HL7 FHIR R4 Implementation Guide: Clinical Study Schedule of Activities v1.0.0

This implementation guide provides a roadmap for implementing a clinical trial schedule of activities structure using Fast Healthcare Interoperability Resources (FHIR) resources and processes. A schedule of activities is a component of a clinical trial protocol. It is a standardised representation of planned clinical trial activities - including interventions, administrative activities and assessments - and when they will occur. The implementation guide considers prospective and retrospective studies.

This document is part of HL7's Vulcan accelerator project for connecting clinical research and health care. The implementation guide is intended to enable the schedule of activities to be shared, interpreted and implemented in healthcare systems, such as electronic health record or personal health record systems, and/or clinical research systems.

Main sections:

- Home

- Core Schedule of Activities model

- Visit windowing

- Investigational product administration

- Use case for integration using CDISC ODM (operational data model)

- Profiles

- Examples

- Downloads

- Credits

- Artifacts summary