CCA CATO Associate Study Close-Out & Archiving 2 — Questions and Answers
Question 1: What is an 'archiving plan' for a clinical trial?
- A schedule for hiring archival staff after the trial
- A documented plan specifying what records will be archived, where, in what format, for how long, and who is responsible (Correct answer)
- A list of documents to be destroyed after 2 years
- A plan for publishing the clinical study report
Correct 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.
Question 2: What is the Trial Master File (TMF), and what happens to it at trial close-out?
- A file containing only the IP accountability records; it is destroyed at close-out
- The sponsor's master collection of all essential documents for the trial; it is finalized, quality-checked, and archived at close-out (Correct answer)
- A document held only by the IRB
- A file opened only after the database is locked
Correct 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.
Question 3: Under GCP, can a site destroy archived clinical trial records before the required retention period?
- Yes, if the PI authorizes destruction
- No, records must not be destroyed before the required retention period without written authorization from the sponsor (Correct answer)
- Yes, if the IRB grants a waiver
- Yes, after the clinical study report is published
Correct 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.
Question 4: What is a 'final study report' (Clinical Study Report, CSR) and who is responsible for its preparation?
- A report prepared by the PI summarizing the site's enrollment
- A comprehensive document prepared by the sponsor summarizing the trial's design, conduct, results, and conclusions (Correct answer)
- A summary prepared by the IRB for public release
- A financial audit report submitted to the FDA
Correct 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.
Question 5: What is the significance of the 'last subject last visit' (LSLV) milestone in a clinical trial?
- It marks when the first subject is enrolled
- It is the date when the final study subject completes their final protocol-required visit, signaling the start of data cleaning and close-out (Correct answer)
- It is the date when the database is locked
- It marks when the last subject signs informed consent
Correct 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.
Question 6: What type of audit may be conducted at a site after the trial is closed to verify the integrity of archived records?
- A site qualification visit
- A regulatory inspection or sponsor audit of the archived Investigator Site File (Correct answer)
- A protocol amendment review
- A staff competency evaluation
Correct 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.
CCA CATO Associate Study Close-Out & Archiving 2
What is an 'archiving plan' for a clinical trial?