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: M11_ProtocolAmendment - TTL Profile

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

TTL representation of the m11-protocol-amendment 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-protocol-amendment"] ; #
      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-protocol-amendment</b></p><a name=\"m11-protocol-amendment\"> </a><a name=\"hcm11-protocol-amendment\"> </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-m11-protocol-amendment-definitions.html#Extension\" title=\"Representation of amendments to a study protocol.\">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\">Amendment to a protocol - from EBM</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-protocol-amendment-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-protocol-amendment-definitions.html#Extension.extension:identifier\" title=\"Slice identifier\">extension:identifier</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\"/><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-protocol-amendment-definitions.html#Extension.extension:identifier.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-protocol-amendment-definitions.html#Extension.extension:identifier.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\">\"identifier\"</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-protocol-amendment-definitions.html#Extension.extension:identifier.value[x]\" title=\"Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page\">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#Identifier\">Identifier</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\">Amendment identifier</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-protocol-amendment-definitions.html#Extension.extension:previous\" title=\"Slice previous\">extension:previous</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\">0..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-protocol-amendment-definitions.html#Extension.extension:previous.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_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-protocol-amendment-definitions.html#Extension.extension:previous.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\">\"previous\"</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-protocol-amendment-definitions.html#Extension.extension:previous.value[x]\">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#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\"><span style=\"opacity: 0.5\">Value of extension</span><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_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-protocol-amendment-definitions.html#Extension.extension:scope\" title=\"Slice scope\">extension:scope</a><a name=\"Extension.extension.5\"> </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-protocol-amendment-definitions.html#Extension.extension:scope.extension\">extension</a><a name=\"Extension.extension.extension.3\"> </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-protocol-amendment-definitions.html#Extension.extension:scope.url\">url</a><a name=\"Extension.extension.url.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\"/><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\">\"scope\"</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-protocol-amendment-definitions.html#Extension.extension:scope.value[x]\" title=\"C218673 Global, Country, Region, or Site.\">value[x]</a><a name=\"Extension.extension.value_x_.3\"> </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\">Global, Not Global<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-study-amendment-scope-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs\" class=\"binding\">ICH M11 Amendment Scope Value Set Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\" class=\"binding\">extensible</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_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-protocol-amendment-definitions.html#Extension.extension:country\" title=\"Slice country\">extension:country</a><a name=\"Extension.extension.6\"> </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\">0..*</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><br/></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-protocol-amendment-definitions.html#Extension.extension:country.extension\">extension</a><a name=\"Extension.extension.extension.4\"> </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-protocol-amendment-definitions.html#Extension.extension:country.url\">url</a><a name=\"Extension.extension.url.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\"><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\">\"country\"</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-protocol-amendment-definitions.html#Extension.extension:country.value[x]\" title=\"C20108\">value[x]</a><a name=\"Extension.extension.value_x_.4\"> </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\"><span style=\"opacity: 0.5\">Value of extension</span><br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-country-region-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs\" class=\"binding\">ICH M11 Study Amendment Country Value Set</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\" class=\"binding\">extensible</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_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-protocol-amendment-definitions.html#Extension.extension:region\" title=\"Slice region\">extension:region</a><a name=\"Extension.extension.7\"> </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\">0..*</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><br/></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-protocol-amendment-definitions.html#Extension.extension:region.extension\">extension</a><a name=\"Extension.extension.extension.5\"> </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-protocol-amendment-definitions.html#Extension.extension:region.url\">url</a><a name=\"Extension.extension.url.5\"> </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\">\"region\"</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-protocol-amendment-definitions.html#Extension.extension:region.value[x]\" title=\"C218674\">value[x]</a><a name=\"Extension.extension.value_x_.5\"> </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\"><span style=\"opacity: 0.5\">Value of extension</span><br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-country-region-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs\" class=\"binding\">ICH M11 Study Amendment Country Value Set</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\" class=\"binding\">extensible</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_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-protocol-amendment-definitions.html#Extension.extension:site\" title=\"Slice site\">extension:site</a><a name=\"Extension.extension.8\"> </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\">0..