Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Extension: M11 Research Study Extension - TTL Profile

Page standards status: Trial-use Maturity Level: 2

TTL representation of the m11-research-study extension.

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:StructureDefinition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "m11-research-study"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition m11-research-study</b></p><a name=\"m11-research-study\"> </a><a name=\"hcm11-research-study\"> </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,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\" 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-m11-research-study-definitions.html#Extension\" title=\"Signature and date for approval.\">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\">Additional concepts for M11</td></tr>#xD;\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 href=\"StructureDefinition-m11-research-study-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\">2..<span style=\"opacity: 0.5\">*</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 style=\"opacity: 0.5; opacity: 0.5\" 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>#xD;\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_bck13.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_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> Slices for extension<a name=\"Extension.extension.2\"> </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\"/><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\">Content/Rules for all slices</td></tr>#xD;\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_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:originalProtocol\" title=\"Slice originalProtocol\">extension:originalProtocol</a><a name=\"Extension.extension.3\"> </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\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</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\">1..1</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 style=\"opacity: 0.5; opacity: 0.5\" 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>#xD;\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_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a style=\"text-decoration:line-through; text-decoration:line-through\" href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:originalProtocol.extension\">extension</a><a name=\"Extension.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\"/><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=\"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: 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=\"font-style: italic\">Extension</span></td></tr>#xD;\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_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:originalProtocol.url\">url</a><a name=\"Extension.extension.url\"> </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\">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: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"color: darkgreen\">\"originalProtocol\"</span></td></tr>#xD;\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_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:originalProtocol.value[x]\" title=\"An indication as to whether the protocol document reflects the original version of the protocol..\">value[x]</a><a name=\"Extension.extension.value_x_\"> </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\">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 href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</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\">Original Protocol Indicator<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-amendment-details-statement-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs\" class=\"binding\">ICH M11 Amendment Details Statement Value Set Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>#xD;\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_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:versionDate\" title=\"Slice versionDate\">extension:versionDate</a><a name=\"Extension.extension.4\"> </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\">1..1</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 style=\"opacity: 0.5; opacity: 0.5\" 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>#xD;\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_bck1250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a style=\"text-decoration:line-through; text-decoration:line-through\" href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:versionDate.extension\">extension</a><a name=\"Extension.extension.extension.2\"> </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=\"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: 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=\"font-style: italic\">Extension</span></td></tr>#xD;\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_bck1250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:versionDate.url\">url</a><a name=\"Extension.extension.url.2\"> </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\">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: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"color: darkgreen\">\"versionDate\"</span></td></tr>#xD;\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_bck1240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-definitions.html#Extension.extension:versionDate.value[x]\" title=\"The date on which the document is versioned.