Validation Results for ClincalStudyProtocol

Generated Thu Jun 04 16:55:09 UTC 2026, FHIR version 6.0.0-ballot3 for hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 (canonical = http://hl7.org/fhir/uv/clinical-study-protocol (history)). See Errors Only & IP

Quality Checks
Publisher Version:IG Publisher Version: v2.2.8
Publication Code:clinical-study-protocol . PackageId = hl7.fhir.uv.clinical-study-protocol, Canonical = http://hl7.org/fhir/uv/clinical-study-protocol
Realm Check for UV:
  • n/a
Language Info:Stated Languages: n/a. IG Resource Lang: en. 2 of 68 (2%) of resources have a language. Population Policy: NONE
Publication Request:
RelatedIgs(None Found)
  • Version 1.0.0-ballot2 has already been published
  • This is not the first publication, so first must not be true
  • Publication Request is for version v1.0.0-ballot2 which is already published
Supressed Messages:21 Suppressed Issues
Dependency Checks:
PackageVersionFHIRCanonicalWeb BaseComment
.. hl7.fhir.uv.clinical-study-protocol1.0.0-ballot2R6http://hl7.org/fhir/uv/clinical-study-protocol
... hl7.terminology.r57.1.0 MR5http://terminology.hl7.orghttp://terminology.hl7.org/7.1.0FHIR Version Mismatch
.... hl7.fhir.uv.extensions.r55.2.0 OR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch. Latest Release is 5.3.0
... hl7.fhir.uv.extensions.r55.3.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.3.0FHIR Version Mismatch
.... hl7.terminology.r57.1.0 MR5http://terminology.hl7.orghttp://terminology.hl7.org/7.1.0FHIR Version Mismatch (as above)
... hl7.fhir.uv.tools.r51.1.2 MR5http://hl7.org/fhir/toolshttp://hl7.org/fhir/tools/1.1.2Internal Dependency. FHIR Version Mismatch
Templates: hl7.vulcan.template#0.1.0 -> hl7.fhir.template#current -> hl7.base.template#current -> fhir2.base.template#current
Related IGs:n/a
Dependent IGs:no references
Global Profiles:(none declared)
Terminology Server(s):https://tx.fhir.org/r5 (details)
HTA Analysis:All OK
R5 Dependencies:(none)
Draft Dependencies:
Modifier Extensions:(none)
Previous Version Comparison:
IPA Comparison: n/a
IPS Comparison: n/a
Validation Flags: On: autoLoad; Off: hintAboutNonMustSupport, anyExtensionsAllowed, checkAggregation, showReferenceMessages, noExperimentalContent, displayWarnings
Summary: errors = 29, warn = 11, info = 4, broken links = 24, pinned = n/a.
FilenameErrorsWarningsHints
Build Errors2510
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/scratch/repo/fsh-generated/resources/Composition-Exemplar-Narrative-2.1000
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/scratch/repo/fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-1000
/scratch/repo/fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-2000
/scratch/repo/fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-3000
/scratch/repo/fsh-generated/resources/Composition-Narrative-Single-Composition000
/scratch/repo/fsh-generated/resources/Group-DIBASY-Eligibility000
/scratch/repo/fsh-generated/resources/Group-JPMA0001-Criteria-JPN000
/scratch/repo/fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol100
/scratch/repo/fsh-generated/resources/MedicinalProductDefinition-Exemplar-MedicinalProduct200
/scratch/repo/fsh-generated/resources/Organization-Exemplar-CoSponsor-Organization000
/scratch/repo/fsh-generated/resources/Organization-Exemplar-Devices-Organization000
/scratch/repo/fsh-generated/resources/Organization-Exemplar-Local-Sponsor-Organization000
/scratch/repo/fsh-generated/resources/Organization-Exemplar-Regulator-Organization000
/scratch/repo/fsh-generated/resources/Organization-Exemplar-Sponsor-Organization000
/scratch/repo/fsh-generated/resources/Organization-JPMA-Organization000
/scratch/repo/fsh-generated/resources/Organization-Narrative-Organization000
/scratch/repo/fsh-generated/resources/Practitioner-Exemplar-CoSponsor-Practitioner000
/scratch/repo/fsh-generated/resources/Practitioner-Exemplar-Local-Sponsor-Practitioner000
/scratch/repo/fsh-generated/resources/Practitioner-Exemplar-Sponsor-Expert-Practitioner000
/scratch/repo/fsh-generated/resources/Practitioner-Exemplar-Sponsor-Practitioner000
/scratch/repo/fsh-generated/resources/ResearchStudy-Exemplar-ResearchStudy-001100
/scratch/repo/fsh-generated/resources/ResearchStudy-Exemplar-ResearchStudy-Current-Amendment000
/scratch/repo/fsh-generated/resources/ResearchStudy-JPMA0001-eng000
/scratch/repo/fsh-generated/resources/ResearchStudy-JPMA0001-jpn000
/scratch/repo/fsh-generated/resources/ResearchStudy-ResearchStudy-Composition-Section-Per-Section-001000
/scratch/repo/fsh-generated/resources/ResearchStudy-ResearchStudy-Narrative-Comp-Per-M11-001000
/scratch/repo/fsh-generated/resources/ResearchStudy-ResearchStudy-Narrative-Complex-001000
