Smithkline Beecham

FDA issued Bioresearch Monitoring Technical Conformance Guide v3.1 in Sept 2024, detailing BIMO section structure in NDA/BLA submissions, crucial for data transparency in clinical trial sections of CTD Module 5. The guide outlines Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and Summary-Level Clinical Site Data Set, aiding FDA in BIMO inspections to ensure data integrity and accurate raw data location categorization.