\">value[x]</a><a name=\"Extension.extension.value_x_.2\"> </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\">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 href=\"http://hl7.org/fhir/R5/datatypes.html#date\">date</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\">Protocol version date</td></tr>#xD;\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_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-research-study-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: #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\">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: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"color: darkgreen\">\"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study\"</span></td></tr>#xD;\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_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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a style=\"text-decoration:line-through; text-decoration:line-through\" href=\"StructureDefinition-m11-research-study-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: 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=\"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: 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=\"font-style: italic\">Value of extension</span></td></tr>#xD;\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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics>     ] ;
fhir:value [
a fhir:Code ;
fhir:v "can-bind"     ]
  ] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm>     ] ;
fhir:value [
a fhir:Integer ;
fhir:v 2     ]
  ] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg>     ] ;
fhir:value [
a fhir:Code ;
fhir:v "brr"     ]
  ] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status>     ] ;
fhir:value [
a fhir:Code ;
fhir:v "trial-use" ;
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom>         ] ;
fhir:value [
a fhir:Canonical ;
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol>         ]       ] )     ]
  ] ) ; # 
  fhir:url [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study>
  ] ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "M11_ResearchStudy"] ; # 
  fhir:title [ fhir:v "M11 Research Study Extension"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:date [ fhir:v "2026-04-08T21:09:32+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "UDP@HL7Vulcan.org" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Additions for M11 not otherwise dealt with"] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ]     ] )
  ] ) ; # 
  fhir:copyright [ fhir:v "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)"] ; # 
  fhir:fhirVersion [ fhir:v "6.0.0-ballot3"] ; # 
  fhir:mapping ( [
fhir:identity [ fhir:v "rim" ] ;
fhir:uri [
fhir:v "http://hl7.org/v3"^^xsd:anyURI ;
fhir:l <http://hl7.org/v3>     ] ;
fhir:name [ fhir:v "RIM Mapping" ]
  ] ) ; # 
  fhir:kind [ fhir:v "complex-type"] ; # 
  fhir:abstract [ fhir:v false] ; # 
  fhir:context ( [
fhir:type [ fhir:v "element" ] ;
fhir:expression [ fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy" ]
  ] ) ; # 
  fhir:type [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension
  ] ; # 
  fhir:baseDefinition [
fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Extension>
  ] ; # 
  fhir:derivation [ fhir:v "constraint"] ; # 
  fhir:snapshot [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version>       ] ;
fhir:value [
a fhir:String ;
fhir:v "6.0.0-ballot3"       ]     ] ) ;
    ( fhir:element [
fhir:id [ fhir:v "Extension" ] ;
fhir:path [ fhir:v "Extension" ] ;
fhir:short [ fhir:v "Additional concepts for M11" ] ;
fhir:definition [ fhir:v "Signature and date for approval." ] ;
fhir:comment [ fhir:v "Additional concepts required by M11 that have no other obvious home." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ] ;
fhir:base [
fhir:path [ fhir:v "Extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] [
fhir:key [ fhir:v "ext-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ;
fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Extension>         ]       ] ) ;
fhir:isModifier [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.id" ] ;
fhir:path [ fhir:v "Extension.id" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "Unique id for inter-element referencing" ] ;
fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Element.id" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "id"^^xsd:anyURI ;
fhir:l fhir:id           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
      ( fhir:condition [ fhir:v "ele-1" ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "n/a" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:slicing [
        ( fhir:discriminator [
fhir:type [ fhir:v "value" ] ;
fhir:path [ fhir:v "url" ]         ] ) ;
fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ;
fhir:rules [ fhir:v "open" ]       ] ;
