Tip of the Week Archive

ClinicalTrials.gov Study Status Changes due to COVID-19 Outbreak

If research activities are halted to any extent during the COVID-19 outbreak, update the ClinicalTrials.gov record to reflect the current Study Status: 

• If the study is not recruiting, but participants are still receiving interventions, the Study Status should be changed to “Active, not recruiting”
• If the study is paused and participants are no longer receiving interventions, the Study Status should be changed to “Suspended”, if it might resume later. This option gives you a space to enter a reason as well. You can use this space to enter a descriptor like “On hold due to COVID-19 outbreak”.
• If the study is completely terminated due to the COVID-19 outbreak, the Study Status should be changed to “Terminated”. For ACTs, “Probable ACTs”, and studies subject to results reporting policies (e.g. NIH funded clinical trials), results will need to be reported to ClinicalTrials.gov within 12 months of the last study visit where data was collected for the Primary Outcome Measure. This deadline applies even if the study was terminated early.