Bioequivalence and Bioavailability Forum

Dear all,

Kindly help me resolve the following query:

In a BE setup, does change of PI comes under administrative changes?

according to schedule Y
"No deviations from or changes to the protocol should be implemented without prior written approval of the ethics committee and the Licensing Authority except when it is necessary to eliminate immediate hazards to the trial Subject(s) or when change(s) involve(s) only logistic or administrative aspects of the trial. All such exceptions must be immediately notified to the ethics committee as well as to the Licensing Authority."

I have been told In case of change of PI (pilot study- BE, healthy volunteers), it's enough to get approval from sponsor and notify DCGI and ethics committee. However, I couldn't find any reference to it.

thank you in advance.

Regs,
Swastik