fhir:short [ fhir:v "Extension" ] ;
fhir:definition [ fhir:v "An Extension" ] ;
fhir:min [ fhir:v "2"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ] ;
fhir:base [
fhir:path [ fhir:v "Element.extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension         ]       ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:sliceName [ fhir:v "originalProtocol" ] ;
fhir:short [ fhir:v "Extension" ] ;
fhir:definition [ fhir:v "An Extension" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Element.extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension         ]       ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:mustSupport [ fhir:v true ] ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.id" ] ;
fhir:path [ fhir:v "Extension.extension.id" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "Unique id for inter-element referencing" ] ;
fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Element.id" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "id"^^xsd:anyURI ;
fhir:l fhir:id           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
      ( fhir:condition [ fhir:v "ele-1" ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "n/a" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.extension" ] ;
fhir:path [ fhir:v "Extension.extension.extension" ] ;
fhir:slicing [
        ( fhir:discriminator [
fhir:type [ fhir:v "value" ] ;
fhir:path [ fhir:v "url" ]         ] ) ;
fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ;
fhir:rules [ fhir:v "open" ]       ] ;
fhir:short [ fhir:v "Extension" ] ;
fhir:definition [ fhir:v "An Extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "0" ] ;
fhir:base [
fhir:path [ fhir:v "Element.extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension         ]       ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.url" ] ;
fhir:path [ fhir:v "Extension.extension.url" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "identifies the meaning of the extension" ] ;
fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ;
fhir:comment [ fhir:v "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." ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.url" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "uri"^^xsd:anyURI ;
fhir:l fhir:uri           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
fhir:fixed [
a fhir:Uri ;
fhir:v "originalProtocol"^^xsd:anyURI ;
fhir:l fhir:originalProtocol       ] ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.value[x]" ] ;
fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
fhir:short [ fhir:v "Original Protocol Indicator" ] ;
fhir:definition [ fhir:v "An indication as to whether the protocol document reflects the original version of the protocol.." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.value[x]" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "CodeableConcept"^^xsd:anyURI ;
fhir:l fhir:CodeableConcept         ]       ] ) ;
      ( fhir:condition [ fhir:v "ext-1" ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
fhir:binding [
fhir:strength [ fhir:v "required" ] ;
fhir:valueSet [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs>         ]       ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension:versionDate" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:sliceName [ fhir:v "versionDate" ] ;
fhir:short [ fhir:v "Extension" ] ;
fhir:definition [ fhir:v "An Extension" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Element.extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension         ]       ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.id" ] ;
fhir:path [ fhir:v "Extension.extension.id" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "Unique id for inter-element referencing" ] ;
fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Element.id" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "id"^^xsd:anyURI ;
fhir:l fhir:id           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
      ( fhir:condition [ fhir:v "ele-1" ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "n/a" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.extension" ] ;
fhir:path [ fhir:v "Extension.extension.extension" ] ;
fhir:slicing [
        ( fhir:discriminator [
fhir:type [ fhir:v "value" ] ;
fhir:path [ fhir:v "url" ]         ] ) ;
fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ;
fhir:rules [ fhir:v "open" ]       ] ;
fhir:short [ fhir:v "Extension" ] ;
fhir:definition [ fhir:v "An Extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "0" ] ;
fhir:base [
fhir:path [ fhir:v "Element.extension" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "*" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "Extension"^^xsd:anyURI ;
fhir:l fhir:Extension         ]       ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v false ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.url" ] ;
fhir:path [ fhir:v "Extension.extension.url" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "identifies the meaning of the extension" ] ;
fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ;
fhir:comment [ fhir:v "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." ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.url" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "uri"^^xsd:anyURI ;
