ClinicalTrials.gov Tip of the Week: Comment: "Outcome Measure Time Frame is not specific and/or in the correct format…"
Addressing common ClinicalTrials.gov comments
Jul 30, 2020Addressing Common ClinicalTrials.gov Comments:
“The Outcome Measure Time Frame includes more than one time point…”
A Common PRS “Major Issue” that will cause a record to be rejected is if an Outcome Measure Time Frame:
- Includes more than one time point AND
- Isn’t measuring a change between those time points.
In these cases, the record will be rejected during QA review and returned with the following comment:
|
”Major Issues: The Outcome Measure Time Frame includes more than one time point, each of which appears to describe a separate measure.” “Each Outcome Measure should typically only specify a single time point of assessment. A common exception to this is a measure assessing change between two time points (e.g., "Change from Baseline Systolic Blood Pressure at 6 months"). If the Outcome Measure(s) are assessing a change, please revise the Outcome Measure Title(s) to specify that "change" is being assessed. If not assessing change, please revise and enter additional Outcome Measures so that there is only one Time Frame per Outcome Measure.” |
Resolving the issue:
IF you ARE measuring a change in your outcome measure over time and reporting the value of that change, add “Change in…” to the title of your outcome.
- UNACCEPTABLE EXAMPLE: Outcome Title: “Visual Analog Scale (VAS) Pain Score”, Outcome Time Frame: “Baseline, 6 Weeks”
- ACCEPTABLE EXAMPLE: Outcome Title: “Change in Visual Analog Scale (VAS) Pain Score”, Outcome Time Frame: “Baseline, 6 Weeks”
IF you are NOT measuring change in your outcome over time, enter each time point as a separate outcome measure. You can easily do this by using the “Copy Outcome” button, then adding “…at [timepoint]” to the end of the title.
- UNACCEPTABLE EXAMPLE: Outcome Title: “Visual Analog Scale (VAS) Pain Score”, Outcome Time Frame: “Baseline, 6 Weeks”
- ACCEPTABLE EXAMPLES:
- Outcome 1 Title: “Visual Analog Scale (VAS) Pain Score at Baseline” Outcome Time Frame: “Baseline”
- Outcome 2 Title: “Visual Analog Scale (VAS) Pain Score at 6 Weeks”, Outcome Time Frame: “6 Weeks”