*</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><br/></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-protocol-amendment-definitions.html#Extension.extension:site.extension\">extension</a><a name=\"Extension.extension.extension.6\"> </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-protocol-amendment-definitions.html#Extension.extension:site.url\">url</a><a name=\"Extension.extension.url.6\"> </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\">\"site\"</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_bck1341.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_choice.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:site.value[x]\" title=\"C83081\">value[x]</a><a name=\"Extension.extension.value_x_.6\"> </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\"/><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\">Value of 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_bck13410.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_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"Identifier Type: An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.\">valueIdentifier</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\"/><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/datatypes.html#Identifier\">Identifier</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\"/></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_bck13400.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_blank.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: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> valueReference</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\"><a href=\"http://hl7.org/fhir/R5/references.html#Reference\">Reference</a>(Any)</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\"/></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-protocol-amendment-definitions.html#Extension.extension:approvalDate\" title=\"Slice approvalDate\">extension:approvalDate</a><a name=\"Extension.extension.9\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:approvalDate.extension\">extension</a><a name=\"Extension.extension.extension.7\"> </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-protocol-amendment-definitions.html#Extension.extension:approvalDate.url\">url</a><a name=\"Extension.extension.url.7\"> </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\">\"approvalDate\"</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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.7\"> </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\"><span style=\"opacity: 0.5\">Value of 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_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-protocol-amendment-definitions.html#Extension.extension:signature\" title=\"Slice signature\">extension:signature</a><a name=\"Extension.extension.10\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:signature.extension\">extension</a><a name=\"Extension.extension.extension.8\"> </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-protocol-amendment-definitions.html#Extension.extension:signature.url\">url</a><a name=\"Extension.extension.url.8\"> </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\">\"signature\"</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-protocol-amendment-definitions.html#Extension.extension:signature.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.8\"> </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#Signature\">Signature</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=\"opacity: 0.5\">Value of 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_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-protocol-amendment-definitions.html#Extension.extension:signatureUrl\" title=\"Slice signatureUrl\">extension:signatureUrl</a><a name=\"Extension.extension.11\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:signatureUrl.extension\">extension</a><a name=\"Extension.extension.extension.9\"> </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-protocol-amendment-definitions.html#Extension.extension:signatureUrl.url\">url</a><a name=\"Extension.extension.url.9\"> </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\">\"signatureUrl\"</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_bck1341.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_choice.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.9\"> </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\"/><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\">Value of 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_bck13410.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_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"string Type: A sequence of Unicode characters\">valueString</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\"/><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/datatypes.html#string\">string</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\"/></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_bck13400.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_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.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\"/> <span title=\"url type: A URI that is a literal reference\">valueUrl</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\"/><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#url\">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\"/></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-protocol-amendment-definitions.html#Extension.extension:signatureMethod\" title=\"Slice signatureMethod\">extension:signatureMethod</a><a name=\"Extension.extension.12\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:signatureMethod.extension\">extension</a><a name=\"Extension.extension.extension.10\"> </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-protocol-amendment-definitions.html#Extension.extension:signatureMethod.url\">url</a><a name=\"Extension.extension.url.10\"> </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\">\"signatureMethod\"</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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.10\"> </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#string\">string</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=\"opacity: 0.5\">Value of 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_bck134.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-protocol-amendment-definitions.html#Extension.extension:scopeImpact\" title=\"Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact\">extension:scopeImpact</a><a name=\"Extension.extension.13\"> </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\">0..3</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\">(Complex)</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><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-m11-amendment-scope-impact.html\">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact</a></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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason\" title=\"Slice primaryReason\">extension:primaryReason</a><a name=\"Extension.extension.14\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.extension\">extension</a><a name=\"Extension.extension.extension.11\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.url\">url</a><a name=\"Extension.extension.url.11\"> </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\">\"primaryReason\"</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_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: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.value[x]\" title=\"Reason for amendment, e.g. Safety.