ConnEDCt, a mobile-first framework for clinical Electronic Data Capture
Ruth, Caleb J.
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Paper-based data capture has long served as the primary means of collecting research data and continues to be the dominant means of data capture through the present day. Despite inertia with adopting information technology in clinical research, electronic methods of information capture have important benefits over traditional, paper-based methods. Electronic Data Capture (EDC) systems can provide integrated error checking, protocol enforcement, decision support, automated randomization, and quicker access to data and results. As EDC systems become more accessible and resourceful, EDC has begun to replace paper-based data capture. Meanwhile, mobile computing, utilizing smartphones and tablets, has become commonplace in business and our everyday lives. Many EDC solutions support mobile devices, yet few were conceived with a “mobile- first” design philosophy and fewer support extensive study protocol-support features. A significant amount of clinical research is conducted in geographic regions with limited or no Internet access such as impoverished and remote communities. Current EDC solutions remain challenging to use in these contexts. While EDC is an increasingly important tool for clinical research, when EDC solutions are built on web-centric architectures, the lack of Internet coverage means that researchers often need to fall back on paper-based data capture methods or build expensive, custom EDC tools. A customizable Mobile Electronic Data Capture (mEDC) framework with an asynchronous data transport layer will better meet the needs of distributed studies in resource- limited, geographical areas. I developed ConnEDCt, a full-featured mEDC application that is customizable for longitudinal study protocols, with regulatory-compliant security, auditability and an asynchronous data transport model. ConnEDCt is adaptable to different study protocols, has extensive study protocol-support built-in, and supports on- or off-line data synchronization to a central data repository. ConnEDCt focuses on mobility and is designed to serve the needs of complex clinical research studies in regions where other EDC platforms cannot be utilized.
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