/scratch/repo/fsh-generated/resources/ResearchStudy-ResearchStudy-Single-Composition-001000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-amendment-detail000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-amendment-scope-impact000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-approval000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-confidentiality-statement000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-protocol-amendment000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-protocol-summary070
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-research-study000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-research-study-narratives000
/scratch/repo/fsh-generated/resources/StructureDefinition-m11-research-study-profile000
/scratch/repo/fsh-generated/resources/StructureDefinition-narrative-elements000
/scratch/repo/fsh-generated/resources/ValueSet-m11-amendment-details-statement-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-amendment-scope-enrollment-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-blinded-roles-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-blindedRoles-vs003
/scratch/repo/fsh-generated/resources/ValueSet-m11-controlType-vs700
/scratch/repo/fsh-generated/resources/ValueSet-m11-country-region-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-independentCommittees-vs400
/scratch/repo/fsh-generated/resources/ValueSet-m11-interventionAssignmentMethod-vs200
/scratch/repo/fsh-generated/resources/ValueSet-m11-interventionModel-vs100
/scratch/repo/fsh-generated/resources/ValueSet-m11-phase-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-populationType-vs200
/scratch/repo/fsh-generated/resources/ValueSet-m11-siteDistribution-vs200
/scratch/repo/fsh-generated/resources/ValueSet-m11-siteGeographicscope-vs200
/scratch/repo/fsh-generated/resources/ValueSet-m11-study-amendment-reason-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-study-amendment-scope-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-target-Maximum-vs031
/scratch/repo/fsh-generated/resources/ValueSet-m11-trialBlindSchema-vs400
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/scratch/repo/fsh-generated/resources/ValueSet-udp-narrative-elements-vs000
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/scratch/repo/fsh-generated/resources/ValueSet-udp-section-codes-vs000
/scratch/repo/fsh-generated/resources/ValueSet-udp-study-title-type-vs000
/scratch/repo/input/assets000
/scratch/repo/input/assets/Mappings000
/scratch/repo/input/assets/Mappings/M11 to FHIR Mapping 02000
/scratch/repo/input/assets/Samples000
/scratch/repo/input/assets/Samples/Exemplar001-Bundle000
/scratch/repo/input/assets/Samples/JPMA001-Bundle000
/scratch/repo/input/images000
/scratch/repo/input/images/ExemplarSchema-01000
/scratch/repo/input/images/ExemplarSoA-01000
/scratch/repo/input/images/Extensions and profiles 02000
/scratch/repo/input/images/FHIR-components000
/scratch/repo/input/images/Mapping000
/scratch/repo/input/images/bundles-01000
/scratch/repo/input/images/bundles-02000
/scratch/repo/input/images/iceberg-03000
/scratch/repo/input/images/image-20260129155349453000
/scratch/repo/input/images/image-20260129155431823000
/scratch/repo/input/images/image-20260129164106045000
/scratch/repo/input/images/image-20260129165903655000
/scratch/repo/input/images/image-20260129165955355000
/scratch/repo/input/images/image-20260129170010341000
/scratch/repo/input/images/narrative-and-structured-02000
/scratch/repo/input/images/narrative-content-01000
/scratch/repo/input/images/narrative-content-02000
/scratch/repo/input/images/protocol-prep-01000
/scratch/repo/input/images/section-vs-01000
/scratch/repo/input/images/shipping-01000
/scratch/repo/input/images/structured-content-01000
/scratch/repo/input/images/work-flow-protocol-approval000
/scratch/repo/input/includes/menu000
/scratch/repo/input/pagecontent/StructureDefinition-m11-approval-intro000
/scratch/repo/input/pagecontent/StructureDefinition-m11-research-study-intro000
/scratch/repo/input/pagecontent/StructureDefinition-m11-research-study-narratives-intro000
/scratch/repo/input/pagecontent/StructureDefinition-m11-research-study-profile-intro000
/scratch/repo/input/pagecontent/acknowledgements000
/scratch/repo/input/pagecontent/background000
/scratch/repo/input/pagecontent/best-practice000
/scratch/repo/input/pagecontent/bundles000
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/scratch/repo/input/pagecontent/downloads000
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/scratch/repo/input/pagecontent/index000
/scratch/repo/input/pagecontent/info-models000
/scratch/repo/input/pagecontent/licenses000
/scratch/repo/input/pagecontent/links000
/scratch/repo/input/pagecontent/terminology000
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/scratch/repo/template/config/_config000

