ClinicalTrials.gov Registration

The University of Louisville is committed to compliance with clinical trial registration and results reporting requirements.

ClinicalTrials.gov is an online registry that provides patients, family members, health-care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The ClinicalTrials.gov information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997. The legislation requires the establishment of a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions.”
While you may choose to voluntarily register your trial in the interest of transparency, some trials must be registered on ClinicalTrials.gov:

    1. If publication is planned for any journal that follows the ICMJE registration requirements;

      • Journals that follow the International Committee of Medical Journal Editors (ICMJE) Trial Registration Policy require clinical trials to be publicly registered at or prior to first patient enrollment. Member journals are fully enforcing this policy and delayed registration risks the inadmissibility of your article.
      • ICMJE broadly defines interventional clinical trials. Intervention types can include, for example, behavioral treatments and educational programs.
      • The ICMJE has also implemented a data sharing policy. Manuscripts reporting clinical trial results that are submitted on or after July 1, 2018, must contain a data sharing statement. Trials that will begin enrollment on or after January 1, 2019 must include a data sharing plan in the trial registration.
      • View ICMJE registration and data sharing policies.
      • View member journals.

    2. If the trial meets federal government requirements for certain drug and device studies;

      • Federal law mandates the registration and reporting of results for Applicable Clinical Trials (PDF). Potential consequences for noncompliance include civil or criminal judicial actions, civil monetary penalty actions, and grant funding actions.
      • View general information about the regulations and Protocol Registration and Results (PRS) System.

    3. If the trial is NIH funded.

UofL recommends registration prior to first-patient-enrollment in order to ensure compliance with any applicable mandatory requirements.
For help creating a PRS account or registering your study on ClinicalTrials.gov, please email the UofL PRS Administration Team or call 502.852.7247.

Access the Protocol Registration System (PRS) website and enter this login information:

    • Organization: ULouisville
    • User Name: (supplied by PRS at account setup)
    • Password: (supplied by PRS at account setup, or as changed by you)

In the Sponsor/Collaborators section, please designate the Principal Investigator of the study as “Responsible Party”. If the Principal Investigator also holds the study’s IND/IDE, then designate the Principal Investigator as “Sponsor-Investigator.”

Once all record information has been entered, return to the Record Status page. In order for the record to be reviewed by the federal PRS administrators and shared with the public, you must press the green button on the Record Status page several times, so that the text within the button changes from "Entry Completed", then to "Approved", and finally to "Released." Any individual with an account can assist with record entry, including pressing the green button to mark it as ‘Entry Completed’ and ‘Approved’, but only the Principal Investigator can ‘Release’ the record.

Additional Resources:

Watch a Registration User Guide video or view a PowerPoint presentation on how to register your study.

View the federal FAQ about registration.

Records must be updated within 30 days of a change to:
    • Study Start Date (update from ‘anticipated’ to ‘actual’)
    • Recruitment Status/Overall Recruitment Status
    • Completion Date/Primary Completion Date
    • IRB review status

Anytime the record is updated, the Record Verification Date must also be updated. The Record Verification Date data element is located in the Study Status section.

Federal administrators recommend that the Record Verification Date be updated at least every 6 months for studies that are not yet complete, even if there are no other changes to the record. The Record Verification Date must be updated annually.

Once all record information has been updated, return to the Record Status page. In order for the record to be reviewed by the federal PRS administrators and shared with the public, you must press the green button on the Record Status page several times, so that the text within the button changes from "Entry Completed", then to "Approved", and finally to "Released." Any individual with an account can assist with record updates, including pressing the green button to mark it as ‘Entry Completed’ and ‘Approved’, but only the Principal Investigator can ‘Release’ the record.

For help submitting your study results on ClinicalTrials.gov, please email the UofL PRS Administration Team.

Read federal guidance on how to submit results.

View a PowerPoint presentation on results reporting compiled by members of the ClinicalTrials.gov Task Force and Clinical and Translational Science Award (CTSA) member Institutions. This slide deck contains screenshots of the current PRS interface.

Watch presentations by the federal PRS administrators: