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# Guide on BIMO Technical Conformance
- URL: https://www.fdaweb.com/guide-on-bimo-technical-conformance/
- Published: 2020-08-10T12:00:00.000Z
- Updated: 2026-09-14T16:24:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147389

FDA has made available a guidance entitled “Bioresearch Monitoring Technical Conformance Guide.” The document provides the agency’s current thinking on preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset used by CDER for planning Bioresearch Monitoring inspections. It also applies when such data and information are submitted under certain INDs in advance of a planned NDA, BLA, or supplemental submission. To view the guidance, click [here](https://www.fda.gov/media/85061/download?ref=fdaweb.com).