n/a Show Validation Information

errorThere are multiple resources with the same title [ICH M11 ...]. This is not allowed because it produces duplicate entries in the table of contents.
warningThe jira specification file appears to be out of date with the versions, artifacts and pages currently defined in the IG. A proposed revised file to be reviewed and, if appropriate, submitted as a pull request against the XML folder in https://github.com/HL7/JIRA-Spec-Artifacts. To see the differences, perform a file compare on 'template/jira-current.xml' (a normalized view of what is in Github) and 'template/jira-new.xml' (reflects current IG content)
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C49648' for "C49648" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 524errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C49649' for "C49649" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 627errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C120841' for "C120841" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 728errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C218505' for "C218505" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 841errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C218506' for "C218506" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 937errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C184727' for "C184727" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-controlType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 1039errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C28280' for "C28280" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-independentCommittees-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 457errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C142578' for "C142578" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-independentCommittees-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 591errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C215671' for "C215671" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-independentCommittees-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 713errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C78726' for "C78726" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-independentCommittees-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 999errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C41132' for "C41132" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-interventionAssignmentMethod-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 457errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C25196' for "C25196" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-interventionAssignmentMethod-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 565errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C222801' for "C222801" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-interventionModel-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C82640' for "C82640" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-populationType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C218503' for "C218503" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-populationType-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 531errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C218504' for "C218504" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-siteDistribution-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C217004' for "C217004" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-siteDistribution-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 532errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C217005' for "C217005" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-siteGeographicscope-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C217006' for "C217006" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-siteGeographicscope-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 533errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C217007' for "C217007" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-trialBlindSchema-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 431errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C15228' for "C15228" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-trialBlindSchema-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 529errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C187674' for "C187674" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-trialBlindSchema-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 631errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C49659' for "C49659" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED
en​/ValueSet-m11-trialBlindSchema-vs​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/ul​/li​/table​/tr​/td​/a at Line 355, column 727errorThe link 'CodeSystem-ncit-cs.html#ncit-cs-C28233' for "C28233" cannot be resolved (valid targets: 415 targets) HTML_LINK_CHECK_FAILED

fsh-generated/includes/fsh-link-references.md Show Validation Information (0)


fsh-generated/resources/CodeSystem-ncit-cs.json Show Validation Information (1)


fsh-generated/resources/Composition-Exemplar-Narrative.json Show Validation Information (1)


fsh-generated/resources/Composition-Exemplar-Narrative-2.1.json Show Validation Information (1)


fsh-generated/resources/Composition-JPMA0001-Section5-jpn.json Show Validation Information (1)


fsh-generated/resources/Composition-Narrative-Complex.json Show Validation Information (2)


fsh-generated/resources/Composition-Narrative-Composition-Section-per-Section.json Show Validation Information (1)


fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-1.json Show Validation Information (1)


fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-2.json Show Validation Information (1)


fsh-generated/resources/Composition-Narrative-Composition-per-M11-Section-3.json Show Validation Information (1)


fsh-generated/resources/Composition-Narrative-Single-Composition.json Show Validation Information (1)


fsh-generated/resources/Group-DIBASY-Eligibility.json Show Validation Information (1)


fsh-generated/resources/Group-JPMA0001-Criteria-JPN.json Show Validation Information (1)


fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.json Show Validation Information (1)

