•   about 5 years ago

Other Inclusion criteria

I noticed that because the eligibility section is free text with a format recommendation (rather than a specific call out to inclusion and exclusion); this (example) study has an additional inclusion.

1. Can/Should we ignore the additional Inclusion criteria (that is applied at randomization for maint phase); OR
2. Should we group it in with the inclusion criteria; OR
3. Should we add it in addition to the inclusion/exclusion sections that are required?

Thank you

  • 3 comments

  • Moderator   •   about 5 years ago

    Hi zxed,

    Please include the information, but in whichever way you feel is the most patient-friendly.

    Thanks,
    Megan

  •   •   about 5 years ago

    Understood.

    In our design explanation, Can we propose changes to how the data is collected/standardized, or is that out of scope?

  • Moderator   •   about 5 years ago

    Hi zxed,

    That sounds slightly out of scope for this challenge. Please present the sample clinical trial data as it was provided.

    Thanks,
    Megan

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