Regulatory Foundations, Ethics, and Law Program

Clinical Trial Registration and Results Reporting

Federal law and journal publication standards require that investigators register their clinical studies in a publicly accessible database. The ClinicalTrials.gov database is a tool to support compliance with these rules and regulations.

You should register your study under your institution’s ClinicalTrials.gov account. For account information and to learn about how to register your study, contact your institution’s Protocol Registration System (PRS) administrator. Once you have a ClinicalTrials.gov username and password, you can log in to your institution’s account.

For more information about the registration and results reporting process, please visit ClinicalTrials.gov.

To request Word documents, email regulatory@catalyst.harvard.edu.

To request any of the documents on this page be made accessible please email communications@catalyst.harvard.edu.

Consults

The Biostatistics program at Harvard Catalyst offers assistance with reporting results to ClinicalTrials.gov to investigators within Harvard-affiliated institutions. To request help with results reporting, submit a consult request and indicate your needs for ClinicalTrials.gov results reporting.

Other Helpful Resources

ClinicalTrials.gov PRS Guided Tutorials

Clinical Trials Registration & Results Reporting (CTR3) Subcommittee

The Clinical Trials Registration and Results Reporting (CTR3) subcommittee has been formed to develop and provide resources to help administrators, investigators, and other research staff involved in registration and results reporting for ClinicalTrials.gov.