An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study

Abstract

Background: Medical research and machine learning for health care depend on high-quality data. Electronic data capture (EDC) systems have been widely adopted for metadata-driven digital data collection. However, many systems use proprietary and incompatible formats that inhibit clinical data exchange and metadata reuse. In addition, the configuration and financial requirements of typical EDC systems frequently prevent small-scale studies from benefiting from their inherent advantages.

Objective: The aim of this study is to develop and publish an open-source EDC system that addresses these issues. We aim to plan a system that is applicable to a wide range of research projects.

Methods: We conducted a literature-based requirements analysis to identify the academic and regulatory demands for digital data collection. After designing and implementing OpenEDC, we performed a usability evaluation to obtain feedback from users.

Results: We identified 20 frequently stated requirements for EDC. According to the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 25010 norm, we categorized the requirements into functional suitability, availability, compatibility, usability, and security. We developed OpenEDC based on the regulatory-compliant Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) standard. Mobile device support enables the collection of patient-reported outcomes. OpenEDC is publicly available and released under the MIT open-source license.

Conclusions: Adopting an established standard without modifications supports metadata reuse and clinical data exchange, but it limits item layouts. OpenEDC is a stand-alone web app that can be used without a setup or configuration. This should foster compatibility between medical research and open science. OpenEDC is targeted at observational and translational research studies by clinicians.

Keywords: data interoperability; data standard; electronic data capture; metadata reuse; mobile health; mobile phone; open science.

Figure 1

User interface of the metadata design mode. The hierarchical order of metadata elements is represented by the centered column view (1). By means of a referencing system, electronic case report forms (eCRFs) can be reused entirely or partially (2). The language of eCRFs can be changed with the drop-down at the top left (3).

Figure 2

User interface of the clinical data capture mode. Subjects can be managed with the left column where an audit trail can be accessed as well (4). Filled or empty circles in the 2 center columns indicate whether an event or form has been completed (5). A survey view button within the right electronic case report form column switches to a mode for patient-reported outcomes (6).

Figure 3

Sequence diagram of a typical use scenario with OpenEDC. In this example, the stand-alone OpenEDC web application is used to design electronic case report forms and capture data. A Clinical Data Interchange Standards Consortium Operational Data Model file can be uploaded to reuse metadata or import clinical data. Optionally, the user can initialize an empty OpenEDC server with locally stored data. This enables the user to set up a multiuser system and conduct multicentric research studies. EDC: electronic data capture; ODM: operational data model.