Reference 1 GAO Report to Congressional Requesters – Oversight of Clinical Investigators, Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators
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Title: Reference 1 GAO Report to Congressional Requesters – Oversight of Clinical Investigators, Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators
Reference 2 Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions – Disqualification
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Title: Reference 2 Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions – Disqualification
Reference 3 Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct
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Title: Reference 3 Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct
Reference 4 Full Analysis of Impacts of Final Rule
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Title: Reference 4 Full Analysis of Impacts of Final Rule
Disqualification of a Clinical Investigator
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Reference 1 GAO Report to Congressional Requesters – Oversight of Clinical Investigators, Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators
View Attachment:Reference 2 Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions – Disqualification
View Attachment:Reference 3 Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct
View Attachment:Reference 4 Full Analysis of Impacts of Final Rule
View Attachment:Comments
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