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FHIR IG Statistics: ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol

Packagehl7.fhir.uv.pharmaceutical-research-protocol
TypeImplementationGuide
Idhl7.fhir.uv.pharmaceutical-research-protocol
FHIR VersionR6
Sourcehttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/https://build.fhir.org/ig/HL7/vulcan-udp-ig/index.html
URLhttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol
Version0.4.0
Statusdraft
Date2025-07-18T09:47:38+00:00
Namepharmaceuticalresearchprotocol
TitleVulcan UDP IG
Realmuv
Authorityhl7

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ImplementationGuide hl7.fhir.uv.pharmaceutical-research-protocol

pharmaceuticalresearchprotocol

The official URL for this implementation guide is:

http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol

Source

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  "id": "hl7.fhir.uv.pharmaceutical-research-protocol",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
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      "valueCode": "draft"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 0
    }
  ],
  "url": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol",
  "version": "0.4.0",
  "name": "pharmaceuticalresearchprotocol",
  "title": "Vulcan UDP IG",
  "status": "draft",
  "date": "2025-07-18T09:47:38+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
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          "value": "http://www.hl7.org/Special/committees/rcrim"
        },
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          "value": "UDP@HL7Vulcan.org"
        }
      ]
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  "jurisdiction": [
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      "coding": [
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          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
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  ],
  "packageId": "hl7.fhir.uv.pharmaceutical-research-protocol",
  "license": "CC0-1.0",
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    },
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      "uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
      "packageId": "hl7.fhir.uv.extensions",
      "version": "5.2.0"
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    {
      "id": "hl7_terminology",
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  "definition": {
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    ],
    "resource": [
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/ddf-study-title-type-vs"
        },
        "name": "CDISC DDF Study Title Type Value Set",
        "description": "Codes drawn from NCI Thesaurus value set $NCIT#C207419 CDISC DDF Study Title Type Value Set Terminology\nThese codes represent the types of title or name a study can have according to CDISC DDF",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/cdisc-yes-no-vs"
        },
        "name": "CDISC Yes No Unknown Not Applicable Value Set",
        "description": "Contains all values from C66742 - CDISC SDTM Yes No Unknown or Not Applicable Response Terminology",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "Organization"
          }
        ],
        "reference": {
          "reference": "Organization/org-EliLilly"
        },
        "name": "IBGJ Organization",
        "description": "An illustrative example of an Organization providing the informatin required by the protocol",
        "isExample": true
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "MedicinalProductDefinition"
          }
        ],
        "reference": {
          "reference": "MedicinalProductDefinition/IGBJ-MedicinalProduct"
        },
        "name": "IGBJ Medicinal Product",
        "description": "Illustration of a MedicinalProductDefinition used by the protocol",
        "isExample": true
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "Composition"
          }
        ],
        "reference": {
          "reference": "Composition/IGBJ-Narrative-1.3"
        },
        "name": "IGBJ Protocol Narrative 1.3 - Schedule of Activities",
        "description": "1.3 Schedule of Activities",
        "isExample": true,
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        ]
      },
      {
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          }
        ],
        "reference": {
          "reference": "Composition/IGBJ-Narrative-2.1"
        },
        "name": "IGBJ Protocol Narrative 2.1",
        "description": "2.1 Purpose of Trial",
        "isExample": true,
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      },
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            "valueString": "Composition"
          }
        ],
        "reference": {
          "reference": "Composition/IGBJ-Narrative-5.1"
        },
        "name": "IGBJ Protocol Narrative 5.1",
        "description": "5.1\tDescription of Trial Population and Rationale",
        "isExample": true,
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      },
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            "valueString": "Composition"
          }
        ],
        "reference": {
          "reference": "Composition/IGBJ-Narrative-9"
        },
        "name": "IGBJ Protocol Narrative 9",
        "description": "9\tADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION",
        "isExample": true,
        "profile": [
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          }
        ],
        "reference": {
          "reference": "ResearchStudy/IGBJ-ResearchStudy"
        },
        "name": "IGBJ Research Study with narrative",
        "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://fs-01.azurewebsites.net/Bundle/ICH-M11-Template-IGBJ-Bundle",
        "isExample": true
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        ],
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        },
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        "description": "Identification of the type of identifier.",
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      },
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            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-phase-vs"
        },
        "name": "M11 Phase Value Set",
        "description": "Codes drawn from NCI Thesaurus value set $NCIT#C217045 ICH M11 Trial Phase Value Set Terminology\nThese codes represent phases of a study as defined by ICH.",
        "isExample": false
      },
      {
        "extension": [
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            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/m11-research-study-profile"
        },
        "name": "M11 Research Study",
