Introduction to (e)COA and (e)PRO
Patient-reported outcomes are no longer an add-on to clinical trials. With regulators, payers, and patients themselves putting more weight on patient-subjective endpoints, (e)COA and (e)PRO have become central to how new therapies are evaluated — and one of the areas where sponsors and CROs still struggle most to make consistent design and operational decisions.
At TriTiCon, we've developed a new online course that turns (e)COA and (e)PRO from a specialist topic into something you can confidently design, manage, and quality-check.
Why (e)COA and (e)PRO matter now
The patient experience is becoming central to how new therapies are evaluated. Regulators expect evidence that goes beyond the lab and the clinic, payers want proof of real-world impact, and patients increasingly expect their voice to be reflected in the data that supports a product.
(e)COA — and especially (e)PRO — sits at the centre of that shift. But (e)PRO data behaves differently from eCRF data: it is mostly live, the patient is the source, and what is not collected at the moment it should be is gone for good. That single distinction reshapes how (e)PRO must be designed, deployed, and managed across the trial.
What the course covers
The course takes a hands-on approach, grounded in real (e)COA and (e)PRO workflows. It is organised into three chapters that build progressively from fundamentals to practical application:
- C06a — Definitions and key concepts. What (e)COA, (e)PRO, ClinRO, and ObsRO are, the broader umbrella including devices and wearables, validated instruments and licensing, and the realities of live data, parking-lot syndrome, recall bias, and compliance.
- C06b — Different scenarios and key considerations. Practical (e)PRO scenarios including supervised vs unsupervised, paper vs electronic, BYOD vs provisioning, and fallback planning for when something doesn't work as expected.
- C06c — Operational basics. The three rules of thumb, the six build parts of an (e)PRO solution, start-up, conduct, and close-out activities, data changes myth-busting, and archiving with investigator access.
Three scenarios that shape every (e)PRO design
At the core of the course are the practical design decisions that determine whether (e)PRO data will be fit for purpose — clarifying trade-offs, anticipating compliance challenges, and making operational realities visible from the start.
What you'll take away
After completing the course, you'll be able to:
- Apply a clear, working understanding of (e)COA, (e)PRO, ClinRO, and ObsRO — and how each differs from eCRF data.
- Make informed decisions across supervised vs unsupervised, paper vs electronic, and BYOD vs provisioning scenarios.
- Use validated instruments correctly — and recognise when none fit and a defined measurement is the right path.
- Define and measure compliance so it actually means something — split between site and patient, partial and missing, and tied to the analysis.
Who it's for
The course is designed for clinical research professionals who design, manage, or oversee (e)COA and (e)PRO components in modern trials:
- Clinical Data Management
- Clinical Operations
- Clinical Trial Managers
- Vendor Managers
- Biometrics
- (e)COA Specialists
A foundational understanding of clinical trials and clinical data management is recommended. No prior (e)COA or (e)PRO experience is required — the course builds the discipline from the ground up.
Start the course today
Build the foundation every modern (e)COA and (e)PRO programme depends on.
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