The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors Guidance for Clinical Trial Sponsors – Establishment and Operation of Clinical Trial Data Monitoring Committees

3/2006 – Guidance for Clinical Trial Sponsors

Establishment and Operation of Clinical Trial Data Monitoring Committees

Contains Nonbinding Recommendations
http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

Center for Drug Evaluation and Research (CDER)

Center for Devices and Radiological Health (CDRH)
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf
DMCs AND OTHER OVERSIGHT GROUPS

3.1. Institutional Review Boards

3.2. Clinical Trial Steering Committees

3.3. Endpoint Assessment/Adjudication Committees

3.4. Site/Clinical Monitoring

3.5. Others with Monitoring Responsibilities

Advertisements