Abstracting Eligibility Criteria - Include 20170405

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.

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.

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. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.

3. On the Scientific Data menu, under Interventional Trial Design, click Eligibility Criteria. The Interventional Trial Design – Eligibility Criteria page appears.
   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).

4. 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.
   Sex*	Indicate the sex of the individuals who may participate in the clinical trial: Male: Indicates that the trial studies only male participants. Female: Indicates that the trial studies only female participants. All: Indicates that the recruitment criteria do not limit eligibility based on the sex of participants. If you select Female or Male in this field, the system requires you to specify a value in the Gender Based field.
   Gender Based	If participant eligibility is based on self-representation of gender identity, select Yes. Otherwise, select No. If you select Yes in this field, the optional Gender Eligibility Description field becomes available.
   Gender Eligibility Description	Enter any available information about gender eligibility.
   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

   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

5. 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. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
3. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
4. Modify the information as necessary, and then click Save.

How to Abstract Non-Interventional Trial Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.

3. On the Scientific Data menu, under Non-interventional Trial Design, click Eligibility Criteria. The Non-Interventional Trial Design – Eligibility Criteria page appears. 
   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).

4. 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/Description
   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*	Type the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.
   Maximum Age*	Type 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
   Sampling Method*	Select the sampling method from the drop-down list. Valid values are as follows: Probability Sample. Exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling Non-Probability Sample. Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer
   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).

   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

5. 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. In the search results, click the NCI Trial Identifier link for that trial.
2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
3. 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.
4. Click Add Another Criterion.
   The Add/Edit Eligibility Criterion Page appears.
   

5. 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.

6. 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. In the search results, click the NCI Trial Identifier link for that trial.
2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
3. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
4. 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.
5. 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. In the search results, click the NCI Trial Identifier link for that trial.
2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
3. 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.
   
4. Hover your mouse in the Eligibility Criterion Type column.
   The cursor changes shape.
5. 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. In the search results, click the NCI Trial Identifier link for that trial.
2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
3. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.

4. In the Delete column for the record you want to delete, click the Delete icon.

   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.