fhir:l fhir:uri           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
fhir:fixed [
a fhir:Uri ;
fhir:v "versionDate"^^xsd:anyURI ;
fhir:l fhir:versionDate       ] ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.value[x]" ] ;
fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
fhir:short [ fhir:v "Protocol version date" ] ;
fhir:definition [ fhir:v "The date on which the document is versioned." ] ;
fhir:comment [ fhir:v "The date on ResearchStudy is the date the resource last significantly changed - not the same as the protocol version date" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.value[x]" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "date"^^xsd:anyURI ;
fhir:l fhir:date         ]       ] ) ;
      ( fhir:condition [ fhir:v "ext-1" ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] [
fhir:id [ fhir:v "Extension.url" ] ;
fhir:path [ fhir:v "Extension.url" ] ;
      ( fhir:representation [ fhir:v "xmlAttr" ] ) ;
fhir:short [ fhir:v "identifies the meaning of the extension" ] ;
fhir:definition [ fhir:v "Source of the definition for the extension code - a logical name or a URL." ] ;
fhir:comment [ fhir:v "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." ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.url" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
        ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type>           ] ;
fhir:value [
a fhir:Url ;
fhir:v "uri"^^xsd:anyURI ;
fhir:l fhir:uri           ]         ] ) ;
fhir:code [
fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhirpath/System.String>         ]       ] ) ;
fhir:fixed [
a fhir:Uri ;
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study>       ] ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] [
fhir:id [ fhir:v "Extension.value[x]" ] ;
fhir:path [ fhir:v "Extension.value[x]" ] ;
fhir:short [ fhir:v "Value of extension" ] ;
fhir:definition [ fhir:v "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)." ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "0" ] ;
fhir:base [
fhir:path [ fhir:v "Extension.value[x]" ] ;
fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]       ] ;
      ( fhir:type [
fhir:code [
fhir:v "base64Binary"^^xsd:anyURI ;
fhir:l fhir:base64Binary         ]       ] [
fhir:code [
fhir:v "boolean"^^xsd:anyURI ;
fhir:l fhir:boolean         ]       ] [
fhir:code [
fhir:v "canonical"^^xsd:anyURI ;
fhir:l fhir:canonical         ]       ] [
fhir:code [
fhir:v "code"^^xsd:anyURI ;
fhir:l fhir:code         ]       ] [
fhir:code [
fhir:v "date"^^xsd:anyURI ;
fhir:l fhir:date         ]       ] [
fhir:code [
fhir:v "dateTime"^^xsd:anyURI ;
fhir:l fhir:dateTime         ]       ] [
fhir:code [
fhir:v "decimal"^^xsd:anyURI ;
fhir:l fhir:decimal         ]       ] [
fhir:code [
fhir:v "id"^^xsd:anyURI ;
fhir:l fhir:id         ]       ] [
fhir:code [
fhir:v "instant"^^xsd:anyURI ;
fhir:l fhir:instant         ]       ] [
fhir:code [
fhir:v "integer"^^xsd:anyURI ;
fhir:l fhir:integer         ]       ] [
fhir:code [
fhir:v "integer64"^^xsd:anyURI ;
fhir:l fhir:integer64         ]       ] [
fhir:code [
fhir:v "markdown"^^xsd:anyURI ;
fhir:l fhir:markdown         ]       ] [
fhir:code [
fhir:v "oid"^^xsd:anyURI ;
fhir:l fhir:oid         ]       ] [
fhir:code [
fhir:v "positiveInt"^^xsd:anyURI ;
fhir:l fhir:positiveInt         ]       ] [
fhir:code [
fhir:v "string"^^xsd:anyURI ;
fhir:l fhir:string         ]       ] [
fhir:code [
fhir:v "time"^^xsd:anyURI ;
fhir:l fhir:time         ]       ] [
fhir:code [
fhir:v "unsignedInt"^^xsd:anyURI ;
fhir:l fhir:unsignedInt         ]       ] [
fhir:code [
fhir:v "uri"^^xsd:anyURI ;
fhir:l fhir:uri         ]       ] [
fhir:code [
fhir:v "url"^^xsd:anyURI ;
fhir:l fhir:url         ]       ] [
fhir:code [
fhir:v "uuid"^^xsd:anyURI ;
fhir:l fhir:uuid         ]       ] [
fhir:code [
fhir:v "Address"^^xsd:anyURI ;
fhir:l fhir:Address         ]       ] [
fhir:code [
fhir:v "Age"^^xsd:anyURI ;
fhir:l fhir:Age         ]       ] [
fhir:code [
fhir:v "Annotation"^^xsd:anyURI ;
fhir:l fhir:Annotation         ]       ] [
fhir:code [
fhir:v "Attachment"^^xsd:anyURI ;
fhir:l fhir:Attachment         ]       ] [
fhir:code [
fhir:v "CodeableConcept"^^xsd:anyURI ;
fhir:l fhir:CodeableConcept         ]       ] [
fhir:code [
fhir:v "CodeableReference"^^xsd:anyURI ;
fhir:l fhir:CodeableReference         ]       ] [
fhir:code [
fhir:v "Coding"^^xsd:anyURI ;
fhir:l fhir:Coding         ]       ] [
fhir:code [
fhir:v "ContactPoint"^^xsd:anyURI ;
fhir:l fhir:ContactPoint         ]       ] [
fhir:code [
fhir:v "Count"^^xsd:anyURI ;
fhir:l fhir:Count         ]       ] [
fhir:code [
fhir:v "Distance"^^xsd:anyURI ;
fhir:l fhir:Distance         ]       ] [
fhir:code [
fhir:v "Duration"^^xsd:anyURI ;
fhir:l fhir:Duration         ]       ] [
fhir:code [
fhir:v "HumanName"^^xsd:anyURI ;
fhir:l fhir:HumanName         ]       ] [
fhir:code [
fhir:v "Identifier"^^xsd:anyURI ;
fhir:l fhir:Identifier         ]       ] [
fhir:code [
fhir:v "Money"^^xsd:anyURI ;
fhir:l fhir:Money         ]       ] [
fhir:code [
fhir:v "Period"^^xsd:anyURI ;
fhir:l fhir:Period         ]       ] [
fhir:code [
