{
"description": null,
"_filename": "ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.json",
"package_name": "hl7.fhir.uv.clinical-study-protocol",
"definition": {
"page": {
"name": "toc.html",
"page": [ {
"name": "index.html",
"title": "Home",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "index.html",
"generation": "html"
}, {
"name": "acknowledgements.html",
"title": "Acknowledgements",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "acknowledgements.html",
"generation": "markdown"
}, {
"name": "background.html",
"title": "Background",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "background.html",
"generation": "markdown"
}, {
"name": "best-practice.html",
"title": "Best Practice",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "best-practice.html",
"generation": "markdown"
}, {
"name": "bundles.html",
"title": "Bundles",
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"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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} ],
"sourceUrl": "bundles.html",
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}, {
"name": "changes.html",
"title": "Changes",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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} ],
"sourceUrl": "changes.html",
"generation": "markdown"
}, {
"name": "crossreferences.html",
"title": "Crossreferences",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "crossreferences.html",
"generation": "markdown"
}, {
"name": "downloads.html",
"title": "Downloads",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "downloads.html",
"generation": "markdown"
}, {
"name": "fhir-representation.html",
"title": "Fhir Representation",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "fhir-representation.html",
"generation": "markdown"
}, {
"name": "info-models.html",
"title": "Info Models",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "info-models.html",
"generation": "markdown"
}, {
"name": "licenses.html",
"title": "Licenses",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "licenses.html",
"generation": "markdown"
}, {
"name": "links.html",
"title": "Links",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "links.html",
"generation": "markdown"
}, {
"name": "terminology.html",
"title": "Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "terminology.html",
"generation": "markdown"
}, {
"name": "use-cases.html",
"title": "Use Cases",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "use-cases.html",
"generation": "markdown"
} ],
"title": "Table of Contents",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
} ],
"sourceUrl": "toc.html",
"generation": "html"
},
"grouping": [ {
"id": "GroupBASE",
"name": "Profiles & Extensions: Base",
"description": "Base Profiles and Extensions. M11 as part of the name only signifies alignment to M11 - HL7 is the owner"
}, {
"id": "GroupNAR",
"name": "Profiles & Extensions: Narrative Structures",
"description": "Profiles and Extensions to allow representation of narrative structures. M11 as part of the name only signifies alignment to M11 - HL7 is the owner"
}, {
"id": "GroupAMD",
"name": "Profiles & Extensions: Protocol amendment",
"description": "Profiles and Extensions representing amendments to a protocol. M11 as part of the name only signifies alignment to M11 - HL7 is the owner"
}, {
"id": "GroupCS",
"name": "Terminology: Code Systems",
"description": "The majority of required code systems are maintained by CDISC on the NCI Thesaurus. The code system here is a fragment to enable terminology validation."
}, {
"id": "GroupVSM11",
"name": "Terminology: M11 Value Sets",
"description": "These define sets of codes used by systems conforming to this implementation guide. This list has value sets defined by the M11 Techncial Specification. These are FHIR representations of those value sets. (NOTE ICH and CDISC have a Memorandum of Understanding (MOU) to support the maintenance and governance of ICH M11 controlled terminology ocusing on the use of CDISC’s unified governance process and terminology services for long-term support.)"
}, {
"id": "GroupVSUDP",
"name": "Terminology: UDP Value Sets",
"description": "These define sets of codes used by systems conforming to this implementation guide. This list is value sets that are defined by this IG."
}, {
"id": "GroupExemplar",
"name": "Example Instances: Exemplar Protocol",
"description": "These examples are a synthetic set of data that aims to exercise as many data points as possible. The protocol described is entierly made up for illustration."
}, {
"id": "GroupJPN",
"name": "Example Instances: Japanese Protocol",
"description": "These examples show how the same content can be represented in both English and Japanese. See the [Downloads section](downloads.html) for a file to load the instance set to a server."
