Validation Results for PharmaceuticalResearchProtocol

Generated Thu Jul 31 20:42:04 UTC 2025, FHIR version 6.0.0-ballot3 for hl7.fhir.uv.pharmaceutical-research-protocol#1.0.0-ballot (canonical = http://hl7.org/fhir/uv/pharmaceutical-research-protocol (history)). See Full QA Report & IP

Quality Checks
Publisher Version:IG Publisher Version: v2.0.12
Publication Code:pharmaceutical-research-protocol . PackageId = hl7.fhir.uv.pharmaceutical-research-protocol, Canonical = http://hl7.org/fhir/uv/pharmaceutical-research-protocol
Realm Check for UV:
  • n/a
Language Info:This IG has no language information
Publication Request:
package-idhl7.fhir.uv.pharmaceutical-research-protocol
version1.0.0-ballot
pathhttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/2025Sep
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
  • 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.pharmaceutical-research-protocol1.0.0-ballotR6http://hl7.org/fhir/uv/pharmaceutical-research-protocol
... hl7.fhir.uv.extensions5.2.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch
.... hl7.terminology.r56.2.0 OR5http://terminology.hl7.orghttp://terminology.hl7.org/6.2.0FHIR Version Mismatch. Latest Release is 6.5.0
... hl7.terminology6.5.0 MR5http://terminology.hl7.orghttp://terminology.hl7.org/6.5.0FHIR Version Mismatch
.... hl7.fhir.uv.extensions.r55.2.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/5.2.0FHIR Version Mismatch
... hl7.fhir.uv.ebm1.0.0-ballot2 IR6http://hl7.org/fhir/uv/ebmhttp://hl7.org/fhir/uv/ebm/2025May
.... 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 (as above). Latest Release is 6.5.0
Templates: hl7.vulcan.template#0.1.0 -> hl7.fhir.template#current -> hl7.base.template#current -> fhir.base.template#current. Tools: 0.7.1
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/pharmaceutical-research-protocol (Problem #1 with package-list.json at http://hl7.org/fhir/uv/pharmaceutical-research-protocol: Not Found)
IPA Comparison: n/a
IPS Comparison: n/a
Validation Flags: On: autoLoad; Off: hintAboutNonMustSupport, anyExtensionsAllowed, checkAggregation, showReferenceMessages, noExperimentalContent, displayWarnings
Summary: errors = 8, warn = 0, info = 0, broken links = 0, pinned = n/a.
FilenameErrorsWarningsHints
Build Errors000
/scratch/repo/fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.pharmaceutical-research-protocol200
/scratch/repo/fsh-generated/resources/ResearchStudy-IGBJ-ResearchStudy600

n/a Show Validation Information


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

PathSeverityMessage
ImplementationGuide​.dependsOn[1] (l1​/c2092)errorThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.extensions#5.2.0 is based on FHIR version 5.0.0. Use the package hl7.fhir.uv.extensions.r6 instead

Editor's Comment: 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 IG_DEPENDENCY_VERSION_ERROR
ImplementationGuide​.dependsOn[2] (l1​/c2236)errorThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology#6.5.0 is based on FHIR version 5.0.0. Use the package hl7.terminology.r6 instead

Editor's Comment: 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 IG_DEPENDENCY_VERSION_ERROR

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

PathSeverityMessage
ResearchStudy​.extension[4]​.extension[9]​.extension[0]​.value​.ofType(code) (l139​/c36)errorThe value provided ('C41065') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot'; 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)

Editor's Comment: 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. (from server, see log) Terminology_TX_NoValid_16
ResearchStudy​.extension[4]​.extension[10]​.extension[0]​.value​.ofType(code) (l152​/c36)errorThe value provided ('C68846') was not found in the value set 'Study Amendment Scope Enrollment Value Set' (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot'; 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)

Editor's Comment: 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. (from server, see log) Terminology_TX_NoValid_16
ResearchStudy​.extension[4]​.extension[14]​.value​.ofType(code) (l191​/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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs|1.0.0-ballot'; 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)

Editor's Comment: 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. (from server, see log) Terminology_TX_NoValid_16
ResearchStudy​.extension[4]​.extension[18]​.extension[2]​.value​.ofType(CodeableConcept) (l217​/c16)errorNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs|1.0.0-ballot), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218515)

Editor's Comment: 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. Terminology_TX_NoValid_1_CC
ResearchStudy​.extension[4]​.extension[19]​.extension[2]​.value​.ofType(CodeableConcept) (l242​/c16)errorNone of the codings provided are in the value set 'M11 Section Codes Value Set' (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs|1.0.0-ballot), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218550)

Editor's Comment: 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. Terminology_TX_NoValid_1_CC
ResearchStudy.phase (l275/c4)errorNone of the codings provided are in the value set 'M11 Phase Value Set' (http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs|1.0.0-ballot), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)

Editor's Comment: 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. Terminology_TX_NoValid_1_CC

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.pharmaceutical-research-protocol.jsonThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.fhir.uv.extensions#5.2.0 is based on FHIR version 5.0.0. Use the package hl7.fhir.uv.extensions.r6 instead
fsh-generated/resources/ImplementationGuide-hl7.fhir.uv.pharmaceutical-research-protocol.jsonThe ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology#6.5.0 is based on FHIR version 5.0.0. Use the package hl7.terminology.r6 instead

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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot'; 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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-amendment-scope-enrollment-vs|1.0.0-ballot'; 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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs|1.0.0-ballot'; 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/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs|1.0.0-ballot), 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/pharmaceutical-research-protocol/ValueSet/m11-phase-vs|1.0.0-ballot), and a coding from this value set is required) (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15602)