Registration of ORD 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.

To assist investigators in meeting these requirements, ORD has standardized the registration process.

Registration Process

All ORD-sponsored clinical trials are registered online through HSR&D's ART Website (http://art.puget-sound.med.va.gov). Once a clinical trial is approved for funding:

• The ORD service funding the study 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.

If you are the PI on a newly approved clinical trial and have not received an email from ART with registration instructions, please contact the appropriate ORD Service contact below.

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 appropriate ORD Service contact below.

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.

Background

• Clinical Trials Registration FAQ (32.8 KB, PDF)

Program Managers Contact

Further questions concerning individual ORD Service registration procedures or policies can be directed to the following trials registry program managers:

Updated: Nov. 13, 2012

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