The protocol is the brain of a study. It’s time we gave it a digital body.”
In clinical trials, the protocol defines the schedule of visits, the data to be collected, the populations to be enrolled, and much more. And yet, we’re still building these foundational documents in Microsoft Word—sending them downstream to be interpreted and re-implemented, over and over again, in every system that touches the trial.
That rework slows things down. It introduces risk, inconsistency, and a mountain of manual effort.
Why Digital Protocols Matter
Through our work in the HL7 Vulcan Accelerator, we’ve been exploring how moving from traditional, text-based protocols to structured, machine-readable formats that can power clinical systems like EDC and EHR eSource. One of the most promising efforts is the FHIR Schedule of Activities (SoA)—a standard designed to digitally express what needs to happen in a trial and when.
Think of the SoA as the central source of truth for visit schedules and data collection. Instead of rebuilding this plan in multiple systems—EDC, eSource, CTMS, even the EHR—we can design it once, and share it everywhere.
If your protocol says the same thing five times in five different systems, it’s only a matter of time before something slips.”
What We’re Piloting (and Why It Matters)
We’ve been testing a working prototype of this digital SoA concept to see what’s possible when structured protocols are shared across systems. Here’s what we’ve demonstrated:
- The EDC can automatically ingest the SoA and generate visits, forms, and timing rules.
- A site’s eSource platform can consume the same definition to drive visit reminders, EHR data pulls, and source documentation—all mapped to the same protocol logic.
- Clean, aligned data can return to the sponsor in a format that matches expectations—without manual rework.
This isn’t just theoretical. It’s influencing how we’re building out capabilities like point-and-click calendaring—which is quickly becoming one of the most-adopted new features across our platform.
Building on a Proven Foundation
This future-facing work extends naturally from what we’ve already achieved with OpenClinica Unite, our EHR-to-EDC eSource solution. Unite is already live at scale—used by over 450 clinical sites and 24 major health systems to automate the flow of source data into EDCs, while preserving audit trails, data integrity, and compliance.
What we’re doing with Vulcan and the SoA standard builds on that foundation. It’s not about adding complexity—it’s about reducing it. Schedule of Activities is one part of a structured digital protocol – particularly important to trial execution and data collection activities. Global efforts like the ICH M11 initiative aim to more broadly and comprehensively standardize the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information. Structured protocols are a way to harmonize the intent of a trial with how it’s actually executed across teams and technologies.
What Comes Next
Adoption of structured protocols won’t happen overnight. Standards only matter when they’re implemented—and that requires coordination, investment, and thoughtful product design. But we’re starting to see the pieces come together.
We’re learning what works and what doesn’t. We’re partnering with others across the industry to shape what’s possible. And we’re staying focused on what really matters: helping study teams do their jobs better, faster, and with fewer surprises along the way.
Ready to Streamline Your Clinical Data Flow?
If you’re already thinking about reducing manual transcription, aligning source data with protocol expectations, and setting your team up for more scalable operations, you don’t have to wait for what’s next.
Unite, our proven EHR-to-EDC eSource solution, is already helping 450+ clinical sites simplify source data workflows while maintaining full compliance and control.
Request a demo to learn how Unite delivers faster, cleaner data—from the EHR to your EDC.