\">value[x]</a><a name=\"Extension.extension.value_x_.11\"> </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/datatypes.html#CodeableConcept\">CodeableConcept</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\">Reason for amendment, e.g. Safety<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-study-amendment-reason-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs\" class=\"binding\">ICH M11 Reason for Amendment Value Set Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\" class=\"binding\">extensible</a><span title=\"null\" class=\"binding\">)</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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason\" title=\"Slice secondaryReason\">extension:secondaryReason</a><a name=\"Extension.extension.15\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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/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\"><span style=\"opacity: 0.5\">Extension</span><br/></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_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-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.extension\">extension</a><a name=\"Extension.extension.extension.12\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.url\">url</a><a name=\"Extension.extension.url.12\"> </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\">\"secondaryReason\"</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_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: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.value[x]\" title=\"Reason for amendment, e.g. Manufacturing change.\">value[x]</a><a name=\"Extension.extension.value_x_.12\"> </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/datatypes.html#CodeableConcept\">CodeableConcept</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\">Reason for amendment, e.g. Manufacturing change<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-study-amendment-reason-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs\" class=\"binding\">ICH M11 Reason for Amendment Value Set Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#extensible\" title=\"To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.\" class=\"binding\">extensible</a><span title=\"null\" class=\"binding\">)</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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:summary\" title=\"Slice summary\">extension:summary</a><a name=\"Extension.extension.16\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:summary.extension\">extension</a><a name=\"Extension.extension.extension.13\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:summary.url\">url</a><a name=\"Extension.extension.url.13\"> </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\">\"summary\"</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_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_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:summary.value[x]\" title=\"Summary of amendmets.\">value[x]</a><a name=\"Extension.extension.value_x_.13\"> </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/datatypes.html#string\">string</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\">summary of changes</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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety\" title=\"Slice substantialImpactSafety\">extension:substantialImpactSafety</a><a name=\"Extension.extension.17\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.extension\">extension</a><a name=\"Extension.extension.extension.14\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.url\">url</a><a name=\"Extension.extension.url.14\"> </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\">\"substantialImpactSafety\"</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_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: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.value[x]\" title=\"Substantial impact on safety.\">value[x]</a><a name=\"Extension.extension.value_x_.14\"> </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/datatypes.html#CodeableConcept\">CodeableConcept</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\">Substantial impact on safety<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-yes-no-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs\" class=\"binding\">ICH M11 No Yes 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: 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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment\" title=\"Slice substantialImpactSafetyComment\">extension:substantialImpactSafetyComment</a><a name=\"Extension.extension.18\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.extension\">extension</a><a name=\"Extension.extension.extension.15\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.url\">url</a><a name=\"Extension.extension.url.15\"> </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\">\"substantialImpactSafetyComment\"</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_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_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.value[x]\" title=\"Comment on substantial impact on safety.\">value[x]</a><a name=\"Extension.extension.value_x_.15\"> </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/datatypes.html#string\">string</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\">Comment on substantial impact on safety</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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability\" title=\"Slice substantialImpactReliability\">extension:substantialImpactReliability</a><a name=\"Extension.extension.19\"> </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\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.extension\">extension</a><a name=\"Extension.extension.extension.16\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.url\">url</a><a name=\"Extension.extension.url.16\"> </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\">\"substantialImpactReliability\"</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_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: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.value[x]\" title=\"Substantial impact on reliability.