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Investigational Human Drugs
Clinical Investigator Inspection List
Clinical Investigator
Inspection List [self extracting archive] or [zip
file]. (Current through 10/8/2004). The list file is ASCII
tilde (~) delimited zipped into a self-extracting file, CLIIL.EXE.
A README.TXT file containing the file layout and
descriptive information is included. (328 KB will unzip to
approximately 1.5 MB.)
The Clinical Investigator Inspection List contains the names, addresses, and other
information gathered from inspections of clinical investigators who have performed studies
with investigational human drugs. The list contains information on investigators inspected
since July 1977 whose inspection files have been closed with a final classification.
Please note that the current retention policy for paper files is 10 years.
Freedom of Information requests for documentation of inspections conducted
over 10 years ago may not be available.
The inspections were conducted as part of the Food and
Drug Administration's Bioresearch Monitoring
Program. This program validates the quality of the clinical studies upon which
drug approval is based. It also assures that the rights and welfare of the human
subjects in the studies have been protected. For more information on clinical
investigators, protection of human subjects, and regulatory and compliance programs,
please see the Information for
Clinical Investigators web page. For information on investigational new drugs,
please see the Investigational New Drug
Application Process web page.
If you have any questions concerning the list content,
please contact Carolanne Currier, Division of Scientific Investigations, Good Clinical
Practice Branch II, at (301) 827-7398, or email: currier@cder.fda.gov.
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Date created: October 8, 2004 |
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