Project Information
Active
25 September, 2025
Project Introduction
Schedule of Activities (SoA)
The Vulcan Schedule of Activities (SoA) project defines how a clinical trial protocol’s schedule can be represented using HL7 FHIR. By enabling EHRs and Electronic Data Capture (EDC) systems to consume and exchange this information, the project helps care providers and researchers plan, execute, and track study activities in a consistent, computable way.
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What is the Schedule of Activities?
The Schedule of Activities (SoA) is a standardized representation of a clinical trial’s planned visits, interventions, assessments, and administrative tasks, as defined in the study protocol. A digital SoA provides a clear, computable structure that can be shared across systems, supporting protocol compliance, participant management, and research data collection.
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Traditionally, the SoA in a study protocol is interpreted manually and implemented separately across EHRs, EDC systems, and sites. This creates inefficiencies and inconsistencies. By representing the SoA in FHIR, this project enables:
- Executable workflows where care teams can plan and reschedule visits with aligned research activities and windows.
- Research–care alignment that links patients, research studies, and care plans directly.
- Regulatory and operational efficiency where consistent implementation of trial protocols across sites.
- Automation from creating EDC specifications to generating downstream research datasets.
The SoA Implementation Guide defines patterns for both prospective use cases (clinical trials, observational studies) and retrospective use cases (real-world evidence, cohort studies). It provides directional guidance that can be iteratively expanded to support complex and dynamic protocol designs including common considerations as treatment cycles, conditional activities and unscheduled encounters
Schedule of Activities (SoA)
Project Status
- Version 1.0.0 of the SoA Implementation Guide is published and available for adopters to begin using.
- Version 2.0 development is complete and will be published as a snapshot prior to the publication of FHIR Release 6.
The SoA project has met the goal of publishing the Implementation Guide so will be doing no further development and is formally in hiatus. The team will meet periodically to evaluate the current state and any outstanding requests.
Vulcan is a member-based initiative where anyone with an interest in advancing digital clinical research can join project teams, contribute expertise, and help shape future standards.
Schedule of Activities (SoA)
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Schedule of Activities (SoA)
How Can Vulcan Help You
The SoA Implementation Guide is complete and ready for adoption. The project team remains available to support the community with:
- Answering questions about the Implementation Guide and its use cases.
- Providing guidance to implementors adopting the IG in their systems.
- Connecting you with FHIR experts to support your implementation.
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