Page History

Problem Statement

FDA drafted the initial Bio-research Monitoring Technical Conformance Guide in December 2017, with an updated version published in July 2020 (https://www.fda.gov/media/85061/download). The guide provides specifications for preparing and submitting the following components in electronic format that are used by FDA for planning of Bio-research Monitoring (

BIMO) inspections.

• Clinical Study-Level Information.
• Subject-Level Data Line Listings by Clinical Site.
• Summary-Level Clinical Site Dataset (clinsite.xpt).

NDA, BLA, and supplemental submissions to FDA require

BIMO as a critical part of the electronic application.

There is currently a lack of clarity

as each sponsor will have defined their own approach to the generation of this content, especially where there is a need to interpret the Technical Conformance Guide. 

Problem Impact

This need for interpretation leads to inconsistencies between

Sponsors when submitting this content to the

agency.  Potentially, this results in the need for

Sponsors to provide additional clarification to the

agency subsequent to the submission of the content.