Major Issue: “The Outcome Measure Time Frame does not appear to be specific and/or in the correct format…”
Addressing Common ClinicalTrials.gov Comments:Jun 2, 2022
ClinicalTrials.gov Outcome Measure Time Frames are the specific time points at which you are collecting data for (measuring) the outcome. If the Time Frames are not entered as specific time points, the record will be rejected with the following comment:
”Major Issues: The Time Frame does not appear to be specific and/or in the correct format.”
Usually, the Time Frame will simply be the study visit time point(s) when you collect data for that Outcome Measure. Don’t abbreviate units of time.
Unacceptable Time Frames:
- “Duration of study”
- “D1, D14, D30”
- "End of Study"
Acceptable Time Frames:
- “Baseline, 6 Weeks”
- “Day 1, Day 14, Day 30”
- “Month 2”
- "Up to 8 Weeks"
For Outcome Measures that aren't measured at specific, pre-specified time points (e.g., time-to-event measures), enter the estimated period of time over which you are measuring the outcome in the format “Up to [estimated maximum time]” or "An average of [estimated time point]".
Unacceptable Time-to Event Time Frames:
- “Duration of participation”
- “Until response”
- “Hospital admission until discharge”
Acceptable Time-to Event Time Frames:
- “Up to 100 Weeks”
- “Baseline, Up to 20 minutes”
- "An average of 10 minutes"
If helpful, include information on how you are defining the time frame parameters:
Acceptable Time Frame with parameters:
- “From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months"
- "From administration until observed response (about 10 minutes)"
For help registering your study or submitting results to ClinicalTrials.gov, contact firstname.lastname@example.org.