Principal Investigator Change Protocol
INSTRUCTIONS TO APPLICANTS
- 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.