Most eCOA roundups are really ePRO roundups. This one starts from the other half: scales scored by a clinician, a caregiver or a standardised performance task. Here are the four assessment types, the criteria that separate platforms, the vendor categories and where Capture fits, and where it does not.
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| Question | Option A | Option B | Option C | |
|---|---|---|---|---|
| Participant questionnaires (PRO) | Ask | Ask | Ask | |
| Clinician-rated scales (ClinRO) | Ask | Ask | Ask | |
| Caregiver reports (ObsRO) | Ask | Ask | Ask | |
| Rater training and qualification | Ask | Ask | Ask | |
| Licence and translation handling | Ask | Ask | Ask |
The short answer
Definitions
A clinical outcome assessment (COA) describes how a patient feels, functions or survives. Industry guides group them into four types by who produces the score. A patient-reported outcome (PRO) comes straight from the patient without interpretation by anyone else. A clinician-reported outcome (ClinRO) rests on the observation and judgement of a trained health professional. An observer-reported outcome (ObsRO) comes from someone such as a parent or caregiver who observes the patient, and is used when the patient cannot report. A performance outcome (PerfO) is based on a standardised task the patient performs, such as a walk test, scored by an assessor or by the patient. The term eCOA is the electronic delivery of any of these, and ePRO is only the first. Our ClinRO, ObsRO, PerfO and PRO glossary entry and the eCOA software overview set out the types.
Most of the buying material online treats eCOA and ePRO as one thing, and for good reason: self-report is the largest and simplest category, and our own roundups of ePRO software and eConsent software cover it. The harder question is the clinician side. A ClinRO score depends on a person, and two raters can score the same patient differently or drift over a long study. Sources describing rater training say it is recommended by regulators and aims to reduce inter- and intra-rater variability, and that raters often need certification before scoring. That is a service and a workflow as much as software, and it is the first thing to ask each vendor about.
This page is the buying guide for that second half. It complements, rather than repeats, the ePRO roundup.
Selection criteria
Score each option on the same sheet, using the same instruments, and keep the written answers for your vendor qualification file.
PRO, ClinRO, ObsRO and PerfO. Ask for each separately; support for one does not imply the others.
For ClinRO and PerfO the identity of the person who scored matters. Check that the rater is a field on the record, and who can sign as one.
Is training or certification offered, by whom, and is completion tracked against the right to score? Capture does not provide a certification programme; your sponsor or a specialist vendor does.
Are totals and subscales calculated by the system, and can the formula be reviewed? Capture supports calculated fields; see calculated fields and skip logic.
How are licence terms recorded and enforced? In Capture, licence controls apply to participant questionnaires only; for site-completed scales the licence stays in the study documents.
Ask for the exact list and the translation validation process. This page makes no multilingual claim for Capture.
BYOD, provisioned devices or site tablets. Capture runs in the browser on participant phones and site devices, with no app install; it does not ship provisioned devices.
Field-level audit trail with user, time, old value, new value and reason. See audit trail software.
Separate vendors mean a data transfer and a reconciliation. A single system avoids it; see clinical trial software with integrated ePRO.
Setup fee, per-instrument or per-participant charges, and how long a build takes. Ask in writing. No numbers are published on this site.
Vendor categories
A category view rather than a ranking. Vendors named elsewhere on this site are described at category level only; verify every point yourself.
| Category | Typical strengths to ask about | Typical trade-offs to ask about | Often a fit for |
|---|---|---|---|
| Specialist eCOA providers | Instrument library, rater training programmes, provisioned devices, translation process, global support | A separate system and data transfer to the EDC; set-up lead time and cost | Large multi-country studies with licensed instruments and many raters |
| EDC suites that include eCOA | One database and one vendor; fewer reconciliations | Depth of the clinician-rated and performance modules varies; ask for a demonstration with your scale | Mid-size studies that want one contract |
| Self-serve all-in-one platforms (Capture) | EDC, ePRO, eConsent and randomization in one record; free sandbox; fast build by the study team | No rater certification programme, provisioned devices or translation-certification service | Phase 1 to 3 studies and investigator-run studies where the team builds its own instruments |
| Institutional research tools | Low cost, local support, flexible forms | Who validates, audit trail and signature scope; compare with Capture vs REDCap | Academic studies with institutional hosting |
| General survey tools | Easy to start | Audit trail, consent records and access control for a regulated trial; see is Qualtrics 21 CFR Part 11 compliant | Pilots and non-regulated studies |
No pricing, hosting or feature claims are made about any vendor other than Capture. This is not a ranking.
The free sandbox includes every feature. Build one phone questionnaire and one site-completed scale, enter sample data and read the audit trail. No credit card, no time limit.
Where Capture fits
In Capture a ClinRO is an eCRF form completed by site staff. The rater is a field, the items and total are stored with the interview date, and every change to a value shows who made it and why.
Rater
RATERAssessment date
RSDTCSeverity (clinician judgement)
SEVChange since baseline
CHGTotal score
TOTALRead-only, calculated
14 CalculatedHonest limits
Capture does not run a rater certification programme, supply a rater-qualification audit, ship provisioned devices or offer a translation-certification service, and this page makes no multilingual claim. If your sponsor requires certified raters and centrally monitored ratings for a pivotal ClinRO endpoint, you will likely need a specialist service alongside the data capture, and you should confirm how its output would be recorded. Capture does not verify licences with rights holders or supply licensed instruments; licence controls exist on participant questionnaires only, and nothing is blocked while a licence number is missing.
Capture is a good fit when the study team builds its own instruments, wants patient and clinician data in one record and one audit trail, and wants to test everything before paying. None of this is about trial phase: Capture is suitable for Phase 1, 2 and 3. For the wider picture, see ePRO software for clinical trials, Capture ePRO and how to choose an EDC system.
How to run the evaluation
Use the same instruments and the same questions with every vendor.
Mark each instrument PRO, ClinRO, ObsRO or PerfO, and who completes it, on what device.
Confirm terms with each rights holder before any build; keep them in the study documents.
A patient questionnaire and a clinician scale, with scoring, and time the build and the first amendment.
Ask how raters are trained, recorded and replaced, and how a score is corrected after review.
Ask for the commercial model in writing, including every module and service.
It depends on the assessment types, countries and instruments. Shortlist on the criteria above, test each platform with your own scales and keep written answers from each vendor.
eCOA is the electronic capture of any clinical outcome assessment: patient, clinician, observer or performance based. ePRO covers the patient-reported part only.
Yes, as eCRF forms completed by site staff, with the rater as a field, calculated totals, edit checks and a field-level audit trail.
No. Capture does not provide a rater certification or training programme. Sponsors usually arrange that separately.
Participant questionnaires can store licence number, holder and expiry. Capture does not verify licences or supply licensed instruments, and site-completed scales have no licence controls; keep those licences in the study documents.
No. It is a selection method with category-level descriptions. Verify every vendor claim in writing.
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