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  • 1.  IND protocol amendment versioning

    This message was posted by a user wishing to remain anonymous
    Posted 03-Nov-2023 09:50
    This message was posted by a user wishing to remain anonymous


    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

  • 2.  RE: IND protocol amendment versioning

    Posted 04-Nov-2023 15:10

    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,

    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United States