FDA Regulations and Compliance Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 FDA Regulations and Compliance flashcards as text
Under 21 CFR Part 11, which combination of controls satisfies FDA's requirements for electronic signatures on clinical trial records?
Answer: At least two distinct identification components (e.g., ID code and password) and a statement binding the signature to the record
21 CFR 11.50 requires that electronic signatures include the printed name of the signer, the date/time, and the meaning of the signature, and 11.100 requires at least two identification components for non-biometric signatures.
Which FDA regulation requires sponsors to monitor clinical investigations and defines the CRO's ability to assume sponsor responsibilities?
Answer: 21 CFR 312.50 and 312.52
21 CFR 312.50 establishes general sponsor responsibilities including monitoring, while 312.52 governs the transfer of sponsor obligations to CROs.
FDA's Guidance on Good Clinical Practice (E6 R2) recommends that the monitor verify source data against CRFs. What is the primary purpose of source data verification (SDV)?
Answer: To ensure the accuracy, completeness, and consistency of data entered in the CRF against original source records
SDV is performed to confirm that data in CRFs accurately reflects what is recorded in original source documents, ensuring data integrity for regulatory submissions.
Under FDA regulations, who holds primary responsibility for ensuring that an IND is in effect before a Phase I study begins?
Answer: The study sponsor
The sponsor is responsible under 21 CFR 312.40 for ensuring an IND is in effect and that FDA has not placed the study on clinical hold before any investigation begins.
A sponsor conducting a Phase III trial discovers that an investigator site has been enrolling subjects without obtaining informed consent. Under 21 CFR 312.70, what action may FDA take?
Answer: Disqualify the investigator from receiving investigational drugs
Under 21 CFR 312.70, FDA may disqualify a clinical investigator from receiving investigational new drugs if the investigator repeatedly or deliberately fails to comply with applicable regulations.
What is the distinction between a 'protocol amendment' and a 'protocol deviation' in an FDA-regulated clinical trial?
Answer: An amendment is a planned prospective change approved before implementation; a deviation is an unplanned departure from the protocol
A protocol amendment is a prospective, approved change to the study design, while a protocol deviation is an unplanned departure that has already occurred and must be documented and reported.
Under the FDA Safety Reporting Final Rule (2010), which of the following is NOT required to be reported as an IND safety report?
Answer: Expected adverse events that occur within the frequency predicted by the protocol
Expected adverse events that fall within the anticipated frequency do not meet the threshold for IND safety reporting; only unexpected or newly identified safety signals require expedited reporting.