        "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 relatedArtifact attribute.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-section-codes-vs"
        },
        "name": "M11 Section Codes Value Set",
        "description": "Codes representing sections of M11.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/m11-research-study-narratives"
        },
        "name": "M11 Specific Research Study Narratives",
        "description": "Further constraint of ResearchStudyNarratives profile to force use of M11 heading.<br>\n\nThe ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organise protocol content.\nFor a FHIR representation of the protocol to be compliant with this template each of the narrative sections must \nbe organised using these headings. Only if there is material that does not properly belong under one of the M11 \nheadings can additional codes be created.<br>\n\n<br><span style='color: red;'>**///TODO**</span> Add example of creating custom code/section",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:extension"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/m11-research-study"
        },
        "name": "M11ResearchStudy",
        "description": "Extensions to ResearchStudy for M11.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:extension"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/narrative-elements"
        },
        "name": "Narrative Elements",
        "description": "Narrative content for the ResearchStudy.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          }
        ],
        "reference": {
          "reference": "CodeSystem/narrative-elements-cs"
        },
        "name": "Narrative Elements Code System",
        "description": "Composition Types to Manage Protocol Narrative Elements",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/narrative-elements-vs"
        },
        "name": "Narrative Elements Value Set",
        "description": "Composition Types to Manage Protocol Narrative Elements",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/nci-study-role-vs"
        },
        "name": "NCI Study Role Value Set",
        "description": "Codes drawn from NCI Thesaurus as children of $NCIT#C48355 Sponsor\nThese codes represent the roles an individual or an organization can play in a study.\nThere is a value set $NCIT#C215480 - CDISC DDF Study Role Code Value Set Terminology \nbut it does not have any members.  This list is created as an interim.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/research-study-narratives"
        },
        "name": "Research Study Narratives",
        "description": "Narrative elements associated with a research study.<br>\n<br>\nUse this profile when the ordering of the narrative sections is not intended to comply with the ICH M11 CeSHarP template\notherwise use the M11ResearchStudyNarratives profile.\n\nFor narrative that is not arranged according to the M11 template create a value set to use in place\nof the  M11SectionCodesVS.<br>\n\n<br><span style='color: red;'>**///TODO**</span>Provide pointers to construction of a non M11 value set",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:extension"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/protocol-amendment"
        },
        "name": "ResearchStudyStudyAmendment",
        "description": "Amendment to a study protocol. This is originally from EBM.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:extension"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/protocol-amendment-detail"
        },
        "name": "ResearchStudyStudyAmendmentDetails",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:extension"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"
        },
        "name": "ResearchStudyStudyAmendmentScopeImpact",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-country-region-vs"
        },
        "name": "Study Amendment Country Value Set",
        "description": "Codes drawn from \nISO 3166 Country Codes, Alpha 3; \nISO 3166 Country Codes, Alpha 2; \nGENC\ncountry affected by an amendment to a study.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-study-amendment-reason-vs"
        },
        "name": "Study Amendment Reaason Value Set",
        "description": "Codes drawn from NCI Thesaurus to represent the reasons a study was amended.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-amendment-scope-enrollment-vs"
        },
        "name": "Study Amendment Scope Enrollment Value Set",
        "description": "Categorising numbers affected by the amendment",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "ValueSet"
          }
        ],
        "reference": {
          "reference": "ValueSet/m11-study-amendment-scope-vs"
        },
        "name": "Study Amendment Scope Value Set",
        "description": "Codes drawn from NCI Thesaurus to represent the scope of an amendment to a study.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "Bundle"
          }
        ],
        "reference": {
          "reference": "Bundle/h1"
        },
        "name": "null (Bundle)"
      }
    ],
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      "extension": [
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          "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode": "informative"
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      ],
      "sourceUrl": "toc.html",
      "name": "toc.html",
      "title": "Table of Contents",
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          "generation": "html"
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              "valueCode": "informative"
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          "sourceUrl": "downloads.html",
          "name": "downloads.html",
          "title": "Downloads",
          "generation": "html"
        }
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    "parameter": [
      {
        "code": {
          "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
          "code": "copyrightyear"
        },
        "value": "2025+"
      },
      {
        "code": {
          "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
          "code": "releaselabel"
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        "value": "ci-build"
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          "code": "path-history"
        },
        "value": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/history.html"
      },
      {
        "code": {
          "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
          "code": "autoload-resources"
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          "code": "path-resource"
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        "value": "input/capabilities"
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        "value": "input/operations"
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}