Notice to Industry: Bioresearch Monitoring Information System (BMIS) Data
In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring Web site that makes clinical research information available to the public. This Web site 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) at http://www.accessdata.fda.gov/scripts/cder/bmis/
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.
The database includes only investigators engaged in research of CDER-regulated drugs and biologics under an IND, for whom FDA has received a Form FDA 1572. This leads to the following limitations important for BMIS data analysis:
- Although the sponsor is required to collect the 1572 from each clinical investigator in a trial conducted under FDA’s IND regulations, FDA does not require the form itself to be submitted to the agency. Many sponsors submit the 1572 to FDA, however, because the form collects, in one place, information that must be submitted to FDA in some fashion under our IND regulations.
- A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. If a clinical study is conducted outside of the United States and is not conducted under an IND, then the investigator need not sign a 1572.
 See 21 CFR 312.23(a)(6)(iii)(b).
The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs.
Update frequency: Quarterly
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 submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.
BMIS Download and Search
The BMIS file contains the following fields:
REVIEWER ID: (6-digit number)
LAST NAME: The last name of the clinical investigator or the IRB chairperson. This field allows a maximum of 23 characters. This field will contain an NG (Not Given) for CROs, and for IRBs if no name is found.
FIRST NAME: The first name of the clinical investigator or the IRB chairperson. This field allows a maximum of 13 characters. This field will contain an NG for CROs, and for IRBs if no name is found.
MIDDLE INITIAL: The middle initial of the clinical investigator or IRB chairperson, if given. It is a 1-character field.
RANK: A 3-character field for name qualifier (e.g., JR, SR).
DEGREE: The educational degree given for the clinical investigator or IRB chairperson. It is a 6-character field.
SITE: For a clinical investigator, this is name of the site of the study, or of the business of the investigator. For an IRB or CRO, it is the name of the organization. It is a 100-character field.
STREET ADDRESS: This is the address of the site named above. If a clinical investigator does not have a study or business site given, it will be the home address. It is a 36-character field.
CITY: The city location of the address given above. It is a 14-character field.
STATE: The 2-letter state code. NG is used for foreign addresses.
ZIP CODE: The 5-digit zip code plus the 4 digit extension if known.
COUNTRY: The letter country code.
RECEIPT DATE: The date the source document (1572, etc.) was received by FDA. It is a 9-character field in the format DD-MMM-YYYY.
TYPE: A 3-character field that designates the entry:
Clinical Investigator (DEM)
Contract Research Organization (CRO)
Institutional Review Board (IRB)
For most fields, if no information is provided, an 'NG' (Not Given) or '??' code is entered. An entry of 01-JAN-1900 in the RECEIPT DATE field is an invalid date. It is the same as NG. The only field that may be blank is MIDDLE INITIAL.
If you have any questions concerning the content of the Bioresearch Monitoring Information System file, please contact the Office of Scientific Investigations.