Bioresearch Monitoring Information System

$716 / year

The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA (Food and Drug Administration) identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs.

Complexity

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.

Date Created

2012

Last Modified

2019-08-31

Version

2019-08-31

Update Frequency

Quarterly

Temporal Coverage

2008-09 to 2016-12-19

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

FDA Clinical Investigators, FDA Institutional Review Boards, New Drug Studies, Human Investigational Drugs, Bioresearch Monitoring, Clinical Research Information, Therapeutic Biologics, BIMO, Health Monitoring, Good Clinical Practice

Other Titles

BIMO Bioresearch Monitoring Information System, Bioresearch Health Monitoring Information System, Good Clinical Practice Bioresearch Monitoring Information System

NameDescriptionTypeConstraints
Reviewer_IDReviewer ID assigned to the investigatorintegerlevel : Nominal
Last_NameThe last name of the clinical investigator or the IRB chairperson. This field will contain an NG (Not Given) for CROs, and for IRBs if no name is found.string-
First_NameThe first name of the clinical investigator or the IRB chairperson. This field will contain an NG for CROs, and for IRBs if no name is found.string-
Middle_InitialThe middle initial of the clinical investigator or IRB chairperson, if given.string-
RankA field for name qualifier (e.g., JR, SR).string-
DegreeThe educational degree given for the clinical investigator or IRB chairperson.string-
Site_DescriptionFor a clinical investigator, this is the 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.string-
AddressThis 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.string-
CityThe city location of the address given above.string-
State_AbbreviationThe 2-letter state code. NG is used for foreign addresses.string-
Zip_CodeThe 5-digit zip code plus the 4 digit extension if known.string-
Country_CodeCountry code of site locationstring-
Receipt_Date_of_Source_DocumentsThe date the source document (1572, etc.) was received by FDAdate-
Type_of_Investigatorsdesignates the entry: Clinical Investigator (DEM), Contract Research Organization (CRO), Institutional Review Board (IRB)string-
Reviewer IDLast NameFirst NameMiddle InitialRankDegreeSite DescriptionAddressCityState AbbreviationZip CodeCountry CodeReceipt Date of Source DocumentsType of Investigators
708594ABBASJIHADNGMDNG2109 HUGHES DRIVE, SUITE 400TOLEDOOH43606USA2017-10-31DEM
574174BARBOSAJERRYNGMDALL CHILDREN'S HOSPITAL SPECIALITY PHYSICIANS880 6TH STREET SOUTH SUITE 140ST. PETERSBURGFL33701USA2009-01-28DEM
703543BOURGINPATRICENGNGCHU DE STRASBOURG1 PLACE DE L'HPITALSTRASBOURGNG67091FRA2017-06-28DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2014-11-05DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2016-03-17DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2015-05-01DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2019-03-08DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2014-12-23DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2013-03-21DEM
549339BOYDTHOMASENGMDUS ONCOLOGY RESEARCH AND CLINICAL PHARMACY13501 PARK VISTA BLVD SUITE 160FORT WORTHTX76177USA2009-07-13DEM