ResearchStudyM11ProtocolAmendment - JSON Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
Extension: ResearchStudyM11ProtocolAmendment - JSON Profile

Page standards status: Trial-use
Maturity Level: 1
JSON representation of the research-study-m11-protocol-amendment extension.
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{
  "resourceType" : "StructureDefinition",
  "id" : "research-study-m11-protocol-amendment",
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition research-study-m11-protocol-amendment</b></p><a name=\"research-study-m11-protocol-amendment\"> </a><a name=\"hcresearch-study-m11-protocol-amendment\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" class=\"xhtTableBorder0\"><tr class=\"xhtRowBorder1\"><th scope=\"col\" style=\"\" class=\"hierarchy xhtCellBorder0\"><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 scope=\"col\" style=\"\" class=\"hierarchy xhtCellBorder0\"><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 scope=\"col\" style=\"\" class=\"hierarchy xhtCellBorder0\"><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 scope=\"col\" style=\"; width: 100px\" class=\"hierarchy xhtCellBorder0\"><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 scope=\"col\" style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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-research-study-m11-protocol-amendment-definitions.html#Extension\" title=\"An amendment to a study protocol.\">Extension</a><a name=\"Extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">*</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">An amendment to a study protocol</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck10.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension\">extension</a><a name=\"Extension.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">2..<span class=\"xhtPieceDeEmphasized\">*</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck13.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.</span>Slices for extension<a name=\"Extension.extension.2\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">Content/Rules for all slices</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier\" title=\"Slice identifier\">extension:identifier</a><a name=\"Extension.extension:identifier\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">1..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:identifier.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:identifier.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:identifier.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier.url\">url</a><a name=\"Extension.extension:identifier.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;identifier&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:identifier.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier.value[x]\" title=\"Amendment identifier.\">value[x]</a><a name=\"Extension.extension:identifier.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Identifier\">Identifier</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Amendment identifier</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous\" title=\"Slice previous\">extension:previous</a><a name=\"Extension.extension:previous\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:previous.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:previous.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:previous.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous.url\">url</a><a name=\"Extension.extension:previous.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;previous&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:previous.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous.value[x]\" title=\"Statement regarding prior amendments.\">value[x]</a><a name=\"Extension.extension:previous.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Statement regarding prior amendments<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-amendment-details-statement.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement\" class=\"binding\">ICH M11 Amendment Details Statement Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope\" title=\"Slice scope\">extension:scope</a><a name=\"Extension.extension:scope\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">1..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:scope.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:scope.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:scope.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope.url\">url</a><a name=\"Extension.extension:scope.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;scope&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:scope.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope.value[x]\" title=\"Global or Not Global (Country, Region, or Site).\">value[x]</a><a name=\"Extension.extension:scope.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Global or Not Global<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-amendment-scope.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope\" class=\"binding\">ICH M11 Amendment Scope Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country\" title=\"Slice country\">extension:country</a><a name=\"Extension.extension:country\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..*</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span><br/></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:country.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:country.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:country.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country.url\">url</a><a name=\"Extension.extension:country.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;country&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:country.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country.value[x]\" title=\"Country.\">value[x]</a><a name=\"Extension.extension:country.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Country</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region\" title=\"Slice region\">extension:region</a><a name=\"Extension.extension:region\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..*</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span><br/></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:region.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:region.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:region.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region.url\">url</a><a name=\"Extension.extension:region.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;region&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:region.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region.value[x]\" title=\"Region.\">value[x]</a><a name=\"Extension.extension:region.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Region</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site\" title=\"Slice site\">extension:site</a><a name=\"Extension.extension:site\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..*</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span><br/></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:site.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:site.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:site.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site.url\">url</a><a name=\"Extension.extension:site.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;site&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1341.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_choice.gif\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:site.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site.value[x]\" title=\"Site.\">value[x]</a><a name=\"Extension.extension:site.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">Site</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck13410.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\"\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:site.value[x].</span><span title=\"Identifier Type: An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.\">valueIdentifier</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Identifier\">Identifier</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck13400.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:site.value[x].</span>valueReference</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/references.html#Reference\">Reference</a>(Any)</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate\" title=\"Slice approvalDate\">extension:approvalDate</a><a name=\"Extension.extension:approvalDate\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:approvalDate.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:approvalDate.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:approvalDate.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.url\">url</a><a name=\"Extension.extension:approvalDate.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;approvalDate&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:approvalDate.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.value[x]\" title=\"Approval date.\">value[x]</a><a name=\"Extension.extension:approvalDate.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#date\">date</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Approval date</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature\" title=\"Slice signature\">extension:signature</a><a name=\"Extension.extension:signature\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signature.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:signature.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signature.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature.url\">url</a><a name=\"Extension.extension:signature.