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 56, an IRB must have at least how many members, and what is a key compositional requirement?
Answer: 5 members, including at least one non-scientist and one member not affiliated with the institution
21 CFR 56.107 requires IRBs to have at least 5 members including at least one whose primary concerns are non-scientific and at least one who is not affiliated with the institution.
What is the maximum period of approval an IRB may grant for a clinical study under 21 CFR Part 56?
Answer: 1 year
Per 21 CFR 56.109(f), IRB approval must be renewed at intervals not exceeding one year; continuing review must occur at least annually.
FDA's expedited review procedure under 21 CFR 56.110 may be used when research involves:
Answer: Research that presents no greater than minimal risk and appears on FDA's list of eligible categories
Expedited review is permitted when research presents no more than minimal risk AND the activities fall within categories identified by the Secretary of HHS.
Under 21 CFR 50.25, which element of informed consent addresses the possibility of unforeseeable risks to an embryo or fetus?
Answer: A statement that the particular treatment may involve risks to the subject that are currently unforeseeable
21 CFR 50.25(b)(1) requires disclosure that the treatment may involve risks to the subject, embryo, or fetus that are currently unforeseeable when participation may affect reproductive capacity.
Which FDA regulation governs financial disclosure by clinical investigators to identify potential bias in clinical studies?
Answer: 21 CFR Part 54
21 CFR Part 54 requires sponsors to certify that investigators have no disqualifying financial interests or to disclose financial arrangements that could affect study reliability.
When FDA conducts a Bioresearch Monitoring (BIMO) inspection of a clinical investigator site, which records are investigators required to make available?
Answer: All records, including case histories, informed consent forms, and financial records
During BIMO inspections, investigators must make all study records available to FDA, including case histories, consent forms, drug accountability records, and financial disclosure documents.
A Phase II clinical trial testing a new drug for a rare pediatric cancer would most likely qualify for which FDA designation to expedite development?
Answer: Orphan Drug Designation
Orphan Drug Designation under 21 CFR Part 316 is granted to drugs intended for rare diseases affecting fewer than 200,000 people in the US, providing incentives like tax credits and market exclusivity.