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
What action must be taken when a protocol amendment changes inclusion/exclusion criteria for already-enrolled subjects?
Answer: Re-screen all enrolled subjects against new criteria and document the assessment
An impact assessment for currently enrolled subjects must be conducted and documented whenever eligibility criteria change.
Which type of audit trail feature is required in electronic data capture (EDC) systems per 21 CFR Part 11?
Answer: Time-stamped record of all data entries, changes, and deletions
21 CFR Part 11 mandates that EDC systems maintain a secure, time-stamped audit trail capturing who changed what data and when.
A 'blinded' copy of randomization codes held by an independent party during a trial is referred to as:
Answer: Sealed randomization list
A sealed randomization list is kept by an independent party to maintain blinding while allowing emergency unblinding if required.
What is the primary purpose of the Trial Master File (TMF)?
Answer: To serve as the comprehensive repository of all essential trial documents
The TMF is the definitive collection of all essential documents demonstrating that the trial was conducted in compliance with GCP and regulations.
Which document must be updated and re-signed by a subject whenever new safety information materially affects willingness to continue participation?
Answer: Re-consent form / updated ICF
When significant new risk information emerges, subjects must be re-consented using an updated informed consent form before continuing.
A certificate of analysis (CoA) for investigational product is filed in the TMF primarily to:
Answer: Confirm that the product meets specified quality standards before dispensing
The CoA verifies that each batch of investigational product meets pre-defined quality, potency, and purity specifications.
Which GCP principle applies when a monitor discovers that source documents have been altered without an audit trail?
Answer: Reporting the finding in the monitoring visit report and escalating to the sponsor
Data integrity findings must be documented in the monitoring report and escalated per the sponsor's procedures for investigation.