Registration of HSR-sponsored Clinical Trials

In support of the VHA health care mission and in keeping with the Office of Research and Development's (ORD) commitment to improve veterans' access to clinical trials, all clinical trials that ORD sponsors are registered with the National Library of Medicine's (NLM) public registry, ClinicalTrials.gov. ClinicalTrials.gov 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, conditions and health problems.

VA investigators funded by an ORD research service (Clinical including Cooperative Studies, Health Services, and Rehabilitation) must have their clinical trial registered before funding will be released and prior to enrolling participants into their study. Additionally, the International Committee of Medical Journal Editors (ICMJE), (whose member journals include, for example, Annals of Medicine, Journal of the American Medical Association, Lancet, and the New England Journal of Medicine), requires registration of clinical trials in a public registry as a condition for publication (N Engl J Med 2004;351:1250-1). For more information, see http://www.icmje.org/publishing_10register.html.

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 observational studies do not require registration.

Registration of HSR-sponsored Clinical Trials

All HSR/QUERI clinical trials are registered through the ART Website (http://art.puget-sound.med.va.gov). Once a clinical trial is approved for funding:

• HSR or QUERI notifies the ART Program that a clinical trial has been approved for funding.
• ART emails the Principal Investigator (PI) with instructions for accessing the Intranet site and completing the data collection form.
• The PI (or project staff person) completes the clinical trial information on the ART Intranet site and submits to the ART Program.
• The ART Program reviews and uploads the information to ClinicalTrials.gov. When registration is complete, ART emails proof of registration (PDF file) to the PI.
• Through an automated process, ART notifies the Just-In-Time system that the registration has been completed.
• After a VA-sponsored trial is registered at ClinicalTrials.gov, a PI may choose to register the trial in other registries; however, the PI is solely responsible for all activities related to these registrations.

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.

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).

Update Process

To keep the clinical trial information current for the public and to meet the ClinicalTrials.gov requirements for maintaining updates, 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. Failure to provide updates in a timely manner may impact project funding.

Additional information is available on the VA ORD Website.

ART Program Contact
Jolie Bergman
Clinical Trials Registration Coordinator
Phone: (206) 277-4163
E-mail: ART@va.gov

Questions about the HSR website? Email the Web Team

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.