Zeeshan Sheikh • over 9 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
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3 comments
Megan Arend Manager • over 9 years ago
Hi zxed,
Please include the information, but in whichever way you feel is the most patient-friendly.
Thanks,
Megan
Zeeshan Sheikh • over 9 years ago
Understood.
In our design explanation, Can we propose changes to how the data is collected/standardized, or is that out of scope?
Megan Arend Manager • over 9 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