Investigational Human Drugs:
Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List (CLIIL)
is updated quarterly. It is available for downloading in two forms:
You can also search this file online at:
http://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm
Each of the downloadable files is in ASCII
format and is tilde (~) delimited.
After extraction, you will have two files: CLIIL.TXT
and README.TXT. CLIIL.TXT contains
investigator names, addresses, inspection dates and other coded
information gathered from inspections.
README.TXT contains descriptions of the codes in the database.If you have any questions concerning the content of
the Clinical Investigator Inspection List,
please contact the Division of
Scientific Investigations.
The Clinical Investigator Inspection List contains 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
ten years.
Freedom of Information requests for documentation of inspections conducted
over ten 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 approvals are
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 page. For information on investigational new drugs
(INDs),
please see the Investigational New
Drug Application Process page.
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Investigators Page
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Date created: April 7, 2005; Last updated:
July 1, 2008 |