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# e-Submission Guide for BIMO Inspection Planning
- URL: https://www.fdaweb.com/e-submission-guide-for-bimo-inspection-planning/
- Published: 2024-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:48:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158316

FDA has released a [final guidance](https://www.fda.gov/media/85056/download?ref=fdaweb.com) entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.” The document describes the electronic submission of certain data and information in standardized formats, which would include all pivotal studies used to support safety and efficacy claims in drug/biologic submissions. It says the guidance becomes effective in 24 months and the information must be submitted electronically in the specified format.

CDER says it uses the data and information described in the guidance to plan bioresearch monitoring (BIMO) inspections and to make sure field investigators have the information needed to conduct such inspections. The following data from NDAs, BLAs, and supplements containing new clinical study reports are used to plan and conduct inspections:

- Identification of all entities that sponsors have contracted to conduct clinical study-related activities
- Locations of clinical study-related documentation (applicant/sponsor/contract research organization records)
- Locations of clinical investigator sites
- Case report tabulations of data for each subject in each study that are needed to conduct a proper review of the application

Additionally, the guidance touches on CDER’s risk-based model to select clinical investigator sites for inspection. “To facilitate site selection, the model uses a summary-level clinical site dataset that describes and summarizes the characteristics and outcomes of clinical investigations, both at the study level and at the level of the individual study site,” it says. “CDER anticipates that the risk-based model will provide for earlier identification of clinical investigator sites for inspection and, therefore, that these inspections will be conducted earlier in the review cycle.”