Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
TTL representation of the protocol-amendment extension.
@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 "protocol-amendment"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition protocol-amendment</b></p><a name=\"protocol-amendment\"> </a><a name=\"hcprotocol-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 & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-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-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\">1..<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-protocol-amendment-definitions.html#Extension.extension:scope\" title=\"Slice scope\">extension:scope</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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:scope.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\">\"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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-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_\"> </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#code\">code</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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs\" class=\"binding\">Study Amendment Scope 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-protocol-amendment-definitions.html#Extension.extension:country\" title=\"Slice country\">extension:country</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..*</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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:country.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\">\"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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-protocol-amendment-definitions.html#Extension.extension:country.value[x]\" title=\"C20108\">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#code\">code</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/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs\" class=\"binding\">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-protocol-amendment-definitions.html#Extension.extension:region\" title=\"Slice region\">extension:region</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:region.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\">\"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_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-protocol-amendment-definitions.html#Extension.extension:region.value[x]\" title=\"C218674\">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#code\">code</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/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs\" class=\"binding\">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-protocol-amendment-definitions.html#Extension.extension:site\" title=\"Slice site\">extension:site</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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:site.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\">\"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_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-protocol-amendment-definitions.html#Extension.extension:site.value[x]\" title=\"C83081\">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#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\"><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-protocol-amendment-definitions.html#Extension.extension:approvalDate\" title=\"Slice approvalDate\">extension:approvalDate</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..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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:approvalDate.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\">\"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-protocol-amendment-definitions.html#Extension.extension:approvalDate.value[x]\">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#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-protocol-amendment-definitions.html#Extension.extension:signature\" title=\"Slice signature\">extension:signature</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..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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:signature.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\">\"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-protocol-amendment-definitions.html#Extension.extension:signature.value[x]\">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\"><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-protocol-amendment-definitions.html#Extension.extension:signatureURL\" title=\"Slice signatureURL\">extension:signatureURL</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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:signatureURL.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\">\"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_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-protocol-amendment-definitions.html#Extension.extension:signatureURL.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#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_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-protocol-amendment-definitions.html#Extension.extension:signatureMethod\" title=\"Slice signatureMethod\">extension:signatureMethod</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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:signatureMethod.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\">\"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-protocol-amendment-definitions.html#Extension.extension:signatureMethod.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#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-protocol-amendment-definitions.html#Extension.extension:scopeImpact\" title=\"Extension URL = http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact\">extension:scopeImpact</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..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-ResearchStudyStudyAmendmentScopeImpact.html\">http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact</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-protocol-amendment-definitions.html#Extension.extension:primaryReason\" title=\"Slice primaryReason\">extension:primaryReason</a><a name=\"Extension.extension.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\">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\"/> <span style=\"text-decoration:line-through\">extension</span><a name=\"Extension.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\"><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\"/></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-protocol-amendment-definitions.html#Extension.extension:primaryReason.url\">url</a><a name=\"Extension.extension.url.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\">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-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_.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\">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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs\" class=\"binding\">Study Amendment Reason 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: 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-protocol-amendment-definitions.html#Extension.extension:secondaryReason\" title=\"Slice secondaryReason\">extension:secondaryReason</a><a name=\"Extension.extension.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\">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\"/> <span style=\"text-decoration:line-through\">extension</span><a name=\"Extension.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\"><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\"/></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-protocol-amendment-definitions.html#Extension.extension:secondaryReason.url\">url</a><a name=\"Extension.extension.url.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\">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-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_.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\">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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs\" class=\"binding\">Study Amendment Reason 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: 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-protocol-amendment-definitions.html#Extension.extension:summary\" title=\"Slice summary\">extension:summary</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:summary.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\">\"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-protocol-amendment-definitions.html#Extension.extension:summary.value[x]\" title=\"Summary of amendmets.\">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#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-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety\" title=\"Slice substantialImpactSafety\">extension:substantialImpactSafety</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.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\">\"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_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.value[x]\" title=\"Substantial impact on safety.\">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#code\">code</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-cdisc-yes-no-vs.html\" title=\"http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs\" class=\"binding\">CDISC Yes No Unknown Not Applicable Value Set</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-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment\" title=\"Slice substantialImpactSafetyComment\">extension:substantialImpactSafetyComment</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.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\">\"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-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_.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\">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-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability\" title=\"Slice substantialImpactReliability\">extension:substantialImpactReliability</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.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\">\"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_primitive.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.value[x]\" title=\"Substantial impact on reliability.\">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#code\">code</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-cdisc-yes-no-vs.html\" title=\"http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs\" class=\"binding\">CDISC Yes No Unknown Not Applicable Value Set</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-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment\" title=\"Slice substantialImpactReliabilityComment\">extension:substantialImpactReliabilityComment</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\"/><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\"/> <span style=\"text-decoration:line-through\">extension</span><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\"/></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-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.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\">\"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-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_.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 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-protocol-amendment-definitions.html#Extension.extension:details\" title=\"Extension URL = http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail\">extension:details</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..*</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-protocol-amendment-detail.html\">http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-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-protocol-amendment-definitions.html#Extension.extension:rationale\" title=\"Slice rationale\">extension:rationale</a><a name=\"Extension.extension.20\"> </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\"/> <span style=\"text-decoration:line-through\">extension</span><a name=\"Extension.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\"/><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\"/></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-protocol-amendment-definitions.html#Extension.extension:rationale.url\">url</a><a name=\"Extension.extension.url.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\">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-protocol-amendment-definitions.html#Extension.extension:rationale.value[x]\">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: 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-protocol-amendment-definitions.html#Extension.extension:description\" title=\"Slice description\">extension:description</a><a name=\"Extension.extension.21\"> </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\"/> <span style=\"text-decoration:line-through\">extension</span><a name=\"Extension.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\"/><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\"/></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-protocol-amendment-definitions.html#Extension.extension:description.url\">url</a><a name=\"Extension.extension.url.