ClinicalTrials.gov guidance
CTSI's Regulatory Support function serves as the University of Minnesota's institutional administrator for ClinicalTrials.gov and provides investigators and study teams guidance on using the website.
Registration determination and assistance
- Assistance in determining whether a study should be registered on ClinicalTrials.gov. Studies that fit the definition of a clinical trial, as defined by the FDAAA, 801 or PHS 245 or the National Institutes of Health (NIH) are required to be registered on ClinicalTrials.gov and PIs are required to provide annual reporting.
- Study registration assistance and ongoing notifications for requests for updates
- Remind study teams on applicable due dates and posting clinical trial analysis results within one year of primary study completion date.
Ancillary review
- Perform ancillary review during IRB submission process to ensure proper determination of ClinicalTrials.gov registration needs
Associated fees and funding for services
There are no fees for the investigator, study team, or department for ClinicalTrials.gov guidance.
Office hours
Contact us to coordinate access to office hours:
- Available during regular business hours
Contact
[email protected]
612-625-4000