The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) "Bioresearch Monitoring Technical Conformance Guide" provides essential technical standards and formatting requirements for the submission of clinical data associated with Bioresearch Monitoring (BIMO) inspections.
BIMO stands for Bioresearch Monitoring. It refers to a program established by the U.S. Food and Drug Administration (FDA) to ensure the integrity and reliability of data submitted to the FDA in support of marketing applications for regulated products. The BIMO program includes the inspection of clinical research sites, laboratories, institutional review boards (IRBs), and manufacturers involved in clinical trials.
Key Objectives of the BIMO Program:
Protecting Study Subjects: Ensuring that the rights, safety, and welfare of study participants are protected during clinical trials.
Data Integrity: Verifying that the data submitted to the FDA are accurate, complete, and reliable.
Compliance: Ensuring that clinical trials are conducted in accordance with FDA regulations, Good Clinical Practice (GCP), and other applicable standards.
The CDER uses this guide to prepare and submit Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and a Summary-Level Clinical Site Dataset that provides current FDA specifications, recommendations, and general considerations, which are used to plan BIMO inspections in electronic format for new drug applications, biologics license applications, and supplemental applications containing clinical data that the CDER regulates.
The guidance details elaborately about
Clinical Study-Level Information refers to the comprehensive documentation related to the clinical study, including details about the clinical sites, protocols, amendments, and entities involved in the study.
Subject-Level Data Line Listings are detailed records of individual participant data, organized by the clinical site. These listings provide a granular view of the study data and are critical for site-specific analysis during inspections.
Summary-Level Clinical Site Dataset is an aggregated dataset that summarizes key data points for each clinical site. This dataset provides a high-level overview of site performance and outcomes.
This guide provides the recommended format for PDFs of comprehensive and readily accessible lists of all clinical sites that participated in each major clinical trial. Typically, the data line listings provided will satisfy reporting requirements for most applications. If a sponsor believes additional listings are needed to allow FDA to verify key study data during inspections, they should be included. It is recommended to split the PDF file into smaller components if its size exceeds 500 megabytes.
The guidance specifies the acceptable file formats and leaf titles for submission. Adhering to these formats is essential for ensuring that the submission is compatible with FDA systems and can be reviewed without technical issues.
By following this guidance, sponsors can ensure that their submissions are complete, consistent, and easy for the FDA to review. For more detailed information, you can refer to the full document on the FDA’s website.