JMIR Publications

ABSTRACT

Background:

Medical research and machine learning for healthcare depend on high-quality data. Electronic data capture (EDC) systems are 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, configuration and financial requirements of typical EDC systems frequently prevent small-scale studies to profit from their eminent benefits.

Objective:

The goal was to develop and publish an open-source EDC system that addresses the aforementioned issues. We planned applicability of the system in a wide range of research projects.

Methods:

We conducted a literature-based requirements analysis to identify academic and regulatory demands towards 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 towards EDC. According to the 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 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 standalone web application that can be used without setup or configuration. This should foster compatibility of medical research and open science. OpenEDC is targeted at observational and translational research studies by clinician scientists.