Establishment of a Research Data Repository at VIReC
Denise M. Hynes PhD MPH BSN
Edward Hines, Jr. VA Hospital, Hines
Hines, IL
Funding Period: January 2004 - December 2004

BACKGROUND/RATIONALE:
Currently, researchers seeking to obtain shared data must explore whether data from previous research studies are available, contact the studies’ investigators, reach an agreement with the investigators for data sharing and ensure that all VA policies regarding release of information and privacy were followed. Establishing a data repository that centralizes the storage and distribution of research data that is shareable would greatly reduce the time and effort now required to obtain and distribute shared data. Researchers would be able to more easily identify data available for sharing. Investigators would no longer need to field inquiries from interested researchers and process their requests. Monitoring of adherence to policies regarding the release of information and privacy would be simpler. A common set of procedures for acquiring shared data would reduce confusion among researchers on how data should be exchanged.

OBJECTIVE(S):
The purposes of this planning and feasibility project are to:
Demonstrate the feasibility of a data repository for archiving the human subjects data sets from VHA-funded Cooperative Studies Program (CSP) clinical trials research, exclusive of any human samples,
Develop procedural templates for use in such a repository,
Create procedures for acquiring, processing, storing and sharing data from this repository within the research community,
Inventory clinical trial data held at VHA Cooperative Studies Program Coordinating Centers (CSPCCs),
Generate a detailed proposal to establish a data-sharing central repository to house VHA funded research, and
Determine resource requirements for accurately forecasting the effort needed to build and maintain this data repository

METHODS:
This feasibility study focused on completed studies of the Cooperative Sttudies Program, since these are large randomized trials. We conducted an inventory of the the CSPCCs to ascertain the scope and breadth of the studies and datasets that are housed at the CSPCCs. Using this information we designed a small data repository and are in the process of testing this design and loading data into it. We are continuing to refine the model and the data acquisition process.

FINDINGS/RESULTS:
Data collection for this project is still underway.

IMPACT:
With increased attention on data sharing and the need to secure and sustain data for large studies, there is a need to have a more efficient system for storing and potentially re-examining research data.

PUBLICATIONS:
None at this time.

DRA: Health Services and Systems
DRE: none
Keywords: Organizational issues
MeSH Terms: none