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Registration of HSR&D-sponsored Clinical Trials

In order to provide, veterans, family members, health care professionals and members of the public easy access to information on clinical trials for a wide range of diseases, conditions and health problems, ORD-sponsored clinical trials are registered in the National Library of Medicine's (NLM) public registry, ClinicalTrials.gov. Funding for all HSR&D-sponsored clinical trials is contingent on proof that the study has been registered with ClinicalTrials.gov by the ART Program.

ORD uses the World Health Organization (WHO) and International Committee of Medical Journal Editors (ICMJE) definition of Clinical Trial: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." Health-related intervention means any intervention used to modify a biomedical or health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes. If your study meets this definition, then registration is required. HSR&D observational studies do not require registration.

Registration of HSR&D-sponsored Clinical Trials

All HSR&D/QUERI clinical trials are registered through the ART Program Website (http://art.puget-sound.med.va.gov).

Please note you must be logged into the VA network in order to access the ART Intranet site. If you do not have access to the VA network, please contact the ART Program at art@va.gov.

Once a clinical trial is approved for funding:

  • Central Office (CO) notifies the ART Program, and ART emails the Principal Investigator (PI) with instructions for accessing the Intranet site and completing the on-line data collection form.
  • The PI (or project staff person) completes the clinical trial information on the ART Intranet site. The ART Program is automatically notified when the information is submitted.
  • The ART Program reviews and uploads the information to ClinicalTrials.gov. When registration is complete, ART emails proof of registration (a PDF file) to the PI.
  • The PI then provides the proof of registration, along with other Just-In-Time documentation, to CO. If you are the PI on a newly approved clinical trial and have not received a registration request, please e-mail your Scientific Program Manager and copy ART (ART@va.gov).

After registering a VA-sponsored trial at ClinicalTrials.gov, an investigator may choose to register the trial in other registries; however, the investigator is solely responsible for additional registrations.

Update Process

To keep the clinical trial information current for the public and to meet the ClinicalTrials.gov requirement that active records be updated at least every six months, the ART Program will send an automated email reminder to the PI when an update is due. Updates, like registrations, are completed using the ART Website.

Additional information is available on the VA ORD Website.


Program Manager Contact
John Messina
VA Clinical Trials Registration Coordinator
Phone: 206-768-5473
E-mail: ART@va.gov