Tip of the Week Archive

If required, results must be submitted to ClinicalTrials.gov within 12 months of the Primary Completion Date, but what if your Primary Completion Date occurs before your Study Completion Date, i.e., because you have longer term follow-up for Secondary Outcome Measures and/or Adverse Events? Does that mean you’ll be facing a results time-crunch or even late results because of your longer-term data collection period for Secondary Outcome Measures?

The answer is no. You still must report the results data for which data collection completed at the time of the PRIMARY Completion Date (including, by definition, all Primary Outcome Measures) within 12 months of that Primary Completion Date. However, the Outcome Measures for which data collection completed at the time of the STUDY Completion Date will be due within 12 moths of the STUDY Completion Date.

EXAMPLE

Sample Record Parameters:

Completion Dates:
•    Primary Completion Date is 8/1/2021
•    Study Completion Date is 8/1/2023

Primary Outcome Measure: 

Title: Minutes of Daily Exercise at 12 Months
Description: Average minutes of daily exercise over the past week as measured by wearable fitness device, assessed at the 12 Month visit.
Time Frame: Month 12    
↑     This time frame defines the PRIMARY Completion Date, and results will be due for this Outcome Measure within 12 months of the Primary Completion Date (i.e., by 8/1/2022)

 

Secondary Outcome Measure: 

Title: Minutes of Daily Exercise at 36 Months
Description: Average minutes of daily exercise over the past week as measured by wearable fitness device, assessed at the 36 Month visit.
Time Frame: Month 36 
↑     This time frame defines the STUDY Completion Date, and results will be due for this Outcome Measure within 12 months of the Study Completion Date (i.e., by 8/1/2024)

Reporting Instructions:
Within 12 months of the Primary Completion Date:

1. Report the data available for Participant Flow, Baseline Characteristics, and Adverse Events.
2. Report all Outcome Measures that are due (i.e., within 12 months of the last visit where data was collected for that Outcome Measure).
3. For the Outcome Measures that are not due yet and for which you cannot yet report data: 
1. Click on the “Edit” link next to the Outcome Measure.
2. Click “Save”.
3. Enter an “Anticipated Reporting Date”. This must be no later than 12 months after the Study Completion Date.
4. Upload the study protocol & Statistical Analysis Plan, if required.
5. Submit the partial results to ClinicalTrials.gov (don’t forget to click the green “Complete” button on the Record Summary page!)

Within 12 months of the Study Completion Date:

1. Go back and report the remaining Outcome Measure(s) 
2. Make any final updates or corrections to the other results data (e.g., adverse events).
3. Submit the final, complete results to ClinicalTrials.gov

For assistance, contact [email protected].