\">value[x]</a><a name=\"Extension.extension.value_x_.16\"> </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/datatypes.html#CodeableConcept\">CodeableConcept</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\">Substantial impact on reliability<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-m11-yes-no-vs.html\" title=\"http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs\" class=\"binding\">ICH M11 No Yes 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: 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_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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment\" title=\"Slice substantialImpactReliabilityComment\">extension:substantialImpactReliabilityComment</a><a name=\"Extension.extension.20\"> </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\">0..1</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/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\"><span style=\"opacity: 0.5\">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_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-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.extension\">extension</a><a name=\"Extension.extension.extension.17\"> </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>#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_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.url\">url</a><a name=\"Extension.extension.url.17\"> </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\">\"substantialImpactReliabilityComment\"</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_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_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.value[x]\" title=\"Comment on substantial impact on reliability.\">value[x]</a><a name=\"Extension.extension.value_x_.17\"> </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/datatypes.html#string\">string</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\">Comment on substantial impact on reliability</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_bck134.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: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:details\" title=\"Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail\">extension:details</a><a name=\"Extension.extension.21\"> </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=\"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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</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\">(Complex)</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=\"opacity: 0.5\">Extension</span><br/><span style=\"font-weight:bold\">URL: </span><a href=\"StructureDefinition-m11-amendment-detail.html\">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail</a><br/></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-protocol-amendment-definitions.html#Extension.extension:rationale\" title=\"Slice rationale\">extension:rationale</a><a name=\"Extension.extension.22\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:rationale.extension\">extension</a><a name=\"Extension.extension.extension.18\"> </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-protocol-amendment-definitions.html#Extension.extension:rationale.url\">url</a><a name=\"Extension.extension.url.18\"> </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\">\"rationale\"</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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:rationale.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.18\"> </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#string\">string</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=\"opacity: 0.5\">Value of 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_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-protocol-amendment-definitions.html#Extension.extension:description\" title=\"Slice description\">extension:description</a><a name=\"Extension.extension.23\"> </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\">0..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-protocol-amendment-definitions.html#Extension.extension:description.extension\">extension</a><a name=\"Extension.extension.extension.19\"> </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-protocol-amendment-definitions.html#Extension.extension:description.url\">url</a><a name=\"Extension.extension.url.19\"> </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\">\"description\"</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_bck1241.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_choice.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <a href=\"StructureDefinition-m11-protocol-amendment-definitions.html#Extension.extension:description.value[x]\">value[x]</a><a name=\"Extension.extension.value_x_.19\"> </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\"/><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\">Value of 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_bck12410.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_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"markdown type: A string that may contain Github Flavored Markdown syntax for optional processing by a mark down presentation engine\">valueMarkdown</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\"/><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/datatypes.html#markdown\">markdown</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\"/></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_bck12400.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_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.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\"/> <span title=\"string Type: A sequence of Unicode characters\">valueString</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\"/><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#string\">string</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\"/></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-protocol-amendment-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-protocol-amendment\"</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-protocol-amendment-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, \" 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-protocol-amendment"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment>
      ] ; #
      fhir:version [ fhir:v "1.0.0-ballot2"] ; #
      fhir:name [ fhir:v "M11_ProtocolAmendment"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:date [ fhir:v "2026-04-09T17:15:23+10:00"^^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 "Amendment to a protocol. This is originally from EBM."] ; #
      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 "Amendment to a protocol - from EBM" ] ;
    fhir:definition [ fhir:v "Representation of amendments to a study protocol." ] ;
    fhir:comment [ fhir:v "The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases." ] ;
    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:identifier" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "identifier" ] ;
    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:identifier.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:identifier.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:identifier.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 "identifier"^^xsd:anyURI ;
    fhir:l fhir:identifier       ] ;
    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:identifier.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Amendment identifier" ] ;
