Site Management & Monitoring 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 Site Management & Monitoring flashcards as text
Under 21 CFR Part 312, how long must an investigator retain essential trial documents after the study is completed or discontinued?
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.
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?
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.
Which of the following is NOT typically included in the Trial Master File (TMF) at the sponsor level?
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.
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?
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.
What is the primary purpose of the Site Initiation Visit (SIV)?
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.
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?
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.
Under ICH E6(R2), who is responsible for implementing and maintaining quality assurance and quality control systems in a clinical trial?
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.