}, {
"id": "GroupComp1",
"name": "Example Instances: Narrative - Single Composition",
"description": "Illustration of a protocol with narrative as Single Composition. For discussion see section: [Narrative Examples](Fhir-representation.html#narrative-examples)"
}, {
"id": "GroupComp2",
"name": "Example Instances: Narrative - Composition per Section",
"description": "Illustration of a protocol with Composition Section for Each M11 Section. For discussion see section: [Narrative Examples](Fhir-representation.html#narrative-examples)"
}, {
"id": "GroupComp3",
"name": "Example Instances: Narrative - Section per Section",
"description": "Illustration of a protocol with composition for each M11 narrative section. For discussion see section: [Narrative Examples](Fhir-representation.html#narrative-examples)"
}, {
"id": "GroupComp4",
"name": "Example Instances: Narrative - Complex",
"description": "Illustration of a protocol with 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. For discussion see section: [Narrative Examples](Fhir-representation.html#narrative-examples)"
}, {
"id": "GroupELIG",
"name": "Example Instances: Eligibility Criteria",
"description": "Structured Representation of Eligbility Criteria"
} ],
"resource": [ {
"name": "M11_Approval",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-approval"
},
"groupingId": "GroupBASE",
"description": "Approval and sign off"
}, {
"name": "M11_ConfidentialityStatement",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-confidentiality-statement"
},
"groupingId": "GroupBASE",
"description": "Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement"
}, {
"name": "Research Study Narratives",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-research-study-narratives"
},
"groupingId": "GroupNAR",
"description": "Narrative elements associated with a research study following the ICH M11 CeSHarP template.\nThe ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organize protocol content.\nFor a FHIR representation of the protocol to be compliant with this template each of the narrative sections must \nbe organized using these headings. Only if there is material that does not properly belong under one of the M11 \nheadings can additional codes be created."
}, {
"name": "M11 Research Study Profile",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-research-study-profile"
},
"groupingId": "GroupNAR",
"description": "Constraint of ResearchStudy to M11 Guidance\nAn instance of this profile represents a single version of the protocol definition. Previous amendments are represented\nby further instances of ResearchStudy linked through the relatesTo attribute."
}, {
"name": "M11 Research Study Extension",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-research-study"
},
"groupingId": "GroupNAR",
"description": "Additions for M11 not otherwise dealt with"
}, {
"name": "Narrative Elements",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/narrative-elements"
},
"groupingId": "GroupNAR",
"description": "Narrative content for the ResearchStudy."
}, {
"name": "M11_ProtocolAmendment",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-protocol-amendment"
},
"groupingId": "GroupAMD",
"description": "Amendment to a protocol. This is originally from EBM."
}, {
"name": "M11_AmendmentDetails",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-amendment-detail"
},
"groupingId": "GroupAMD",
"description": "Provides detail of a single amendment - repeats within the overal amendment report"
}, {
"name": "M11_AmendmentScopeImpact",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/m11-amendment-scope-impact"
},
"groupingId": "GroupAMD",
"description": "Provides number or percentage of each group affected by a single amendment"
}, {
"name": "Fragment of NCIT Code System",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/ncit-cs"
},
"groupingId": "GroupCS",
"description": "This is a fragment from the NCI Thesaurus covering codes used by ICH M11 Value Sets.\nThese should all be moved into tx.fhir.org but are included here in FHIR format for testing and validation."
}, {
"name": "ICH M11 Amendment Details Statement Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-amendment-details-statement-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with whether or not a protocol has been amended.\nThis is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "ICH M11 Amendment Scope Enrollment Description Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-amendment-scope-enrollment-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the amendment scope enrollment description value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217275 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "ICH M11 Trial Blinding Role Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-blinded-roles-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "ICH M11 Study Amendment Country Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-country-region-vs"
},
"groupingId": "GroupVSM11",
"description": "Codes drawn from \nISO 3166 Country Codes, Alpha 3; \nISO 3166 Country Codes, Alpha 2; \ncountry/region codes. This is ICH M11 Value Set represented here in FHIR format."
