SOCRA FDA Regulations and Compliance 3

Question 1

Under 21 CFR Part 56, an IRB must have at least how many members, and what is a key compositional requirement?

Accepted Answer

5 members, including at least one non-scientist and one member not affiliated with the institution

Answer

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?

Accepted Answer

1 year

Answer

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:

Accepted Answer

Research that presents no greater than minimal risk and appears on FDA's list of eligible categories

Answer

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?

Accepted Answer

A statement that the particular treatment may involve risks to the subject that are currently unforeseeable

Answer

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?

Accepted Answer

21 CFR Part 54

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA FDA Regulations and Compliance 3