PathSeverityMessageValidating
ImplementationGuide​.dependsOn[1] (l1​/c2618)errorThe canonical URL http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions points to the package hl7.fhir.uv.extensions which is inconsistent with the stated packageId of hl7.fhir.uv.extensions.r5

Editor's Comment: 06 Can't do anything about these because the necessary R6 packages do not exist yet. (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/R6.20IG.20doesn't.20find.20R6.20extension.20pack.20or.20THO.20pack) IG_DEPENDENCY_CLASH_PACKAGEID
--

fsh-generated/resources/MedicinalProductDefinition-Exemplar-MedicinalProduct.json Show Validation Information (1)

PathSeverityMessageValidating
MedicinalProductDefinition​.name[0]​.type​.coding[0]​.display (l22​/c8)errorWrong Display Name 'Nonproprietary Name(s)' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C97054. Valid display is 'Generic Name' (for the language(s) 'en')

Editor's Comment: 01 These display names are all valid in NCI Thesaurus and are the preferred ones for this application (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/QA.20gives.20error.20on.20Display.20Name.20mismatch/with/583206235) Display_Name_for__should_be_one_of__instead_of
MedicinalProductDefinition
MedicinalProductDefinition​.name[1]​.type​.coding[0]​.display (l34​/c8)errorWrong Display Name 'Proprietary Name(s)' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71898. Valid display is 'Proprietary Name' (for the language(s) 'en')

Editor's Comment: 01 These display names are all valid in NCI Thesaurus and are the preferred ones for this application (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/QA.20gives.20error.20on.20Display.20Name.20mismatch/with/583206235) Display_Name_for__should_be_one_of__instead_of
MedicinalProductDefinition

fsh-generated/resources/Organization-Exemplar-CoSponsor-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-Exemplar-Devices-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-Exemplar-Local-Sponsor-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-Exemplar-Regulator-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-Exemplar-Sponsor-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-JPMA-Organization.json Show Validation Information (1)


fsh-generated/resources/Organization-Narrative-Organization.json Show Validation Information (1)


fsh-generated/resources/Practitioner-Exemplar-CoSponsor-Practitioner.json Show Validation Information (1)


fsh-generated/resources/Practitioner-Exemplar-Local-Sponsor-Practitioner.json Show Validation Information (1)


fsh-generated/resources/Practitioner-Exemplar-Sponsor-Expert-Practitioner.json Show Validation Information (1)


fsh-generated/resources/Practitioner-Exemplar-Sponsor-Practitioner.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-Exemplar-ResearchStudy-001.json Show Validation Information (1)

PathSeverityMessageValidating
ResearchStudy​.associatedParty[6]​.role​.coding[0]​.display (l250​/c8)errorWrong Display Name 'Device Manufacturer' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C156625. Valid display is 'Device Manufacture' (for the language(s) 'en')

Editor's Comment: 01 These display names are all valid in NCI Thesaurus and are the preferred ones for this application (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/QA.20gives.20error.20on.20Display.20Name.20mismatch/with/583206235) Display_Name_for__should_be_one_of__instead_of
M11 Research Study Profile

fsh-generated/resources/ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-JPMA0001-eng.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-JPMA0001-jpn.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-ResearchStudy-Composition-Section-Per-Section-001.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-ResearchStudy-Narrative-Comp-Per-M11-001.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-ResearchStudy-Narrative-Complex-001.json Show Validation Information (1)


fsh-generated/resources/ResearchStudy-ResearchStudy-Single-Composition-001.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-amendment-detail.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-amendment-scope-impact.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-approval.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-confidentiality-statement.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-protocol-amendment.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-protocol-summary.json Show Validation Information (1)

PathSeverityMessageValidating
StructureDefinition​.snapshot​.element[57]​.short (l1​/c348208)warningvalue should not start or finish with whitespace ' C217280 Intervention Assignment Method' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.snapshot​.element[77]​.short (l1​/c362335)warningvalue should not start or finish with whitespace ' C217049 Site Distribution' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.snapshot​.element[142]​.short (l1​/c410494)warningvalue should not start or finish with whitespace ' C218715/C218716 total planned duration of trial participation value/units' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.differential​.element[39]​.short (l1​/c450047)warningvalue should not start or finish with whitespace ' C217280 Intervention Assignment Method' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.differential​.element[55]​.short (l1​/c453002)warningvalue should not start or finish with whitespace ' C217049 Site Distribution' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.differential​.element[105]​.short (l1​/c462928)warningvalue should not start or finish with whitespace ' C218715/C218716 total planned duration of trial participation value/units' Type_Specific_Checks_DT_String_WSStructureDefinition
StructureDefinition​.where(url = 'http:​/​/hl7​.org​/fhir​/uv​/clinical-study-protocol​/StructureDefinition​/m11-protocol-summary')warningThe Implementation Guide contains no examples for this extension --