fhir:v "Quantity"^^xsd:anyURI ;
fhir:l fhir:Quantity         ]       ] [
fhir:code [
fhir:v "Range"^^xsd:anyURI ;
fhir:l fhir:Range         ]       ] [
fhir:code [
fhir:v "Ratio"^^xsd:anyURI ;
fhir:l fhir:Ratio         ]       ] [
fhir:code [
fhir:v "RatioRange"^^xsd:anyURI ;
fhir:l fhir:RatioRange         ]       ] [
fhir:code [
fhir:v "Reference"^^xsd:anyURI ;
fhir:l fhir:Reference         ]       ] [
fhir:code [
fhir:v "SampledData"^^xsd:anyURI ;
fhir:l fhir:SampledData         ]       ] [
fhir:code [
fhir:v "Signature"^^xsd:anyURI ;
fhir:l fhir:Signature         ]       ] [
fhir:code [
fhir:v "Timing"^^xsd:anyURI ;
fhir:l fhir:Timing         ]       ] [
fhir:code [
fhir:v "ContactDetail"^^xsd:anyURI ;
fhir:l fhir:ContactDetail         ]       ] [
fhir:code [
fhir:v "DataRequirement"^^xsd:anyURI ;
fhir:l fhir:DataRequirement         ]       ] [
fhir:code [
fhir:v "Expression"^^xsd:anyURI ;
fhir:l fhir:Expression         ]       ] [
fhir:code [
fhir:v "ParameterDefinition"^^xsd:anyURI ;
fhir:l fhir:ParameterDefinition         ]       ] [
fhir:code [
fhir:v "RelatedArtifact"^^xsd:anyURI ;
fhir:l fhir:RelatedArtifact         ]       ] [
fhir:code [
fhir:v "TriggerDefinition"^^xsd:anyURI ;
fhir:l fhir:TriggerDefinition         ]       ] [
fhir:code [
fhir:v "UsageContext"^^xsd:anyURI ;
fhir:l fhir:UsageContext         ]       ] [
fhir:code [
fhir:v "Availability"^^xsd:anyURI ;
fhir:l fhir:Availability         ]       ] [
fhir:code [
fhir:v "ExtendedContactDetail"^^xsd:anyURI ;
fhir:l fhir:ExtendedContactDetail         ]       ] [
fhir:code [
fhir:v "Dosage"^^xsd:anyURI ;
fhir:l fhir:Dosage         ]       ] [
fhir:code [
fhir:v "Meta"^^xsd:anyURI ;
fhir:l fhir:Meta         ]       ] ) ;
      ( fhir:condition [ fhir:v "ext-1" ] ) ;
      ( fhir:constraint [
fhir:key [ fhir:v "ele-1" ] ;
fhir:severity [ fhir:v "error" ] ;
fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ;
fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ;
fhir:source [
fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/Element>         ]       ] ) ;
fhir:isModifier [ fhir:v false ] ;
fhir:isSummary [ fhir:v true ] ;
      ( fhir:mapping [
fhir:identity [ fhir:v "rim" ] ;
fhir:map [ fhir:v "N/A" ]       ] )     ] )
  ] ; # 
  fhir:differential [
    ( fhir:element [
fhir:id [ fhir:v "Extension" ] ;
fhir:path [ fhir:v "Extension" ] ;
fhir:short [ fhir:v "Additional concepts for M11" ] ;
fhir:definition [ fhir:v "Signature and date for approval." ] ;
fhir:comment [ fhir:v "Additional concepts required by M11 that have no other obvious home." ]     ] [
fhir:id [ fhir:v "Extension.extension" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:min [ fhir:v "2"^^xsd:nonNegativeInteger ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:sliceName [ fhir:v "originalProtocol" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ] ;
fhir:mustSupport [ fhir:v true ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.extension" ] ;
fhir:path [ fhir:v "Extension.extension.extension" ] ;
fhir:max [ fhir:v "0" ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.url" ] ;
fhir:path [ fhir:v "Extension.extension.url" ] ;
fhir:fixed [
a fhir:Uri ;
fhir:v "originalProtocol"^^xsd:anyURI ;
fhir:l fhir:originalProtocol       ]     ] [
fhir:id [ fhir:v "Extension.extension:originalProtocol.value[x]" ] ;
fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
fhir:short [ fhir:v "Original Protocol Indicator" ] ;
fhir:definition [ fhir:v "An indication as to whether the protocol document reflects the original version of the protocol.." ] ;
      ( fhir:type [
fhir:code [
fhir:v "CodeableConcept"^^xsd:anyURI ;
fhir:l fhir:CodeableConcept         ]       ] ) ;
fhir:binding [
fhir:strength [ fhir:v "required" ] ;
fhir:valueSet [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs>         ]       ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate" ] ;
fhir:path [ fhir:v "Extension.extension" ] ;
fhir:sliceName [ fhir:v "versionDate" ] ;
fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
fhir:max [ fhir:v "1" ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.extension" ] ;
fhir:path [ fhir:v "Extension.extension.extension" ] ;
fhir:max [ fhir:v "0" ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.url" ] ;
fhir:path [ fhir:v "Extension.extension.url" ] ;
fhir:fixed [
a fhir:Uri ;
fhir:v "versionDate"^^xsd:anyURI ;
fhir:l fhir:versionDate       ]     ] [
fhir:id [ fhir:v "Extension.extension:versionDate.value[x]" ] ;
fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
fhir:short [ fhir:v "Protocol version date" ] ;
fhir:definition [ fhir:v "The date on which the document is versioned." ] ;
fhir:comment [ fhir:v "The date on ResearchStudy is the date the resource last significantly changed - not the same as the protocol version date" ] ;
      ( fhir:type [
fhir:code [
fhir:v "date"^^xsd:anyURI ;
fhir:l fhir:date         ]       ] )     ] [
fhir:id [ fhir:v "Extension.url" ] ;
fhir:path [ fhir:v "Extension.url" ] ;
fhir:fixed [
a fhir:Uri ;
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study>       ]     ] [
fhir:id [ fhir:v "Extension.value[x]" ] ;
fhir:path [ fhir:v "Extension.value[x]" ] ;
fhir:max [ fhir:v "0" ]     ] )
  ] . #