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  4. Guidance on Patient Reported Outcomes
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Guidance on Patient Reported Outcomes

Scheduled Pinned Locked Moved Guidance on Code Application
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  • D Offline
    D Offline
    devadmin
    wrote on last edited by Jennifer Carroll
    #1

    Enter your comments on this document here.

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    • T Offline
      T Offline
      tk2022
      wrote last edited by
      #2

      As RWE may include PRO collection but RWE sometimes does not have a strict blinded study design - would it disqualify RWE PROs from inclusion in APS? I notice the checklist states "should be" conducted in a blinded study design.

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      • Jennifer CarrollJ Online
        Jennifer CarrollJ Online
        Jennifer Carroll
        wrote last edited by
        #3

        Hi tk2022

        Please see our more recent “Guidance on Real World Evidence/Data” for criteria and direction on the presentation of RWE in advertising to health care professionals. Please also see our "Guidance on the use of the Attention Icon" regarding unblinded data.

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