# hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2: Clinical Study Protocol(en)

## Pages

* [Home](en/index.md)
* [Artifacts Summary](en/artifacts.md)
* [Bundles](en/bundles.md)
* [Crossreferences](en/crossreferences.md)
* [Changes](en/changes.md)
* [Licenses](en/licenses.md)
* [Downloads](en/downloads.md)
* [Fhir Representation](en/fhir-representation.md)
* [Links](en/links.md)
* [Info Models](en/info-models.md)
* [Background](en/background.md)
* [Acknowledgements](en/acknowledgements.md)
* [Use Cases](en/use-cases.md)
* [Best Practice](en/best-practice.md)
* [Terminology](en/terminology.md)

## Resources

### CodeSystems

* [Fragment of NCIT Code System](en/CodeSystem-ncit-cs.md)

### ValueSets

* [ICH M11 Amendment Details Statement Value Set Terminology](en/ValueSet-m11-amendment-details-statement-vs.md)
* [ICH M11 Amendment Scope Enrollment Description Value Set Terminology](en/ValueSet-m11-amendment-scope-enrollment-vs.md)
* [ICH M11 Trial Blinding Role Value Set Terminology](en/ValueSet-m11-blinded-roles-vs.md)
* [ICH M11 Study Amendment Country Value Set](en/ValueSet-m11-country-region-vs.md)
* [ICH M11 Trial Phase Value Set Terminology](en/ValueSet-m11-phase-vs.md)
* [ICH M11 Reason for Amendment Value Set Terminology](en/ValueSet-m11-study-amendment-reason-vs.md)
* [ICH M11 Amendment Scope Value Set Terminology](en/ValueSet-m11-study-amendment-scope-vs.md)
* [ICH M11 No Yes Value Set Terminology](en/ValueSet-m11-yes-no-vs.md)
* [UDP Address Purpose Type Value Set](en/ValueSet-udp-address-purpose-type-vs.md)
* [UDP Identifier Type Value Set](en/ValueSet-udp-identifier-type-vs.md)
* [UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set.](en/ValueSet-udp-narrative-elements-vs.md)
* [UDP Party Role Type Value Set](en/ValueSet-udp-party-role-type-vs.md)
* [UDP Related Artifact Type Value Set](en/ValueSet-udp-related-artifact-type-vs.md)
* [UDP Section Codes Value Set](en/ValueSet-udp-section-codes-vs.md)
* [UDP Study Title Type Value Set](en/ValueSet-udp-study-title-type-vs.md)

### Resource Profiles

* [Research Study Narratives](en/StructureDefinition-m11-research-study-narratives.md)
* [M11 Research Study Profile](en/StructureDefinition-m11-research-study-profile.md)

### Extensions

* [M11_AmendmentDetails](en/StructureDefinition-m11-amendment-detail.md)
* [M11_AmendmentScopeImpact](en/StructureDefinition-m11-amendment-scope-impact.md)
* [M11_Approval](en/StructureDefinition-m11-approval.md)
* [M11_ConfidentialityStatement](en/StructureDefinition-m11-confidentiality-statement.md)
* [M11_ProtocolAmendment](en/StructureDefinition-m11-protocol-amendment.md)
* [M11 Research Study Extension](en/StructureDefinition-m11-research-study.md)
* [Narrative Elements](en/StructureDefinition-narrative-elements.md)

### ImplementationGuides

* [Clinical Study Protocol](en/ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.md)

### Examples

* [Exemplar Protocol Narrative 2.1 (Composition)](en/Composition-Exemplar-Narrative-2.1.md)
* [Exemplar Protocol Narratives (Composition)](en/Composition-Exemplar-Narrative.md)
* [JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria) (Composition)](en/Composition-JPMA0001-Section5-jpn.md)
* [Narrative 15 (Composition)](en/Composition-Narrative-Complex.md)
* [Example Narrative with Section per Section - (this is the Composition Title} (Composition)](en/Composition-Narrative-Composition-Section-per-Section.md)
* [Example Narrative Composition per M11 Section - Section 1 - (this is the Composition Title} (Composition)](en/Composition-Narrative-Composition-per-M11-Section-1.md)
* [Example Narrative Composition per M11 Section - Section 21 - (this is the Composition Title} (Composition)](en/Composition-Narrative-Composition-per-M11-Section-2.md)
* [Example Narrative Composition per M11 Section - Section 3 - (this is the Composition Title} (Composition)](en/Composition-Narrative-Composition-per-M11-Section-3.md)
* [Example Single Narrative- (this is the Composition Title} (Composition)](en/Composition-Narrative-Single-Composition.md)
* [StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial (Group)](en/Group-DIBASY-Eligibility.md)
* [Japanese Protocol from Vulcan UDP Eligibility Criteria (Group)](en/Group-JPMA0001-Criteria-JPN.md)
* [Exemplar-MedicinalProduct (MedicinalProductDefinition)](en/MedicinalProductDefinition-Exemplar-MedicinalProduct.md)
* [Exemplar Pharmazeutika GmBH. (Organization)](en/Organization-Exemplar-CoSponsor-Organization.md)
* [Exemplar Devices Ltd (Organization)](en/Organization-Exemplar-Devices-Organization.md)
* [Fictive Pharmaceuticals (Australia) Pty (Organization)](en/Organization-Exemplar-Local-Sponsor-Organization.md)
* [Exemplar Regulating Authority (ERA) (Organization)](en/Organization-Exemplar-Regulator-Organization.md)
* [Exemplar Pharmaceuticals Co. (Organization)](en/Organization-Exemplar-Sponsor-Organization.md)
* [JPMA (Organization)](en/Organization-JPMA-Organization.md)
* [Exemplar Pharmaceuticals Co. (Organization)](en/Organization-Narrative-Organization.md)
* [Exemplar-CoSponsor-Practitioner (Practitioner)](en/Practitioner-Exemplar-CoSponsor-Practitioner.md)
* [Exemplar-Local-Sponsor-Practitioner (Practitioner)](en/Practitioner-Exemplar-Local-Sponsor-Practitioner.md)
* [Exemplar-Sponsor-Expert-Practitioner (Practitioner)](en/Practitioner-Exemplar-Sponsor-Expert-Practitioner.md)
* [Exemplar-Sponsor-Practitioner (Practitioner)](en/Practitioner-Exemplar-Sponsor-Practitioner.md)
* [A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus (ResearchStudy)](en/ResearchStudy-Exemplar-ResearchStudy-001.md)
* [Exemplar-ResearchStudy-Current-Amendment (ResearchStudy)](en/ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.md)
* [A Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent (ResearchStudy)](en/ResearchStudy-JPMA0001-eng.md)
* [経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験 (ResearchStudy)](en/ResearchStudy-JPMA0001-jpn.md)
* [Illustration of Assembling Narrative Sections (ResearchStudy)](en/ResearchStudy-ResearchStudy-Composition-Section-Per-Section-001.md)
* [Illustration of Complex Narrative and Formatting (ResearchStudy)](en/ResearchStudy-ResearchStudy-Narrative-Comp-Per-M11-001.md)
* [Illustration of Complex Narrative and Formatting (ResearchStudy)](en/ResearchStudy-ResearchStudy-Narrative-Complex-001.md)
* [Illustration of Assembling Narrative Sections (ResearchStudy)](en/ResearchStudy-ResearchStudy-Single-Composition-001.md)
