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 certain clinical research information available to the public. This Web site contains information on clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of clinical studies conducted under an Investigational New Drug (IND) application with human investigational drugs and therapeutic biologics who are listed on a Form FDA 1572 submitted to CDER. BMIS is therefore not intended to provide a comprehensive list of all CIs, CROs or IRBs involved in clinical research.
- Although the sponsor is required to collect the form 1572 from each clinical investigator in a trial conducted under FDA’s IND regulations, FDA does not require the form 1572 itself to be submitted to the agency. Many sponsors submit the form 1572 to FDA because the form collects, in one place, information that must be submitted to FDA in some fashion under IND regulations.
- A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. Form 1572s will not be submitted for clinical studies conducted outside of the United States and not conducted under an IND.
This file contains a separate entry for each time a CI, CRO or IRB is identified in a new submission (FDA Form 1572). For example, if a 1572 is submitted for a clinical investigator in 10 INDs, his/her name will appear 10 times in this file.
The searchable BMIS database and Download File (Zip) includes entities (i.e., CIs, CROs, or IRBs) referenced in a 1572 received by FDA since October 1, 2008. The data are updated quarterly. Requests for other OSI records may be submitted to the FDA under the Freedom of Information Act (FOIA).
 See 21 CFR 312.23(a)(6)(iii)(b).
BMIS Download and Search
The BMIS file contains the following fields:
REVIEWER ID: (6-character field, all numbers)
LAST NAME: The last name of the clinical investigator or the IRB chairperson. This field allows a maximum of 24 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 14 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 7-character field.
SITE: For a clinical investigator, this is name of the site of the study. 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. It is a 37-character field.
CITY: The city location of the address given above. It is a 15-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. It is a 9-character field, all numbers.
COUNTRY: The 5-letter country code.
RECEIPT DATE: The date the FDA Form 1572 was received by FDA. It is a date field.
TYPE: A field that designates the entity:
Clinical Investigator (CI) - Note: CI was previously coded as 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.