The Epidemiology and Clinical Research Informatics Shared Resource (ECRISR) serves a crucial dual role in support of both epidemiological and clinical trial research management by providing overall research management expertise and informatics-based management solutions to Albert Einstein Cancer Center (AECC) investigators.
The ECRISR supports all aspects of epidemiological research with a special focus on the development of Study Management Informatics Systems (SMIS) which facilitate the diverse management, data and operational aspects of implementing complex study protocols. The SMIS incorporate automated workflow processes across shared facilities, implement QA and best practices to ensure data integrity, automate data integration from various sources, and establish real-time data monitoring in order to provide efficient research operations, improved data access and progress/regulatory reporting. The SMIS integrate with internal and external EHR and laboratory systems, and support management of multi-center clinical research projects.
A comprehensive clinical trial management program has been developed to standardize and streamline all AECC clinical trial and research process management. In support of this process, the Velos Clinical Trial and Research Management System has been customized to provide QA oversight and facilitate compliance/monitoring of all clinical trial activity. Workflows, policies and procedures have been established that collaboratively engage, guide and/or provide oversight to other shared resources involved in cancer research (e.g. CPDMU, Biorepository, Epic Research, IRB, OCT, Pharmacy, etc.). The research management process spans the lifecycle of protocol management from IRB submission to completion and the ECRISR continually expands the purview of the program with the design of custom interfaces between the CTRMS, Epic and multiple IRB institutional systems to provide fully integrated regulatory and operational management of clinical trials.
The ECRISR offers data concierge service to provide investigators with guidance on available data resources and access to both custom self-service data access tools. ECRISR also serves as an honest broker and provides custom data extraction and transformation, secure IRB-compliant data distribution and QA services to facilitate complex data analytics. The ECRISR created a Cancer Database Repository (CDR) to support epidemiological/clinical research and patient recruitment. Data management, transformation, harmonization and QA are part of the workflow process. Patient profiles capture demographic, diagnosis, tumor, treatment, recurrence, site-specific factor, medication, lab result, pathology and mortality data. ALICE, a custom self-service data extraction and cohort building tool, allows users to define cohorts, present summary tables and export data for analysis.