Basic Flashcards

Which of the following is NOT one of the basic elements of informed consent required by 21 CFR 50.25(a)?

Answer: The amount the sponsor pays the investigator per enrolled subject

Investigator payment amounts are not a required basic element under 50.25(a), while voluntariness, risks, and contacts are.

What approvals does a nonsignificant risk (NSR) device study need before it starts under 21 CFR 812?

Answer: IRB approval only, under the abbreviated IDE requirements

NSR device studies are considered to have an approved IDE once the IRB approves them, following the abbreviated requirements of 21 CFR 812.2(b).

Under ICH E6, what are the original documents, data, and records where clinical findings are first recorded called?

Answer: Source documents

ICH GCP defines source documents as the original records, such as hospital charts and lab reports, that contain source data.

When the short form written consent method is used under 21 CFR 50.27(b)(2), what additional requirement applies?

Answer: A witness must be present for the oral presentation

The short form method requires a witness to the oral presentation, who signs both the short form and the written summary.

Which FDA regulation sets out the exception from informed consent requirements for emergency research?

Answer: 21 CFR 50.24

21 CFR 50.24 allows emergency research without informed consent under strict conditions, including community consultation and public disclosure.

Which subpart of 45 CFR 46 gives additional protections for children involved as research subjects?

Answer: Subpart D

Subpart D covers children; Subpart B covers pregnant women, fetuses, and neonates, and Subpart C covers prisoners.

Under ICH E6, who is responsible for providing the Investigator's Brochure and keeping it up to date?

Answer: The sponsor

The sponsor compiles the clinical and nonclinical data on the investigational product into the Investigator's Brochure and updates it as new information becomes available.