IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural, Good Clinical Practice (GCP)
Published
August 27, 2013
Last updated
July 22, 2021
Description
This document provides guidance for IRBs, clinical investigators, and sponsors on IRB responsibilities and GCP in reviewing qualifications and research sites.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)