Principal Investigator

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Soup for the Busy Coordinator (October 2010]

Principal Investigator

The Principal Investigator (PI) is the individual who assumes 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 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

For Feedback or For Feedback or SuggestionsSuggestions

Principal Investigator

Email: researchcoord@nhg.com.sg

Clinical Research Coordinator Societyc/o Research & Development Office6 Commonwealth Lane#04-01/02 GMTI BuildingSingapore 149547