Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural, Good Clinical Practice (GCP)
Published
January 14, 2009
Last updated
May 6, 2020
Description
This document provides guidance for clinical investigators, sponsors, and IRBs on improving human subject protection in adverse event reporting.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)