}, {
"name": "ICH M11 Trial Phase Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-phase-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the trial phase value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217045 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "ICH M11 Reason for Amendment Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-study-amendment-reason-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the reason for amendment value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217276 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "ICH M11 Amendment Scope Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-study-amendment-scope-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format.\n\nThe M11 guidance to \"leave blank\" if not applicable has to be replaced by an explicit \"Not Applicable\""
}, {
"name": "ICH M11 No Yes Value Set Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/m11-yes-no-vs"
},
"groupingId": "GroupVSM11",
"description": "Terminology associated with the no yes value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217046 drawn from the NCI Thesaurus and represented here in FHIR format."
}, {
"name": "UDP Address Purpose Type Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-address-purpose-type-vs"
},
"groupingId": "GroupVSUDP",
"description": "These codes represent intended use of an address. There is an HL7 value set \nfor Contact entity type - this has \"prefered\" binding and must therefore be included in this value set\nThis is a UDP specific value set using NCIT codes to extend a required HL7 value set.\n\nNeither HL7 nor NCIT have the simle concept of a \"legal address\". HL7 has the concept of an Administrative address\nwhich is not precise enough and NCIT has Sponsor Legal Address, Co-SPonsor Legal Address etc\nFor the present we shall use the HL7 ADMIN address as the designation of the legal address."
}, {
"name": "UDP Identifier Type Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-identifier-type-vs"
},
"groupingId": "GroupVSUDP",
"description": "These codes represent the types of identifier used ina study.\nThis is a UDP specific value set.\nThese are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute \nrather than being a classifier for a more general attribute. FHIR structures are designed to work with a repeating\nidentifier attribute classified by an approriate terminology. This value set enables that by using NCIT codes to create a FHIR value set."
}, {
"name": "UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set.",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-narrative-elements-vs"
},
"groupingId": "GroupVSUDP",
"description": "Composition Types to Manage Protocol Narrative Elements. This is a UDP specific value set."
}, {
"name": "UDP Party Role Type Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-party-role-type-vs"
},
"groupingId": "GroupVSUDP",
"description": "These codes represent the types of role ResearchStudy.AssociatedParty can play. This is required for the\nmechanism used by FHIR for associating one entity with another. This is a UDP specific value set and uses NCIT codes to \ncreate an appropriate FHIR value set."
}, {
"name": "UDP Related Artifact Type Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-related-artifact-type-vs"
},
"groupingId": "GroupVSUDP",
"description": "These codes represent the relationship between an artifact and it related target.\nThere is an HL7 value set for Related Artifact type - this has \"extensible\" binding. This will \nbe included in this value set.\nThis is a UDP specific value set using NCIT codes to extend a required HL7 value set.\n\nThe HL7 value set does not have the concept of information that is a summary of an amendment that has been applied.\nThe amends and amended-with concepts talk of content that must be applied to get the final version. M11 only\nwants to know what has been done - it is more of an amendment trail than an actual amendment. M11 uses a concept\nfrom the NCI Thesaurus which is suitable for use here."
}, {
"name": "UDP Section Codes Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-section-codes-vs"
},
"groupingId": "GroupVSUDP",
"description": "Codes representing sections of M11.\nThis value set is not identified in the M11 specification but is in the NCI Thesaurus and was \noriginally specified for M11. It is NCI Value Set C217272 drawn from the NCI Thesaurus and represented here in FHIR format.\nThese codes are present in UDP to allow granularity in narrative compositions."
