Validation Results for ClincalStudyProtocol

Generated Wed Nov 26 16:58:52 UTC 2025, FHIR version 6.0.0-ballot3 for hl7.fhir.uv.clinical-study-protocol#1.0.1-ballot2 (canonical = http://hl7.org/fhir/uv/clinical-study-protocol (history)). See Errors Only & IP

Quality Checks
Publisher Version:IG Publisher Version: v2.0.26
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. 9 of 28 (32%) of resources have a language. Population Policy: NONE
Publication Request:
Pub-Modeworking release
statusballot
Release-LabelSTU 1 - Ballot
Sequence (Group)STU 1
descInitial release
firsttrue
categoryResearch
titlePharmaceutical Clinical Trial Protocols
introductionDescribes the representation of a Clinical Trial protocol to enable to exchange of the protocol between different actors. This includes transfers: > from Sponsor to Regulator(s) and responses as part of the protocol approval process; > from Clinical Trial Management Systems to EHR systems to enable integration of trial execution and individual patient care plans; > between Clinical Trial Managers and potential Trial Sites to establish if a site can provide sufficient suitable trial subjects. The IG also provides a basic mapping of the necessary concepts to their FHIR equivalents and defines necessary vocabulary.
ci-buildhttps://github.com/HL7/vulcan-udp-ig
RelatedIgs(None Found)
  • This IG has never been published
  • Publication Request is for 'hl7.fhir.uv.pharmaceutical-research-protocol' but package is hl7.fhir.uv.clinical-study-protocol
  • Publication Request is for v'1.0.0-ballot' but package version is v1.0.1-ballot2
  • Proposed path for this publication does not start with the canonical URL (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/2025Sep vs http://hl7.org/fhir/uv/clinical-study-protocol)
  • Proposed path for this publication should usually be the canonical with the version or sequence appended and then some kind of label (typically '-snapshot')
Supressed Messages:163 Suppressed Issues
Dependency Checks:
PackageVersionFHIRCanonicalWeb BaseComment
.. hl7.fhir.uv.clinical-study-protocol1.0.1-ballot2R6http://hl7.org/fhir/uv/clinical-study-protocol
... hl7.fhir.uv.extensionscurrent VR5http://hl7.org/fhir/extensionshttps://build.fhir.org/ig/HL7/fhir-extensions/FHIR Version Mismatch
.... hl7.terminology.r56.5.0 OR5http://terminology.hl7.orghttp://terminology.hl7.org/6.5.0FHIR Version Mismatch. Latest Release is 7.0.0
..... hl7.fhir.uv.extensions.r55.2.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch
... hl7.terminology7.0.0 MR5http://terminology.hl7.orghttp://terminology.hl7.org/7.0.0FHIR Version Mismatch
.... hl7.fhir.uv.extensions.r55.2.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch (as above)
... hl7.fhir.uv.ebm1.0.0-ballot2 IR6http://hl7.org/fhir/uv/ebmhttp://hl7.org/fhir/uv/ebm/2025MayFHIR Version Mismatch
.... hl7.fhir.uv.extensions.r55.2.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch (as above)
.... hl7.terminology.r56.2.0 OR5http://terminology.hl7.orghttp://terminology.hl7.org/6.2.0FHIR Version Mismatch. Latest Release is 7.0.0
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: Unable to compare with previous version: Unable to find version history at http://hl7.org/fhir/uv/clinical-study-protocol (Problem #1 with package-list.json at http://hl7.org/fhir/uv/clinical-study-protocol: Not Found)
IPA Comparison: n/a
IPS Comparison: n/a
Validation Flags: On: autoLoad; Off: hintAboutNonMustSupport, anyExtensionsAllowed, checkAggregation, showReferenceMessages, noExperimentalContent, displayWarnings
Summary: errors = 15, warn = 15, info = 2, broken links = 6, pinned = n/a.
FilenameErrorsWarningsHints
Build Errors1300
/scratch/repo/fsh-generated/resources/CodeSystem-narrative-elements-cs000
/scratch/repo/fsh-generated/resources/Composition-IGBJ-Narrative020
/scratch/repo/fsh-generated/resources/Composition-IGBJ-Narrative-1.3000
/scratch/repo/fsh-generated/resources/Composition-IGBJ-Narrative-2.1000
/scratch/repo/fsh-generated/resources/Composition-IGBJ-Narrative-5.1000
/scratch/repo/fsh-generated/resources/Composition-IGBJ-Narrative-9000
/scratch/repo/fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol212
/scratch/repo/fsh-generated/resources/MedicinalProductDefinition-IGBJ-MedicinalProduct000
/scratch/repo/fsh-generated/resources/Organization-IGBJ-Organization000
/scratch/repo/fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy690
/scratch/repo/fsh-generated/resources/StructureDefinition-ResearchStudyStudyAmendmentScopeImpact010
/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/StructureDefinition-protocol-amendment000
/scratch/repo/fsh-generated/resources/StructureDefinition-protocol-amendment-detail010
/scratch/repo/fsh-generated/resources/StructureDefinition-study-design010
/scratch/repo/fsh-generated/resources/ValueSet-cdisc-yes-no-vs000
/scratch/repo/fsh-generated/resources/ValueSet-ddf-study-title-type-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-amendment-scope-enrollment-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-country-region-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-identifier-type-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-phase-vs000
/scratch/repo/fsh-generated/resources/ValueSet-m11-section-codes-vs000
/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-narrative-elements-vs000
/scratch/repo/fsh-generated/resources/ValueSet-nci-study-role-vs000

