From paper to platform: supporting digital migration of OUI’s Clinical Outcome Assessments
11th February 2026
Oxford University Innovation’s Clinical Outcomes team safeguards the integrity of our Clinical Outcome Assessments during digital migration, ensuring eCOA implementations preserve validity, regulatory alignment and scientific value.
The Clinical Outcomes team at Oxford University Innovation (OUI) manage a diverse portfolio of validated Clinical Outcome Assessments (COAs) that support clinical research and healthcare by capturing patients’ perspectives on their health and the impact of treatments. As healthcare increasingly embraces patient-centred and digital data capture, a growing proportion of these instruments are being migrated from paper formats to electronic platforms, known as electronic Clinical Outcome Assessments (eCOA).
Digital migration offers clear advantages in many settings, including improved data quality through automated checks, reduced administrative and transcription burden to electronic healthcare records, support for real-time monitoring, and enhanced participant engagement, to name a few. However, these benefits are only realised if the migration is conducted carefully. Poorly-executed digital adaptations risk altering how patients interpret questions, interact with response options or complete assessments, ultimately threatening the validity and comparability of the data collected.
This is why, as part of our licensing activities, OUI undertakes reviews of eCOA implementations for instruments in our portfolio. Our role is not to approve technology platforms, but to ensure that the core measurement properties of the original COA are preserved during digital migration. This includes reviewing changes to the following and assessing whether our recommendations align with established regulatory and industry-best practice methodological guidance:
– Layout
– Wording
– Formatting
– Response scales and scoring
– User navigation and interaction
We work closely with licensees to understand the proposed implementation, provide feedback on potential risks and recommend mitigations where needed, supporting more efficient study set-up and avoiding downstream issues with healthcare providers, regulators, trial sponsors and end users.
Staying on top of sector best practice is central to this work. The eCOA landscape is not static; expectations continue to evolve as new technologies emerge and regulatory thinking develops. Most recently, this has been impacted by the growing role of artificial intelligence. By maintaining an active understanding of these developments, OUI aims to support responsible innovation while safeguarding the scientific value of the Clinical Outcome Assessments we steward. Our eCOA reviews are one way we help ensure that digital transformation enhances, rather than compromises, the quality of clinical research.
If you have any questions related to our eCOA review methodology or would like to find out more information the Clinical Outcome Assessments available through OUI, please contact the Clinical Outcomes team via healthoutcomes@innovation.ox.ac.uk.
