Establishment and Operation of Clinical Trial Data Monitoring Committees

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 Establishment and Operation of Clinical Trial Data Monitoring Committees expires 2021-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Sponsor Reporting to FDA on DMC Recommendations Other-Guidance
DMC reports of meeting minutes to the sponsor Other-Guidance
Sponsor notification to the DMC regarding waivers Other-Guidance
DMC Meeting Records Other-Guidance
Standard Operating Procuedres for Data Monitoring Committees Other-Guidance

All Historical Document Collections

202108-0910-007 Approved without change	Extension without change of a currently approved collection	2021-09-30
201809-0910-002 Approved without change	Extension without change of a currently approved collection	2018-09-13
201509-0910-004 Approved without change	Extension without change of a currently approved collection	2015-09-22
201204-0910-002 Approved with change	Extension without change of a currently approved collection	2012-04-23
200903-0910-008 Approved without change	Extension without change of a currently approved collection	2009-03-30
200512-0910-007 Approved without change	New collection (Request for a new OMB Control Number)	2005-12-29

OMB Details

Sponsor Reporting to FDA on DMC Recommendations

Federal Enterprise Architecture: Health - Health Care Services