}, {
"name": "UDP Study Title Type Value Set",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/udp-study-title-type-vs"
},
"groupingId": "GroupVSUDP",
"description": "These codes represent the types of title or name a study can have \nThis is a UDP specific value set using NCIT codes to extend an HL7 value set.\n\nThese are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute \nrather than being a classifier for a more general attribute. FHIR structures are designed to work with a repeating\nattribute classified by an approriate terminology. This value set enables that.\nNote that the NCI Thesaurus holds separate codes for protocol name (C132300) that are separate from study title (C49802)"
}, {
"name": "START HERE: Exemplar Research Study with narrative",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/Exemplar-ResearchStudy-001"
},
"groupingId": "GroupExemplar",
"description": "Illustration of a protocol with some parts in narrative form and some in granular form. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Exemplar-ResearchStudy-001.\n\nThis desceribes an entirely ficticious protocol for an imaginary product with Brand name Exotex and generic name Exoticillin produced by Exemplar \nPharmaceuticals. The regulator is the Exemplar Regulating Authority (ERA)"
}, {
"name": "Exemplar Protocol Narrative",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Exemplar-Narrative"
},
"groupingId": "GroupExemplar",
"description": "1.3 Schedule of Activities and 5.1\tDescription of Trial Population and Rationale"
}, {
"name": "Exemplar Protocol Narrative 2.1",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Exemplar-Narrative-2.1"
},
"groupingId": "GroupExemplar",
"description": "2.1 Purpose of Trial"
}, {
"name": "Exemplar Medicinal Product",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
} ],
"isExample": true,
"reference": {
"reference": "MedicinalProductDefinition/Exemplar-MedicinalProduct"
},
"groupingId": "GroupExemplar",
"description": "Illustration of a MedicinalProductDefinition used by the protocol"
}, {
"name": "Exemplar CoSponsor Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Exemplar-CoSponsor-Organization"
},
"groupingId": "GroupExemplar",
"description": "A minimal Organization definition"
}, {
"name": "Exemplar Devices Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Exemplar-Devices-Organization"
},
"groupingId": "GroupExemplar",
"description": "A minimal Organization definition"
}, {
"name": "Exemplar Local Sponsor Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Exemplar-Local-Sponsor-Organization"
},
"groupingId": "GroupExemplar",
"description": "A minimal Organization definition"
}, {
"name": "Exemplar Regulating Authority (ERA)",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Exemplar-Regulator-Organization"
},
"groupingId": "GroupExemplar",
"description": "A minimal Regulator definition"
}, {
"name": "Exemplar Sponsor Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Exemplar-Sponsor-Organization"
},
"groupingId": "GroupExemplar",
"description": "A minimal Organization definition"
}, {
"name": "Exemplar CoSponsor Practitioner",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Practitioner"
} ],
"isExample": true,
"reference": {
"reference": "Practitioner/Exemplar-CoSponsor-Practitioner"
},
"groupingId": "GroupExemplar",
"description": "A minimal Practitioner definition"
}, {
"name": "Exemplar Local Sponsor Practitioner",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Practitioner"
} ],
"isExample": true,
"reference": {
"reference": "Practitioner/Exemplar-Local-Sponsor-Practitioner"
},
"groupingId": "GroupExemplar",
"description": "A minimal Practitioner definition"
}, {
"name": "Exemplar Sponsor Expert Medical Practitioner",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Practitioner"
} ],
"isExample": true,
"reference": {
"reference": "Practitioner/Exemplar-Sponsor-Expert-Practitioner"
},
"groupingId": "GroupExemplar",
"description": "A minimal Practitioner definition"
}, {
"name": "Exemplar Sponsor Practitioner",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Practitioner"
} ],
"isExample": true,
"reference": {
"reference": "Practitioner/Exemplar-Sponsor-Practitioner"
},
"groupingId": "GroupExemplar",
"description": "A minimal Practitioner definition"
}, {
"name": "Current amendments details",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/Exemplar-ResearchStudy-Current-Amendment"
},
"groupingId": "GroupExemplar",
"description": "Illustration of a protocol with some parts in narrative form and some in granular form. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Exemplar-ResearchStudy-001.\n\nThis desceribes an entirely ficticious protocol for an imaginary product with Brand name Exotex and generic name Exoticillin produced by Exemplar \nPharmaceuticals. The regulator is the Exemplar Regulating Authority (ERA)"
