Vulcan Schedule of Study Activites FHIR Implementation Guide
0.1.0 - ci-build International flag

Vulcan Schedule of Study Activites FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

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Official URL: http://hl7.org/fhir/uv/vulcan-schedule/ImplementationGuide/hl7.fhir.uv.vulcan-schedule Version: 0.1.0
Draft as of 2022-09-15 Computable Name: VulcanSchedule

Background

Vulcan Schedule of Activities (SoA) Project

This IG is intended to provide a roadmap for adopters looking to use FHIR resources in order to support the planning and implementing Clinical Research designs. The Schedule of Activities is defined ​in a clinical trial as a standardised representation of planned activities, including interventions (e.g., administering drug, surgery), studying administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomisation) and assessments.​

​The purpose of the Schedule of Activities is to communicate the scheduling of the planned activities required to support the research objectives of the study to enable operational implementation.​

Within the Vulcan SoA project we have considered two principal study types:

  • Prospective – e.g., randomised clinical trials (RCT), concurrent cohort studies, observational studies, epidemiology, real world evidence (RWE)
  • Retrospective – e.g., cohort studies, case-control studies, real world evidence

Examples of positive outcomes for this project include:

  • Participant identification – feasibility , inclusion/exclusion criteria (prospective/retrospective)​
  • Participant management – appointment scheduling (prospective)​
  • Real world evidence – research data selection (retrospective)​
  • Audit/Inspection – regulatory oversight period identification ​
  • Resource planning (prospective)​
  • Logistics planning (prospective)​

This iteration for the project is designed to be directional purely - 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.