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Bioresearch Monitoring Information System File
The following 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.
The 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 one character field.
RANK: A three 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 2 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 three 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) 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.
The file is an ASCII text file. Columns of data are tab delimited.
File size: unzipped file size = 58 megabytes; zipped file size = 9
megabytes.
If you have questions or comments regarding this file, contact the Good Clinical
Practice Branches, Division of Scientific Investigations, Center for Drug Evaluation and
Research, FDA, at (301) 594-1032.
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Created April 4, 2002; updated: October 4, 2004 |