    fhir:definition [ fhir:v "Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page" ] ;
    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 "Identifier"^^xsd:anyURI ;
    fhir:l fhir:Identifier         ]       ] ) ;
          ( 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.extension:previous" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "previous" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:previous.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:previous.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:previous.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 "previous"^^xsd:anyURI ;
    fhir:l fhir:previous       ] ;
    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:previous.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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:scope" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "scope" ] ;
    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:scope.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:scope.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:scope.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 "scope"^^xsd:anyURI ;
    fhir:l fhir:scope       ] ;
    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:scope.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Global, Not Global" ] ;
    fhir:definition [ fhir:v "C218673 Global, Country, Region, or Site." ] ;
    fhir:comment [ fhir:v "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n  If amending a single-country study, enter global. \n  If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. \n  Use the ISO-3166 region or country identifier (for example, DE or EU)." ] ;
    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 "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:country" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "country" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:country.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:country.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:country.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 "country"^^xsd:anyURI ;
    fhir:l fhir:country       ] ;
    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:country.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Value of extension" ] ;
    fhir:definition [ fhir:v "C20108" ] ;
    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 "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:region" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "region" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:region.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:region.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:region.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 "region"^^xsd:anyURI ;
    fhir:l fhir:region       ] ;
    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:region.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Value of extension" ] ;
    fhir:definition [ fhir:v "C218674" ] ;
    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 "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:site" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "site" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:site.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:site.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:site.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 "site"^^xsd:anyURI ;
    fhir:l fhir:site       ] ;
    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:site.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Value of extension" ] ;
    fhir:definition [ fhir:v "C83081" ] ;
    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 "Identifier"^^xsd:anyURI ;
    fhir:l fhir:Identifier         ]       ] [
    fhir:code [
    fhir:v "Reference"^^xsd:anyURI ;
    fhir:l fhir:Reference         ]       ] ) ;
          ( 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.extension:approvalDate" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "approvalDate" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:approvalDate.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:approvalDate.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:approvalDate.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 "approvalDate"^^xsd:anyURI ;
    fhir:l fhir:approvalDate       ] ;
    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:approvalDate.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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.extension:signature" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signature" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:signature.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:signature.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:signature.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 "signature"^^xsd:anyURI ;
    fhir:l fhir:signature       ] ;
    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:signature.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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 "Signature"^^xsd:anyURI ;
    fhir:l fhir:Signature         ]       ] ) ;
          ( 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.extension:signatureUrl" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signatureUrl" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:signatureUrl.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:signatureUrl.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:signatureUrl.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 "signatureUrl"^^xsd:anyURI ;
    fhir:l fhir:signatureUrl       ] ;
    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:signatureUrl.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] [
    fhir:code [
    fhir:v "url"^^xsd:anyURI ;
    fhir:l fhir:url         ]       ] ) ;
          ( 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.extension:signatureMethod" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signatureMethod" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:signatureMethod.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:signatureMethod.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:signatureMethod.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 "signatureMethod"^^xsd:anyURI ;
    fhir:l fhir:signatureMethod       ] ;
    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:signatureMethod.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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.extension:scopeImpact" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "scopeImpact" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "Provides number or percentage of each group affected by a single amendment" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "3" ] ;
    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:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact>         ] )       ] ) ;
