Tip of the Week Archive

Addressing Common ClinicalTrials.gov Comments:
“The Outcome Measure Time Frame does not appear to be specific and/or in the correct format…”

  

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 a 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) where you collect data for that Outcome Measure. Don’t abbreviate units of time.

• Unacceptable Time Frames:       
  • “Duration of study”
  • “D1, D14, D30”

     

• Acceptable Time Frames:
  • “Baseline, 6 Weeks”
  • “Day 1, Day 14, Day 30”
  • “Month 2”

   

  For Outcome Measures where traditional visit time points don’t apply (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]”.

• Unacceptable Time Frames:       
  • “Duration of participation”
  • “Hospitalization”
  • “Hospital admission until discharge”

     

• Acceptable Time Frames:
  • “Up to 100 Weeks”
  • “Baseline, Up to 20 minutes”

 

If helpful, include information on how you are defining the time frame boundaries:

 

Acceptable Time Frame:                “From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"