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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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Date created: April 7, 2005; Last updated: July 1, 2008

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