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\">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_bck1240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-protocol-amendment-definitions.html#Extension.extension:description.value[x]\">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: 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_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-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/pharmaceutical-research-protocol/StructureDefinition/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\"/> <span style=\"text-decoration:line-through\">value[x]</span><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\"/></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,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\" 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:value [ a fhir:code ; fhir:v "can-bind" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 1 ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "brr" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ; 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:value [ a fhir:canonical ; fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol> ] ] ) ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0-ballot"] ; # fhir:name [ fhir:v "M11_ProtocolAmendment"] ; # fhir:status [ fhir:v "draft"] ; # fhir:date [ fhir:v "2025-07-31T20:39:04+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "UDP@HL7Vulcan.org" ] ] ) ] ) ; # fhir:description [ fhir:v "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:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ] ) ; # 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: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 "ResearchStudy" ] ] ) ; # fhir:type [ fhir:v "Extension"^^xsd:anyURI] ; # fhir:baseDefinition [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <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: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:link <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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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 "1"^^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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:isModifier [ fhir:v false ] ; fhir:isSummary [ fhir:v false ] ] [ 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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "scope"^^xsd:anyURI ] ; 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 "code"^^xsd:anyURI ] ] ) ; ( 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:link <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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "country"^^xsd:anyURI ] ; 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 "code"^^xsd:anyURI ] ] ) ; ( 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:link <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/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "region"^^xsd:anyURI ] ; 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 "code"^^xsd:anyURI ] ] ) ; ( 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:link <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/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "site"^^xsd:anyURI ] ; 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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "approvalDate"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "signature"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/extensibility.html) for a list)." ] ; fhir:comment [ fhir:v "//TODO Need to review the example" ] ; 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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "signatureURL"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "signatureMethod"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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: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:link <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:profile [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact> ] ) ] ) ; ( 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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "primaryReason"^^xsd:anyURI ] ; 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: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:link <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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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 "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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "secondaryReason"^^xsd:anyURI ] ; 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: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:link <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/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "summary"^^xsd:anyURI ] ; 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: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:link <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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "substantialImpactSafety"^^xsd:anyURI ] ; 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 "code"^^xsd:anyURI ] ] ) ; ( 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:link <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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-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: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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ] ; 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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "substantialImpactReliability"^^xsd:anyURI ] ; 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 "code"^^xsd:anyURI ] ] ) ; ( 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:link <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/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ] ; 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: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:link <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:profile [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-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:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; 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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "rationale"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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: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:link <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: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:link <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:value [ a fhir:url ; fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; ( 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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "description"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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: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:link <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:value [ a fhir:url ; fhir:v "uri"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:fixed [ a fhir:uri ; fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"^^xsd:anyURI ] ; 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://hl7.org/fhir/6.0.0-ballot3/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:code [ fhir:v "boolean"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "canonical"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "code"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "date"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "dateTime"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "decimal"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "id"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "instant"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "integer"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "integer64"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "markdown"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "oid"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "positiveInt"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "time"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "unsignedInt"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "uri"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "url"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "uuid"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Address"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Age"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Annotation"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Attachment"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "CodeableReference"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Coding"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "ContactPoint"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Count"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Distance"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Duration"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "HumanName"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Money"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Period"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Quantity"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Range"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Ratio"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "RatioRange"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "SampledData"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Signature"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Timing"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "ContactDetail"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "DataRequirement"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Expression"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "ParameterDefinition"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "RelatedArtifact"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "TriggerDefinition"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "UsageContext"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Availability"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "ExtendedContactDetail"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Dosage"^^xsd:anyURI ] ] [ fhir:code [ fhir:v "Meta"^^xsd:anyURI ] ] ) ; ( 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:link <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 "1"^^xsd:nonNegativeInteger ] ] [ 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: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: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 "code"^^xsd:anyURI ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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 "code"^^xsd:anyURI ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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 "code"^^xsd:anyURI ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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: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: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: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:id [ fhir:v "Extension.extension:signature.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; fhir:comment [ fhir:v "//TODO Need to review the example" ] ; ( fhir:type [ fhir:code [ fhir:v "Signature"^^xsd:anyURI ] ] ) ] [ 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: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: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: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: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:profile [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact> ] ) ] ) ] [ 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: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: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:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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 "1" ] ] [ 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: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:binding [ fhir:strength [ fhir:v "extensible" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-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: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: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: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: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: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 "code"^^xsd:anyURI ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-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: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: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: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: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 "code"^^xsd:anyURI ] ] ) ; fhir:binding [ fhir:strength [ fhir:v "required" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-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: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: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:profile [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail> ] ) ] ) ] [ 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: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: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:id [ fhir:v "Extension.extension:description.value[x]" ] ; fhir:path [ fhir:v "Extension.extension.value[x]" ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ] [ fhir:id [ fhir:v "Extension.url" ] ; fhir:path [ fhir:v "Extension.url" ] ; fhir:fixed [ a fhir:uri ; fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"^^xsd:anyURI ] ] [ fhir:id [ fhir:v "Extension.value[x]" ] ; fhir:path [ fhir:v "Extension.value[x]" ] ; fhir:max [ fhir:v "0" ] ] ) ] . #
IG © 2025+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharmaceutical-research-protocol#1.0.0-ballot based on FHIR 6.0.0-ballot3. Generated 2025-07-31
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