SVS PSO Data Analysis Guidelines for Use
In order to ensure protection of de-identified datasets and fair access for members, investigators should familiarize themselves with the SVS PSO guidelines and policies on use, listed below.
Global guidelines for VQI Dataset Requests:
- Data Security: All investigators and team members are responsible for security of datasets, which are only to be used for the project for which they were approved.
- Dataset Access: Investigators have free access to the datasets to which their center has subscribed, providing that their center has at least 50% Long Term Follow-Up for the registry data being requested. Please confirm that your center subscribes to the dataset(s) you wish to analyze before submitting your proposal.
- Device-related Datasets
- Regional datasets are not available for device-specific projects due to concerns around the low “n” in regional datasets, industry sensitivities around proprietary devices and the potential for identification of physicians.
- National datasets for device-specific projects will only be released after completion of the steps outlined in the SVS PSO Device Identification Policy (click here to read the policy in full). Please note that the additional safeguards in the Device Identification Policy require additional time to complete so you may wish to build in additional time to guarantee that you can meet deadlines for journal or event submission.
- Medicare-Match: Medicare-match datasets are available through TDI only (please click here for more details), and the additional analysis will take time to complete.Please note that there are regulatory and resource constraints limiting our ability to process analytic requests using the VQI-Medicare linked datasets. The VQI is working in partnership with their sponsor and CMS to establish a mechanism to facilitate access to these datasets. In the meantime, we urge investigators to use the BDS data made available by the VQI to meet upcoming deadlines.
- Dataset Refresh Requests: One dataset refresh is allowed within 24 months of the approval of the original study – please email Nancy Heatley if you wish to receive a dataset refresh.
- Overlap of Topics: The RAC has dropped the requirement to avoid overlap as a criterion for SVS PSO RAC approval. Research protocols now need only to demonstrate feasibility that the research can be accomplished using data available in the VQI dataset. Overlap with an existing project will not be used as grounds for rejection of a research protocol application. The RAC are unable to ensure that no overlap exists, because of the large numbers of active research efforts underway. Therefore, researchers will need to ensure that their work takes into consideration what has already been approved as a research topic. Please check your topic using the RAC Search Tool.