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# FDA Issues Data Monitoring Committee Draft Guide
- URL: https://www.fdaweb.com/fda-issues-data-monitoring-committee-draft-guide/
- Published: 2024-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:22:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156333

FDA has made available a [draft guidance](https://www.fda.gov/media/176107/download?ref=fdaweb.com) entitled “Use of Data Monitoring Committees in Clinical Trials.” The document provides recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be useful for trial monitoring, and the procedures and practices that should be considered to guide their operation.

“Although all clinical trials have a plan for monitoring data and subject safety, not all trials call for involvement or monitoring by a DMC,” the guidance says. “An important consideration in determining whether to use a DMC in a development program is whether DMC review is practical for the particular clinical trial. Although the practicality of having a DMC for long-term trials is well established, it is not as clear for short-term trials. If the trial is likely to complete enrollment quickly and the follow-up period is short, convening a DMC to review interim data to assess continued exposure of subjects to investigational interventions may be impractical and of little value.”