Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Good Clinical Practice (GCP), Pediatric Product Development

Published

August 15, 2023

Last updated

April 11, 2024

Description

A guidance document providing information on informed consent for IRBs, clinical investigators, and sponsors, focusing on Good Clinical Practice (GCP).

Organization

Country / Region

United States

License

Other (Public Domain)

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