          ( 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:primaryReason" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "primaryReason" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:primaryReason.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:primaryReason.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:primaryReason.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 "primaryReason"^^xsd:anyURI ;
    fhir:l fhir:primaryReason       ] ;
    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:primaryReason.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ;
    fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ;
    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 "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "secondaryReason" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:mustSupport [ fhir:v true ] ;
    fhir:isModifier [ fhir:v false ] ;
    fhir:isSummary [ fhir:v false ]     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason.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:secondaryReason.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:secondaryReason.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 "secondaryReason"^^xsd:anyURI ;
    fhir:l fhir:secondaryReason       ] ;
    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:secondaryReason.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Reason for amendment, e.g. Manufacturing change" ] ;
    fhir:definition [ fhir:v "Reason for amendment, e.g. Manufacturing change." ] ;
    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 "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:summary" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "summary" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:summary.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:summary.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:summary.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 "summary"^^xsd:anyURI ;
    fhir:l fhir:summary       ] ;
    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:summary.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "summary of changes" ] ;
    fhir:definition [ fhir:v "Summary of amendmets." ] ;
    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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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.extension:substantialImpactSafety" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactSafety" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:substantialImpactSafety.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:substantialImpactSafety.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:substantialImpactSafety.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 "substantialImpactSafety"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactSafety       ] ;
    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:substantialImpactSafety.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Substantial impact on safety" ] ;
    fhir:definition [ fhir:v "Substantial impact on safety." ] ;
    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-yes-no-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactSafetyComment" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:substantialImpactSafetyComment.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:substantialImpactSafetyComment.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:substantialImpactSafetyComment.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 "substantialImpactSafetyComment"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactSafetyComment       ] ;
    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:substantialImpactSafetyComment.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Comment on substantial impact on safety" ] ;
    fhir:definition [ fhir:v "Comment on substantial impact on safety." ] ;
    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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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.extension:substantialImpactReliability" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactReliability" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:substantialImpactReliability.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:substantialImpactReliability.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:substantialImpactReliability.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 "substantialImpactReliability"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactReliability       ] ;
    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:substantialImpactReliability.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Substantial impact on reliability" ] ;
    fhir:definition [ fhir:v "Substantial impact on reliability." ] ;
    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-yes-no-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs>         ]       ] ;
          ( fhir:mapping [
    fhir:identity [ fhir:v "rim" ] ;
    fhir:map [ fhir:v "N/A" ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactReliabilityComment" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:substantialImpactReliabilityComment.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:substantialImpactReliabilityComment.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:substantialImpactReliabilityComment.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 "substantialImpactReliabilityComment"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactReliabilityComment       ] ;
    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:substantialImpactReliabilityComment.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Comment on substantial impact on reliability" ] ;
    fhir:definition [ fhir:v "Comment on substantial impact on reliability." ] ;
    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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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.extension:details" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "details" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "Provides detail of a single amendment - repeats within the overal amendment report" ] ;
    fhir:min [ fhir:v "0"^^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:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail>         ] )       ] ) ;
          ( 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:rationale" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "rationale" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:rationale.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:rationale.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:rationale.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 "rationale"^^xsd:anyURI ;
    fhir:l fhir:rationale       ] ;
    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:rationale.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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 "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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.extension:description" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "description" ] ;
    fhir:short [ fhir:v "Extension" ] ;
    fhir:definition [ fhir:v "An Extension" ] ;