fsh-generated/resources/StructureDefinition-m11-research-study.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-research-study-narratives.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-m11-research-study-profile.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-narrative-elements.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-amendment-details-statement-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-amendment-scope-enrollment-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-blinded-roles-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-blindedRoles-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet​.compose​.include[0]​.concept[0] (l1​/c4567)informationWrong Display Name 'Participant' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C142710. Valid display is 'Study Participant' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code VALUESET_CODE_CONCEPT_HINT--
ValueSet​.compose​.include[0]​.concept[1] (l1​/c4611)informationWrong Display Name 'Care Provider' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17445. Valid display is 'Caregiver' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code VALUESET_CODE_CONCEPT_HINT--
ValueSet​.compose​.include[0]​.concept[4] (l1​/c4741)informationWrong Display Name 'Sponsor' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70793. Valid display is 'Clinical Study Sponsor' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code VALUESET_CODE_CONCEPT_HINT--

fsh-generated/resources/ValueSet-m11-controlType-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C49648' at 'div/ul/li/table/tr/td/a' for 'C49648' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C49649' at 'div/ul/li/table/tr/td/a' for 'C49649' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C120841' at 'div/ul/li/table/tr/td/a' for 'C120841' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C218505' at 'div/ul/li/table/tr/td/a' for 'C218505' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C218506' at 'div/ul/li/table/tr/td/a' for 'C218506' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C184727' at 'div/ul/li/table/tr/td/a' for 'C184727' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C28280' at 'div/ul/li/table/tr/td/a' for 'C28280' does not resolve --

fsh-generated/resources/ValueSet-m11-country-region-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-independentCommittees-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C142578' at 'div/ul/li/table/tr/td/a' for 'C142578' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C215671' at 'div/ul/li/table/tr/td/a' for 'C215671' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C78726' at 'div/ul/li/table/tr/td/a' for 'C78726' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C41132' at 'div/ul/li/table/tr/td/a' for 'C41132' does not resolve --

fsh-generated/resources/ValueSet-m11-interventionAssignmentMethod-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C25196' at 'div/ul/li/table/tr/td/a' for 'C25196' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C222801' at 'div/ul/li/table/tr/td/a' for 'C222801' does not resolve --

fsh-generated/resources/ValueSet-m11-interventionModel-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C82640' at 'div/ul/li/table/tr/td/a' for 'C82640' does not resolve --

fsh-generated/resources/ValueSet-m11-phase-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-populationType-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C218503' at 'div/ul/li/table/tr/td/a' for 'C218503' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C218504' at 'div/ul/li/table/tr/td/a' for 'C218504' does not resolve --

fsh-generated/resources/ValueSet-m11-siteDistribution-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C217004' at 'div/ul/li/table/tr/td/a' for 'C217004' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C217005' at 'div/ul/li/table/tr/td/a' for 'C217005' does not resolve --

fsh-generated/resources/ValueSet-m11-siteGeographicscope-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C217006' at 'div/ul/li/table/tr/td/a' for 'C217006' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C217007' at 'div/ul/li/table/tr/td/a' for 'C217007' does not resolve --

fsh-generated/resources/ValueSet-m11-study-amendment-reason-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-study-amendment-scope-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-m11-target-Maximum-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet​.compose​.include[0]​.system (l1​/c2740)warningNo definition could be found for URL value 'https://HL7Vulcan.org/UDP/target' Type_Specific_Checks_DT_URL_ResolveValueSet
ValueSet (l1/c2821)warningConstraint failed: cnl-0: 'Name should be usable as an identifier for the module by machine processing applications such as code generation (name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$'))' (defined in http://hl7.org/fhir/StructureDefinition/ValueSet) http://hl7.org/fhir/StructureDefinition/ValueSet#cnl-0ValueSet
ValueSet.compose.include[0] (l1/c2818)informationThe concepts in the value set include have not been validated because the code system 'https://HL7Vulcan.org/UDP/target' is not known, and no terminology service supports it VALUESET_INC_CS_NO_SUPPORT--
ValueSet​.where(id = 'm11-target-Maximum-vs')warningError from https://tx.fhir.org/r5: Error: A definition for CodeSystem 'https://HL7Vulcan.org/UDP/target' could not be found, so the value set cannot be expanded (from server, see log) --

fsh-generated/resources/ValueSet-m11-trialBlindSchema-vs.json Show Validation Information (1)

