Others titles
- FDA Inspections Clinical Investigator Inspection List
- BIMO Clinical Investigator Inspection List
- Good Clinical Practice Investigator Inspection List
Keywords
- FDA Inspections
- BIMO
- Good Clinical Practice
Clinical Investigator Inspection List

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.
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Description
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.
About this Dataset
Data Info
Date Created | 2015-10-01 |
---|---|
Last Modified | 2020-07-15 |
Version | 2020-07-15 |
Update Frequency |
Quarterly |
Temporal Coverage |
1900-01-01 to 2020-04-09 |
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 |
Data Fields
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 | - |
Data Preview
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 |
531754 | LEDERMAN | SAMUEL | ALTUS RESEARCH INC. | 4671 S. CONGRESS AVE., SUITE 100-B | LAKE WORTH | FL | USA | 33461 | 2018-12-10 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
449399 | VARDI | GIL | ST LOUIS HEART AND VASCULAR P.C | 11155 DUNN RD STE 304E | ST LOUIS | MO | USA | 63136 | 2018-10-01 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
726324 | NASVELD | PETER | GALLIPOLI BARRACKS | WEARY DUNLOP DRIVE | BRISBANE | NG | AUS | QLD 4051 | 2018-05-21 | 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 | Failure to follow investigational plan |
659816 | CUBALA | WIESLAW | UNIWERSYTECKIE CENTRUM KLINICZNE KLINIKA CHOROB PSYCHICZNYCH I ZABURZEN NERWICOWYCH | UL DEBINKI 7 | GDANSK | NG | POL | 80 952 | 2019-01-14 | 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 | Failure to follow investigational plan |
651946 | TRIPATHY | DEVJIT | STVHCS AUDIE L MURPHY MEMORIAL VETERANS HOSPITAL / SOUTH TEXAS VETERANS HLTH CARE SYSTEM | 7400 MERTON MINTON BLVD, SUITE A723 | SAN ANTONIO | TX | USA | 78229 | 2018-08-21 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
550967 | EUBANK | CHARLES | ADVANCED RESEARCH ASSOCIATES | 5920 SARATOGA BLVD SUITE 110B | CORPUS CHRISTI | TX | USA | 78414 | 2018-11-14 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
407370 | FELDMAN | ROBERT | UROLOGY SPEC PC | 160 ROBBINS ST | WATERBURY | CT | USA | 6708 | 2018-12-10 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
727656 | KEISER | JENNIFER | SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE | SOCINSTR 57 | BASEL | NG | SWZ | CH-4002 | 2018-12-03 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
686316 | KUKIELKA-BUDNY | BOZENA | CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. SW. JANA Z DUKLI/ ODDZ CHEM Z PODODDZIALEM RADIO | UL. JACZEWSKIEGO 7 | LUBLIN | NG | POL | 20-090 | 2018-10-15 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |
654101 | SIENKIEWICZ-KOZLOWSKA | RENATA | CENTRUM ONKOLOGII INSTYTUT IM M SKLODOWSKIEJ-CURIE KNPCR | UL ROENTGENA 5 | WARSZAWA | NG | POL | 2781 | 2018-10-22 | DA - Data Audit | NAI | No Action Indicated. No objectionable conditions or practices were found during the inspection. | 0 | No deficiencies noted |