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UUSOP - 4 (INVESTIGATOR RESPONSIBILITIES) is a Course

UUSOP - 4 (INVESTIGATOR RESPONSIBILITIES)

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The Principal Investigator (PI) of a clinical trial has responsibilities and obligations for the conduct and oversight of the trial detailed in the Code of Federal Regulations (CFR) and in the Good Clinical Practice (GCP) guidelines, to ensure protection of the rights, safety and welfare of study participants, and to ensure the integrity of study results. The PI of a clinical trial is required to follow the regulations for the protection of human subjects, including obtaining informed consent from study participants and ensuring review and approval by the Institutional Review Board (IRB), as found in the U.S. Food and Drug Administration (FDA) regulations (21 CFR §50, and 21 CFR §56).

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