•   about 10 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

  • Manager   •   about 10 years ago

    Hi zxed,

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

    Thanks,
    Megan

  •   •   about 10 years ago

    Understood.

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

  • Manager   •   about 10 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

Comments are closed.