PathSeverityMessageValidating
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C15228' at 'div/ul/li/table/tr/td/a' for 'C15228' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C187674' at 'div/ul/li/table/tr/td/a' for 'C187674' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C49659' at 'div/ul/li/table/tr/td/a' for 'C49659' does not resolve --
ValueSet.text.diverrorHyperlink 'CodeSystem-ncit-cs.html#ncit-cs-C28233' at 'div/ul/li/table/tr/td/a' for 'C28233' does not resolve --

fsh-generated/resources/ValueSet-m11-yes-no-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-address-purpose-type-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-identifier-type-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-narrative-elements-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-party-role-type-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-related-artifact-type-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-section-codes-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-udp-study-title-type-vs.json Show Validation Information (1)


input/assets Show Validation Information (0)


input/assets/Mappings Show Validation Information (0)


input/assets/Mappings/M11 to FHIR Mapping 02.xlsx Show Validation Information (0)


input/assets/Samples Show Validation Information (0)


input/assets/Samples/Exemplar001-Bundle.json Show Validation Information (0)


input/assets/Samples/JPMA001-Bundle.json Show Validation Information (0)


input/images Show Validation Information (0)


input/images/ExemplarSchema-01.png Show Validation Information (0)


input/images/ExemplarSoA-01.png Show Validation Information (0)


input/images/Extensions and profiles 02.png Show Validation Information (0)


input/images/FHIR-components.png Show Validation Information (0)


input/images/Mapping.png Show Validation Information (0)


input/images/bundles-01.png Show Validation Information (0)


input/images/bundles-02.png Show Validation Information (0)


input/images/iceberg-03.png Show Validation Information (0)


input/images/image-20260129155349453.png Show Validation Information (0)


input/images/image-20260129155431823.png Show Validation Information (0)


input/images/image-20260129164106045.png Show Validation Information (0)


input/images/image-20260129165903655.png Show Validation Information (0)


input/images/image-20260129165955355.png Show Validation Information (0)


input/images/image-20260129170010341.png Show Validation Information (0)


input/images/narrative-and-structured-02.png Show Validation Information (0)


input/images/narrative-content-01.png Show Validation Information (0)


input/images/narrative-content-02.png Show Validation Information (0)


input/images/protocol-prep-01.png Show Validation Information (0)


input/images/section-vs-01.png Show Validation Information (0)


input/images/shipping-01.png Show Validation Information (0)


input/images/structured-content-01.png Show Validation Information (0)


input/images/work-flow-protocol-approval.png Show Validation Information (0)


input/includes/menu.xml Show Validation Information (0)


input/pagecontent/StructureDefinition-m11-approval-intro.md Show Validation Information (0)


input/pagecontent/StructureDefinition-m11-research-study-intro.md Show Validation Information (0)


input/pagecontent/StructureDefinition-m11-research-study-narratives-intro.md Show Validation Information (0)


input/pagecontent/StructureDefinition-m11-research-study-profile-intro.md Show Validation Information (0)


input/pagecontent/acknowledgements.md Show Validation Information (0)


input/pagecontent/background.md Show Validation Information (0)


input/pagecontent/best-practice.md Show Validation Information (0)


input/pagecontent/bundles.md Show Validation Information (0)


input/pagecontent/changes.md Show Validation Information (0)


input/pagecontent/crossreferences.md Show Validation Information (0)


input/pagecontent/downloads.md Show Validation Information (0)


input/pagecontent/fhir-representation.md Show Validation Information (0)


input/pagecontent/index.xml Show Validation Information (0)


input/pagecontent/info-models.md Show Validation Information (0)


input/pagecontent/licenses.md Show Validation Information (0)


input/pagecontent/links.md Show Validation Information (0)


input/pagecontent/terminology.md Show Validation Information (0)


input/pagecontent/use-cases.md Show Validation Information (0)


temp/pages/_includes/artifacts.xml Show Validation Information (0)


template/config Show Validation Information (0)


template/config/_config.yml Show Validation Information (0)