n/a Show Validation Information

ImplementationGuide​/hl7​.fhir​.uv​.clinical-study-protocolerrorThis IG is version 6.0.0-ballot3, while the IG 'hl7.fhir.uv.extensions' is from version 5.0.0
ImplementationGuide​/hl7​.fhir​.uv​.clinical-study-protocolerrorThis IG is for FHIR version 6.0.0-ballot3, while the package 'hl7.terminology.r5#6.5.0' is for FHIR version 5.0.0
ImplementationGuide​/hl7​.fhir​.uv​.clinical-study-protocolerrorThis IG is version 6.0.0-ballot3, while the IG 'hl7.terminology' is from version 5.0.0
ImplementationGuide​/hl7​.fhir​.uv​.clinical-study-protocolerrorThis IG is version 6.0.0-ballot3, while the IG 'hl7.fhir.uv.ebm' is from version 6.0.0-ballot2
ImplementationGuide​/hl7​.fhir​.uv​.clinical-study-protocolerrorThis IG is version 6.0.0-ballot3, while the IG 'hl7.fhir.uv.tools.r5' is from version 5.0.0
errorThere is no jira specification file defined with the expected name of FHIR-clinical-study-protocol in the xml folder of the https://github.com/HL7/Jira-Spec-Artifacts project. This must exist before ballot or publication.
errorIn your menu.xml file, it's no longer allowed to have href='#' on dropdown items. Change them to be href='menu.html' instead. (It won't link, but it needs to be something valid.)
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 244, column 7errorThe link 'definitions.xml.zip' for "XML" cannot be resolved HTML_LINK_CHECK_FAILED
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 249, column 7errorThe link 'definitions.json.zip' for "JSON" cannot be resolved HTML_LINK_CHECK_FAILED
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 254, column 7errorThe link 'definitions.ttl.zip' for "Turtle" cannot be resolved HTML_LINK_CHECK_FAILED
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 262, column 7errorThe link 'examples.xml.zip' for "XML" cannot be resolved HTML_LINK_CHECK_FAILED
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 267, column 7errorThe link 'examples.json.zip' for "JSON" cannot be resolved HTML_LINK_CHECK_FAILED
en​/downloads​.html​#​/html​/body​/div​/div​/div​/div​/div​/div​/table​/tbody​/tr​/td​/a at Line 272, column 7errorThe link 'examples.ttl.zip' for "Turtle" cannot be resolved HTML_LINK_CHECK_FAILED

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


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

PathSeverityMessage
Composition​.section[0]​.code​.coding[0]​.code (l26​/c8)warningUnknown Code 'C218519' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT
Composition​.section[1]​.code​.coding[0]​.code (l41​/c8)warningUnknown Code 'C218548' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT

fsh-generated/resources/Composition-IGBJ-Narrative-1.3.json Show Validation Information (1)


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


fsh-generated/resources/Composition-IGBJ-Narrative-5.1.json Show Validation Information (1)


fsh-generated/resources/Composition-IGBJ-Narrative-9.json Show Validation Information (1)


