In order to foster transparency and encourage information sharing within the clinical research community, FDA’s (Food and Drug Administration) Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring Website that makes clinical research information available to the public. This Website contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics. This information is extracted from IND-related documents submitted to the agency and made available to the public as the Bioresearch Monitoring Information System (BMIS).
The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs. The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND (Investigational New Drug) submissions (e.g., C.V.s, cover letters, investigator lists, etc.)
In early 2012, CDER became aware that the BMIS dataset did not contain clinical investigator information from all IND studies reviewed by CDER. Specifically, data from submissions received in electronic format were not included in the publicly searchable information. As a result, BMIS reflects only a portion of the information CDER received from sponsors regarding clinical investigators participating in their trials.
CDER is aware that data from the BMIS database are being used to analyze trends in clinical research. In order to provide the public with a more comprehensive picture of the information the agency receives, CDER changed the process of the BMIS data entry procedures to include documents submitted in electronic format and instituted a plan for entry of the electronic format data received since September of 2008. The entry of this electronic format data backlog is complete.
BMIS is not intended to provide a comprehensive list of all clinical investigators, CROs or IRBs involved in CDER-regulated clinical research. Although CDER is changing some procedures to make the BMIS list more comprehensive, these changes will not address two data limitations described below.