    fhir:min [ fhir:v "0"^^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:description.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:description.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:description.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 "description"^^xsd:anyURI ;
    fhir:l fhir:description       ] ;
    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:description.value[x]" ] ;
    fhir:path [ fhir:v "Extension.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 "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 "markdown"^^xsd:anyURI ;
    fhir:l fhir:markdown         ]       ] [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] ) ;
          ( 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-protocol-amendment"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment>       ] ;
    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 "Amendment to a protocol - from EBM" ] ;
    fhir:definition [ fhir:v "Representation of amendments to a study protocol." ] ;
    fhir:comment [ fhir:v "The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases." ]     ] [
    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:identifier" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "identifier" ] ;
    fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:identifier.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:identifier.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "identifier"^^xsd:anyURI ;
    fhir:l fhir:identifier       ]     ] [
    fhir:id [ fhir:v "Extension.extension:identifier.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Amendment identifier" ] ;
    fhir:definition [ fhir:v "Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "Identifier"^^xsd:anyURI ;
    fhir:l fhir:Identifier         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:previous" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "previous" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:previous.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:previous.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "previous"^^xsd:anyURI ;
    fhir:l fhir:previous       ]     ] [
    fhir:id [ fhir:v "Extension.extension:previous.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( 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:scope" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "scope" ] ;
    fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:scope.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:scope.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "scope"^^xsd:anyURI ;
    fhir:l fhir:scope       ]     ] [
    fhir:id [ fhir:v "Extension.extension:scope.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Global, Not Global" ] ;
    fhir:definition [ fhir:v "C218673 Global, Country, Region, or Site." ] ;
    fhir:comment [ fhir:v "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n  If amending a single-country study, enter global. \n  If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. \n  Use the ISO-3166 region or country identifier (for example, DE or EU)." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "CodeableConcept"^^xsd:anyURI ;
    fhir:l fhir:CodeableConcept         ]       ] ) ;
    fhir:binding [
    fhir:strength [ fhir:v "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:country" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "country" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "*" ]     ] [
    fhir:id [ fhir:v "Extension.extension:country.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:country.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "country"^^xsd:anyURI ;
    fhir:l fhir:country       ]     ] [
    fhir:id [ fhir:v "Extension.extension:country.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:definition [ fhir:v "C20108" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "CodeableConcept"^^xsd:anyURI ;
    fhir:l fhir:CodeableConcept         ]       ] ) ;
    fhir:binding [
    fhir:strength [ fhir:v "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:region" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "region" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "*" ]     ] [
    fhir:id [ fhir:v "Extension.extension:region.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:region.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "region"^^xsd:anyURI ;
    fhir:l fhir:region       ]     ] [
    fhir:id [ fhir:v "Extension.extension:region.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:definition [ fhir:v "C218674" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "CodeableConcept"^^xsd:anyURI ;
    fhir:l fhir:CodeableConcept         ]       ] ) ;
    fhir:binding [
    fhir:strength [ fhir:v "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:site" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "site" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "*" ]     ] [
    fhir:id [ fhir:v "Extension.extension:site.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:site.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "site"^^xsd:anyURI ;
    fhir:l fhir:site       ]     ] [
    fhir:id [ fhir:v "Extension.extension:site.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:definition [ fhir:v "C83081" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "Identifier"^^xsd:anyURI ;
    fhir:l fhir:Identifier         ]       ] [
    fhir:code [
    fhir:v "Reference"^^xsd:anyURI ;
    fhir:l fhir:Reference         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:approvalDate" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "approvalDate" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:approvalDate.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:approvalDate.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "approvalDate"^^xsd:anyURI ;
    fhir:l fhir:approvalDate       ]     ] [
    fhir:id [ fhir:v "Extension.extension:approvalDate.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "date"^^xsd:anyURI ;
    fhir:l fhir:date         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:signature" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signature" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signature.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signature.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "signature"^^xsd:anyURI ;
    fhir:l fhir:signature       ]     ] [
    fhir:id [ fhir:v "Extension.extension:signature.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "Signature"^^xsd:anyURI ;
    fhir:l fhir:Signature         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:signatureUrl" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signatureUrl" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureUrl.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureUrl.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "signatureUrl"^^xsd:anyURI ;
    fhir:l fhir:signatureUrl       ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureUrl.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] [
    fhir:code [
    fhir:v "url"^^xsd:anyURI ;
