Others titles
- BIMO Bioresearch Monitoring Information System
- Bioresearch Health Monitoring Information System
- Good Clinical Practice Bioresearch Monitoring Information System
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
Bioresearch Monitoring Information System
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.
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Description
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.
About this Dataset
Data Info
Date Created | 2012 |
---|---|
Last Modified | 2021-11-05 |
Version | 2021-11-05 |
Update Frequency |
Quarterly |
Temporal Coverage |
N/A |
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 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Reviewer_ID | Reviewer ID assigned to the investigator | integer | level : Nominal |
Last_Name | The 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_Name | The 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_Initial | The middle initial of the clinical investigator or IRB chairperson, if given. | string | - |
Rank | A field for name qualifier (e.g., JR, SR). | string | - |
Degree | The educational degree given for the clinical investigator or IRB chairperson. | string | - |
Site_Description | For 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 | - |
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. | string | - |
City | The city location of the address given above. | string | - |
State_Abbreviation | The 2-letter state code. NG is used for foreign addresses. | string | - |
Zip_Code | The 5-digit zip code plus the 4 digit extension if known. | string | - |
Country_Code | Country code of site location | string | - |
Receipt_Date_of_Source_Documents | The date the source document (1572, etc.) was received by FDA | date | - |
Type_of_Investigators | designates the entry: Clinical Investigator (DEM), Contract Research Organization (CRO), Institutional Review Board (IRB) | string | - |
Data Preview
Reviewer ID | Last Name | First Name | Middle Initial | Rank | Degree | Site Description | Address | City | State Abbreviation | Zip Code | Country Code | Receipt Date of Source Documents | Type of Investigators | Unnamed: 14 | Unnamed: 15 | Unnamed: 16 |
708594 | ABBAS | JIHAD | NG | MD | NG | 2109 HUGHES DRIVE, SUITE 400 | TOLEDO | OH | 43606 | USA | 2017-10-31 | DEM | ||||
574174 | BARBOSA | JERRY | NG | MD | ALL CHILDREN'S HOSPITAL SPECIALITY PHYSICIANS | 880 6TH STREET SOUTH SUITE 140 | ST. PETERSBURG | FL | 33701 | USA | 2009-01-28 | DEM | ||||
703543 | BOURGIN | PATRICE | NG | NG | CHU DE STRASBOURG | 1 PLACE DE L'HPITAL | STRASBOURG | NG | 67091 | FRA | 2017-06-28 | DEM | ||||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2016-03-17 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2020-05-08 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2015-05-01 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2019-03-08 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2014-11-05 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2014-12-23 | DEM | |||
549339 | BOYD | THOMAS | E | NG | MD | US ONCOLOGY RESEARCH AND CLINICAL PHARMACY | 13501 PARK VISTA BLVD SUITE 160 | FORT WORTH | TX | 76177 | USA | 2013-03-21 | DEM |