Decentralized monitoring pilot — solid tumour cohort
A pilot study at ULS São João evaluating the feasibility of continuous remote patient monitoring and electronic patient-reported outcomes in a solid tumour cohort, run on the Vitruvian Shield platform as part of the Vitruvian Academic Research Program.
Trial design
Single-arm prospective feasibility pilot evaluating tolerability and acceptance of a decentralized monitoring workflow that combines weekly electronic patient-reported outcomes with passive vital-sign capture from a wrist-worn wearable, with adverse event reporting via the patient-facing mobile application and clinician review on the Vitruvian Shield dashboard.
- Indication
- Solid tumours (pilot cohort)
- Sponsor
- Investigator-initiated
- Clinical site
- ULS São João, Porto, Portugal
Platform modules deployed
The study uses the following Vitruvian Shield modules in production: EDC, eConsent, ePRO, RPM. Each module operates within the same audit trail, consent record, and access-control surface, so the study team works against one platform rather than a stitched set of tools.
Study metrics
Data volume captured to date
Recruitment and retention
Preliminary signal quality
Principal investigator
Regulatory framing
Conducted under the institution's research ethics committee approval, with informed consent captured electronically through the Vitruvian Shield eConsent module. Data handled in accordance with EU GDPR and the institution's data protection framework. No regulatory submission planned at the pilot stage.
More on Oncology on Vitruvian Shield
See how Vitruvian Shield supports the full workflow for studies in this therapeutic area, from protocol design through remote monitoring.