JSM 2011 Online Program

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Abstract Details

Activity Number: 647
Type: Topic Contributed
Date/Time: Thursday, August 4, 2011 : 10:30 AM to 12:20 PM
Sponsor: Section on Government Statistics
Abstract - #302281
Title: Considerations for a Central Data Sharing System for VA CSP Trials
Author(s): Tracey Serpi*+ and Cheylynne Bosley and Lauren Weil and Heather Campbell and Gary Johnson and Ying Lu
Companies: Department of Veterans Affairs and Department of Veterans Affairs and Department of Veterans Affairs and Department of Veterans Affairs and Department of Veterans Affairs and Palo Alto VA CSP Coordinating Center/Stanford
Address: Cooperative Studies Program, Perry Point, MD, 21902,
Keywords: data repository ; Cooperative Studies Program
Abstract:

The Cooperative Studies Program (CSP) is responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies in US Department of Veterans Affairs (VA). The VA Library of Trials (VALT) initiative has been designed to determine the feasibility of creating a repository for study data to be shared with researchers inside and outside of the VA. The objectives of VALT are: (1) Creation of a central repository for completed CSP study datasets; (2) Development of procedures and policies for submitting completed study data into the VALT; and (3) Development of procedures and policies for access to VALT datasets. This paper describes our two-step process for implementation of VALT: (1) Determine the data submission requirements, and (2) Develop the criteria to provide a mechanism for sharing the VALT data with researchers. We reviewed federal regulations, evaluated data sharing policies in government and industry, and have proposed standards and procedures for timely release and sharing of data that considers the protection of the study participants and the investment of the investigators conducting the research, while still facilitating data sharing.


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