SOCRA FDA Regulations and Compliance 3 — Questions and Answers
Question 1: Under 21 CFR Part 56, an IRB must have at least how many members, and what is a key compositional requirement?
- 3 members, all with scientific backgrounds
- 5 members, including at least one non-scientist and one member not affiliated with the institution (Correct answer)
- 7 members, including a physician, statistician, and patient advocate
- 5 members, all licensed healthcare providers
Correct 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.
Question 2: What is the maximum period of approval an IRB may grant for a clinical study under 21 CFR Part 56?
- 6 months
- 1 year (Correct answer)
- 2 years
- Until the study ends
Correct 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.
Question 3: FDA's expedited review procedure under 21 CFR 56.110 may be used when research involves:
- Any study with fewer than 100 participants
- Minor increases over minimal risk in vulnerable populations
- Research that presents no greater than minimal risk and appears on FDA's list of eligible categories (Correct answer)
- Phase I studies in healthy volunteers only
Correct 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.
Question 4: Under 21 CFR 50.25, which element of informed consent addresses the possibility of unforeseeable risks to an embryo or fetus?
- A statement of voluntariness
- A description of foreseeable risks
- A statement that the particular treatment may involve risks to the subject that are currently unforeseeable (Correct answer)
- Disclosure of appropriate alternative treatments
Correct 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.
Question 5: Which FDA regulation governs financial disclosure by clinical investigators to identify potential bias in clinical studies?
- 21 CFR Part 11
- 21 CFR Part 54 (Correct answer)
- 21 CFR Part 312 Subpart E
- 21 CFR Part 56
Correct 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.
Question 6: When FDA conducts a Bioresearch Monitoring (BIMO) inspection of a clinical investigator site, which records are investigators required to make available?
- Only protocol-specified source documents and IRB correspondence
- All records, including case histories, informed consent forms, and financial records (Correct answer)
- Medical records and case report forms only, with patient identifiers redacted
- CRFs, IRB approvals, and sponsor monitoring reports only
Correct 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.
Question 7: 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?
- Accelerated Approval
- Fast Track Designation
- Breakthrough Therapy Designation
- Orphan Drug Designation (Correct answer)
Correct 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.
SOCRA FDA Regulations and Compliance 3
Under 21 CFR Part 56, an IRB must have at least how many members, and what is a key compositional requirement?