Contributed Commentary by Chris Walker, Alimentiv 

August 1, 2025 | As gastrointestinal (GI) trials grow more sophisticated, the volume, velocity, and variety of study data have all expanded. One of the fastest-growing streams is electronic patient-reported outcomes (ePROs): diaries, symptom scores, quality-of-life surveys, and other instruments that come straight from the participant. Collecting this data quickly and conveniently is now mission critical. 

There is no one-size-fits-all template for ePRO deployment. Yet, particularly for small and mid-sized data teams, building ePROs inside the electronic data-capture (EDC) environment can strike the right balance of speed, cost, and control. That shift, however, requires a fresh look at who leads ePRO execution. For us, that leader is the Clinical Data Manager (CDM). 

Four Challenges Redefining ePRO Delivery 

Four forces impact ePRO with implications for data teams.  

• Complex trial designs: As clinical trials become more complex with more endpoints, languages, and data points, they call for earlier, deeper involvement of data experts in protocol review and instrument design. 

• Disparate technology stacks: Integrations can be costly and prone to lag. Data teams have the advantage if they can configure ePRO natively in the EDC.  

• Patient-centricity expectations: Despite heavier data demands, the ePRO user experience must stay intuitive. CDMs help harmonize data rigor with user-friendly design. 

• Rapidly evolving privacy regulations: With greater regional variability and audit scrutiny, CDMs mastery of data governance becomes a strategic asset.   

Why CDM Is Uniquely Suited to Own ePRO

Clinical Data Management has long been evolving toward Clinical Data Science—an investigative, analytics-driven discipline that informs trial decisions in real time. ePRO oversight fits naturally into their remit. CDMs already own data standards, edit checks, and quality gateways. They track guidance from regulatory bodies (such as the Food and Drug Administration), and emerging authorities. And their familiarity with the EDC shortens the learning curve for taking on this responsibility. 

One option to formalize this alignment is through an “ePRO Sprint” model: a focused burst of work—spanning form build, validation, and translation—that runs in parallel with broader database set-up. A CDM leads the sprint, freeing the rest of the study team to maintain overall database timelines while giving ePRO the concentrated attention it deserves. 

We have achieved two real-world wins with this approach: 

• Time-Sensitive Eligibility Decisions: GI protocols often use a composite of site-entered and patient-reported data (e.g., stool frequency, rectal bleeding) to confirm eligibility. Our company previously outsourced this to an external ePRO vendor, accepting a 24-hour data lag. By configuring the instruments directly within our EDC, our CDMs delivered live diary data that flowed straight into eligibility algorithms—no imports, no reconciliation headaches. The result: faster eligibility and randomization decisions. 

• Enhanced Safety Monitoring: In a first-in-human study, a transient fever signal prompted a requirement for twice-daily temperature reporting in the subsequent trial. Our team needed a way to collect this reliably, without overwhelming the participants or adding too much operational burden. We built a simple, intuitive temperature form alongside the participant’s existing daily diary, making it a natural extension of what they were already doing. This setup gave our team immediate visibility to temperature readings and allowed us to easily reconcile this critical data against other relevant forms. It helped us support protocol compliance without adding friction—a true win for patient centricity and operational oversight. 

Best Practices for CDM Success

Enabling CDMs to lead ePRO has tangible benefits for multiple stakeholders. For sponsors, it can lower costs and centralize oversight. CROs can see accelerated timelines, reduced risks during integration and deeper ownership of delivery. Study teams can get real-time access to patient data, streamlined workflows and unified edit-check logic. Participants and sites can use one login, have a consistent user interface, require less training – all of which supports higher engagement. ePRO execution no longer has to be a black-box service purchased at arm’s length.  

Here are a few lessons learned to help CDMs succeed as the role continues to evolve. 

1. Front-load resource planning. Even when you build within the EDC, regulatory and language services often sit on the critical path.
   
2. Prototype. A clickable demo in the EDC surfaces user experience issues far earlier than a paper specification file.
   
   
3. Automate reconciliation. Embed cross-form edit checks so discrepancies surface the moment data arrives.
   
4. Careful planning. Assess what’s right for the trial, the sponsor, and your team. This model may not be applicable to every situation, but it can certainly be a tool in your toolbox. 

By empowering Clinical Data Managers to architect, configure, and validate ePROs within a familiar EDC setting, sponsors and CROs can gain speed, transparency, and quality—all while giving patients a simpler, more coherent study experience. The role of the CDM is expanding, and the industry can reap the benefits.