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 | 2023-08-07 |
Version | 2023-08-07 |
Update Frequency |
Quarterly |
Temporal Coverage |
1900-01-01 to 2023-08-07 |
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 | - |
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 |
670953 | AAZAMI | HESSAM | HOPE CLINICAL RESEARCH | 22030 SHERMAN WAY, STE 101 (IP), 110 | CANOGA PARK | CA | USA | 91303 | 2020-01-29 | DA | VAI | 5 |
511372 | ABABA | MICHELLE | W COAST CLINL TRIALS LLC | 5630 CERRITOS AVE | CYPRESS | CA | USA | 90630 | 2017-10-03 | FC | NAI | 0 |
624462 | ABDALLA | KATHIA | FUNDACAO PIO XII - HOSPITAL DE CANCER DE BARRETOS | RUA ANTENOR DUARTE VILELA, 1331 | BARRETOS | NG | BRA | 14784-400 | 2013-10-28 | DA | NAI | 0 |
473867 | ABDELSAYED | NADER | CENTENNIAL HILLS OB-GYN ASSOC | 1815 E LAKE MEAD STE 314 | N LAS VEGAS | NV | USA | 89030 | 2011-04-26 | DA | VAI | 5 |
473867 | ABDELSAYED | NADER | CENTENNIAL HILLS OB-GYN ASSOC | 1815 E LAKE MEAD STE 314 | N LAS VEGAS | NV | USA | 89030 | 2011-04-26 | DA | VAI | 6 |
520708 | ABDULLA | SALIM | IFAKARA HEALTH RESEARCH AND DEVELOPMENT CENTRE | DAR ES SALAAM | DAR ES SALAAM | NG | TZA | NG | 2008-10-27 | DA | VAI | 6 |
507529 | ABE | KOJI | NG | 7-23 HAMA-MACHI | NAGASAKI-SHI | NG | JPN | NG | 2016-10-24 | DA | NAI | 0 |
675851 | ABERG | JUDITH | ICAHN SCHOOL OF EMD AT MOUNT SINAI-CLIN AND TRANSLATIONAL RES CTR | 17 EAST 102 ST 8TH FLOOR | NEW YORK | NY | USA | 10029 | 2020-01-27 | DA | NAI | NG |
622561 | ABERGEL | ARMANDO | CENTRE HOSPITALIER UNIVERSITAIRE ESTAING | 1 PLACE LUCIE-AUBRAC | CLERMONT-FERRAN | NG | FRA | 63003 | 2015-08-17 | DA | VAI | 5 |
679308 | ABIDA | WASSIM | MEMORIAL SLOAN KETTERING CANCER CENTER/SIDNEY KIMMEL CTR FOR PROSTATE AND UROLOGIC CANCERS | 353 E 68TH ST | NEW YORK | NY | USA | 10065 | 2020-02-20 | DA | NAI | 0 |