Data & Quality
Electronic Patient-Reported Outcomes (ePRO)
Electronic Patient-Reported Outcomes (ePRO) are clinical trial data collected directly from participants via electronic devices (smartphone apps, tablets, web portals) on symptoms, function, quality of life, and treatment experience, without interpretation by a clinician.
ePRO replaces paper diaries with timestamped, validated electronic capture, eliminating recall bias and back-filling. FDA's PRO Guidance (2009) and the recent Patient-Focused Drug Development guidance series set evidentiary standards for PRO instruments and their psychometric validation.
Common platforms include Medidata Patient Cloud, Clario eCOA, and Signant Health. Bring-Your-Own-Device (BYOD) ePRO is increasingly accepted when equivalence studies have been conducted.
Related terms
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) is the system used to collect, manage, and store clinical trial data electronically via electronic case report forms (eCRFs), replacing paper-based data collection.
Decentralized Clinical Trial (DCT)
A decentralized clinical trial (DCT) is a clinical study in which some or all trial activities; recruitment, consent, dosing, monitoring, data capture; occur outside traditional brick-and-mortar sites, typically in the participant's home or community setting and supported by digital tools.
Endpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
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