Investigator Responsibilities under GCP: From Ethical Duty to Audit-Ready Execution
Investigator Responsibilities under GCP: From Ethical Duty to Audit-Ready Execution Owning Investigator Duties: Ethical Leadership, Data Integrity, and Everyday GCP Controls Defining the Investigator Role: Accountability, Agreements, and GCP Ground Rules The Investigator (PI) is the accountable medical leader at a site. Under Good Clinical Practice (GCP), the PI’s responsibility is threefold: protect participant rights…
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