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

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_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
531754LEDERMANSAMUELALTUS RESEARCH INC.4671 S. CONGRESS AVE., SUITE 100-BLAKE WORTHFLUSA334612018-12-10DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
449399VARDIGILST LOUIS HEART AND VASCULAR P.C11155 DUNN RD STE 304EST LOUISMOUSA631362018-10-01DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
726324NASVELDPETERGALLIPOLI BARRACKSWEARY DUNLOP DRIVEBRISBANENGAUSQLD 40512018-05-21DA - Data AuditVAIVoluntary 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.5Failure to follow investigational plan
659816CUBALAWIESLAWUNIWERSYTECKIE CENTRUM KLINICZNE KLINIKA CHOROB PSYCHICZNYCH I ZABURZEN NERWICOWYCHUL DEBINKI 7GDANSKNGPOL80 9522019-01-14DA - Data AuditVAIVoluntary 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.5Failure to follow investigational plan
651946TRIPATHYDEVJITSTVHCS AUDIE L MURPHY MEMORIAL VETERANS HOSPITAL / SOUTH TEXAS VETERANS HLTH CARE SYSTEM7400 MERTON MINTON BLVD, SUITE A723SAN ANTONIOTXUSA782292018-08-21DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
550967EUBANKCHARLESADVANCED RESEARCH ASSOCIATES5920 SARATOGA BLVD SUITE 110BCORPUS CHRISTITXUSA784142018-11-14DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
407370FELDMANROBERTUROLOGY SPEC PC160 ROBBINS STWATERBURYCTUSA67082018-12-10DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
727656KEISERJENNIFERSWISS TROPICAL AND PUBLIC HEALTH INSTITUTESOCINSTR 57BASELNGSWZCH-40022018-12-03DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
686316KUKIELKA-BUDNYBOZENACENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. SW. JANA Z DUKLI/ ODDZ CHEM Z PODODDZIALEM RADIOUL. JACZEWSKIEGO 7LUBLINNGPOL20-0902018-10-15DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
654101SIENKIEWICZ-KOZLOWSKARENATACENTRUM ONKOLOGII INSTYTUT IM M SKLODOWSKIEJ-CURIE KNPCRUL ROENTGENA 5WARSZAWANGPOL27812018-10-22DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0No deficiencies noted
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