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	2017-06-19
Version	2017-06-19
Update Frequency	Quarterly
Temporal Coverage	1900-01-01 to 2017-04-04
Spatial Coverage	World
Source	John Snow Labs => U.S. Food and Drug Administration (FDA)
Source License URL	John Snow Labs Standard License
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

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	-

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