Hi Anon,
That sort of thing is typically governed by internal written procedures. If you don't have an SOP for clinical document control, I urge you to get one in place ASAP. If you are using a CRO, ask to see their document control SOP. If they don't have one, I would send a red flag up and determine if this CRO is a liability or just missing a critical document.
As a side bar, the general practice I have seen over the last 30 years is a change that does not impact execution of the protocol/SOP is a decimal point change (xxx.02.01 becomes xxx.02.02), where a change with even a small impact on procedure execution would be a whole number shift (xxx.02.01 to xxx.03.00).
I hope this helps,
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Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
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Original Message:
Sent: 03-Nov-2023 08:08
From: Anonymous Member
Subject: IND protocol amendment versioning
This message was posted by a user wishing to remain anonymous
Hello,
Is there any guidance on versioning for protocol amendments for INDs? I'm specifically looking for a reference document that would explain what is considered a significant change that would require a whole number increase, e.g., 1.0 to 2.0, versus a minor change that would deserve only an incremental version increase, e.g., 1.0 to 1.1.
Thank you