Bioresearch Monitoring Information System (BMIS)

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.

You can also search this file online at: Bioresearch Monitoring Information System¹

BMIS Zip Download File (ZIP - 15.2MB)²

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 Division of Scientific Investigations³.

Additional Information

BMIS Zip Download File (ZIP - 15.2MB)⁴ The file is an ASCII text file. Columns of data are tab delimited. Updated through 12/20/2011
Bioresearch Monitoring Information System⁵ Bioresearch Monitoring Information System For Investigational New Drug Studies