An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation

Caleb J Ruth,Jesse T Krisher,Amy Fothergill,Bryan M Gannon,Saurabh Mehta,Samantha Lee Huey,Susannah Colt,Julia Leigh Finkelstein,Laura S Hackl,Elizabeth Centeno-Tablante,Camille Elyse Jones

doi:10.2196/18580

Abstract

BackgroundWhen 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 offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador.ObjectiveThis paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs.MethodsWe developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage.ResultsConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection).ConclusionsConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

Highlights

BackgroundOur research on human nutrition and global health spans multiple countries, encompasses both interventional and observational study designs, and requires secure data collection and management
ConnEDCt’s features, quality, and safety are reliable compared with existing guidelines and requirements, including Good Clinical Data Management Practices [8], the Food and Drug Administration (FDA) [9], and Title 21 Code of Federal Regulations (CFR) Part 21 [10]
Description of Current Implementation: Case Studies The ConnEDCt platform has been used in a variety of contexts within our research teams, including cross-sectional studies in clinical settings, surveillance studies, and randomized controlled trial REDCap (RCT) (Table 2)

Summary

Introduction

BackgroundOur research on human nutrition and global health spans multiple countries, encompasses both interventional and observational study designs, and requires secure data collection and management. With several research projects on our roadmap that would be deployed in remote, international regions with complex longitudinal protocols, strict eligibility requirements, and distributed research teams, we aimed to use EDC over paper-based data capture to enforce our study protocols and provide better data security, data validation, and have instant access to data. 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. Objective: This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. Methods: We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement

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Discussion

Conclusion