eCOA is the electronic collection of clinical outcome assessments: measures of how a patient feels, functions or survives, captured on a phone, tablet or browser instead of on paper. ePRO is the patient-reported part of it.
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Electronic clinical outcome assessment
noun · clinical research
Collecting clinical outcome assessments, reported by patients, clinicians or observers, or based on performance tasks, in electronic form.
Related terms
In short
Explained
A clinical outcome assessment reflects how a patient feels, functions or survives. The widely used FDA-NIH BEST glossary groups COAs into four types according to who provides the information: the patient (PRO), a clinician (ClinRO), a non-clinician observer (ObsRO) or the patient doing a standardised task (PerfO). Our page on PRO, ClinRO, ObsRO and PerfO explains each with examples.
eCOA simply means doing that in electronic form. In everyday use people often say eCOA when they mean ePRO diaries and questionnaires, because patient-reported data is where the shift from paper has been biggest. Strictly, though, eCOA also covers site-completed rating scales and observer reports. For the patient-completed part, see ePRO software for clinical trials.
Paper diaries can be filled in later, from memory, without anyone knowing. Electronic entries carry a timestamp, required fields cannot be skipped, skip logic hides irrelevant questions, and scores are calculated instead of transcribed. Reminders can be scheduled. Data arrives in the study database without a separate transcription step. Diary completion rates also depend on participant burden and completion rates.
Moving an established questionnaire from paper to screen is not neutral. The layout, scale display and wording must remain faithful to the original, and many instruments have licence terms that apply to electronic use. Check the rights holder's terms before you build, and see the instrument templates for examples of how common scales are laid out.
When COA scores are used as endpoints, regulators expect evidence that the measure suits the intended population and context. That evidence is separate from the software, but the software should not weaken it: consistent presentation, timed capture and an audit trail. See clinical trial endpoints and MCID for how scores are interpreted.
Patient-reported
Participant, own phone
Observer-reported
Caregiver
Clinician-reported
Site staff, clinic tablet
Performance outcome
Site-run test, e.g. chair rise
Paper to electronic
Create an ePRO questionnaire in the free sandbox and complete it on any device browser. No app, no credit card.
In Capture
Capture includes ePRO with ten question types (including linear scale and slider), a diary schedule and reminders, and forms work in a browser on a participant's phone, a home tablet or a clinic device. For licensed patient questionnaires, a study team can record licence number, holder and expiry; Capture does not verify licences or supply licensed instruments. Site-completed assessments use eCRF forms in the same study and the same audit trail.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Electronic clinical outcome assessment: collecting patient-, clinician- or observer-reported measures, or performance outcomes, electronically.
ePRO is the patient-reported subset of eCOA. eCOA also covers clinician-reported, observer-reported and performance-based assessments collected electronically.
Yes. An electronic patient diary is an ePRO, and ePRO is a type of eCOA.
It depends on the platform. In Capture, questionnaires open in a web browser on a phone, tablet or computer, so no app install is needed.
Many validated instruments have licence terms, some specific to electronic use. Check the rights holder's terms and keep the licence with your study documents.
Timestamped entries, required-field checks, automatic scoring and reminders reduce missing and unreliable data.
Build a questionnaire and a diary schedule with every feature. No credit card.