Clinical Research Data Warehouse Sharepoint Site
At the heart of utCRIS is an enterprise-class integrated data warehouse (utCR-DW) composed of a clinical data research repository (utCR-DW-CDRR), containing de-identified patient information from EPIC, CDR and IDX. It will also include and experiment data research repository (utCR-DWEDRR) from laboratory experiments and a reference data knowledge base (utCR-DW-RDKB) so that researcher can compare data against national data banks as well as utilize standard terminology to characterize data.
The data warehouse will contain data regarding study protocol management and subject clinical parameters derived from administrative interfaces to EPIC, CDR and case report forms. The warehouse will be developed and maintained as a separate database to segregate the use of clinical data for research purposes from its use for patient management, to ensure compliance with clinical research regulatory requirements, and to allow for structuring to support research-related activities. Transfer of data from the institutional CDR into the warehouse will be mediated through an ETL (Extract, Transform, Load) process supported by the existing CIS HL7 messaging interface engine. The structure of the data warehouse will be based on the evolving CDISC and BRIDG standards and include tables structured around administrative, demographic, medical history, family history, laboratory testing, treatment, adverse events and outcome components. Additional clinical data not supported in the CDR will be loaded into the warehouse using an electronic case report form application. Another phase of warehouse includes experimental data, the utCR-DW-EDRR, will contain research laboratory experiment performance data and results.
The utCRIS Data Warehouse project is designed to extend over multiple years and will be constructed using logical phases. Currently, the AIS data warehouse team is utilizing the promising i2b2 platform (CRDW Frequently Asked Questions) for developing the basic star schema structure and testing data inputs for patent demographics, diagnostic codes and medications. Concurrently, the AIS clinical trials team is in the early implementation of the Velos eResearch product, which will allow complete development of electronic clinical trials management from beginning to end. Our AIS pre-awards team is evaluating systems to ease the IRB processes and developing implementation strategies for integrating and migrating data for other systems. The AIS team is acutely abreast of changing systems on campus. As such, integration of certain data inputs to the warehouse will be integrated based on stability of the “source of truth” system.
