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Abstracting Interventional Trial Eligibility Criteria 

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How to Abstract Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design, click Eligibility Criteria. The Interventional Trial Design – Eligibility Criteria page appears.
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   If the trial has been abstracted previously, the Eligibility Criteria section displays the demographic eligibility elements. The Other Criteria section may also display inclusion and/or exclusion criteria that have been added previously (see Adding Other Eligibility Criteria).

3. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.

   Field	Instruction
   Accepts Healthy Volunteers*	If the trial accepts healthy participants, select Yes. Otherwise, select No.
   Gender*	Indicate the gender criteria by selecting either Female, Male, or Both.
   Minimum Age*	Enter the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.
   Maximum Age*	Enter the maximum participant age. If there is no maximum age, type 999 , and select Years from the Unit drop-down list.
   Unit*	Select the age unit from the drop-down list. Valid values are as follows: Years Months Weeks Days Hours Minutes

   Tip
   title You can expand the Other Criterion table columns to read full criteria descriptions and names
   To increase the size of a description or name cell, click and drag the lower right corner handles. Image Removed Original cell size with hidden text Image Removed Expanded cell revealing all text

4. Click Save.
   The trial is updated with the information you provided, and a new interface appears which enables you to add other criteria. See Adding Other Eligibility Criteria.

Editing Demographic Eligibility Criteria

How to Edit Demographic Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
3. Modify the information as necessary, and then click Save.

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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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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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Adding Other Eligibility Criteria

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How to Add Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. 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.
3. Click Add Another Criterion.
   The Add/Edit Eligibility Criterion Page appears.
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4. 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	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.

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

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Editing Other Trial Eligibility Criteria

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Reordering Other Eligibility Criteria

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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

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. 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.
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3. Hover your mouse in the Eligibility Criterion Type column.
   The cursor changes shape.
4. 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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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

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.

3. 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.

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Abstracting Diseases and Conditions 

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You can search for, and select, interventions from a stored list of active intervention terms extracted from NCIt and link them to a trial. NCIt is an online database developed and maintained by the National Cancer Institute Enterprise Vocabulary Services. You can find more detailed information about NCIt at http://ncit.nci.nih.gov/.

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