1+ <?xml version =" 1.0" encoding =" UTF-8" ?>
2+ <specification xmlns : xsi =" http://www.w3.org/2001/XMLSchema-instance" ballotUrl =" http://hl7.org/fhir/uv/pharmaceutical-research-protocol/2025Sep" ciUrl =" https://github.com/HL7/vulcan-udp-ig" defaultVersion =" 1.0.0-ballot" defaultWorkgroup =" brr" url =" http://hl7.org/fhir/uv/pharmaceutical-research-protocol" gitUrl =" https://github.com/HL7/vulcan-udp-ig" >
3+ <version code =" current" url =" https://github.com/HL7/vulcan-udp-ig" />
4+ <version code =" 1.0.0-ballot" url =" http://hl7.org/fhir/uv/pharmaceutical-research-protocol/2025Sep" />
5+ <artifactPageExtension value =" -definitions" />
6+ <artifactPageExtension value =" -examples" />
7+ <artifactPageExtension value =" -mappings" />
8+ <artifact id =" ValueSet/ddf-study-title-type-vs" key =" ValueSet-ddf-study-title-type-vs" name =" CDISC DDF Study Title Type Value Set" />
9+ <artifact id =" ValueSet/cdisc-yes-no-vs" key =" ValueSet-cdisc-yes-no-vs" name =" CDISC Yes No Unknown Not Applicable Value Set" />
10+ <artifact id =" MedicinalProductDefinition/IGBJ-MedicinalProduct" key =" MedicinalProductDefinition-IGBJ-MedicinalProduct" name =" IGBJ Medicinal Product" />
11+ <artifact id =" Organization/IGBJ-Organization" key =" Organization-IGBJ-Organization" name =" IGBJ Organization" />
12+ <artifact id =" Composition/IGBJ-Narrative-1.3" key =" Composition-IGBJ-Narrative-1.3" name =" IGBJ Protocol Narrative 1.3 - Schedule of Activities" />
13+ <artifact id =" Composition/IGBJ-Narrative-2.1" key =" Composition-IGBJ-Narrative-2.1" name =" IGBJ Protocol Narrative 2.1" />
14+ <artifact id =" Composition/IGBJ-Narrative-5.1" key =" Composition-IGBJ-Narrative-5.1" name =" IGBJ Protocol Narrative 5.1" />
15+ <artifact id =" Composition/IGBJ-Narrative-9" key =" Composition-IGBJ-Narrative-9" name =" IGBJ Protocol Narrative 9" />
16+ <artifact id =" ResearchStudy/IGBJ-ResearchStudy" key =" ResearchStudy-IGBJ-ResearchStudy" name =" IGBJ Research Study with narrative" />
17+ <artifact id =" ValueSet/m11-identifier-type-vs" key =" ValueSet-m11-identifier-type-vs" name =" M11 Identifier Type Value Set" />
18+ <artifact id =" ValueSet/m11-phase-vs" key =" ValueSet-m11-phase-vs" name =" M11 Phase Value Set" />
19+ <artifact id =" StructureDefinition/m11-research-study-profile" key =" StructureDefinition-m11-research-study-profile" name =" M11 Research Study" />
20+ <artifact id =" ValueSet/m11-section-codes-vs" key =" ValueSet-m11-section-codes-vs" name =" M11 Section Codes Value Set" />
21+ <artifact id =" StructureDefinition/protocol-amendment" key =" StructureDefinition-protocol-amendment" name =" M11_ProtocolAmendment" />
22+ <artifact id =" ValueSet/nci-study-role-vs" key =" ValueSet-nci-study-role-vs" name =" NCI Study Role Value Set" />
23+ <artifact id =" StructureDefinition/narrative-elements" key =" StructureDefinition-narrative-elements" name =" Narrative Elements" />
24+ <artifact id =" CodeSystem/narrative-elements-cs" key =" CodeSystem-narrative-elements-cs" name =" Narrative Elements Code System" />
25+ <artifact id =" ValueSet/narrative-elements-vs" key =" ValueSet-narrative-elements-vs" name =" Narrative Elements Value Set" />
26+ <artifact id =" StructureDefinition/m11-research-study-narratives" key =" StructureDefinition-m11-research-study-narratives" name =" Research Study Narratives" />
27+ <artifact id =" StructureDefinition/protocol-amendment-detail" key =" StructureDefinition-protocol-amendment-detail" name =" ResearchStudyStudyAmendmentDetails" />
28+ <artifact id =" StructureDefinition/ResearchStudyStudyAmendmentScopeImpact" key =" StructureDefinition-ResearchStudyStudyAmendmentScopeImpact" name =" ResearchStudyStudyAmendmentScopeImpact" />
29+ <artifact id =" ValueSet/m11-country-region-vs" key =" ValueSet-m11-country-region-vs" name =" Study Amendment Country Value Set" />
30+ <artifact id =" ValueSet/m11-study-amendment-reason-vs" key =" ValueSet-m11-study-amendment-reason-vs" name =" Study Amendment Reason Value Set" />
31+ <artifact id =" ValueSet/m11-amendment-scope-enrollment-vs" key =" ValueSet-m11-amendment-scope-enrollment-vs" name =" Study Amendment Scope Enrollment Value Set" />
32+ <artifact id =" ValueSet/m11-study-amendment-scope-vs" key =" ValueSet-m11-study-amendment-scope-vs" name =" Study Amendment Scope Value Set" />
33+ <artifact id =" StructureDefinition/study-design" key =" StructureDefinition-study-design" name =" StudyDesign" />
34+ <page key =" NA" name =" (NA)" />
35+ <page key =" many" name =" (many)" />
36+ <page key =" 02-background" name =" 02 Background" />
37+ <page key =" 03-best-practice" name =" 03 Best Practice" />
38+ <page key =" 04-use-cases" name =" 04 Use Cases" />
39+ <page key =" 05-protocol-preparation" name =" 05 Protocol Preparation" />
40+ <page key =" 06-info-models" name =" 06 Info Models" />
41+ <page key =" 07-fhir-representation" name =" 07 Fhir Representation" />
42+ <page key =" 08-bundles" name =" 08 Bundles" />
43+ <page key =" 09-links" name =" 09 Links" />
44+ <page key =" 10-credits" name =" 10 Credits" />
45+ <page key =" 11-changes" name =" 11 Changes" />
46+ <page key =" artifacts" name =" Artifacts Summary" />
47+ <page key =" downloads" name =" Downloads" />
48+ <page key =" index" name =" Home" />
49+ <page key =" toc" name =" Table of Contents" />
50+ </specification >
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