The informatics core has been developing a flexible, generic, and portable framework to collect disparate data sources together, and specialized towards solid organ transplant clinical and research data. This is housed in the Northwestern Medicine Enterprise Data Warehouse (EDW) in a physically secure datacenter and has audited access control and granular data control. For example, data access can be limited by study role or by specific site. The EDW acts as an “honest broker” and maintains data stewardship and provenance for upstream data sources, and is HIPAA final common rule and IRB common rule compliance. Collaborating sites enter a contractual agreement with the EDW but maintain full and exclusive ownership of any contributed or stored data. The EDW is updated once daily and all reports and analytics can be run “on demand.” A modified MIT-Harvard de-identification algorithm is run on all data and de-identified datamarts can be made publically available. The NUTI datamart allows linkage to disparate data collection, including but not limited to the following:
- Electronic Case Report Forms (eCRF)
- Electronic health records
- Pathology (including images)
- Radiology (including images)
- Tissue Typing
- Billing and coding data
- National registry data (Social Security Death Index, etc.)
Study subjects are assigned randomly generated ID numbers that link all study information. Biological specimens inventory can also be maintained.
Northwestern Comprehensive Transplant Center has an extensive clinical research management staff. Dedicated, full time, transplant experienced project coordinators and study coordinators are available for study management. A biostatistician and data manager provide quality assurance. Analytics can be extensively customized for each study. Custom reports can be generated for any contributed study data, including datasets suitable for statistical analysis or regulatory purposes. Custom datamarts and queries can be created for specific tasks. Furthermore, interactive, custom dashboards can be created which update in real-time, which can monitor study enrollment, adverse events, or study visits. Front end web-based eCRF development that enters directly into the EDW can be designed, piloted, and validated by the Department of Medical Social Sciences (MSS) Assessment Center, which has been used by over 3,000 primarily NIH-funded investigators. In addition, over the past 4 years MSS has conducted over 30 Assessment Center training sessions to enable more than 500 of these users to independently configure the software to enable both complicated and simple research designs. Notably, Assessment Center provides data collection support for an ongoing transplant observational trial of living liver donors (www.nih-a2all.org).
RAPID (Real-time Analysis and Process Improvement Dashboard) is a free and open-source software originally developed at Northwestern Medicine Comprehensive Transplant Center and distributed through the ASTS. For more information please visit:http://asts.org/rapid