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- What is ePRO in clinical trials?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
- Related Terms
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What is ePRO in clinical trials?
Electronic Patient-Reported Outcomes (ePRO) refers to the digital collection of data directly from trial participants about their symptoms, quality of life, or treatment experience. ePRO replaces paper questionnaires, enabling real-time, accurate, and consistent capture of patient-reported information throughout the study.
Where is it used in clinical trials?
ePRO is used whenever participant-reported data is required, across study phases. Participants complete assessments on tablets, smartphones, or web portals for symptom tracking, adverse event reporting, or quality-of-life evaluations. These data help investigators and sponsors monitor treatment impact, safety, and adherence while maintaining standardized and auditable patient input.
How does Clinion implement it?
Clinion implements ePRO through its integrated platform, offering secure portals and mobile applications for participants to submit responses directly. Scheduled assessments are delivered automatically, with automated reminders for pending entries. Data flows in real time into Clinion EDC, enabling investigators and CRAs to access it promptly while maintaining blinding and role-based access controls. Audit trails capture submissions, edits, and validations, ensuring regulatory compliance and a fully traceable record of patient-reported outcomes.
What does it look like in practice?
Participants log in to the Clinion ePRO system and complete scheduled questionnaires on their device. The system highlights incomplete or inconsistent responses and notifies the study team if a potential adverse event is reported. Investigators and CRAs review responses directly in EDC, while site staff monitor compliance and follow up with participants as needed. Every action, from submission to review, is automatically logged, creating a complete, auditable record of patient-reported data.
Category
ePRO / eCOA