Notice to Industry: Bioresearch Monitoring Information System (BMIS) Data

In order to foster transparency and inspire data sharing inside the scientific analysis neighborhood, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch tracking Web web site that makes scientific analysis data to be had to the general public. This Web web site incorporates data that identifies scientific investigators, contract analysis organizations, and institutional evaluate forums concerned within the habits of Investigational New Drug (IND) research with human investigational medicine and healing biologics. This data is extracted from IND-related paperwork submitted to the company and made to be had to the general public because the Bioresearch Monitoring Information System (BMIS) at http://www.accessdata.fda.gov/scripts/cder/bmis/

In early 2012, CDER turned into mindful that the BMIS dataset didn’t comprise scientific investigator data from all IND research reviewed by means of CDER. Specifically, information from submissions won in digital layout weren’t integrated within the publicly searchable data. As a outcome, BMIS displays just a portion of the guidelines CDER won from sponsors referring to scientific investigators collaborating of their trials.

CDER is mindful that information from the BMIS database are getting used to research developments in scientific analysis. In order to give you the public with a extra complete image of the guidelines the company receives, CDER modified the method of the BMIS information access procedures to incorporate paperwork submitted in digital layout and instituted a plan for access of the digital layout information won since September of 2008. The access of this digital layout information backlog is whole.

BMIS isn’t supposed to supply a complete record of all scientific investigators, CROs or IRBs occupied with CDER-regulated scientific analysis. Although CDER is converting some procedures to make the BMIS record extra complete, those adjustments is not going to cope with two information barriers described underneath.

The database comprises handiest investigators engaged in analysis of CDER-regulated medicine and biologics below an IND, for whom FDA has won a Form FDA 1572. This ends up in the next barriers vital for BMIS information research:

  • Although the sponsor is needed to gather the 1572 from each and every scientific investigator in an ordeal carried out below FDA’s IND rules, the FDA does now not require the shape itself to be submitted to the company. Many sponsors publish the 1572 to FDA, then again, since the shape collects, in a single position, data that should be submitted to FDA in some model below our IND rules.[1]
  • A sponsor would possibly select, however isn’t required, to habits a international scientific find out about below an IND. If a scientific find out about is carried out outdoor of the United States and isn’t carried out below an IND, then the investigator needn’t signal a 1572.

    [1] See 21 CFR 312.23(a)(6)(iii)(b).

The Bioresearch Monitoring Information System (BMIS) record incorporates data submitted to FDA figuring out scientific investigators, contract analysis organizations, and institutional evaluate forums concerned within the habits of Investigational New Drug research with human investigational medicine.

Update frequency: Quarterly

The Bioresearch Monitoring Information System (BMIS) record incorporates data submitted to FDA figuring out scientific investigators (CIs), contract analysis organizations (CROs), and institutional evaluate forums (IRBs) concerned within the habits of Investigational New Drug (IND) research with human investigational medicine. The data has been abstracted from FDA Forms 1571 and 1572 and different pertinent paperwork contained in IND submissions (eg, CVs, quilt letters, investigator lists, and so on.). Please word that this record incorporates a separate access for each and every time an investigator, CRO or IRB is recognized in a brand new submission. For instance, if an investigator is known as in 10 INDs, his/her identify will seem 10 occasions on this record.

BMIS Download and Search

The BMIS record incorporates the next fields:

REVIEWER ID: (6-digit quantity)

LAST NAME: The remaining identify of the scientific investigator or the IRB chairperson. This box permits a most of 23 characters. This box will comprise an NG (Not Given) for CROs, and for IRBs if no identify is located.

FIRST NAME: The first identify of the scientific investigator or the IRB chairperson. This box permits a most of 13 characters. This box will comprise an NG for CROs, and for IRBs if no identify is located.

MIDDLE INITIAL: The center preliminary of the scientific investigator or IRB chairperson, if given. It is a 1-character box.

RANK: A three-character box for identify qualifier (eg, JR, SR).

DEGREE: The instructional level given for the scientific investigator or IRB chairperson. It is a 6-character box.

SITE: For a scientific investigator, that is the identify of the web site of the find out about, or of the trade of the investigator. For an IRB or CRO, it’s the identify of the group. It is a 100-character box.

STREET ADDRESS: This is the cope with of the web site named above. If a scientific investigator does now not have a find out about or trade web site given, it’ll be the house cope with. It is a 36-character box.

City: The town location of the cope with given above. It is a 14-character box.

STATE: The 2-letter state code. NG is used for international addresses.

ZIP CODE: The 5-digit zip code plus the 4 digit extension if identified.

COUNTRY: The letter nation code.

RECEIPT DATE: The date the supply record (1572, and so on.) used to be won by means of FDA. It is a 9-character box within the layout DD-MMM-YYYY.

TYPE: A three-character box that designates the access:

Clinical Investigator (DEM)
Contract Research Organization (CRO)
Institutional Review Board (IRB)

For maximum fields, if no data is supplied, an ‘NG’ (Not Given) or ‘??’ code is entered. An access of 01-JAN-1900 within the RECEIPT DATE box is an invalid date. It is equal to NG. The handiest box that can be clean is MIDDLE INITIAL.

If you will have any questions regarding the content material of the Bioresearch Monitoring Information System record, please contact the Office of Scientific Investigations.