Pharmaceutical Research Protocol (Vulcan UDP)
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Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

10 Credits

Page standards status: Informative

Credits

This IG is sponsored by the HL7 Biomedical Research and Regulation work group and was developed under the auspices of the HL7 Vulcan umbrella project, Utilizing the Digital Protocol (UDP), in collaboration with TransCelerate Biopharma, Inc. and CDISC.

Contributing individuals and organizations are:

Current project Leads:

  • Hugh Glover - Vulcan
  • Stacy Tegan - TransCelerate Biopharma

Core project members:

  • Smita Hastak – Samvit Solutions
  • Dave Iberson-Hurst - CDISC
  • Mark Kramer - MITRE
  • Geoff Low - Medidata
  • Jimita Parekh – European Medicines Agency (EMA)
  • Rik Smithies – NProgram Ltd
  • Panagiotis Telonis – European Medicines Agency (EMA)

Connectathon Contributors :

  • Computable Publishing
  • ONC
  • ZS Associates
  • Espero
  • Firely
  • ICH M2
  • IDIAL
  • Novartis
  • fhir4pharma
  • Osaka Metropolitan University Hospital
  • ICH M11
  • HL7 Europe
  • Roche
  • Berlin Institute of Health
  • DNAnexus

Contribution from the Evidence Based Medicine (EBM) work group and Vulcan Schedule of Activities (SoA) project was greatly appreciated and we recognize those co-chairs:

  • Brian Alper – EBM
  • Geoff Low – SoA
  • Mike Buckley - SoA

Project Management:

  • Robert Ferendo – TransCelerate Biopharma
  • Enam Rahman - Vynamic
  • Shani Sampson – TransCelerate Biopharma

With contributions from other members who have from time to time, or quietly, participated in meetings, attended conference calls, and supported the core team during the development process.

This FHIR implementation guide has the following relationships with other FHIR implementation guides:

Vulcan Schedule of Activities (SoA) - Originated in PHUSE and later transitioned into a Vulcan project, this IG provides a FHIR representation of the Schedule of Activities, a crucial component of most protocols. The use case focuses on maintaining an unambiguous definition of the Schedule of Activities during study execution, which can be utilized to generate a detailed care plan for specific patients.

Evidence Based Medicine (EBM) - EBM is a project within HL7 also working on practices for leveraging FHIR for exchange of protocol information. While Vulcan Utilizing the Digital Protocol (UDP) project focuses on the design, conduct, and generation of data generally to support clinical development, EBM aims at a systematic approach to clinical decision-making that integrates the best available research evidence with clinical expertise and patient values. It involves systematically finding, appraising, and applying the results of well-designed clinical research, particularly randomized controlled trials (RCTs) and systematic reviews, to inform clinical decisions and optimize patient outcomes. Together, they enable a learning health system by utilizing digital protocol standards to facilitate research and apply systematic evidence. Vulcan UDP leverages practices and learnings from EBM.

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Package hl7.fhir.uv.extensions#5.2.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.extensions.r5#5.2.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)