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# Guidance on BIMO Data Technical Specifications
- URL: https://www.fdaweb.com/guidance-on-bimo-data-technical-specifications/
- Published: 2024-09-03T12:00:00.000Z
- Updated: 2026-09-14T14:40:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157702

FDA has posted a [guidance](https://www.fda.gov/media/85061/download?ref=fdaweb.com) entitled “Bioresearch Monitoring Technical Conformance Guide — Technical Specifications Document” that provides current agency specifications, recommendations, and general considerations for preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset. The submitted information is used by CDER for planning bioresearch monitoring inspections in electronic format for regulated NDAs, BLAs and related supplemental applications containing clinical data. The guidance also applies to data submitted under certain INDs when submitted in advance of a planned NDA, BLA, or supplemental submission.