Managing ePRO in Clinical Trials

This course is ideal for Clinical Data Managers, Clinical Trial Managers, Project and Vendor Managers, and clinical operations, biometrics, or quality staff who plan, source, build, or run the ePRO component of a clinical trial.

It is particularly relevant for anyone who has to make and defend the practical decisions an ePRO trial depends on, in sponsor, CRO, or ePRO-vendor settings.

Yes, a working understanding of clinical trials and clinical data management is expected.

This is an intermediate, operational module. Completion of module C06, Introduction to eCOA and ePRO, is strongly recommended first, since this course builds directly on its vocabulary: live and source data, compliance, the collection scenarios, BYOD and provisioning. Where those are needed, we recap them in a sentence or two.

Estimated learning time is approximately 5 to 9 hours, depending on your pace and how deeply you work through the step-by-step drill-downs, templates, and checklists.

Yes! Once enrolled, you can access all course materials at any time and progress at your own pace. There are no deadlines or live sessions required.

Yes! Upon completing the course content and passing the certification test, you'll receive a certificate of completion. Note: The certificate supports professional development but is not a license or regulatory credential.

This is a highly practical, operational course.

It follows the life of an ePRO trial step by step, across four stages, and for every step it sets out when it happens, whether it applies to your trial, what to decide and document, and the classic pitfalls. Each lesson has a drill-down with step cards, templates, and checklists you can use directly.

The whole module is illustrated with one running example trial, to keep the decisions concrete.

C06, Introduction to eCOA and ePRO, builds the foundation: what (e)COA and (e)PRO are, the key concepts, and the scenarios that shape their design.

C07 is the operational step up. It takes you through actually running an ePRO trial, from the first design decisions in the protocol to decommissioning, with the timing, decisions, and pitfalls at each step. C06 teaches the vocabulary and the "what"; C07 teaches the "how".

This course supports professionals aiming for or currently working in roles such as Clinical Data Manager, Clinical Trial Manager, Project Manager, Vendor Manager, or ePRO or (e)COA specialist.

It strengthens competencies in ePRO planning, vendor sourcing and oversight, build and go-live readiness, and conduct and close-out, skills that are increasingly critical as patient-reported outcomes become more central to trials.

The structured, step-by-step framework helps you move from understanding ePRO to confidently running it.

Yes. An entire stage is devoted to it: defining the full scope as an execution checklist, evaluating the service rather than the demo, closing the gap between sponsor, CRO, and vendor, settling data protection and hosting, and challenging the statement of work and cost line by line, with investigator control written into the contracts.

Yes. The final stage walks through hyper-care at go-live, monitoring compliance from day one, device reconciliation, data changes and queries with the investigator in control, audit trail review, handling change during conduct, and closing out in the right order, including archiving with investigator access before decommissioning.

Yes. Each lesson has a drill-down with step cards, and the module includes a printable timeline reference, templates, and checklists you can apply to your own ePRO trials.

No. The course teaches principles and decisions you can apply across vendors, therapeutic areas, and trial types. It uses one running example trial to make the steps concrete, not to recommend a particular product.