OMB control number

Establishment and Operation of Clinical Trial Data Monitoring Committees

OMB 0910-0581 · HHS/FDA.

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 is listed under ICR 201809-0910-002.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
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All Historical Document Collections

Historical document collections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

OMB Details

Sponsor Reporting to FDA on DMC Recommendations

Federal Enterprise Architecture: Health - Health Care Services