•   about 5 years ago

Specifics of eligibility criteria

In the Required Fields documentation, it lists bullet points for:

• 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.)

Only the first two items are specifically delineated either on the ClinicalTrials.gov website or in the sample documents provided. Can we assume that all of these bullet point items would be covered within the inclusion & exclusion criteria sections? (And thus not break them out as a separate section in the design?)

  • 3 comments

  • Moderator   •   about 5 years ago

    Hi Jared,

    Thanks for writing. You have creative freedom in presenting the required sections fields as you see fit, but just make sure that you do include all of them. If no gender requirements are specified, for example, you'll still need to include that field in your design, but can denote "NA" or "None."

    Does that make sense? Please let me know if I can clarify anything.

    All the best,
    Megan

  •   •   about 5 years ago

    To clarify further... the bullet points I mentioned are things that are inherently part of "Inclusion & Exclusion Criteria". Therefore, it seems weird to me to separate that as separate fields.

    For example, if the study only enrolls patients who are 18 years or older, one of the items in "Inclusion Criteria" would read "You must be 18 years of age or older".

  • Moderator   •   about 5 years ago

    Hi Jared,

    Thanks for the clarification. If you want to list Gender, Age Limits, Ethnicity, Genetic Mutation type and Biomarker(s) as sub-sections of the inclusion/exclusion criteria, you are free to do so, but you must still show each of these required sections and fields in your design:

    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.)

    Best,
    Megan

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