> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments Sought on Trial Data Information Collection
- URL: https://www.fdaweb.com/comments-sought-on-trial-data-information-collection/
- Published: 2018-05-30T12:00:00.000Z
- Updated: 2026-09-15T00:09:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141564

*Federal Register* notice: FDA is seeking comments on an information collection extension for its “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The document is intended to assist sponsors in determining when a DMC is needed for monitoring a study and how such committees should operate. It also addresses the roles, responsibilities, and operating procedures for DMCs and describes certain reporting and recordkeeping responsibilities. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-11647.pdf?ref=fdaweb.com).