Trial Documentation Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Trial Documentation flashcards as text
When archiving trial documents at study close-out, the minimum retention period required by ICH E6(R2) after study completion is:
Answer: At least 2 years after the last marketing approval, or at least 2 years if no approval
ICH E6(R2) requires essential documents to be retained for at least 2 years after the last approval of a marketing application or 2 years after formal discontinuation.
A site delegation log (Signature and Delegation Log) documents:
Answer: Staff qualifications and trial tasks delegated by the PI to sub-investigators and coordinators
The delegation log shows which qualified personnel have been assigned specific trial responsibilities by the principal investigator.
What distinguishes a protocol deviation from a protocol violation in trial documentation?
Answer: Deviations are unintentional minor departures; violations are deviations that significantly affect subject safety or data integrity
Violations are a subset of deviations that significantly compromise subject safety, rights, or data reliability and typically require expedited reporting.
Which section of an eTMF system is specifically designed to hold sponsor-to-site correspondence?
Answer: Zone 5 – Central Trial Documents
Per the TMF Reference Model, site-specific correspondence and communication are typically filed under Zone 5 or equivalent site management sections.
An investigator site receives an unannounced regulatory inspection. The first document the inspector is likely to request is:
Answer: The Investigator Site File (ISF) or Site TMF
Regulatory inspectors review the ISF/Site TMF to verify GCP compliance and the completeness of essential trial documentation.
Under 21 CFR Part 312, which document must an investigator sign to confirm they will conduct the study in accordance with the protocol and applicable regulations?
Answer: FDA Form 1572 (Statement of Investigator)
Form FDA 1572 is the binding commitment signed by investigators to comply with GCP, the protocol, and reporting obligations.
When a subject withdraws from a trial, which documentation step is mandatory at the site?
Answer: Record the withdrawal date, reason if given, and any follow-up per protocol
Subject withdrawal must be documented with date, reason (if volunteered), and any safety follow-up required by the protocol.