Unattributed Code Systems

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External References

Type Reference Content
web github.com 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
web github.com NOTE: ICH M11 USDM The relationship between the M11 protocol template specification and the structured and unstructured capabilities of the USDM is illustrated on the DDF GitHub site. Each logical area of the M11 protocol template is highlighted along with the associated area within the USDM. in this infographic: See usdm_m11.pdf
web www.ema.europa.eu ICH M11 (EMA)
web www.cdisc.org CDISC Digital Data Flow (DDF)
web www.hl7vulcan.org HL7 Vulcan Utilizing the Digital Protocol
web euclinicaltrials.eu CTIS
web github.com CTIS Mapping
web github.com SDTM Mapping
web github.com ClinicalTrials.gov Mapping
web github.com Common Protocol Template Mapping
web github.com M11 Mapping
web github.com CDISC USDM Data Model

Internal Images

Extensions and profiles 01.png
Extensions and profiles 01.png
InfoModelLayers.png
InfoModelLayers.png
Mapping.png
Mapping.png
bundles-01.png
bundles-01.png
bundles-02.png
bundles-02.png
iceberg-02.png
iceberg-02.png
image-20250415143104846.png
image-20250415143104846.png
narrative-and-structured-01.png
narrative-and-structured-01.png
narrative-content-01.png
narrative-content-01.png
narrative-content-02.png
narrative-content-02.png
plan-01.png
plan-01.png
protocol-prep-01.png
protocol-prep-01.png
section-vs-01.png
section-vs-01.png
shipping-01.png
shipping-01.png
structured-content-01.png
structured-content-01.png
tree-filter.png
tree-filter.png
work-flow-protocol-approval.png
work-flow-protocol-approval.png