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

PathSeverityMessage
ImplementationGuide​.jurisdiction[0] (l1​/c1816)informationReference to deprecated ValueSet http://hl7.org/fhir/ValueSet/jurisdiction|6.0.0-ballot3 (from https://tx.fhir.org/r5, see log, or see the servers logic) MSG_DEPRECATED
ImplementationGuide (l1/c21275)informationThe resource status 'draft' and the standards status 'trial-use' may not be consistent and should be reviewed VALIDATION_VAL_STATUS_INCONSISTENT_HINT
ImplementationGuide​.dependsOn[0] (l1​/c2099)errorThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.extensions#dev is based on FHIR version 5.0.0. Use the package hl7.fhir.uv.extensions.r6 instead IG_DEPENDENCY_VERSION_ERROR
ImplementationGuide​.dependsOn[1] (l1​/c2243)errorThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology#7.0.0 is based on FHIR version 5.0.0. Use the package hl7.terminology.r6 instead IG_DEPENDENCY_VERSION_ERROR
ImplementationGuide​.dependsOn[2] (l1​/c2383)warningThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.ebm#1.0.0-ballot2 is based on FHIR version 6.0.0-ballot2. In general, this version mismatch should be avoided - some tools will try to make this work with variable degrees of success, but others will not even try IG_DEPENDENCY_VERSION_WARNING

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


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


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

PathSeverityMessage
ResearchStudy​.extension[3]​.extension[0]​.value​.ofType(code) (l90​/c33)warningUnknown Code 'C217026' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5, see log, or see the servers logic) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[7]​.value​.ofType(url) (l123​/c45)warningNo definition could be found for URL value 'https://somelocation' Type_Specific_Checks_DT_URL_Resolve
ResearchStudy​.extension[3]​.extension[9]​.extension[0]​.value​.ofType(code) (l133​/c36)warningUnknown Code 'C41065' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5, see log, or see the servers logic) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[9]​.extension[0]​.value​.ofType(code) (l133​/c36)errorThe value provided ('C41065') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41065' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2'; Unknown Code 'C41065' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment) (from server, see log, or see the servers logic) Terminology_TX_NoValid_16
ResearchStudy​.extension[3]​.extension[10]​.extension[0]​.value​.ofType(code) (l146​/c36)warningUnknown Code 'C68846' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5, see log, or see the servers logic) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[10]​.extension[0]​.value​.ofType(code) (l146​/c36)errorThe value provided ('C68846') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C68846' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2'; Unknown Code 'C68846' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment) (from server, see log, or see the servers logic) Terminology_TX_NoValid_16
ResearchStudy​.extension[3]​.extension[11]​.value​.ofType(CodeableConcept)​.coding[0]​.code (l157​/c12)warningUnknown Code 'C218490' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[12]​.value​.ofType(CodeableConcept)​.coding[0]​.code (l169​/c12)warningUnknown Code 'C218494' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[14]​.value​.ofType(code) (l185​/c32)warningUnknown Code 'C49488' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5, see log, or see the servers logic) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[14]​.value​.ofType(code) (l185​/c32)errorThe value provided ('C49488') was not found in the value set 'CDISC Yes No Unknown Not Applicable Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/cdisc-yes-no-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49488' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/cdisc-yes-no-vs|1.0.1-ballot2'; Unknown Code 'C49488' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment) (from server, see log, or see the servers logic) Terminology_TX_NoValid_16
ResearchStudy​.extension[3]​.extension[18]​.extension[2]​.value​.ofType(CodeableConcept)​.coding[0]​.code (l211​/c16)warningUnknown Code 'C218515' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[18]​.extension[2]​.value​.ofType(CodeableConcept) (l211​/c16)errorNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218515) Terminology_TX_NoValid_1_CC
ResearchStudy​.extension[3]​.extension[19]​.extension[2]​.value​.ofType(CodeableConcept)​.coding[0]​.code (l236​/c16)warningUnknown Code 'C218550' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment (from https://tx.fhir.org/r5) UNKNOWN_CODE_IN_FRAGMENT
ResearchStudy​.extension[3]​.extension[19]​.extension[2]​.value​.ofType(CodeableConcept) (l236​/c16)errorNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218550) Terminology_TX_NoValid_1_CC
ResearchStudy.phase (l269/c4)errorNone of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602) Terminology_TX_NoValid_1_CC

