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  3. Gating requirements

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Gating requirements

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  • NatBourreN Offline
    NatBourreN Offline
    NatBourre
    wrote on last edited by
    #1

    We currently use the mechanism "Automated cross-validation based on an abstraction from user-level data" in the D.5 section of PAAB Guidance for gating mechanisms. However, the recent online training mentions that it is necessary to use a "Validated License Number" which may suggest a verification from a third party or in-house verification.
    It may be a misinterpretation, but we would like to make sure the current methodology we are using is valid for our future projects and that the guidelines are not subject to any change in a near future.

    Natalie Bourré
    Marketing 4 Health Inc.
    Medical Marketing Consultant, Medical Writer
    nat@marketing4health.net

    Jennifer CarrollJ 1 Reply Last reply
    0
    • NatBourreN NatBourre

      We currently use the mechanism "Automated cross-validation based on an abstraction from user-level data" in the D.5 section of PAAB Guidance for gating mechanisms. However, the recent online training mentions that it is necessary to use a "Validated License Number" which may suggest a verification from a third party or in-house verification.
      It may be a misinterpretation, but we would like to make sure the current methodology we are using is valid for our future projects and that the guidelines are not subject to any change in a near future.

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @natbourre

      The training speaks to an option for gating that would meet a sufficient barrier. The current methodology you are using (D.5 section of the PAAB Guidance for gating mechanisms) remains to be a valid gating mechanism. The guidance document provides additional options that would meet Code section 1.4.k.E. A gate should meet the standards outlined in the guidance which could be met by using a third party or in-house verification as one option.

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