Study Closure
Main Content
Clinicaltrials.gov Closure
Definition
- Clinicaltrials.gov closure involves updating the study status to indicate the conclusion of the study and to post study results.
Policies/guidelines
- The responsible party should ensure that the status is updated with clinicaltrials.gov.
- Depending on your study, you may be required to enter study results.
- Submit summary results (including adverse event information) no later than one year after the trial’s Primary Completion Date.
Templates/forms
- How to submit your results - External site
Training
- Clinicaltrials.gov training materials - External site
- FDAAA 801 requirements - External site