}, {
"name": "JPMA0001 Inclusion/Exclusion Narrative",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/JPMA0001-Section5-jpn"
},
"groupingId": "GroupJPN",
"description": "Protocol Narrative Sections 5.2 and 5.3"
}, {
"name": "Japanese Protocol from Vulcan UDP Eligibility Criteria",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Group"
} ],
"isExample": true,
"reference": {
"reference": "Group/JPMA0001-Criteria-JPN"
},
"groupingId": "GroupJPN",
"description": "Example showing Janapese text"
}, {
"name": "JPMA Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/JPMA-Organization"
},
"groupingId": "GroupJPN",
"description": "A minimal Organization definition"
}, {
"name": "JPMA0001 Provided Example - English Language",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/JPMA0001-eng"
},
"groupingId": "GroupJPN",
"description": "Illustration of a Japanese language protocol - this is the English translation"
}, {
"name": "JPMA0001 Provided Example - Japanese Language",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/JPMA0001-jpn"
},
"groupingId": "GroupJPN",
"description": "Illustration of a Japanese language protocol - this is the original Japanese"
}, {
"name": "IGBJ Research Study with narrative as Single Composition",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/ResearchStudy-Single-Composition-001"
},
"groupingId": "GroupComp1",
"description": "Illustration of a protocol with narrative as Single Composition. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Simple-001."
}, {
"name": "Example Narrative Single Composition",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Single-Composition"
},
"groupingId": "GroupComp1",
"description": "Example Narrative Single Composition. This illustrates taking the illustration protocol and putting \nall the content in a single section within a single composition.\nThis is not a recommended pattern."
}, {
"name": "Narrative Author Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/Narrative-Organization"
},
"groupingId": "GroupComp1",
"description": "A minimal Organization definition"
}, {
"name": "IGBJ Research Study with Composition Section for Each M11 Section",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/ResearchStudy-Composition-Section-Per-Section-001"
},
"groupingId": "GroupComp2",
"description": "Illustration of a protocol with Composition Section for Each M11 Section. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Section-001."
}, {
"name": "Example Narrative Composition per M11 Section - Section 1",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Composition-per-M11-Section-1"
},
"groupingId": "GroupComp2",
"description": "Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting \neach major M11 Section in a composition. This is M11 Section 1.\nThis pattern may be useful when working with part of a protocol."
}, {
"name": "Example Narrative Composition per M11 Section - Section 2",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Composition-per-M11-Section-2"
},
"groupingId": "GroupComp2",
"description": "Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting \neach major M11 Section in a composition. This is M11 Section 2.\nThis pattern may be useful when working with part of a protocol."
}, {
"name": "Example Narrative Composition per M11 Section - Section 3",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Composition-per-M11-Section-3"
},
"groupingId": "GroupComp2",
"description": "Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting \neach major M11 Section in a composition. This is M11 Section 3.\nThis pattern may be useful when working with part of a protocol."
}, {
"name": "IGBJ Research Study with composition for each M11 narrative section",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001"
},
"groupingId": "GroupComp3",
"description": "Illustration of a protocol with composition for each M11 narrative section. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001."
}, {
"name": "Example Narrative Single Composition with a Section for Each M11 Section",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Composition-Section-per-Section"
},
"groupingId": "GroupComp3",
"description": "Example Narrative Single Composition with a Section for Each M11 Section. This illustrates taking the illustration protocol and putting the content for each section in a section within the same composition.\nThis is probably the most appropriate general purpose pattern."
}, {
"name": "IGBJ Research Study with complex narrative",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
} ],
"isExample": true,
"reference": {
"reference": "ResearchStudy/ResearchStudy-Narrative-Complex-001"
},
"groupingId": "GroupComp4",
"description": "Illustration of a protocol with 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Complex-001."
