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Registration of ORD Sponsored Clinical Trials
In support of the VHA health care mission and in keeping with Office of Research and Development's (ORD) commitment to improve veterans' access to clinical trials, ORD registers the clinical trials it sponsors 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 ORD 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 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/clin_trialup.htm.
To assist investigators in meeting ORD and ICMJE requirements, ORD has standardized the registration process.
Registration Process
All ORD-sponsored clinical trials are registered on-line through the ART Program. (Website at http://art.puget-sound.med.va.gov)
Once a clinical trial is approved for funding:
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The ORD service funding the study notifies the ART Program and ART emails the Principal Investigator (PI) with instructions for accessing the Intranet site and completing the data collection form.
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The PI (or project staff person) completes the clinical trial information on the ART Intranet site and submits to the ART Program.
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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.
- The PI then provides the proof of registration, along with other Just-In-Time documentation, to Central Office.
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.
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 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.
Background
Program Managers Contact
Clinical Science Research & Development Service
Cheylynne Bosley, MS
Program Analyst/Technical Writer, CSR&D
Phone: 202-254-2544
E-mail: cheylynne.bosley@va.gov
Note: For VA Cooperative Studies, please contact your CSP Coordinating Center.
Health Services Research & Development
John Messina
Coordinator, ART Program, HSR&D
Phone: 206-768-5473
E-mail: ART@va.gov
Rehabilitation Research & Development Service
Ricardo Gonzalez
Administrative Officer, RR&D
Phone: (202) 254-0196
Email: Ricardo.gonzalez@va.gov
Wijegupta Ellepola, CPO
Program Analyst, RR&D
Phone: (202) 254-0103
Email: wijegupta.ellepola@va.gov
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