Principal Investigator (PI) Oversight / Staff Roles and Responsibilities Standard Practice Guideline


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


PI Oversight Final


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