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Ind safety report - PowerPoint PPT Presentation

Investigator-held IND Studies

Investigator-held IND Studies. Jeffrey W. Clark, MD DF/HCC Medical Director for Clinical Trials Operations April 25, 2008. Regulations allow an individual to be both study sponsor (IND holder) and clinical investigator. Objectives. Describe factors that influence whether an IND is required

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Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators

Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators. MICHR IND/IDE Assistance Program (MIAP). Definitions.

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Ind safety report - PowerPoint PPT Presentation

Investigator-held IND Studies

Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators