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The Trial Eligibility Criteria information provides a summary of the qualifications for subject enrollment in the study. It is optional for Abbreviated trials. If you choose to record trial eligibility criteria for Abbreviated trials, be sure to complete all fields.
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Eligibility criteria include a set of demographic information (i.e., health, gender, age) and other eligibility criteria in a table consisting of both “Inclusion” and “Exclusion” criteria.
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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Abstracting Interventional Trial Eligibility Criteria
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| MultiExcerptName | interventionalcriteria |
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How to Abstract Eligibility Criteria
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.
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Field
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Instruction
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Accepts Healthy Volunteers*
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If the trial accepts healthy participants, select Yes. Otherwise, select No.
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Gender*
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Indicate the gender criteria by selecting either Female, Male, or Both.
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Minimum Age*
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Enter the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.
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Maximum Age*
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Enter the maximum participant age. If there is no maximum age, type 999 , and select Years from the Unit drop-down list.
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Unit*
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Select the age unit from the drop-down list. Valid values are as follows:
- Years
- Months
- Weeks
- Days
- Hours
- Minutes
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To increase the size of a description or name cell, click and drag the lower right corner handles.
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Editing Demographic Eligibility Criteria
How to Edit Demographic Criteria
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
- Modify the information as necessary, and then click Save.
Abstracting Non-Interventional Trial Eligibility Criteria
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How to Abstract Non-Interventional Trial Eligibility Criteria
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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.
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Field
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Instruction/Description
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Accepts Healthy Volunteers*
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If the trial accepts healthy participants, select Yes. Otherwise, select No.
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Gender*
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Indicate the gender criteria by selecting either Female, Male, or Both.
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Minimum Age*
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Type the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.
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Maximum Age*
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Type the maximum participant age. If there is no maximum age, type 999 , and select Years from the Unit drop-down list.
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Unit*
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Select the age unit from the drop-down list. Valid values are as follows:
- Years
- Months
- Weeks
- Days
- Hours
- Minutes
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This page tree contains the following topics.
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Describe the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).
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To increase the size of a description or name cell, click and drag the lower right corner handles.
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Adding Other Eligibility Criteria
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| MultiExcerptName | addingeligibilitycriteria |
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How to Add Eligibility Criteria
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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.
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Field
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Instruction/Description
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Eligibility Criterion Type
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Indicate whether satisfying the criterion qualifies or disqualifies a subject from participation in the trial by selecting Inclusion or Exclusion respectively.
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Structured or Unstructured*
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The Unstructured option is preselected. This is the only method by which you can record eligibility criteria via Protocol Abstraction.
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Eligibility Criterion Description*
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Enter a comprehensive description of the criterion.
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Editing Other Trial Eligibility Criteria
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How to Edit Other Eligibility Criteria
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Reordering Other Eligibility Criteria
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| MultiExcerptName | reordereligibilitycriteria |
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You can change the order in which the eligibility criteria are displayed in the criteria table and in the TSR/XML documents.
How to Re-Order Other Eligibility Criteria
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears, displaying all other eligibility criteria currently abstracted.
- Hover your mouse in the Eligibility Criterion Type column.
The cursor changes shape. - Click and drag the record you want to move to a new location in the Other Criteria table. The record background changes to grey as you move it.
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Deleting Eligibility Criteria
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| MultiExcerptName | deleteeligibilitycriteria |
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Although you cannot delete the demographic fields, you can delete other criteria records that may have been added during abstraction.
How to Delete Eligibility Criteria
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
In the Delete column for the record you want to delete, click the Delete icon.
Warning title Warning There is no way to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Other Eligibility Criteria to add it back.
