Tip of the Week - Primary Completion Dates and Study Completion Dates
What They Are, & What They Are NotJun 25, 2020
ClinicalTrials.gov Completion Dates: What They Are, & What They Are Not
The Primary Completion Date and Study Completion Date are NOT connected to:
- Data analysis
- Enrollment completion
- IRB closure
The Study Completion Date is the date of the last study visit where data was collected for any of the study outcomes.
The Primary Completion Date is the date of the last study visit where data was collected for the primary study outcome(s). This will be the same as the Study Completion Date unless the last study visit for primary outcome data collection occurs before the last study visit where data is collected for secondary or other outcomes.
Results information, if required, must be posted to ClinicalTrials.gov by the responsible party no later than 12 months after the primary completion date, even if the study was terminated early. If you are required to report results to ClinicalTrials.gov and you use the wrong study milestone (e.g. IRB closure) as your completion date, you may have late results!For help reporting results to ClinicalTrials.gov, or if you have other ClinicalTrials.gov questions, contact ClinicalResearchSupportCenter@ucdenver.edu.