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Trials can have multiple outcome measures. When abstracting outcome measure information, ensure that each trial has at least one primary and one secondary outcome measure

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Adding Outcome Measure Records

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How to Add Outcome Measures

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For instructions, refer to

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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

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Outcome Measure Type*

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Select the type of outcome measure from the drop-down list. Valid values are as follows:

• Primary. Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
• Secondary. Secondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
• Other Pre-specified. Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
  

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Title*

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Enter a concise name for the specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment.

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Time Frame*

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Enter the time point(s) at which outcome measure is assessed. For example, collected every 28 days.

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Description

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Enter additional information about the outcome measure, if needed for clarification.

following pages:

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Editing Outcome Measures

You can modify existing outcome measure records during abstraction.

How to Edit Outcome Measures

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 Outcome Measures. The Outcome Measures page displays one or more outcome measure records.
4. In the Edit column for the record you want to modify, click the Edit (pencil) icon.
   The Add/Edit Outcome Measures page appears.
5. Modify the information, and then click Save.

Reordering Outcome Measures

You can change the order in which the outcome measure records are displayed in the Outcome Measures table and in the TSR/XML documents.

How to Re-Order Outcome Measure Records

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Click and drag the record you want to move to a new location in the Outcome Measures table. The record background changes to grey as you move the record. 

Copying Outcome Measures

You can copy existing outcome measure records during abstraction to facilitate recording variations of attributes for the same measure.

How to Copy Outcome Measures

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 Outcome Measures. The Outcome Measures page displays one or more outcome measure records.
4. In the Copy column for the record you want to copy, click the Copy icon (Image Removed).
   The Add/Edit Outcome Measures page is displayed with the fields populated with information from the copied record.
5. Enter the information for the outcome measure variation, and then click Save.

Deleting Outcome Measures

You can delete existing outcome measure records during abstraction. However, each trial must have one primary outcome measure.

How to Delete Outcome Measures

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In the Delete column, select the check box for each record you want to delete, and then click Delete. To delete all records, click Select All, and then click Delete.

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