Page History

How to Abstract 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

   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, click Eligibility Criteria. The Interventional Trial Design – Eligibility Criteria page appears.

   HTML Comment
   hidden true
   Screenshot TBD.

   
   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).

5. Include Page
   Eligibility Criteria Fields - Include 20170410 Eligibility Criteria Fields - Include 20170410

   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. Original cell size with hidden text Expanded cell revealing all text

6. 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. 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. Check

   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.

5. Modify the information as necessary, and then click Save.

How to Abstract Non-Interventional Trial 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. Check

   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 Non-interventional Trial Design, click Eligibility Criteria. The Non-Interventional Trial Design – Eligibility Criteria page appears. 

   HTML Comment
   hidden true
   Screenshot TBD.

   
   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).

5. Include Page
   Eligibility Criteria Fields - Include 20170410 Eligibility Criteria Fields - Include 20170410

6. In the additional fields for non-interventional trials, select or enter the appropriate information. The following table describes the fields. All fields are required.

   Field	Instruction/Description
   Sampling Method*	Select the sampling method from the drop-down list. Valid values are as follows: Include Page Non-Interventional Trials Sampling Method - Include v4.4 Non-Interventional Trials Sampling Method - Include v4.4
   Study Population Description*	Describe the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).

   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. Original cell size with hidden text Expanded cell revealing all text

7. Click Save.
   The trial is updated with the information you provided, and a new interface appears which enables you to add other criteria.

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 records.

How to Add 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. Check

   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. Click Add Another Criterion.
   The Add/Edit Eligibility Criterion Page appears.
   

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	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.

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

How to Edit Other 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

   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.

5. In the Edit column for the record you want to modify, click the Edit (pencil) icon.
   The Add/Edit Eligibility Criterion page appears, displaying the criterion as submitted.
6. Modify any or all of the information, and then click Save.

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. 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. Check

   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, displaying all other eligibility criteria currently abstracted.
   Image Modified

5. Hover your mouse in the Eligibility Criterion Type column.
   The cursor changes shape.
6. 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.
   

The system displays a message to confirm that the record has been updated.

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. 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. Check

   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.

5. 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.