Principal Investigator (PI) Oversight / Staff Roles and Responsibilities

Overview

Documentation of staff roles and responsibilities, as well as their qualifications is required in order to verify the safe and appropriate conduct of clinical research. The principal investigator is responsible for the oversight of research staff, which includes the following:

  • Provide documented training on the research protocol and any related procedures which staff must perform
  • Demonstrate that staff are appropriately qualified by training and/or experience to perform the delegated duties assigned
  • Require appropriately documented delegation of authority by the investigator before engaging in the implementation of the protocol

Related Resources

U-M Institutional Review Board Medical School (IRBMED) SOP: Part 6 - Roles and Responsibilities of Investigators and Research Staff

Food and Drug Administration (FDA): Title 21 CFR 312.60 General responsibilities for investigators

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials (link to page w/complete list of downloads)

Downloadable Templates and Appendices

PI Oversight Final.docx

Questions?

Contact us at MICHR-SPGSupport@umich.edu.

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