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
Which document tracks the dispensing, return, and destruction of all investigational product at a site?
Answer: Drug Accountability Log
The drug accountability log records every movement of investigational product at the site, enabling reconciliation at close-out.
A Clinical Study Report (CSR) appendix that lists all protocol deviations serves primarily to:
Answer: Provide regulators with a transparent account of all departures from the planned conduct
A full deviation listing in the CSR demonstrates regulatory transparency and helps evaluators assess whether deviations impacted trial validity.
What is the correct procedure when an error is discovered in a paper CRF?
Answer: Draw a single line through the error, write the correction, date, and initial
GCP requires that corrections in paper CRFs preserve the original entry by using a single strikethrough with the corrector's initials and date.
The purpose of a blinding maintenance log in a double-blind study is to:
Answer: Document any instances where blinding was broken and the reason
A blinding maintenance log provides a transparent record of any unblinding events, preserving the trial's integrity and interpretability.
Which ICH E6(R2) requirement applies to training documentation for site staff performing delegated trial tasks?
Answer: Staff must be qualified by education, training, and experience, with documentation on file
ICH E6(R2) mandates that all staff delegated trial responsibilities have documented qualifications and protocol-specific training records.
A sponsor conducts a pre-study site qualification visit. The resulting qualification report is used to:
Answer: Inform the decision on whether the site is appropriate to participate in the trial
The qualification visit report documents assessment findings that the sponsor uses to decide whether the site meets criteria to conduct the trial.
When a regulatory authority requests access to subject-level source data during an inspection, the investigator should:
Answer: Allow access in accordance with applicable privacy regulations while maintaining subject confidentiality
Investigators must permit regulatory inspection of source data while protecting subject identifiers as required by privacy laws and the consent form.