Principal Investigator C hicken S oup for the B usy C oordinator

Principal Investigator The Principal Investigator (PI) is the individual who assume the authority and responsibility for the conduct of a research study. PI’s responsibilities include: Promoting proper conduct of research by assuring adherence to protocol requirements Protecting the rights and welfare of subjects Assuring the integrity of data generated at the site and directing the conduct of the research according to applicable regulations and guidance.

WHEN MUST A NEW PRINCIPLE INVESTIGATOR (PI) BE APPOINTED? The research project should be formally transferred to another Investigator when the existing PI is Resigning from NHG or Going away for an extended duration of time. The prospective Investigator assumes all the responsibilities as the PI for the conduct of the research project until the original PI returns. Principal Investigator

HOW TO CHANGE PI Any change to the study team members should be reviewed and approved by the NHG DSRB. The existing Principal Investigator must submit a Protocol Amendment Cover Note, along with the relevant documents, to the DSRB for approval. The relevant document may include the prospective Investigator’s latest Curriculum Vitae, CITI Certification, etc. Principal Investigator