Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Good Clinical Practice (GCP)

Published

October 1, 2008

Last updated

July 21, 2021

Description

This document provides guidance on data retention when subjects withdraw from FDA-regulated clinical trials. Topics include Good Clinical Practice (GCP).

Organization

Country / Region

United States

License

Other (Public Domain)

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