Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Extension: Narrative Elements - JSON Profile

Page standards status: Trial-use | Maturity Level: 2

JSON representation of the narrative-elements extension.

Raw json | Download

    {
      "resourceType" : "StructureDefinition",
      "id" : "narrative-elements",
      "language" : "en",
      "text" : {
        "status" : "extensions",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition narrative-elements</b></p><a name=\"narrative-elements\"> </a><a name=\"hcnarrative-elements\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64, \" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-narrative-elements-definitions.html#Extension\" title=\"Narrative content for the ResearchStudy.\">Extension</a><a name=\"Extension\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Narrative Elements</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a style=\"text-decoration:line-through; text-decoration:line-through\" href=\"StructureDefinition-narrative-elements-definitions.html#Extension.extension\">extension</a><a name=\"Extension.extension\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Extension</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-narrative-elements-definitions.html#Extension.url\">url</a><a name=\"Extension.url\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"color: darkgreen\">&quot;http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements&quot;</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-narrative-elements-definitions.html#Extension.value[x]\">value[x]</a><a name=\"Extension.value_x_\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-m11-research-study-narratives.html\">Research Study Narratives</a>)</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Pointer to the narrative content for the protocol</td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64, \" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
          "valueCode" : "can-bind"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
          "valueInteger" : 2
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode" : "trial-use",
          "_valueCode" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
      "version" : "1.0.0-ballot2",
      "name" : "NarrativeElements",
      "title" : "Narrative Elements",
      "status" : "active",
      "date" : "2026-04-09T17:15:23+10:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International / Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            },
            {
              "system" : "email",
              "value" : "UDP@HL7Vulcan.org"
            }
          ]
        }
      ],
      "description" : "Narrative content for the ResearchStudy.",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
              "code" : "001",
              "display" : "World"
            }
          ]
        }
      ],
      "copyright" : "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nCDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
      "fhirVersion" : "6.0.0-ballot3",
      "mapping" : [
        {
          "identity" : "rim",
          "uri" : "http://hl7.org/v3",
          "name" : "RIM Mapping"
        }
      ],
      "kind" : "complex-type",
      "abstract" : false,
      "context" : [
        {
          "type" : "element",
          "expression" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy"
        }
      ],
      "type" : "Extension",
      "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Extension",
      "derivation" : "constraint",
      "snapshot" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
            "valueString" : "6.0.0-ballot3"
          }
        ],
        "element" : [
          {
            "id" : "Extension",
            "path" : "Extension",
            "short" : "Narrative Elements",
            "definition" : "Narrative content for the ResearchStudy.",
            "min" : 0,
            "max" : "*",
            "base" : {
              "path" : "Extension",
              "min" : 0,
              "max" : "*"
            },
            "constraint" : [
              {
                "key" : "ele-1",
                "severity" : "error",
                "human" : "All FHIR elements must have a @value or children",
                "expression" : "hasValue() or (children().count() > id.count())",
                "source" : "http://hl7.org/fhir/StructureDefinition/Element"
              },
              {
                "key" : "ext-1",
                "severity" : "error",
                "human" : "Must have either extensions or value[x], not both",
                "expression" : "extension.exists() != value.exists()",
                "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
              }
            ],
            "isModifier" : false
          },
          {
            "id" : "Extension.id",
            "path" : "Extension.id",
            "representation" : [
              "xmlAttr"
            ],
            "short" : "Unique id for inter-element referencing",
            "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
            "min" : 0,
            "max" : "1",
            "base" : {
              "path" : "Element.id",
              "min" : 0,
              "max" : "1"
            },
            "type" : [
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                    "valueUrl" : "id"
                  }
                ],
                "code" : "http://hl7.org/fhirpath/System.String"
              }
            ],
            "condition" : [
              "ele-1"
            ],
            "isModifier" : false,
            "isSummary" : false,
            "mapping" : [
              {
                "identity" : "rim",
                "map" : "n/a"
              }
            ]
          },
          {
            "id" : "Extension.extension",
            "path" : "Extension.extension",
            "slicing" : {
              "discriminator" : [
                {
                  "type" : "value",
                  "path" : "url"
                }
              ],
              "description" : "Extensions are always sliced by (at least) url",
              "rules" : "open"
            },
            "short" : "Extension",
            "definition" : "An Extension",
            "min" : 0,
            "max" : "0",
            "base" : {
              "path" : "Element.extension",
              "min" : 0,
              "max" : "*"
            },
            "type" : [
              {
                "code" : "Extension"
              }
            ],
            "constraint" : [
              {
                "key" : "ele-1",
                "severity" : "error",
                "human" : "All FHIR elements must have a @value or children",
                "expression" : "hasValue() or (children().count() > id.count())",
                "source" : "http://hl7.org/fhir/StructureDefinition/Element"
              }
            ],
            "isModifier" : false,
            "isSummary" : false
          },
          {
            "id" : "Extension.url",
            "path" : "Extension.url",
            "representation" : [
              "xmlAttr"
            ],
            "short" : "identifies the meaning of the extension",
            "definition" : "Source of the definition for the extension code - a logical name or a URL.",
            "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
            "min" : 1,
            "max" : "1",
            "base" : {
              "path" : "Extension.url",
              "min" : 1,
              "max" : "1"
            },
            "type" : [
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                    "valueUrl" : "uri"
                  }
                ],
                "code" : "http://hl7.org/fhirpath/System.String"
              }
            ],
            "fixedUri" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
            "isModifier" : false,
            "isSummary" : true,
            "mapping" : [
              {
                "identity" : "rim",
                "map" : "N/A"
              }
            ]
          },
          {
            "id" : "Extension.value[x]",
            "path" : "Extension.value[x]",
            "short" : "Pointer to the narrative content for the protocol",
            "definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
            "min" : 0,
            "max" : "1",
            "base" : {
              "path" : "Extension.value[x]",
              "min" : 0,
              "max" : "1"
            },
            "type" : [
              {
                "code" : "Reference",
                "targetProfile" : [
                  🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
                ]
              }
            ],
            "condition" : [
              "ext-1"
            ],
            "constraint" : [
              {
                "key" : "ele-1",
                "severity" : "error",
                "human" : "All FHIR elements must have a @value or children",
                "expression" : "hasValue() or (children().count() > id.count())",
                "source" : "http://hl7.org/fhir/StructureDefinition/Element"
              }
            ],
            "isModifier" : false,
            "isSummary" : true,
            "mapping" : [
              {
                "identity" : "rim",
                "map" : "N/A"
              }
            ]
          }
        ]
      },
      "differential" : {
        "element" : [
          {
            "id" : "Extension",
            "path" : "Extension",
            "short" : "Narrative Elements",
            "definition" : "Narrative content for the ResearchStudy."
          },
          {
            "id" : "Extension.extension",
            "path" : "Extension.extension",
            "max" : "0"
          },
          {
            "id" : "Extension.url",
            "path" : "Extension.url",
            "fixedUri" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
          },
          {
            "id" : "Extension.value[x]",
            "path" : "Extension.value[x]",
            "short" : "Pointer to the narrative content for the protocol",
            "type" : [
              {
                "code" : "Reference",
                "targetProfile" : [
                  🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
                ]
              }
            ]
          }
        ]
      }
    }