•   about 5 years ago

Omitting Information

Would it be acceptable to omit some information for, say, the eligibility section (among others)? If the design is sufficiently self-explanatory that other items would follow in the same manner that is presented.

More concisely:
- You must sign an informed consent document for clinical research.
- You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
...
- Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).

Although it is do-able, I do not see any value-added in doing so.

Please advise.

Regards,

Karel Vuong

  • 7 comments

  •   •   about 5 years ago

    in my vision doesnt make sense to post all the content, if its similar, but lets wait for official answer)

  • Moderator   •   about 5 years ago

    Hi Karel and SergeyV,

    Thanks for writing. For your submission to be eligible, you will need to show all of the required sections and fields found in this document: http://challenges.s3.amazonaws.com/eli-lilly/Required%20Sections%20and%20Fields.pdf. You will need to populate those sections and fields with content from the sample clinical trial documents, which can be found on the Resources page: http://ctdesign.challengepost.com/details/resources.

    Since the Eligibility section is a required section, it (and the fields associated with it) must be included in your design. This section is required because the sponsor, Eli Lilly, believes that it encompasses important information.

    Best,
    Megan

  •   •   about 5 years ago

    but the question is little different, do we need to post all of the info, for example we can show the structure in which we will show criterias to the patients, as sample design, having 5 items in inclusion criteria is ok to show our vision and design, adding tons of similar items will not make it better)

  • Moderator   •   about 5 years ago

    Hi SergeyV,

    You will need to show the information itself, not just a sample of it.

    Thanks,
    Megan

  •   •   about 5 years ago

    What I meant is if our mockup contains the sections and fields from the aforementioned document, is it necessary to populate our design with ALL information from the sample documents?

    For example:
    In the Required Sections and Fields document, the eligibility section contains the following fields:

    Eligibility
    • Inclusion Criteria
    • Exclusion Criteria
    • Gender
    • Age Limits
    • Ethnicity (e.g. Caucasian, Asian, Any, etc.)
    • Genetic Mutation type (e.g. CYP2C19 poor metabolizers, etc.)
    • Biomarker(s) (e.g. KRAS mutation, etc.)

    Under the Inclusion Criteria for instance, in the sample document, there are at least 10 different criteria listed.

    If the mockup contains two of these criteria and the design sufficiently illustrates that additional content from the sample document would be included in a working model of the design, would this be acceptable?

  • Moderator   •   about 5 years ago

    Hi Karel,

    You must include all of the information.

    Thanks,
    Megan

  •   •   about 5 years ago

    Understood, thanks Megan.

    Karel

Comments are closed.