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

A guide to ensure clinical research is conducted safely and accurately by documenting clear roles and responsibilities for each member of the team

What is this resource?

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

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.