Principal Investigator Change Protocol


  • A request for change of Principal Investigator must be made in Duplicate
  • There may be a reason for change of Principal Investigator due to the following reasons
a.    Desire of the Principal Investigator to withdraw from project
b.    Transfer of Principal Investigator to another MCGM Hospital
c.    Resignation of the Principal Investigator from the Institution
d.    Superannuation of the Principal Investigator.
  • In the above circumstances, the project will deem a necessary change in Principal Investigator.
  • The change in Principal Investigator must be referenced to the IEC no of the project.
  • The assigned IEC No., Sponsor name ( if applicable ) and the Abbreviated Trial Name shall be incorporated as footnote on each and every page of the submitted Communications  for change of Principal Investigator.
  • In case of sponsored projects, it will be mandatory to obtain a “ No Objection Certificate from the Sponsor” which must be attached  to the application
  • In case the Principal investigator desires to opt out of the project,  a letter to that effect from the existing Principal Investigator must be attached in addition to  the letter of change.
  • In the event that the Principal Investigator is transferred out of the institution, or has resigned from the institution or superannuates,
a.    The co investigator  ( if faculty from the same department as the Principal Investigator ) may be appointed as the new Principal Investigator if agreed by the sponsor.
b.    If the sponsor is desirous of not opting for the co investigator ( as in sub section (a)), a totally new Principal Investigator may be appointed as per the recommendation of the Head of the concerned Departments.

  • A suitable agreement between the sponsor and the new Principal Investigator will have to be attached.
  • The letter for change of Principal Investigator will have to be endorsed by
a.    Authorized signatory of the Sponsor
b.    New Principal Investigator
c.    Head of concerned Departments
d.    Dean.
  • Acknowledgement of the submission must be obtained immediately from the SRS office.
  • The amendment for change of the Principal Investigator will be put up to the IEC.
  • The change of Principal Investigator shall be effected only after the IEC approves the changes to the  Principal Investigator and the letter is issued by the IEC HR which is duly acknowledged by the new Principal Investigator.