Goal:
- Identify relevant and unresolved issues that must be considered in establishing standards for the development, testing, and application of electronic data capture for patient-reported outcome (PRO) measures
- Contribute to the debate and potential resolution of ePRO-related methodological issues based on the scientific literature and expert opinion;
- Develop and disseminate principles of good practice surrounding the migration of paper-based PRO measures to electronic modes of administration.
Background:
The collection of clinical trial data is rapidly transitioning to electronic data capture (EDC), including patient-reported outcome (PRO) data. The development of new PRO measures specifically for EDC platforms and the migration of existing paper-based PRO measures to electronic formats present unique opportunities and challenges that affect outcomes research.
The ePRO Working Group is comprised of 3 subgroups:
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