Tip of the Week Archive

For ClinicalTrials.gov's purposes, an Outcome Measure must be described as an individual variable or measurement with a single unit of measure.

If an Outcome Measure includes multiple measurements or variables with different units of measure, PRS will reject the record with the following comment:
 

Major Issues: More than one outcome measure appears to be described.

To resolve the comment, review the Outcome Measure to identify the separate variables being described, paying special attention to the word "and". Then, describe each one as a separate Outcome Measure.

Example: Unacceptable Outcome Measure

• Outcome Measure: “Hospitalization”
• Description: “Number and Duration of inpatient hospital stays”

Since "Number" and "Duration" have two different units of measure, they need to be separated into two distinct outcome measures:

Example: Acceptable Outcome Measures:

• Outcome 1: “Number of Hospitalizations”
• Outcome 2: "Duration of Hospitalizations"

For help addressing ClinicalTrials.gov QC comments, contact [email protected].