Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural, Good Clinical Practice (GCP)
Published
August 7, 2013
Last updated
November 21, 2022
Description
This document is a guidance for industry on a risk-based approach to monitoring clinical investigations, focusing on administrative and procedural aspects and good clinical practice.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)