Clinical Investigator Inspection List

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

$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.

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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.

Date Created

2015-10-01

Last Modified

2019-12-02

Version

2019-12-02

Update Frequency

Quarterly

Temporal Coverage

1900-01-01 to 2019-08-19

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

NameDescriptionTypeConstraints
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-
Investigator IdLast Name of InvestigatorFirst Name of InvestigatorAddress Line1Address Line2CityState AbbreviationCountryZIP CodeInspection DateClassification TypeClassification CodeDescription of Classification CodeDeficiency CodeDescription of Deficiency Code
79914AABERGTHOMASEMORY EYE CTR1365 B CLIFTON RD RM B4403ATLANTAGAUSA303221980-08-04DA - Data AuditVAI2No response requested3.0Inadequate informed consent form
79914AABERGTHOMASEMORY EYE CTR1365 B CLIFTON RD RM B4403ATLANTAGAUSA303221980-08-04DA - Data AuditVAI2No response requested5.0Failure to follow investigational plan
466554AARONJOHNMED CHOICE11 N 3RD STOXFORDPAUSA193632003-01-03FC - For CauseVAIVoluntary 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.2.0Failure to obtain and/or document subject consent
466554AARONJOHNMED CHOICE11 N 3RD STOXFORDPAUSA193632003-01-03FC - For CauseVAIVoluntary 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.3.0Inadequate informed consent form
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161994-11-08DA - Data AuditCANCCancelled. The inspection assignment was canceled before the inspection was started.
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161997-04-24DA - Data AuditNAINo Action Indicated.  No objectionable conditions or practices were found during the inspection.0.0No deficiencies noted
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161998-02-10DA - 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.5.0Failure to follow investigational plan
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161998-02-10DA - 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.6.0Inadequate and inaccurate records
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161998-02-10DA - 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.16.0Failure to report adverse drug reactions
125815AARONSONDONALDAARONSON ASTHMA & ALLERGY ASSOC LTD9301 GOLF RD STE 301DES PLAINESILUSA600161998-02-10DA - 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.18.0Other
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