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# Draft Guide on Investigator Safety Reporting
- URL: https://www.fdaweb.com/draft-guide-on-investigator-safety-reporting/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:17:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150258

*Federal Register* notice: FDA has released a draft guidance entitled *Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices*. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to IRBs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21316.pdf?ref=fdaweb.com).