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

PathSeverityMessage
StructureDefinition.context[0]warningReview the extension type for ResearchStudyStudyAmendmentScopeImpact: extensions should not have a context of Element unless it's really intended that they can be used anywhere SD_CONTEXT_SHOULD_NOT_BE_ELEMENT

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/StructureDefinition-protocol-amendment.json Show Validation Information (1)


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

PathSeverityMessage
StructureDefinition.context[0]warningReview the extension type for protocol-amendment-detail: extensions should not have a context of Element unless it's really intended that they can be used anywhere SD_CONTEXT_SHOULD_NOT_BE_ELEMENT

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

PathSeverityMessage
StructureDefinition​.where(url = 'http:​/​/hl7​.org​/fhir​/uv​/clinical-study-protocol​/StructureDefinition​/study-design')warningThe Implementation Guide contains no examples for this profile

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


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


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


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


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


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-narrative-elements-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-nci-study-role-vs.json Show Validation Information (1)

Suppressed Messages (Warnings, hints, broken links)

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

02 This comes from the dependancy on items from the EBM IG which which are not currently up for ballot

03 The profile properly belongs in EBM where examples can be found - content relevant to UDP is illustrated in the IGBJ-ResearchStudy example

04 These codes have only just been added (or are still being added) to NCI Thesaurus. The "error" entries have been checked and are all on the NCI Thesaurus.

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

06 Will start this process

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

08 Standards status set to trial-use at request of FMG (eMail from Marc Duteau 2025-07-30)

Errors sorted by type


IG_DEPENDENCY_VERSION_ERROR

fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.extensions#dev is based on FHIR version 5.0.0. Use the package hl7.fhir.uv.extensions.r6 instead
fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology#7.0.0 is based on FHIR version 5.0.0. Use the package hl7.terminology.r6 instead

IG_DEPENDENCY_VERSION_WARNING

fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.ebm#1.0.0-ballot2 is based on FHIR version 6.0.0-ballot2. In general, this version mismatch should be avoided - some tools will try to make this work with variable degrees of success, but others will not even try

MSG_DEPRECATED

fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonReference to deprecated ValueSet http://hl7.org/fhir/ValueSet/jurisdiction|6.0.0-ballot3

SD_CONTEXT_SHOULD_NOT_BE_ELEMENT

fsh-generated/resources/StructureDefinition-ResearchStudyStudyAmendmentScopeImpact.jsonReview the extension type for ResearchStudyStudyAmendmentScopeImpact: extensions should not have a context of Element unless it's really intended that they can be used anywhere
fsh-generated/resources/StructureDefinition-protocol-amendment-detail.jsonReview the extension type for protocol-amendment-detail: extensions should not have a context of Element unless it's really intended that they can be used anywhere

Terminology_TX_NoValid_16

fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonThe value provided ('C41065') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41065' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2'; Unknown Code 'C41065' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment)
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonThe value provided ('C68846') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C68846' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.1-ballot2'; Unknown Code 'C68846' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment)
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonThe value provided ('C49488') was not found in the value set 'CDISC Yes No Unknown Not Applicable Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/cdisc-yes-no-vs|1.0.1-ballot2), and a code is required from this value set (error message = The provided code 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49488' was not found in the value set 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/cdisc-yes-no-vs|1.0.1-ballot2'; Unknown Code 'C49488' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment)

Terminology_TX_NoValid_1_CC

fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218515)
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-section-codes-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218550)
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonNone of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs|1.0.1-ballot2), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)

Type_Specific_Checks_DT_URL_Resolve

fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonNo definition could be found for URL value 'https://somelocation'

UNKNOWN_CODE_IN_FRAGMENT

fsh-generated/resources/Composition-IGBJ-Narrative.jsonUnknown Code 'C218519' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/Composition-IGBJ-Narrative.jsonUnknown Code 'C218548' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C217026' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C41065' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C68846' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C218490' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C218494' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C49488' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C218515' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment
fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy.jsonUnknown Code 'C218550' in the CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' version '' - note that the code system is labeled as a fragment, so the code may be valid in some other fragment

VALIDATION_VAL_STATUS_INCONSISTENT_HINT

fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.jsonThe resource status 'draft' and the standards status 'trial-use' may not be consistent and should be reviewed