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;signature&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signature.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature.value[x]\" title=\"Signature.\">value[x]</a><a name=\"Extension.extension:signature.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Signature\">Signature</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Signature</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl\" title=\"Slice signatureUrl\">extension:signatureUrl</a><a name=\"Extension.extension:signatureUrl\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureUrl.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:signatureUrl.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureUrl.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.url\">url</a><a name=\"Extension.extension:signatureUrl.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;signatureUrl&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1341.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_choice.gif\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureUrl.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.value[x]\" title=\"Signature URL.\">value[x]</a><a name=\"Extension.extension:signatureUrl.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">Signature URL</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck13410.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\"\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureUrl.value[x].</span><span title=\"string Type: A sequence of Unicode characters\">valueString</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck13400.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureUrl.value[x].</span><span title=\"url type: A URI that is a literal reference\">valueUrl</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#url\">url</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod\" title=\"Slice signatureMethod\">extension:signatureMethod</a><a name=\"Extension.extension:signatureMethod\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureMethod.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:signatureMethod.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureMethod.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.url\">url</a><a name=\"Extension.extension:signatureMethod.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;signatureMethod&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:signatureMethod.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.value[x]\" title=\"Signature Method.\">value[x]</a><a name=\"Extension.extension:signatureMethod.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Signature Method</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scopeImpact\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact\">extension:scopeImpact</a><a name=\"Extension.extension:scopeImpact\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..3</td><td style=\"\" class=\"hierarchy xhtCellBorder0\">(Complex)</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Provides number or percentage of each group affected by a single amendment</span><br/><span class=\"xhtPieceBold\">URL: </span><a href=\"StructureDefinition-m11-amendment-scope-impact.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact</a></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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_element.gif\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:scopeImpact.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scopeImpact.url\">url</a><a name=\"Extension.extension:scopeImpact.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;scopeImpact&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason\" title=\"Slice primaryReason\">extension:primaryReason</a><a name=\"Extension.extension:primaryReason\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:primaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:primaryReason.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:primaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.url\">url</a><a name=\"Extension.extension:primaryReason.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;primaryReason&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:primaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.value[x]\" title=\"Reason for amendment, e.g. Safety.\">value[x]</a><a name=\"Extension.extension:primaryReason.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Reason for amendment, e.g. Safety<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-amendment-reason.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason\" class=\"binding\">ICH M11 Reason for Amendment Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/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 class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason\" title=\"Slice secondaryReason\">extension:secondaryReason</a><a name=\"Extension.extension:secondaryReason\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..*</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span><br/></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:secondaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:secondaryReason.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:secondaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.url\">url</a><a name=\"Extension.extension:secondaryReason.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;secondaryReason&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:secondaryReason.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.value[x]\" title=\"Reason for amendment, e.g. Safety.\">value[x]</a><a name=\"Extension.extension:secondaryReason.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Reason for amendment, e.g. Safety<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-amendment-reason.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason\" class=\"binding\">ICH M11 Reason for Amendment Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/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 class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary\" title=\"Slice summary\">extension:summary</a><a name=\"Extension.extension:summary\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:summary.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:summary.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:summary.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary.url\">url</a><a name=\"Extension.extension:summary.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;summary&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:summary.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary.value[x]\" title=\"Summary of changes.\">value[x]</a><a name=\"Extension.extension:summary.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Summary of changes</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety\" title=\"Slice substantialImpactSafety\">extension:substantialImpactSafety</a><a name=\"Extension.extension:substantialImpactSafety\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:substantialImpactSafety.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.url\">url</a><a name=\"Extension.extension:substantialImpactSafety.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;substantialImpactSafety&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.value[x]\" title=\"Substantial impact on safety.\">value[x]</a><a name=\"Extension.extension:substantialImpactSafety.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Substantial impact on safety<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-yes-no.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no\" class=\"binding\">ICH M11 Yes No Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment\" title=\"Slice substantialImpactSafetyComment\">extension:substantialImpactSafetyComment</a><a name=\"Extension.extension:substantialImpactSafetyComment\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:substantialImpactSafetyComment.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.url\">url</a><a name=\"Extension.extension:substantialImpactSafetyComment.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;substantialImpactSafetyComment&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.value[x]\" title=\"Comment on substantial impact on safety.\">value[x]</a><a name=\"Extension.extension:substantialImpactSafetyComment.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Comment on substantial impact on safety</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability\" title=\"Slice substantialImpactReliability\">extension:substantialImpactReliability</a><a name=\"Extension.extension:substantialImpactReliability\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:substantialImpactReliability.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.url\">url</a><a name=\"Extension.extension:substantialImpactReliability.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;substantialImpactReliability&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.value[x]\" title=\"Substantial impact on reliability.\">value[x]</a><a name=\"Extension.extension:substantialImpactReliability.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Substantial impact on reliability<br class=\"binding\"/><span class=\"xhtPieceBold binding\">Binding: </span><a href=\"ValueSet-ich-m11-yes-no.html\" title=\"http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no\" class=\"binding\">ICH M11 Yes No Value Set</a><span class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span class=\"binding\">)</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment\" title=\"Slice substantialImpactReliabilityComment\">extension:substantialImpactReliabilityComment</a><a name=\"Extension.extension:substantialImpactReliabilityComment\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:substantialImpactReliabilityComment.