ClinicalTrials.gov is a registry and results database for clinical trial and other health-related research. Requirements for registration and results reporting evolve, so ask for help early. Further information about training can be found in the Education and Training section of the MICHR Resource Center.
Even if you do not consider your research to be a clinical trial, it is very important that you determine whether your study is required to be listed on ClinicalTrials.gov before you start your study.
A checklist tool is now available on ClinicalTrials.gov to help you determine whether your study is required by law to register and report results. There are many reasons to register a trial on ClinicalTrials.gov, including but not limited to: NIH policy, external billing requirements, and preserving the ability to publish in more than 2,000 journals.
ClinicalTrials.gov is a registry of clinical trials that is sponsored by the United States National Library of Medicine at the National Institutes of Health. Learn more about the steps for submitting study results, what data elements are required, and the record review process on ClinicalTrials.gov.
ClinicalTrials.gov Registration Requirements
At U-M, the Office of Regulatory Affairs is responsible for assisting with ClinicalTrials.gov registration and maintenance. U-M study teams should contact Diane Wilson, Regulatory Affairs Compliance Specialist, at 734.764.0634 or firstname.lastname@example.org with questions or for more information. If your project will be enrolling human subjects and you are not sure if you are required to register or report results in clinicaltrials.gov contact this office.
If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.
Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.