IP Review

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This publication includes IP covered under the following statements.

This material contains content from LOINC . LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license . LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
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- LOINC: DIBASY Eligibility Criteria and JPMA Eligibility Example
This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/get-snomed or info@snomed.org .
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- SNOMED Clinical Terms® (SNOMED CT®): DIBASY Eligibility Criteria , JPMA Eligibility Example and ResearchStudy/Exemplar-ResearchStudy-001
This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
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- Contact entity type : Exemplar Devices Ltd , Exemplar Pharmaceuticals Co. , Exemplar Pharmazeutika GmBH. , Exemplar Regulating Authority (ERA) and Fictive Pharmaceuticals (Australia) Pty
- identifierType : DIBASY Eligibility Criteria and JPMA Eligibility Example

IG © 2026+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2026-04-02 Links: Table of Contents | QA Report | Version History | CC0 | Propose a change ( src )

hl7.fhir.us.hai: Healthcare Associated Infection Implementation Guide ®© HL7 | CC0 ( src )

Clinical Study Protocol, 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-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 ( src )

This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc. Show Usage * LOINC: DIBASY Eligibility Criteria and JPMA Eligibility Example ( src )

This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html Show Usage * Contact entity type: Exemplar Devices Ltd, Exemplar Pharmaceuticals Co., Exemplar Pharmazeutika GmBH., Exemplar Regulating Authority (ERA) and Fictive Pharmaceuticals (Australia) Pty * identifierType: DIBASY Eligibility Criteria and JPMA Eligibility Example ( src )

テストEX、9-1: ＝（イコール）、9-2: ≠（ノットイコール）、9-3: ®（商標記号） ( src )

External References

Type	Reference	Content
web	somelocation	signatureUrl: https://somelocation
web	github.com	Clinical Study Protocol, 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-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
web	www.HL7Vulcan.org
web	github.com	Support is available at the DDF GitHub .
web	github.com	For more examples and also to find links a viewer for this content go to the Vulcan UDP Examples GitHub page
web	github.com	The relationships between the elements of M11, USDM and FHIR are shown in the Mapping spreadsheet described in the following section. The present focus of this mapping is representation of M11 so the mapping does not cover the whole of USDM. There is a useful infographic from CDISC here: ( usdm_m11_classes ) that shows the overlap between M11 and USDM and in the bottom right USDM classes not covered by M11.
web	hl7vulcan.org	Why Vulcan ?
web	github.com	NOTE: 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. See infographic usdm_m11.pdf
web	www.cdisc.org	USDM is a reference architecture produced by CDISC to be used by TransCelerate and " anyone who wishes to create conformant standards-based technologies, which produce or consume study definitions - source DDF-RA/README.md at v4.0.0 · cdisc-org/DDF-RA · GitHub ".
web	www.transceleratebiopharmainc.com	USDM is a reference architecture produced by CDISC to be used by TransCelerate and " anyone who wishes to create conformant standards-based technologies, which produce or consume study definitions - source DDF-RA/README.md at v4.0.0 · cdisc-org/DDF-RA · GitHub ".
web	github.com	USDM is a reference architecture produced by CDISC to be used by TransCelerate and " anyone who wishes to create conformant standards-based technologies, which produce or consume study definitions - source DDF-RA/README.md at v4.0.0 · cdisc-org/DDF-RA · GitHub ".
web	github.com	Content based on DDF-RA (GitHub) used under the CC-BY-4.0 license.
web	creativecommons.org	Content based on DDF-RA (GitHub) used under the CC-BY-4.0 license.
web	github.com	The Implementation Guide makes NO changes to this content with the exception of copying content from the m11 mapping document . The actual mappings are not changed.
web	database.ich.org	M11 Template
web	database.ich.org	M11 Guideline
web	database.ich.org	M11 Technical Specification
web	github.com	CDISC USDM Data Model
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	www.transceleratebiopharmainc.com	During preparation for earlier UDP connectathons it was noted that a significant number of sponsors had implemented the TransCelerate Common Protocol Template (CPT) . To support end-users, there is a mapping tool (below) highlighting which CPT sections and content are aligned with the December 2025, ICH M11 Step 3 version of the Template, Guideline and Technical Specification.
web	github.com	Enterprise Vocabulary Services](https://evs.nci.nih.gov/tools). Within the options presented there are packages for POSTMAN™ that allow the querying of the thesaurus. For the preparation of this IG we used the FHIR R5 set.

Type

Reference

Content

web

somelocation

signatureUrl: https://somelocation

web

github.com

web

www.HL7Vulcan.org

web

github.com

Support is available at the DDF GitHub .

web

github.com

For more examples and also to find links a viewer for this content go to the Vulcan UDP Examples GitHub page

web

github.com

The relationships between the elements of M11, USDM and FHIR are shown in the Mapping spreadsheet described in the following section. The present focus of this mapping is representation of M11 so the mapping does not cover the whole of USDM. There is a useful infographic from CDISC here: ( usdm_m11_classes ) that shows the overlap between M11 and USDM and in the bottom right USDM classes not covered by M11.

web

hl7vulcan.org

Why Vulcan ?

web

github.com

NOTE: 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. See infographic usdm_m11.pdf

web

www.cdisc.org

USDM is a reference architecture produced by CDISC to be used by TransCelerate and " anyone who wishes to create conformant standards-based technologies, which produce or consume study definitions - source DDF-RA/README.md at v4.0.0 · cdisc-org/DDF-RA · GitHub ".

web

www.transceleratebiopharmainc.com

web

github.com

web

github.com

Content based on DDF-RA (GitHub) used under the CC-BY-4.0 license.

web

creativecommons.org

Content based on DDF-RA (GitHub) used under the CC-BY-4.0 license.

web

github.com

The Implementation Guide makes NO changes to this content with the exception of copying content from the m11 mapping document . The actual mappings are not changed.

web

database.ich.org

M11 Template

web

database.ich.org

M11 Guideline

web

database.ich.org

M11 Technical Specification

web

github.com

CDISC USDM Data Model

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

www.transceleratebiopharmainc.com

During preparation for earlier UDP connectathons it was noted that a significant number of sponsors had implemented the TransCelerate Common Protocol Template (CPT) . To support end-users, there is a mapping tool (below) highlighting which CPT sections and content are aligned with the December 2025, ICH M11 Step 3 version of the Template, Guideline and Technical Specification.

web

github.com

Enterprise Vocabulary Services](https://evs.nci.nih.gov/tools). Within the options presented there are packages for POSTMAN™ that allow the querying of the thesaurus. For the preparation of this IG we used the FHIR R5 set.

Internal Images

../assets/images/001.svg