CTA Site Management & Monitoring 3 — Questions and Answers
Question 1: Under 21 CFR Part 312, how long must an investigator retain essential trial documents after the study is completed or discontinued?
- 1 year after study closure
- 2 years after NDA approval or 2 years after the investigation is discontinued (Correct answer)
- 5 years after study completion
- Indefinitely
Correct answer: 2 years after NDA approval or 2 years after the investigation is discontinued
21 CFR 312.62 requires investigators to retain records for 2 years after the FDA approves a marketing application or 2 years after the study is discontinued.
Question 2: A sponsor's risk-based monitoring (RBM) approach results in centralized statistical review flagging Site 07 for unusually low variability in blood pressure readings. What is the most appropriate next step?
- Close the site immediately
- Issue a corrective action plan without visiting the site
- Schedule a targeted on-site visit to review source data and assess data integrity (Correct answer)
- Transfer all Site 07 subjects to another site
Correct answer: Schedule a targeted on-site visit to review source data and assess data integrity
Centralized monitoring signals warrant a targeted on-site visit to evaluate data integrity and determine whether data fabrication or transcription errors have occurred.
Question 3: Which of the following is NOT typically included in the Trial Master File (TMF) at the sponsor level?
- Signed investigator agreements
- IRB approval letters
- Subject medical histories and source records (Correct answer)
- Regulatory agency correspondence
Correct answer: Subject medical histories and source records
Subject medical histories and source records are confidential documents held at the site, not in the sponsor's TMF.
Question 4: During a monitoring visit, the CRA finds that a subject's signed ICF is dated two days after the first study procedure. What type of GCP violation does this represent?
- A minor administrative error requiring no action
- A protocol deviation related to improper informed consent (Correct answer)
- A serious adverse event
- An eligibility protocol deviation
Correct answer: A protocol deviation related to improper informed consent
Consent must be obtained before any study procedure; a post-procedure consent date is a GCP violation classified as a protocol deviation.
Question 5: What is the primary purpose of the Site Initiation Visit (SIV)?
- To audit the site's financial records
- To train site staff, confirm regulatory documents are in place, and verify site readiness before enrollment (Correct answer)
- To perform SDV on the first enrolled subject's CRF
- To deliver investigational product to the site
Correct answer: To train site staff, confirm regulatory documents are in place, and verify site readiness before enrollment
The SIV ensures the site team is trained on the protocol, equipment is qualified, regulatory files are complete, and the site is ready to enroll subjects.
Question 6: A CTA is reviewing an investigational product accountability log and finds a discrepancy between the quantity dispensed and the quantity received minus returns. What should the CTA do?
- Correct the log without documenting the change
- Ignore minor discrepancies under 5%
- Document the discrepancy and escalate to the CRA and sponsor's drug supply team (Correct answer)
- Dispose of any missing units as an accounting measure
Correct answer: Document the discrepancy and escalate to the CRA and sponsor's drug supply team
IP accountability discrepancies must be documented and reported; they may indicate dispensing errors, protocol deviations, or diversion.
Question 7: Under ICH E6(R2), who is responsible for implementing and maintaining quality assurance and quality control systems in a clinical trial?
- The IRB/IEC
- The principal investigator
- The sponsor (Correct answer)
- The regulatory authority
Correct answer: The sponsor
ICH E6(R2) Section 5.1 places primary responsibility for QA and QC systems on the sponsor to ensure trials are conducted and data generated in compliance with GCP.
CTA Site Management & Monitoring 3
Under 21 CFR Part 312, how long must an investigator retain essential trial documents after the study is completed or discontinued?