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Study Data Standardization Plan (SDSP)

  • 1.  Study Data Standardization Plan (SDSP)

    This message was posted by a user wishing to remain anonymous
    Posted 11-Mar-2024 16:37
    This message was posted by a user wishing to remain anonymous

    Curious how everyone has been handling the SDSP?  Seems FDA would like them sooner rather than later.  Are you submitting with initial IND?  Waiting until later phase?  If submitting do you include all studies or just the studies  that will be in the required electronic format?  I have hear of all above variations from different colleagues, please lets discuss how you are implementing this.