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
Which section of the Code of Federal Regulations defines 'minimal risk' as a standard for IRB review categories?
Answer: 21 CFR 56.102(i)
21 CFR 56.102(i) defines 'minimal risk' as the probability and magnitude of harm anticipated in the research not being greater than those ordinarily encountered in daily life or routine examinations.
A clinical investigator must retain study records for how long after the investigation is discontinued or completed, per 21 CFR 312.62(c)?
Answer: 2 years after the investigational drug is approved, or 2 years after shipment is discontinued
Per 21 CFR 312.62(c), investigators must retain records for 2 years after the drug is approved for marketing or, if not approved, 2 years after the investigation is discontinued and FDA is notified.
Under 21 CFR Part 50 Subpart D, which population is classified as a 'vulnerable subject' requiring additional protections in FDA-regulated research?
Answer: Prisoners, as defined by 21 CFR 50.3(f)
21 CFR Part 50 Subpart D provides additional consent protections specifically for prisoners because their incarceration may affect voluntariness of participation.
What does the FDA's 'Disqualification of Clinical Investigators' process under 21 CFR 312.70 require before a final order of disqualification is issued?
Answer: Opportunity for the investigator to respond in writing and request a regulatory hearing
Before disqualification, FDA must provide the investigator written notice and an opportunity to respond in writing and, if requested, a regulatory hearing under 21 CFR Part 16.
A sponsor submits an NDA. FDA issues a Complete Response Letter (CRL). What does this mean?
Answer: FDA has completed its review and the drug is not approvable without additional information or changes
A Complete Response Letter indicates FDA has completed its review and identified deficiencies that must be addressed before approval; the applicant may resubmit after correcting the issues.
Under 21 CFR 312.305, expanded access (compassionate use) for an individual patient in an emergency requires which of the following before treatment may begin?
Answer: FDA verbal authorization, with a written protocol submission within 15 days
For emergency individual patient expanded access, FDA may authorize treatment verbally or via other rapid means; the IND or protocol may be submitted within 15 working days after authorization.
Which of the following actions constitutes a 'major protocol deviation' that must be reported to the sponsor and IRB in an FDA-regulated trial?
Answer: Administering study drug to a subject who did not meet an eligibility criterion
Enrolling a subject who fails to meet eligibility criteria is a major protocol deviation because it directly affects subject safety and the integrity of the study data requiring mandatory reporting.