HL7 FHIR® Implementation Guide: Clinical Study Protocol, Edition 1
introduction
Describes 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-build
https://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')
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
There 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.
ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide: Validated against fhir.ImplementationGuide
Path
Severity
Message
Validating
ImplementationGuide.dependsOn[1] (l1/c2618)
error
The 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
Wrong 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
Wrong 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
Wrong 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
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)
ERROR: MedicinalProductDefinition/Exemplar-MedicinalProduct: MedicinalProductDefinition.name[0].type.coding[0].display: Wrong 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') (1 uses)
ERROR: MedicinalProductDefinition/Exemplar-MedicinalProduct: MedicinalProductDefinition.name[1].type.coding[0].display: Wrong 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') (1 uses)
ERROR: ResearchStudy/Exemplar-ResearchStudy-001: ResearchStudy.associatedParty[6].role.coding[0].display: Wrong 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') (1 uses)
INFORMATION: ValueSet/udp-party-role-type-vs: ValueSet.compose.include[0].concept[6]: Wrong 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, 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 (1 uses)
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
%The value set references CodeSystem 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' which has status 'fragment'% (14 uses)
03 These are the locations for illustration in examples - they don't have to resolve
%No definition could be found for URL value 'https://exemplarEMA.org/registry-identifier'% (1 uses)
%No definition could be found for URL value 'https://exemplarRegulator.org/registry-identifier'% (1 uses)
%No definition could be found for URL value 'https://exemplarSponsor.com/sponsor-identifier'% (9 uses)
%No definition could be found for URL value 'https://somelocation'% (2 uses)
04 Binding is extensible and a value set has been created with original value set plus additional codes
INFORMATION: Organization/Exemplar-Sponsor-Organization: Organization.contact[1].purpose: None of the codings provided are in the value set 'Contact entity type' (http://terminology.hl7.org/ValueSet/contactentity-type|2.0.0), and a coding is recommended to come from this value set (codes = http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70946) (1 uses)
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)
WARNING: StructureDefinition/m11-research-study-narratives: StructureDefinition.snapshot.element[4].binding.additional[0]: Constraint failed: eld-31: 'additionalBindings should have a key (key.exists())' (defined in http://hl7.org/fhir/StructureDefinition/ElementDefinition) (Best Practice Recommendation) (1 uses)
WARNING: StructureDefinition/m11-research-study-profile: StructureDefinition.snapshot.element[4].binding.additional[0]: Constraint failed: eld-31: 'additionalBindings should have a key (key.exists())' (defined in http://hl7.org/fhir/StructureDefinition/ElementDefinition) (Best Practice Recommendation) (1 uses)
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)
ERROR: ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide.dependsOn[1]: The 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 (1 uses)
ERROR: ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: This IG is version 6.0.0-ballot3, while the IG 'hl7.fhir.uv.extensions.r5' is from version 5.0.0 (1 uses)
ERROR: ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: This IG is version 6.0.0-ballot3, while the IG 'hl7.fhir.uv.tools.r5' is from version 5.0.0 (1 uses)
ERROR: ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: This IG is version 6.0.0-ballot3, while the IG 'hl7.terminology.r5' is from version 5.0.0 (1 uses)
WARNING: ImplementationGuide/hl7.fhir.uv.clinical-study-protocol: ImplementationGuide.dependsOn[0]: The ImplementationGuide is based on FHIR version 6.0.0-ballot3 but package hl7.terminology.r5#7.1.0 is based on FHIR version 5.0.0. 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 (1 uses)
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
%Reference to deprecated ValueSet http://hl7.org/fhir/ValueSet/jurisdiction|6.0.0-ballot3% (26 uses)
08 fhirpath-types is flagged as experimental! This is not in our control.
%Reference to experimental CodeSystem http://hl7.org/fhir/CodeSystem/fhirpath-types|6.0.0-ballot3% (93 uses)
09 Why is this draft?
%Reference to draft CodeSystem urn:iso:std:iso:3166:-2|2021 from fhir.tx.support.r4#0.36.0% (1 uses)
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)
%The link 'Fhir-representation.html#narrative-examples' for "Narrative Examples" cannot be resolved% (4 uses)
Wrong 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')
Wrong 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')
Wrong 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')
The 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
hl7.fhir.uv.clinical-study-protocol
hl7.fhir.uv.tools.r5