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

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

2021-08-28
Version

2021-07-21
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_IdID Assigned to the Investigatorstringrequired : 1
Last_Name_of_InvestigatorClinical investigator’s last namestring-
First_Name_of_InvestigatorClinical investigator’s first namestring-
Address_Line1Location of clinical investigator’s sitestring-
Address_Line2The address of clinical investigator’s sitestring-
CityCity of clinical investigator’s sitestring-
State_AbbreviationState of clinical investigator’s sitestring-
CountryCountry of clinical investigator’s sitestringrequired : 1
ZIP_CodeZip code of the sitestring-
Inspection_DateDate the inspection was carried outdate-
Classification_TypeType 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"stringrequired : 1
Classification_CodeCode pertaining to Classification Typestringrequired : 1
Description_of_Classification_CodeDescription of the code pertaining to Classification Typestring-
Deficiency_CodeRepresents deviations from applicable statutes and regulationsstring-
Description_of_Deficiency_CodeDescription of the Deficiency Codestring-

Data Preview

Investigator IdLast Name of InvestigatorFirst Name of InvestigatorAddress Line1Address Line2CityState AbbreviationCountryZIP CodeInspection DateClassification TypeClassification CodeDescription of Classification CodeDeficiency CodeDescription of Deficiency Code
358849AHMADMASOODUNIV TEXAS MEDICAL BRANCH301 UNIVERSITY BLVD.GALVESTONTXUSA775501900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
96468ANDERSONLORENNG2610 W BETHANY HOMEPHOENIXAZUSA01900-01-01DA - Data AuditWASHWashout. An inspection was initiated but no meaningful information could be obtained.
208366ARMANKAMBIZFRIENDLY HILLS MEDICAL GRP951 SOUTH BEACH BLVDLA HABRACAUSA906311900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
403150AUGERPIERRECENTRE HOSP FLEURY2180 RUE FLEURY EMONTREAL PQNGCANH2B 1K31900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
96480AZOURYFARIDNG3023 BUNKER HILL STSAN DIEGOCAUSA01900-01-01DA - Data AuditWASHWashout. An inspection was initiated but no meaningful information could be obtained.
80013BACHARACKSAMUELNGNGSHREWSBURYMAUSA01900-01-01DA - Data AuditWASHWashout. An inspection was initiated but no meaningful information could be obtained.
80068BALCHUMOSCARUNIV SOUTHERN CALIFORNIA SCH MEDICINE2025 ZONAL AVELOS ANGELESCAUSA900331900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
434718BARGHOORNJUERGENPRACTICE, TEUCHSTRASSE 341539 DORMAGEN KURT TUCHOLSKY, STR 5COLNNGDEUNG1900-01-01DA - Data AuditWASHWashout. An inspection was initiated but no meaningful information could be obtained.
21512BECKERALFREDHELEN HAYES HOSPNGW HAVERSTRAWNYUSA109931900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
469985BEN-YEHUDADINAHADASSAH UNIV HOSPEIN KEREM BOX 12000JERUSALEMNGISR911201900-01-01DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
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