CTA Trial Documentation 3 — Questions and Answers
Question 1: What action must be taken when a protocol amendment changes inclusion/exclusion criteria for already-enrolled subjects?
- Re-screen all enrolled subjects against new criteria and document the assessment (Correct answer)
- Withdraw all enrolled subjects automatically
- Notify only the sponsor without site documentation
- Amend only future consent forms without retroactive review
Correct 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.
Question 2: Which type of audit trail feature is required in electronic data capture (EDC) systems per 21 CFR Part 11?
- Automatic data export to sponsor servers daily
- Time-stamped record of all data entries, changes, and deletions (Correct answer)
- Real-time IRB access to subject identifiers
- Auto-lock of records after 48 hours
Correct 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.
Question 3: A 'blinded' copy of randomization codes held by an independent party during a trial is referred to as:
- Emergency unblinding kit
- Sealed randomization list (Correct answer)
- Drug accountability record
- Subject screening log
Correct answer: Sealed randomization list
A sealed randomization list is kept by an independent party to maintain blinding while allowing emergency unblinding if required.
Question 4: What is the primary purpose of the Trial Master File (TMF)?
- To summarize subject demographics for the clinical study report
- To serve as the comprehensive repository of all essential trial documents (Correct answer)
- To store financial invoices between sponsor and site
- To record CRO employee training certificates only
Correct 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.
Question 5: Which document must be updated and re-signed by a subject whenever new safety information materially affects willingness to continue participation?
- Subject diary
- Re-consent form / updated ICF (Correct answer)
- Adverse event log
- Protocol deviation form
Correct 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.
Question 6: A certificate of analysis (CoA) for investigational product is filed in the TMF primarily to:
- Confirm that the product meets specified quality standards before dispensing (Correct answer)
- Record subject dosing schedules
- Document shipping costs
- Approve the site's pharmacy facilities
Correct 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.
Question 7: Which GCP principle applies when a monitor discovers that source documents have been altered without an audit trail?
- Reporting the finding in the monitoring visit report and escalating to the sponsor (Correct answer)
- Correcting the documents on behalf of the site
- Notifying the IRB directly without sponsor involvement
- Closing the site immediately without documentation
Correct 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.
CTA Trial Documentation 3
What action must be taken when a protocol amendment changes inclusion/exclusion criteria for already-enrolled subjects?