My Study was Paused, Then Closed due to COVID-19. How Should I Handle the Completion Dates and Results Deadlines?
Jul 22, 2021
If you paused enrollment and study visits due to the COVID-19 pandemic, and then later decided that you would not resume the study, how should you handle the Primary and Study Completion Dates and results reporting?
Your Primary Completion Date and Study Completion Date should still be entered according to the definitions of each in ClinicalTrials.gov (often this is the last participant’s last visit date).
However, if you are required to submit results and your Primary Completion Date is now over a year in the past, there are steps you can take to avoid a “Late Results” status.
For Applicable Clinical Trials (ACTs), submit a Delayed Results Request explaining the circumstances that caused the primary completion date to be retroactively determined to be over a year in the past, and propose a new results submission date. Make sure to give yourself enough extra time to allow for ClinicalTrials.gov to review twice (up to 60 days).
Delay requests should be thorough and should justify why results will be submitted late. Requests are reviewed by the Director of NIH, and will be denied if they do not show just cause for the delay. Email clinicalresearchsupportcenter@ucdenver.edu for help submitting a delay request through ClinicalTrials.gov.
Delayed results requests can only be submitted for Applicable Clinical Trials. If your study is not an ACT, but you are required to submit results because you have an NIH or other federal funding, get in touch with clinicalresearchsupportcenter@ucdenver.edu for help submitting results as soon as possible.
Your Primary Completion Date and Study Completion Date should still be entered according to the definitions of each in ClinicalTrials.gov (often this is the last participant’s last visit date).
However, if you are required to submit results and your Primary Completion Date is now over a year in the past, there are steps you can take to avoid a “Late Results” status.
For Applicable Clinical Trials (ACTs), submit a Delayed Results Request explaining the circumstances that caused the primary completion date to be retroactively determined to be over a year in the past, and propose a new results submission date. Make sure to give yourself enough extra time to allow for ClinicalTrials.gov to review twice (up to 60 days).
Delay requests should be thorough and should justify why results will be submitted late. Requests are reviewed by the Director of NIH, and will be denied if they do not show just cause for the delay. Email clinicalresearchsupportcenter@ucdenver.edu for help submitting a delay request through ClinicalTrials.gov.
Delayed results requests can only be submitted for Applicable Clinical Trials. If your study is not an ACT, but you are required to submit results because you have an NIH or other federal funding, get in touch with clinicalresearchsupportcenter@ucdenver.edu for help submitting results as soon as possible.
Tags:
clinicaltrials.gov
COVID-19
funding
NIH
primary completion date
results
study completion date
study status