Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Clinical Trial Registration and Results Reporting

Overview

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.

Harvard Catalyst 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.

CTR3 Resources

  • Registration Tip Sheet [PDF]
  • Results Reporting Data Elements Overview [PDF]
  • Outcome Measure Considerations [PDF]

    To request Word documents, email us.
  • Request a Consult
    The Biostatistics program at Harvard Catalyst offers assistance with reporting results to ClinicalTrials.gov to investigators within Harvard partnering 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: Why Does it Affect Me? Should I Be Concerned? [PDF]
  • ClinicalTrials.gov: Registration User Guide [PDF]
  • ClinicalTrials.gov: Results Reporting from the Ground Up [PDF]

Contacts

If you have any questions, please email us.