OpenEDC

OpenEDC provides electronic data capture for medical research, enabling standards-compliant collection, exchange, and reuse of clinical metadata.

Key Features:

• CDISC ODM compliance: Adheres to the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) standard without modifications to enable data exchange and reuse.
• Mobile patient-reported outcomes: Supports collection of patient-reported outcomes via mobile devices.
• Regulatory and standards alignment: Based on a literature-derived requirements analysis that incorporates 20 requirements across functional suitability, availability, compatibility, usability, and security according to ISO/IEC 25010.

Scientific Applications:

• Observational and translational research: Supports clinician-led observational and translational studies by providing standards-based electronic data capture for clinical data.
• Clinical data interoperability and metadata reuse: Enables exchange and reuse of clinical metadata across platforms through CDISC ODM compliance.
• Machine learning and secondary analysis: Produces interoperable, standards-compliant datasets suitable for downstream machine learning and secondary analyses.

Methodology:

Development followed an iterative process including a literature-based requirements analysis, design based on identified requirements, implementation according to the CDISC ODM standard, and usability evaluations with potential users.