Tip of the Week Archive

One of the most common sources of QC comments that cause ClinicalTrials.gov records to be rejected is the Outcome Measure Time Frame field. The requirements for Outcome Measure Time Frames can be summed up as:

1. Outcome Measure Time Frames need to be specific
2. Unless you are measuring a value of change over time, Time Frames for Primary Outcome Measures must have only one time point.

Let’s explore these further:

____________

Outcome Measure Time Frames need to be specific.

The Outcome Measure Time Frame is the specific time point or window (e.g. Week 6) when you will be collecting the outcome measure data for each participant. It is not the overall duration of the study.

Vague Time Frames (e.g. “during study visit”) will be rejected. If you have a large visit window, or you are collecting a time-to-event outcome measure, such as “days until progression”, use “About [AVERAGE TIME POINT]” or “Up to [MAXIMUM TIME POINT]” to describe your Time Frame.


Examples:

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Time Frames for Primary Outcome Measures must have only one time point, or must be assessing a change between 2 time points.

Unless you are measuring a value of change over time, Time Frames for Primary Outcome Measures must have only one time point per outcome measure, or the record will be rejected. This can be a frustrating requirement, but it is easily addressed:

Option 1: Not assessing a change (most common).

If you are NOT measuring and reporting a value of change between two time points for your outcome measure, write your outcome measure, and then use the “Copy Outcome” button to duplicate it for each time point. Just don’t forget to update the title and time frame for each one!

The Copy Outcome button is located below the Outcome Measure fields.

Use the Copy Outcome button to create an Outcome Measure for each time point. For example:

• Outcome 1: Number of Participants Fully Vaccinated at Baseline [Time Frame: Baseline]
• Outcome 2: Number of Participants Fully Vaccinated at Month 2 [Time Frame: Month 2]
• Outcome 3: Number of Participants Fully Vaccinated at Month 4 [Time Frame: Month 4]
• Outcome 4: Number of Participants Fully Vaccinated at Month 6 [Time Frame: Month 6]

Option 2: Assessing and reporting a change between 2 time points:

If you ARE assessing a change between two time points, simply include both time points in the Time Frame, and add “Change In…” to the Title: 

Examples:

• Title: “Change in Minutes of Physical Activity” [Time Frame: Baseline, Week 6]
• Title: “Change in Visual Analog Scale Pain Scores” [Time Frame: Baseline (immediately prior to surgery), Month 6]
• Title: “Change in A1c Levels” [Time Frame: Baseline, Day 10]

For help entering time frames, contact clinicalresearchsupportcenter@ucdenver.edu.