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# BIMO Inspection e-Submission Requirements Outlined
- URL: https://www.fdaweb.com/bimo-inspection-e-submission-requirements-outlined/
- Published: 2025-05-06T12:00:00.000Z
- Updated: 2026-09-14T15:11:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159125

Drug study information in NDAs/BLAs will need to be electronically submitted, beginning 12/2026, in a certain format to assist FDA in planning its bioresearch monitoring (BIMO) inspections, according to a just-posted agency [Webinar](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.fda.gov/drugs/news-events-human-drugs/cder-bioresearch-monitoring-electronic-submission-requirements-new-drug-and-biologic-licensing&ved=2ahUKEwiJiIbSxI-NAxUmj4kEHQARBI0QvOMEKAB6BAgVEAE&usg=AOvVaw3y5wxwT73SV5VaP-BpZDCi).

CDER says it uses the data and information described in a recent [guidance](https://www.fda.gov/media/85056/download?ref=fdaweb.com) to make sure field investigators have the information needed to conduct such inspections. The Webinar outlined the following data from NDAs, BLAs, and supplements containing new clinical study reports that 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

CDER Office of Scientific Investigations deputy director **Laurie Muldowney** said on the Webinar that BIMO inspections are conducted to determine whether this study was conducted according to the protocol and the investigational plan. “This may include an evaluation of how randomization and blinding procedures were carried out at a site,” she said. “They may include determining whether participants at a site met eligibility criteria, and if they didn't, were those captured as protocol deviations? We may also look at participant study visits, procedures and evaluations that were conducted to ensure that they were conducted as described in the protocol.”

BIMO inspections will also assess whether the study complied with FDA regulations regarding the conduct of clinical trials, and this includes things like requirements for Institutional Review Board approval and the review of informed consent procedures and financial disclosures, she said. Additionally, FDA investigators will assess whether critical data that were submitted to FDA are consistent with source documents at the clinical trial sites. “And we consider data to be the data that are necessary to make regulatory decisions. This is generally limited to data related to the primary endpoint, an important adverse event and protocol deviation data,” she added.

Additionally, the Webinar touched on CDER’s risk-based model to select clinical investigator sites for inspection. The tool standardizes site-specific data and facilitates the timely selection of sites for inspection, Muldowney said. “In making these site selection decisions, we look at a number of site level details, and we consider factors like data irregularities, inspection history and investigator experience,” she said. “We also use this tool, in addition to looking at site differences, to explore data by regions and by countries. The tool requires standardized data and information, and this is what is described in the recently finalized guidance.”