Regulatory Requirements Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Requirements flashcards as text
What is the regulatory significance of a 'serious adverse event' (SAE) report timeline requirement under ICH E6 for sponsors?
Answer: Sponsors must report fatal or life-threatening unexpected SAEs to the FDA within 7 calendar days
ICH E6 and 21 CFR 312.32 require sponsors to report fatal or life-threatening unexpected serious adverse reactions to the FDA within 7 calendar days of awareness.
Which component of a Clinical Study Report (CSR) is required by ICH E3 to include a comprehensive listing of all protocol deviations?
Answer: Section 10 (Study Patients)
ICH E3 requires Section 10 of the CSR to discuss all protocol deviations, including those that affected subject eligibility, conduct, or evaluation.
When a clinical data manager creates a Data Management Plan (DMP), which regulatory requirement makes this document essential for FDA inspections?
Answer: It demonstrates that data handling procedures were pre-specified and followed consistently
A DMP demonstrates to inspectors that data collection, processing, and quality control procedures were defined prospectively and consistently followed, supporting data integrity.
Under 21 CFR Part 11, which of the following is a requirement for electronic records to be considered trustworthy by the FDA?
Answer: Records must be accurate, reliable, and their authenticity must be readily available for inspection
21 CFR Part 11 requires that electronic records be accurate, reliable, consistent, and their authenticity, integrity, and confidentiality must be maintained and available for FDA review.
What is the primary regulatory purpose of requiring source document verification (SDV) during clinical trial monitoring?
Answer: To confirm that data recorded in the CRF accurately reflects the original source records
SDV ensures that data transcribed into CRFs or EDC systems accurately and completely reflects the original source data, supporting data integrity for regulatory submissions.
According to ICH E6 R2, what is a key responsibility of the sponsor regarding the quality management system for clinical trials?
Answer: Implementing a system that focuses on preventing and detecting errors and deviations that matter most to participant protection and data reliability
ICH E6 R2 emphasizes a risk-proportionate quality management system focused on critical processes and data that have the most impact on participant safety and decision-making.
In the US regulatory framework, what distinguishes a 'waiver of informed consent' from a 'waiver of informed consent documentation'?
Answer: A waiver of documentation allows verbal consent without a written signature, while a waiver of consent allows proceeding without any consent process
A waiver of documentation means consent is still obtained verbally but no signed form is required, whereas a waiver of consent means the entire informed consent process can be bypassed under specific emergency or minimal-risk conditions.