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

Area of Science:

• Clinical Research Technology
• Health Informatics
• Mobile Health (mHealth)

Background:

• Developed countries often have advanced electronic data capture (EDC) systems, but these are frequently impractical for resource-limited regions due to unreliable internet access.
• Traditional paper-based data collection methods lack the efficiency and data integrity benefits of EDC systems.
• A need exists for a robust, adaptable EDC solution tailored to the unique challenges of conducting clinical research in diverse, low-resource environments.

Purpose of the Study:

• To create a reusable, mobile electronic data capture (EDC) framework capable of supporting complex clinical research protocols in resource-limited settings.
• To develop a system that enables offline data capture and on-demand synchronization, overcoming unreliable internet connectivity.
• To design a customizable platform that enforces strict eligibility criteria and manages intricate longitudinal study designs.

Main Methods:

• Developed ConnEDCt, a mobile EDC framework utilizing Claris FileMaker software for data capture and storage on iOS devices and personal computers.
• Integrated features for offline data collection, on-demand synchronization, user roles, and simultaneous multi-location data syncing.
• Incorporated functionalities for complex randomization, informed consent processes, and diverse data types, including laboratory results and sociodemographic information.

Main Results:

• ConnEDCt was successfully deployed and refined in clinical, surveillance, and randomized controlled trial (RCT) research contexts in India and Ecuador.
• The framework demonstrated ease of use and optimization for specific user roles, multi-location synchronization, and complex study designs.
• The system effectively handled diverse data collection needs, from laboratory measurements to biological specimen collection, within challenging field conditions.

Conclusions:

• ConnEDCt offers a customizable, regulatory-compliant EDC solution with robust security and data synchronization capabilities for various research settings and study designs.
• The user-friendly interface and real-time error checking significantly reduce data entry errors and enhance protocol adherence.
• This mobile EDC framework provides a practical and effective alternative to traditional methods, facilitating high-quality clinical research in resource-limited regions.