•   over 5 years ago

Can we change text to make patient-friendly?

Are allowed to tweak the text provided in the sample trial document to make it more patient-friendly, or are we supposed to use them as is? In order not to scare a patient, information can be provided in a nicer language, while keeping all the points explained. But I believe it may also be a legal concern.

  • 3 comments

  • Moderator   •   over 5 years ago

    Hi msawired,

    Thanks for the question. This is what the challenge rules state about the required clinical trial data: "Contestants must create a patient-centric design, which visualizes and incorporates clinical trial information (each a “Design”). The Design must include each data field identified in the Required Sections and Fields document and must utilize information from the sample clinical trial documents provided on the Resources page. For the purpose of consistency, all Contestants are required to populate their Designs with content from the same sample clinical trial."

    So while the rules do require that you use the content mentioned above, they do not require that you use the content word for word. You are allowed to change the order and hierarchy of information, and you shouldn't feel constrained to the current layout, structure or presentation.

    So to summarize: you are free to rephrase or restructure the information, but please make sure that the overall content remains the same and that you include ALL of the required data. Does that make sense? Please let me know if I can clarify anything.

    All the best,
    Megan

  •   •   about 5 years ago

    I understand that we can modify the over all content, but does that include making the Subject information and consent form or does it have to remain the the same?

  • Moderator   •   about 5 years ago

    Hi geeodz,

    Can you tell me what you mean by "making the Subject information and consent form"? I just want to clarify your question so I can provide you with the right answer.

    Thanks.
    Megan

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