Automating SoA Extraction from Legacy Clinical Protocols into FHIR/USDM

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This research addresses the challenge of handling 'Schedules of Activities (SoA)' found in clinical trial protocols. Historically, these protocols use diverse and inconsistent table formats, making it difficult to convert them into standardized interoperable digital forms like FHIR or USDM. Using a tool called ProtocolMiner developed by MITRE Corporation, the study successfully automated the extraction of SoAs from PDF legacy protocols while interpreting their semantics. The extracted data was mapped to FHIR resources such as PlanDefinition and ActivityDefinition, and also utilized components from the Unified Study Definitions Model (USDM), including ScheduleTimeline, Encounter, and Activity classes. The validation showed that ProtocolMiner accurately created detailed timelines for 22 out of 29 analyzed SoAs. Furthermore, it demonstrated that FHIR can successfully represent complex temporal relationships—including relative timing with windows, open-ended repetitions with stopping criteria, and conditional execution. The USDM mapping also enables integration with CDISC-compliant study design workflows. This technology significantly contributes to computational protocol management and achieving cross-system interoperability in clinical research.

Technology Note

FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: FHIR