Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Good Clinical Practice (GCP)
Published
October 11, 2018
Last updated
July 18, 2019
Description
This document provides guidance on the impact of certain provisions of the Revised Common Rule on FDA-regulated clinical investigations.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)