Oversight of Clinical Investigations — A Risk-Based Approach This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and
Guidance for Industry Oversight of Clinical Investigators-A Risk-Based . . . 1 This guidance has been prepared by the following components of the Food and Drug Administration: CDER’s Division of Scientific Investigations in the Office of Compliance, CBER’s Office of Compliance and Biologics Quality, CDRH’s Office of Compliance, and CDER’s Office of Medical Policy
21 CFR Part 812 Subpart E -- Responsibilities of Investigators An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA
PI Responsibilities in HSR. 1. 9. 2025. final - irb. emory. edu FDA and SACHRP recommendations provide the foundation of Emory Policies that define PI Responsibilities (chapters 5 and 80 in Emory IRB P Ps) PI availability and responsiveness is key in ensuring that the responsibilities are being carried out effectively
Documenting PI Oversight Responsibilities – Clinical Research Made Simple This article details the scope of PI oversight, how to document it effectively, and provides tools, checklists, and real-world examples that can be included in the Trial Master File (TMF) or Investigator Site File (ISF)
PI Supervision and Oversight: Multi-Center IITs Develop an institutional Principal Investigator (PI) Supervision and Oversight Plan for multi-center IITs based on FDA guidance and ICH-GCP Educate and familiarize PIs and clinical research staff with the essential elements of conducting multi-center trials as the lead coordinating center
FDA-Regulated PI Responsiblities Summary 22jan24. pdf PIs may delegate responsibilities, but documentation of delegation is required and the PI must maintain oversight of all research activities Oversee budget expenditure completeness and accuracy, and revenue realization (as applicable)
Guidance - Special Considerations for the Oversight of Research . . . The following regulations apply to control of the investigational drug: The PI will administer the drug only to participants under the PI's personal supervision or under the supervision of a sub-investigator responsible to the PI [21 CFR §312 61]