This guide outlines best practices for deploying electronic clinical outcome assessments (eCOAs). Recommendations include: starting with a clear protocol, balancing data collection with patient burden, ensuring user-friendly design, leveraging pre-existing assessments, demonstrating data equivalency, offering both BYOD and provisioned devices, validating translations, and planning for training/support. By focusing on usability and regulatory compliance, sponsors can reduce trial risks, improve patient adherence, and capture higher-quality data. A robust eCOA strategy transforms patient-reported outcomes into reliable, regulatory-grade insights that accelerate trial success.

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