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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR® R4 Implementation Guide: Clinical Study Schedule of Activities, Edition 1

DESCRIPTION

The core of this project is to define a usable pattern for a Clinical Trial Schedule of Activities structure using FHIR Resources and Processes, such that:

  • it can be shared
  • it can be interpreted, and
  • it can be implemented in healthcare systems (such as EHR or PHR systems) and/or clinical research systems

See the specification at http://hl7.org/fhir/uv/rvulcan-schedule/STU1

ALTERNATIVE NAMES

HL7 FHIR® R4 Implementation Guide: Clinical Study Schedule of Activities, Edition 1 may also go by the following names or acronyms:

"HL7 FHIR® IG: Clinical Study Schedule of Activities, R1",

BENEFITS

  • Enables consistency by adoption of a FHIR based representation of research study activities that must be performed and avoid repeated data entry. As the events occur a record is built up of the execution of the study for that specific subject. 
  • Facilitates uniform implementation of the schedule of activities across investigational sites.

IMPLEMENTATIONS/CASE STUDIES

  • Eli Lilly
  • Phuse
  • TransCelerate

DEVELOPMENT BACKGROUND

This iteration of the IG is designed to provide directional guidance and not be a prescriptive instruction of how to exactly implement SOA across all systems. As we learn more about how the different systems work and can be interfaced, we will continue to improve the IG to accommodate more use cases; iteratively working towards a solution that will be both functional and scalable.

RELATED DOCUMENTS

HL7 FHIR® R4 Implementation Guide: Clinical Study Schedule of Activities, Edition 1

STU DOCUMENTS

HL7 FHIR® R4 Implementation Guide: Clinical Study Schedule of Activities, Edition 1 See the standard at http://hl7.org/fhir/uv/vulcan-schedule/STU1. (Submit Feedback on STU)

TOPIC

  • Regulated Studies

BALLOT TYPE

  • STU

STATUS DATE

2023-04-18

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • Clinical Decision Support Systems Vendors
  • EHR, PHR Vendors
  • Health Care IT Vendors
  • Healthcare Institutions
  • Pharmaceutical Vendors
  • Regulatory Agency

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • Universal