As clinical trials grow more complex, the need for a consistent, unambiguous, and machine-readable way to represent the Schedule of Activities (SOA) has never been greater. CDISC’s Unified Study Definitions Model (USDM) provides the foundation for meeting this need. Built on USDM as the core architectural model, the SOA project will establish a standardized, computable approach to SOA design. By using USDM as the authoritative structure, this work enables consistent interpretation across systems, reduces reliance on free text and footnotes, and supports CDISC’s broader vision for model-driven study definition.
This webinar will introduce a collaborative effort to define this standardized approach to SOA using USDM. You will gain insight into the vision, scope, and planned deliverables of the project. You will also see how it provides a clear, structured view of schedule data across the study lifecycle.
Learn how this USDM-based guidance will support improved protocol design, enable automation (e.g., scheduling and deviation detection), and enhance interoperability across CTMS, EDC, and downstream systems. We will also share example use cases demonstrating how anchoring SOA in USDM drives reusability, traceability, and cross-study consistency.
This is a community-driven effort, and your expertise is essential to its success. We are actively seeking contributors across medical writing, clinical operations, data standards, and technology. Join this session to learn how to get involved, explore available roles, and help shape a practical standard for the industry.
Agenda:
- Introduction to the SoA project - Why SOA Standardization Matters Now
- Get Involved: Roles, Timeline & Call for Volunteers
- Questions and Answers
Presenter
- John Owen | Head, Project Management Office | CDISC