Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c): Guidance for Sponsors, Investigators, and Institutional Review Boards

Information

Type

Small Entity Compliance Guide

Regulated products

Biologics, Drugs, Medical Devices

Topics

Good Clinical Practice (GCP)

Published

February 1, 2012

Last updated

April 19, 2019

Description

A small entity compliance guide providing guidance on informed consent elements in clinical trials under 21 CFR § 50.25(c).

Organization

Country / Region

United States

License

Other (Public Domain)

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