    fhir:l fhir:url         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:signatureMethod" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "signatureMethod" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureMethod.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureMethod.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "signatureMethod"^^xsd:anyURI ;
    fhir:l fhir:signatureMethod       ]     ] [
    fhir:id [ fhir:v "Extension.extension:signatureMethod.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:scopeImpact" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "scopeImpact" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "3" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "Extension"^^xsd:anyURI ;
    fhir:l fhir:Extension         ] ;
            ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact>         ] )       ] ) ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:primaryReason" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "primaryReason" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:primaryReason.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:primaryReason.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "primaryReason"^^xsd:anyURI ;
    fhir:l fhir:primaryReason       ]     ] [
    fhir:id [ fhir:v "Extension.extension:primaryReason.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Reason for amendment, e.g. Safety" ] ;
    fhir:definition [ fhir:v "Reason for amendment, e.g. Safety." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "CodeableConcept"^^xsd:anyURI ;
    fhir:l fhir:CodeableConcept         ]       ] ) ;
    fhir:binding [
    fhir:strength [ fhir:v "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "secondaryReason" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "*" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "secondaryReason"^^xsd:anyURI ;
    fhir:l fhir:secondaryReason       ]     ] [
    fhir:id [ fhir:v "Extension.extension:secondaryReason.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Reason for amendment, e.g. Manufacturing change" ] ;
    fhir:definition [ fhir:v "Reason for amendment, e.g. Manufacturing change." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "CodeableConcept"^^xsd:anyURI ;
    fhir:l fhir:CodeableConcept         ]       ] ) ;
    fhir:binding [
    fhir:strength [ fhir:v "extensible" ] ;
    fhir:valueSet [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:summary" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "summary" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:summary.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:summary.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "summary"^^xsd:anyURI ;
    fhir:l fhir:summary       ]     ] [
    fhir:id [ fhir:v "Extension.extension:summary.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "summary of changes" ] ;
    fhir:definition [ fhir:v "Summary of amendmets." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafety" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactSafety" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "substantialImpactSafety"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactSafety       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafety.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Substantial impact on safety" ] ;
    fhir:definition [ fhir:v "Substantial impact on safety." ] ;
          ( 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-yes-no-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactSafetyComment" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ] ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactSafetyComment       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactSafetyComment.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Comment on substantial impact on safety" ] ;
    fhir:definition [ fhir:v "Comment on substantial impact on safety." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliability" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactReliability" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "substantialImpactReliability"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactReliability       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliability.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Substantial impact on reliability" ] ;
    fhir:definition [ fhir:v "Substantial impact on reliability." ] ;
          ( 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-yes-no-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs>         ]       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "substantialImpactReliabilityComment" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ;
    fhir:l fhir:substantialImpactReliabilityComment       ]     ] [
    fhir:id [ fhir:v "Extension.extension:substantialImpactReliabilityComment.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
    fhir:short [ fhir:v "Comment on substantial impact on reliability" ] ;
    fhir:definition [ fhir:v "Comment on substantial impact on reliability." ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:details" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "details" ] ;
    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:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail>         ] )       ] ) ;
    fhir:mustSupport [ fhir:v true ]     ] [
    fhir:id [ fhir:v "Extension.extension:rationale" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "rationale" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:rationale.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:rationale.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "rationale"^^xsd:anyURI ;
    fhir:l fhir:rationale       ]     ] [
    fhir:id [ fhir:v "Extension.extension:rationale.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    fhir:id [ fhir:v "Extension.extension:description" ] ;
    fhir:path [ fhir:v "Extension.extension" ] ;
    fhir:sliceName [ fhir:v "description" ] ;
    fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ;
    fhir:max [ fhir:v "1" ]     ] [
    fhir:id [ fhir:v "Extension.extension:description.extension" ] ;
    fhir:path [ fhir:v "Extension.extension.extension" ] ;
    fhir:max [ fhir:v "0" ]     ] [
    fhir:id [ fhir:v "Extension.extension:description.url" ] ;
    fhir:path [ fhir:v "Extension.extension.url" ] ;
    fhir:fixed [
    a fhir:Uri ;
    fhir:v "description"^^xsd:anyURI ;
    fhir:l fhir:description       ]     ] [
    fhir:id [ fhir:v "Extension.extension:description.value[x]" ] ;
    fhir:path [ fhir:v "Extension.extension.value[x]" ] ;
          ( fhir:type [
    fhir:code [
    fhir:v "markdown"^^xsd:anyURI ;
    fhir:l fhir:markdown         ]       ] [
    fhir:code [
    fhir:v "string"^^xsd:anyURI ;
    fhir:l fhir:string         ]       ] )     ] [
    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-protocol-amendment"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment>       ]     ] [
    fhir:id [ fhir:v "Extension.value[x]" ] ;
    fhir:path [ fhir:v "Extension.value[x]" ] ;
    fhir:max [ fhir:v "0" ]     ] )
      ] . #