GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB 0910-0581

OMB 0910-0581

This information collection supports the Food and Drug Administration guidance document entitled, “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The guidance is intended to assist sponsors of clinical trials in determining when a Data Monitoring Committee (DMC) is needed for monitoring a study and how such committees should operate.

The latest form for GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees expires 2021-10-31 and can be found here.

OMB Details

Sponsor Reporting to FDA on DMC Recommendations

Federal Enterprise Architecture: Health - Health Care Services


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