The Integration of a Canonical Workflow Framework with an Informatics System for Disease Area Research

Abstract A recurring pattern of access to existing databases, data analyses, formulation of new hypotheses, use of an experimental design, institutional review board approvals, data collection, curation, and storage within trusted digital repositories is observable during clinical research work. The workflows that support the repeated nature of these activities can be ascribed as a Canonical Workflow Framework for Research (CWFR). Disease area clinical research is protocol specific, and during data collection, the electronic case report forms can use Common Data Elements (CDEs) that have precisely defined questions and are associated with the specified value(s) as responses. The CDE-based CWFR is integrated with a biomedical research informatics computing system, which consists of a complete stack of technical layers including the Protocol and Form Research Management System. The unique data dictionaries associated with the CWFR for Traumatic Brain Injury and Parkinson's Disease resulted in the development of the Federal Interagency Traumatic Brain Injury and Parkinson's Disease Biomarker systems. Due to a canonical workflow, these two systems can use similar tools, applications, and service modules to create findable, accessible, interoperable, and reusable Digital Objects. The Digital Objects for Traumatic Brain Injury and Parkinson's disease contain all relevant information needed from the time data is collected, validated, and maintained within a Storage Repository for future access. All Traumatic Brain Injury and Parkinson's Disease studies can be shared as Research Objects that can be produced by aggregating related resources as information packages and is findable on the Internet by using unique identifiers. Overall, the integration of CWFR with an informatics system has resulted in the reuse of software applications for several National Institutes of Health-supported biomedical research programs.