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
Under 21 CFR Part 11, which technical control is specifically required for electronic signatures used in clinical data systems?
Answer: A unique identifier combined with a password or biometric
21 CFR Part 11 requires electronic signatures to consist of at least two distinct identification components, such as a unique identifier combined with a password or biometric.
Which ICH guideline specifically addresses the statistical principles for clinical trials, relevant to data management planning?
Answer: ICH E9
ICH E9 covers statistical principles for clinical trials, guiding how clinical data should be collected, handled, and analyzed.
When a sponsor makes a change to an already-approved protocol, what regulatory document must be submitted to the IRB before implementing the change?
Answer: A protocol amendment
Protocol amendments must be submitted to and approved by the IRB before any changes are implemented, unless they are necessary to eliminate immediate hazards.
According to FDA regulations, how long must a sponsor retain essential clinical trial records after the marketing application is approved or discontinued?
Answer: 2 years
FDA 21 CFR 312.62 requires sponsors to retain records for at least 2 years after a marketing application is approved, or 2 years after the IND is withdrawn if no application is filed.
Which regulation governs the protection of individually identifiable health information in the context of clinical research in the US?
Answer: HIPAA Privacy Rule
The HIPAA Privacy Rule establishes standards for the protection of individually identifiable health information, including in clinical research settings.
In the context of GCP, who is ultimately responsible for the conduct of a clinical trial at a study site?
Answer: The principal investigator
Under GCP, the principal investigator is ultimately responsible for the conduct of the clinical trial at their site.
What is the primary purpose of a Data Safety Monitoring Board (DSMB) in clinical trials?
Answer: To monitor accumulating data for participant safety and trial integrity
A DSMB independently monitors accumulating safety and efficacy data to recommend continuation, modification, or termination of a trial to protect participants.