| Sampath Madanu |
Food and Drug Administration (FDA) has suggested the Pharma companies and CRO’s to include the Bioresearch
Monitoring (BIMO) package as part of their regulatory submissions. This BIMO package helps FDA’s Office of
Bioresearch Monitoring Inspectorate (OBMI) to carry out site-level inspections of clinical research sites to ensure the
quality, integrity and reliability of data, Clinical trials are conducted as per applicable FDA’s regulations and make sure
that rights, welfare of participants involved in clinical trial are protected. The BIMO package mainly consists of Part I
(General study related information and specific Clinical Investigator information, Part II (Subject level listings organised by
site and listing type) Part III (Site Level Dataset). Statistical programmer plays an important role in creation of
Subject-Level Data Listings by Clinical Site, a Summary-Level Clinical Site Dataset (clinsite.xpt), Data definition file
(define.xml) and BIMO Data Reviewer guide (bdrg.pdf) which are key components of BIMO package. |