The requirements

According to FDA :

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FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, as well as, to provide for protection of the rights and welfare of the thousands of human subjects and animals involved in FDA regulated research.

The deliverables are described in the Bioresearch Monitoring Technical Conformance Guide.

This information is required for each of the main (i.e., pivotal) studies for the following types of submissions:

  • New Drug Applications (NDA) ;
  • Biologics License Applications (BLA) ;
  • NDA or BLA supplements containing clinical data regulated by the CDER.

What AdClin offers

  • Part II. Subject data listings sorted by site

    • These listings can be provided either with option A (by site, by listing) or with option B (by site, by subject)

  • Partie III. Site-level dataset

    • Filename clinsite.xpt
    • File define.xml

  • BIMO Data Reviewer's Guide

    • This document is produced according to the template available from PHUSE.