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.
Clinical Investigator Inspection List
$179 / year
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.
Complexity



Date Created | 2015-10-01 |
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Last Modified | 2019-06-26 |
Version | 2019-06-26 |
Update Frequency | Quarterly |
Temporal Coverage | 1900-01-01 to 2017-04-04 |
Spatial Coverage | World |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements | N/A |
Source Citation | N/A |
Keywords | FDA Inspections, BIMO, Good Clinical Practice |
Other Titles | FDA Inspections Clinical Investigator Inspection List, BIMO Clinical Investigator Inspection List, Good Clinical Practice Investigator Inspection List |
Name | Description | Type | Constraints |
---|---|---|---|
Investigator_Id | ID Assigned to the Investigator | string | required : 1 |
Last_Name_of_Investigator | Clinical investigator’s last name | string | - |
First_Name_of_Investigator | Clinical investigator’s first name | string | - |
Address_Line1 | Location of clinical investigator’s site | string | - |
Address_Line2 | The address of clinical investigator’s site | string | - |
City | City of clinical investigator’s site | string | - |
State_Abbreviation | State of clinical investigator’s site | string | - |
Country | Country of clinical investigator’s site | string | required : 1 |
ZIP_Code | Zip code of the site | string | - |
Inspection_Date | Date the inspection was carried out | date | - |
Classification_Type | Type the inspection, where DA stands for "Data Audit": An inspection in which the focus is on verification of study data, FC stands for "For Cause": An inspection in which the focus is on the conduct of the study by the Clinical Investigator, IG stands for "Information Gathering" | string | required : 1 |
Classification_Code | Code pertaining to Classification Type | string | required : 1 |
Description_of_Classification_Code | Description of the code pertaining to Classification Type | string | - |
Deficiency_Code | Represents deviations from applicable statutes and regulations | string | - |
Description_of_Deficiency_Code | Description of the Deficiency Code | string | - |
Investigator Id | Last Name of Investigator | First Name of Investigator | Address Line1 | Address Line2 | City | State Abbreviation | Country | ZIP Code | Inspection Date | Classification Type | Classification Code | Description of Classification Code | Deficiency Code | Description of Deficiency Code |
79914 | AABERG | THOMAS | EMORY EYE CTR | 1365 B CLIFTON RD RM B4403 | ATLANTA | GA | USA | 30322 | 1980-08-04 | DA - Data Audit | VAI2 | No response requested | 3.0 | Inadequate informed consent form |
79914 | AABERG | THOMAS | EMORY EYE CTR | 1365 B CLIFTON RD RM B4403 | ATLANTA | GA | USA | 30322 | 1980-08-04 | DA - Data Audit | VAI2 | No response requested | 5.0 | Failure to follow investigational plan |
466554 | AARON | JOHN | MED CHOICE | 11 N 3RD ST | OXFORD | PA | USA | 19363 | 2003-01-03 | FC - For Cause | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 2.0 | Failure to obtain and/or document subject consent |
466554 | AARON | JOHN | MED CHOICE | 11 N 3RD ST | OXFORD | PA | USA | 19363 | 2003-01-03 | FC - For Cause | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 3.0 | Inadequate informed consent form |
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1994-11-08 | DA - Data Audit | CANC | Cancelled. The inspection assignment was canceled before the inspection was started. | ||
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1997-04-24 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0.0 | No deficiencies noted |
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1998-02-10 | DA - Data Audit | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 5.0 | Failure to follow investigational plan |
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1998-02-10 | DA - Data Audit | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 6.0 | Inadequate and inaccurate records |
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1998-02-10 | DA - Data Audit | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 16.0 | Failure to report adverse drug reactions |
125815 | AARONSON | DONALD | AARONSON ASTHMA & ALLERGY ASSOC LTD | 9301 GOLF RD STE 301 | DES PLAINES | IL | USA | 60016 | 1998-02-10 | DA - Data Audit | VAI | Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. | 18.0 | Other |
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