Clinical Investigators Disqualification Proceedings

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The Clinical Investigators Disqualification Proceedings dataset lists clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.

Complexity

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices.
Physicians and other qualified experts (“clinical investigators”) who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.
In certain situations in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding.

Date Created

2013

Last Modified

2018-05-01

Version

2018-05-01

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

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

Clinical Investigators, FDA Disqualification, FDA Warning Letters

Other Titles

FDA Clinical Investigators Disqualification, FDA Administrative Clinical Investigators Disqualification, FDA Administrative Clinical Investigators Disqualification Proceedings

Name Description Type Constraints
NameClinical investigator namestringrequired : 1
CenterFDA centerstringrequired : 1
CityClinical investigator citystringrequired : 1
State_AbbreviationClinical investigator statestring-
StatusCurrent clinical investigator disqualification proceedings statusstringrequired : 1
Date_Of_StatusCurrent status datedate-
Date_NIDPOE_IssuedNotice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) datedate-
Date_NOOH_IssuedNotice of Opportunity for Hearing (NOOH) datedate-
Date_Of_Presiding_Officer_ReportPresiding officer datedate-
Date_Of_Commissioners_DecisionCommissioner's decision datedate-
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