This message was posted by a user wishing to remain anonymous
If you have a protocol already submitted to the IND and the study is ongoing, please submit an amendment to the protocol, regardless whether they are significant or non-significant changes. For some reason you thought about a new protocol, can you explain why?
Let me give you a hypothetical scenario when you should consider a new protocol vs. Amendment to the protocol:
Just an example of an
amendment to the protocol with dosage form being same for both situations:
Original active IND: Parkinson Disease,
original protocol on file with the active IND: typical Parkinson disease patients.
Proposed amendment to the protocol: Any changes to the above protocol like inclusion/exclusion criteria, efficacy or safety evaluation or any changes with the same population as above
requires only an amendment to the protocol
New Protocol:New patient population for Parkinson disease such as MSA only patients (a subset of Parkinson disease).
However, if your proposed change is to add a cohort of MSA patients to the above original Parkinson disease patient population then you can get away with an amendment to the protocol.
Original Message:
Sent: 22-May-2017 11:41
From: Anonymous Member
Subject: Protocol Amendment vs. New Protocol
This message was posted by a user wishing to remain anonymous
Dear Community-
I am new with providing regulatory support to clinical. We currently have a study in process, and we need to modify the protocol (significant changes). Would it be best to amend the current protocol or create a new protocol – what factors should I consider while offering guidance to my clinical colleagues?
Any insight or advice is greatly appreciated. Thank you for your help.