Clinical Investigator Inspection List (CLIIL)
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. The Clinical Investigator Inspection List (CLIIL) database contains information on clinical investigator inspections conducted since October 1, 2008, and that have a final classification. The data are updated quarterly. Requests for other OSI records may be submitted to the FDA under the Freedom of Information Act (FOIA)
- Clinical Investigator Inspection List (Search)
- Clinical Investigator Inspection List Zip File
- Clinical Investigator Inspection List (CLIL) Database Codes
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 Office of Scientific Investigations.
The clinical investigator inspections were conducted as part of the Food and Drug Administration's Bioresearch Monitoring Program (BIMO) within the Center for Drug Evaluation and Research (CDER). Please note that the BIMO information for other centers is not available here. The BIMO program is a comprehensive, agency-wide program of on-site inspections and data audits, designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The goals of the BIMO program are:
- To protect the rights, safety, and welfare of human research subjects
- To verify the accuracy, reliability, and integrity of clinical and nonclinical trial data submitted to FDA
- To assess compliance with FDA’s regulations governing the conduct of clinical and nonclinical trials, including regulations for informed consent and ethical review.