regulatory submissions.

Question 5

What is the significance of the 'last subject last visit' (LSLV) milestone in a clinical trial?

Accepted 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

Answer

LSLV is a key milestone indicating that all subject participation is complete, after which data cleaning, query resolution, and close-out activities begin.

(CCA) CATO Certified Associate Practice Test

(CCA) CATO Certified Associate Practice Test

CCA CATO Associate Study Close-Out & Archiving 2