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If the trial that you are abstracting uses other criteria in addition to the demographics (i.e., health, gender, age) of study participants, you can create additional eligibility criteria recordsStructured Eligibility Criteria records for Prior Therapies referenced in the NCI Thesaurus can be added in the Structured Eligibility Criteria page

How to Add add Structured Eligibility Criteria

  1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

  2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

  3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

  4. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears. If the Add Another Criterion button is not displayed, complete all demographic fields on the Eligibility page first.

  5. In the Structured Eligibility Criteria section, Click AddClick Add Another Criterion.
    The Add/Edit Structured Eligibility Criterion Page appears.
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  6. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field

    Instruction/Description

    Eligibility Criterion Type *

    Used to indicate the Structured Eligibility Criteria type. Currently the only option is Prior Therapy.

    C-Code Value*

    Enter the NCI Thesaurus C-Code in this field. Only records containing valid NCI Thesaurus C-Codes can be saved.

    Inclusion Indicator*

    Indicate whether satisfying the criterion qualifies or disqualifies a subject from participation in the trial by selecting Inclusion or Exclusion respectively.

    Structured or Unstructured*

    The Unstructured option is preselected. This is the only method by which you can record eligibility criteria via Protocol Abstraction.

    Eligibility Criterion Description*

    Enter a comprehensive description of the criterion.

    Exclusion respectively.

  7. Click Save.
    The new criterion record is displayed on the Eligibility Criteria page.
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