Clinical Study Protocol (Vulcan UDP)
1.0.1-ballot2 - STU 1 - Ballot International flag

Clinical Study 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 1.0.1-ballot2 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

09 Links

Page standards status: Informative

The following links provide important context for parties looking to make use of the Implementation Guide:

These links provide general information that are germane to the development of the standards.

Link Description
ICH M11 (EMA) ICH M11 guideline, protocol template and technical specifications - Scientific guideline (EMA)
ICH M11 (FDA) M11 Clinical Electronic Structured Harmonized Protocol, Center for Drug Evaluation and Research, Office of Regulatory Policy
CDISC Digital Data Flow (DDF) CDISC/TransCelerate Digital Data Flow (DDF)
HL7 Vulcan Utilizing the Digital Protocol UDP: Utilizing the Digital Protocol
CTIS Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organizations involved in running clinical trials in preparing and compiling clinical trial applications and dossiers to submit for assessment by Member States in the European Union (EU) and European Economic Area (EEA).

These links are published mappings between the different standards developed as part of the development process

Link Target Source Description
CTIS Mapping USDM CTIS CDISC Mapping from USDM to EMA CTIS
SDTM Mapping USDM SDTM CDISC Mapping from USDM to CDISC SDTM Model
ClinicalTrials.gov Mapping USDM ClinicalTrials.gov CDISC Mapping from USDM to NCI ClinicalTrials.gov schema
Common Protocol Template Mapping USDM Common Protocol Template CDISC Mapping from USDM to TransCelerate Common Protocol Template (CPT)
M11 Mapping USDM M11 CDISC Mapping from USDM to ICH M11 Technical Specification
M11 to USDM to FHIR Mapping FHIR M11
FHIR		 Three way mapping discussed in the FHIR Representation section
Link Description
CDISC USDM Data Model Reference implementation for the CDISC/TransCelerate DDF Reference Architecture (home of the USDM model)
Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2 From the introduction to EBM “This implementation guide is intended for developers of systems using FHIR for data exchange of scientific knowledge and for authors of more specialized implementation guides in this domain”. As such this IG has some profiles and extensions of ResearchStudy that are a basis for further use by the UDP IG.
HL7 Vulcan Schedule of Activities Implementation Guide The link here is to the build version of the EBM IG as late 2025 – this has content that is anticipated by the UDP IG but is not yet published and useable. Readers should check for the latest version.HL7 Vulcan Schedule of Activities Implementation Guide