FDA Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
Title:
FDA Guidance for Clinical
Trial Sponsors
On the Establishment and Operation
of Clinical Trial Data Monitoring
Committees
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/
Document Type:
Guidance for Clinical Trial Sponsors
Content:
This guidance is intended to assist clinical trial sponsors in determining when a DMC may be useful for study monitoring, and how such committees should operate.