Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 5, 2020
Date Accepted: May 14, 2020
ConnEDCt: an electronic data capture framework (EDC) for research studies including surveillance programs, clinic-based studies, and randomized controlled trials in global and public health
ABSTRACT
Background:
When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable, EDC framework. We needed to capture data when off-line, to sync on demand, to enforce strict eligibility requirements, and complex longitudinal protocols. Our experience with the geographical areas of interest for our research was of unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper data capture because we wanted other benefits of EDC and so we decided to build our own re-usable, software platform. In this manuscript, we describe our customizable EDC framework, and highlight how we have used it in our ongoing surveillance programs, cohort studies, and clinical trials in various settings in India and Ecuador.
Objective:
To create and adapt a a mobile EDC framework to support complex clinical research protocols in a variety of settings: clinical, surveillance, and randomized controlled trials.
Methods:
We developed ConnEDCt, a mobile EDC framework for iOS devices and PCs, using Claris FileMaker software for electronic data capture and data storage.
Results:
ConnEDCt was pilot tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and further refined for ease-of-use and optimization.
Conclusions:
ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Further, ConnEDCt is user-friendly and lowers the risks for errors in data entry due to real-time error checking and protocol enforcement. ConnEDCt will continue to be used with our current and implemented for future trials. Clinical Trial: PM: NCT02233764 MBFC: NCT02648893 QFS: NCT03853304 Surveillance: NCT04048330
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