}, {
"name": "Example Narrative Complex - Other Patterns and Non M11 Content Suggestion",
"profile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/Narrative-Complex"
},
"groupingId": "GroupComp4",
"description": "Example Narrative Complex - Custom Content\nThis example shows: 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. These illustrations show what is possible. It is not a recommended way of laying out the protocol. Individual use cases may need other solutions."
}, {
"name": "StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Group"
} ],
"isExample": true,
"reference": {
"reference": "Group/DIBASY-Eligibility"
},
"groupingId": "GroupELIG",
"description": "Simple Eligibility criteria - Age 30-60 years + BMI>=35 + History type 2 diabetes >5y"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
"valueCode": "hl7.fhir.uv.tools.r5#1.1.2"
} ],
"parameter": [ {
"code": {
"code": "copyrightyear",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "2026+"
}, {
"code": {
"code": "releaselabel",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "STU 1 Ballot2"
}, {
"code": {
"code": "jira-code",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "pharmaceutical-research-protocol"
}, {
"code": {
"code": "special-url",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
}, {
"code": {
"code": "path-history",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/uv/clinical-study-protocol/history.html"
}, {
"code": {
"code": "autoload-resources",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/capabilities"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/examples"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/extensions"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/models"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/operations"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/profiles"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/resources"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/vocabulary"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/maps"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/testing"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/history"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "fsh-generated/resources"
}, {
"code": {
"code": "path-pages",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "template/config"
}, {
"code": {
"code": "path-pages",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/assets"
}, {
"code": {
"code": "path-pages",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/images"
}, {
"code": {
"code": "path-liquid",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template/liquid"
}, {
"code": {
"code": "path-liquid",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "input/liquid"
}, {
"code": {
"code": "path-qa",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "temp/qa"
}, {
"code": {
"code": "path-temp",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "temp/pages"
}, {
"code": {
"code": "path-output",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "output"
}, {
"code": {
"code": "path-tx-cache",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input-cache/txcache"
}, {
"code": {
"code": "path-suppressed-warnings",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "input/ignoreWarnings.txt"
}, {
"code": {
"code": "template-html",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template-page.html"
}, {
"code": {
"code": "template-md",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template-page-md.html"
}, {
"code": {
"code": "apply-contact",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-context",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-copyright",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-jurisdiction",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-license",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-publisher",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-version",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-wg",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "active-tables",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "fmm-definition",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/versions.html#maturity"
}, {
"code": {
"code": "propagate-status",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "excludelogbinaryformat",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "tabbed-snapshots",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "i18n-default-lang",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "en"
} ]
},
"date": "2026-04-08T21:16:18+10:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": [ "6.0.0-ballot3" ],
"license": "CC0-1.0",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"dependsOn": [ {
"id": "hl7tx",
"uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
"version": "7.1.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
"valueMarkdown": "Automatically added as a dependency - all IGs depend on HL7 Terminology"
} ],
"packageId": "hl7.terminology.r5"
}, {
"id": "hl7ext",
"uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
"version": "5.2.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
"valueMarkdown": "Automatically added as a dependency - all IGs depend on the HL7 Extension Pack"
} ],
"packageId": "hl7.fhir.uv.extensions.r5"
} ],
"name": "ClincalStudyProtocol",
"type": null,
"experimental": null,
"resourceType": "ImplementationGuide",
"title": "Clinical Study Protocol",
"package_version": "1.0.0-ballot2",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 2
} ],
"status": "active",
"language": "en",
"id": "69809eaa-c0d1-45bb-8828-f3cbd1aeb151",
"kind": null,
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol",
"version": "1.0.0-ballot2",
"packageId": "hl7.fhir.uv.clinical-study-protocol",
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "UDP@HL7Vulcan.org",
"system": "email"
} ]
} ]
}