Suppressed Messages (Warnings, hints, broken links)

01 These display names are all valid in NCI Thesaurus and are the preferred ones for this application (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/QA.20gives.20error.20on.20Display.20Name.20mismatch/with/583206235)

02 These codes will eventually be added to the NCI Thesaurus content already in THO - for now they are in a CodeSystem that is a fragment of the NCI Thesaurus

03 These are the locations for illustration in examples - they don't have to resolve

04 Binding is extensible and a value set has been created with original value set plus additional codes

05 The definition is writtten in FSH and using a caret path of ^binding.additonal.key is rejected. No suggestions forthcoming on a solution as yet. (See: Zulip https://chat.fhir.org/#narrow/channel/215610-shorthand/topic/FSH.20for.20binding.2Eadditional.2Ekey)

06 Can't do anything about these because the necessary R6 packages do not exist yet. (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/R6.20IG.20doesn't.20find.20R6.20extension.20pack.20or.20THO.20pack)

07 The Jurisdiction value set does not seem to be deprecated (https://terminology.hl7.org/7.0.1/ValueSet-jurisdiction.html) and we have no control over these bindings

08 fhirpath-types is flagged as experimental! This is not in our control.

09 Why is this draft?

10 The link does resolve so this error seems wrong (See: Zulip https://chat.fhir.org/#narrow/channel/179252-IG-creation/topic/Internal.20link.20.20works.20but.20generates.20IG.20build.20error/with/583203588)

Errors sorted by type


Display_Name_for__should_be_one_of__instead_of

fsh-generated/resources/MedicinalProductDefinition-Exemplar-MedicinalProduct.jsonWrong Display Name 'Nonproprietary Name(s)' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C97054. Valid display is 'Generic Name' (for the language(s) 'en')MedicinalProductDefinition
fsh-generated/resources/MedicinalProductDefinition-Exemplar-MedicinalProduct.jsonWrong Display Name 'Proprietary Name(s)' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71898. Valid display is 'Proprietary Name' (for the language(s) 'en')MedicinalProductDefinition
fsh-generated/resources/ResearchStudy-Exemplar-ResearchStudy-001.jsonWrong Display Name 'Device Manufacturer' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C156625. Valid display is 'Device Manufacture' (for the language(s) 'en')M11 Research Study Profile

IG_DEPENDENCY_CLASH_PACKAGEID

fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonThe canonical URL http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions points to the package hl7.fhir.uv.extensions which is inconsistent with the stated packageId of hl7.fhir.uv.extensions.r5--

Type_Specific_Checks_DT_String_WS

fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C217280 Intervention Assignment Method'StructureDefinition
fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C217049 Site Distribution'StructureDefinition
fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C218715/C218716 total planned duration of trial participation value/units'StructureDefinition
fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C217280 Intervention Assignment Method'StructureDefinition
fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C217049 Site Distribution'StructureDefinition
fsh-generated/resources/StructureDefinition-m11-protocol-summary.jsonvalue should not start or finish with whitespace ' C218715/C218716 total planned duration of trial participation value/units'StructureDefinition

Type_Specific_Checks_DT_URL_Resolve

fsh-generated/resources/ValueSet-m11-target-Maximum-vs.jsonNo definition could be found for URL value 'https://HL7Vulcan.org/UDP/target'ValueSet

VALUESET_CODE_CONCEPT_HINT

fsh-generated/resources/ValueSet-m11-blindedRoles-vs.jsonWrong Display Name 'Participant' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C142710. Valid display is 'Study Participant' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code--
fsh-generated/resources/ValueSet-m11-blindedRoles-vs.jsonWrong Display Name 'Care Provider' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17445. Valid display is 'Caregiver' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code--
fsh-generated/resources/ValueSet-m11-blindedRoles-vs.jsonWrong Display Name 'Sponsor' for http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70793. Valid display is 'Clinical Study Sponsor' (for the language(s) 'en, en-US'). Note that the display in the ValueSet does not have to match; this check exists to help check that it's not accidentally the wrong code--

VALUESET_INC_CS_NO_SUPPORT

fsh-generated/resources/ValueSet-m11-target-Maximum-vs.jsonThe concepts in the value set include have not been validated because the code system 'https://HL7Vulcan.org/UDP/target' is not known, and no terminology service supports it--