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.url\">url</a><a name=\"Extension.extension:substantialImpactReliabilityComment.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;substantialImpactReliabilityComment&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.value[x]\" title=\"Comment on substantial impact on reliability.\">value[x]</a><a name=\"Extension.extension:substantialImpactReliabilityComment.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Comment on substantial impact on reliability</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:details\" title=\"Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail\">extension:details</a><a name=\"Extension.extension:details\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..*</td><td style=\"\" class=\"hierarchy xhtCellBorder0\">(Complex)</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Provides detail of a single change within an amendment</span><br/><span class=\"xhtPieceBold\">URL: </span><a href=\"StructureDefinition-m11-amendment-detail.html\">http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail</a><br/></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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_element.gif\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:details.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:details.url\">url</a><a name=\"Extension.extension:details.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;details&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck135.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale\" title=\"Slice rationale\">extension:rationale</a><a name=\"Extension.extension:rationale\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:rationale.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:rationale.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:rationale.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale.url\">url</a><a name=\"Extension.extension:rationale.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;rationale&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1340.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:rationale.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale.value[x]\" title=\"Rationale.\">value[x]</a><a name=\"Extension.extension:rationale.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\">Rationale</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck125.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description\" title=\"Slice description\">extension:description</a><a name=\"Extension.extension:description\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">0..1</td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension\" class=\"xhtPieceDeEmphasized\">Extension</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1250.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:description.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description.extension\" class=\"xhtPieceStrikeout\">extension</a><a name=\"Extension.extension:description.extension\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Extension</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1250.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:description.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description.url\">url</a><a name=\"Extension.extension:description.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;description&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1241.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_choice.gif\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Choice of Types\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:description.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description.value[x]\" title=\"Description.\">value[x]</a><a name=\"Extension.extension:description.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\">Description</td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck12410.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\"\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:description.value[x].</span><span title=\"markdown type: A string that may contain Github Flavored Markdown syntax for optional processing by a mark down presentation engine\">valueMarkdown</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#markdown\">markdown</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck12400.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_primitive.png\" alt=\"\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.Slices for extension.extension:description.value[x].</span><span title=\"string Type: A sequence of Unicode characters\">valueString</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string\">string</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck10.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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\"/> <span style=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.url\">url</a><a name=\"Extension.url\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDeEmphasized\">1</span><span class=\"xhtPieceDeEmphasized\">..</span><span class=\"xhtPieceDeEmphasized\">1</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><a href=\"http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri\" class=\"xhtPieceDeEmphasized\">uri</a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceDarkGreen\">&quot;http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment&quot;</span></td></tr>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck00.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><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=\"position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0\" class=\"sr-only\">Extension.</span><a href=\"StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.value[x]\" class=\"xhtPieceStrikeout\">value[x]</a><a name=\"Extension.value_x_\"> </a></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceStrikeout\"/><span class=\"xhtPieceStrikeout xhtPieceDeEmphasized\">0</span><span class=\"xhtPieceStrikeout\">..</span><span class=\"xhtPieceStrikeout\">0</span></td><td style=\"\" class=\"hierarchy xhtCellBorder0\"/><td style=\"\" class=\"hierarchy xhtCellBorder0\"><span class=\"xhtPieceItalic xhtPieceDeEmphasized\">Value of extension</span></td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
      "valueCode" : "can-bind"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 1
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "cds"
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    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use"
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  "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.44.42.163"
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  "date" : "2026-11-05T14:34:28+00:00",
  "publisher" : "HL7 International / Clinical Decision Support",
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    {
      "name" : "HL7 International / Clinical Decision Support",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/dss"
        }
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    }
  ],
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      "coding" : [
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          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
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      ]
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  "fhirVersion" : "6.0.0-snapshot1",
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    {
      "identity" : "rim",
      "uri" : "http://hl7.org/v3",
      "name" : "RIM Mapping"
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  ],
  "kind" : "complex-type",
  "abstract" : false,
  "context" : [
    {
      "type" : "element",
      "expression" : "ResearchStudy"
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  ],
  "type" : "Extension",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Extension",
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        "url" : "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
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        "definition" : "An amendment to a study protocol.",
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        "max" : "*",
        "base" : {
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          "max" : "*"
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        "constraint" : [
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            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
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          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
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        ],
        "isModifier" : false
      },
      {
        "id" : "Extension.id",
        "path" : "Extension.id",
        "representation" : [
          "xmlAttr"
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        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
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        "base" : {
          "path" : "Element.id",
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        "type" : [
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              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
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        "condition" : [
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        "mapping" : [
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        "id" : "Extension.extension",
        "path" : "Extension.extension",
        "slicing" : {
          "discriminator" : [
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              "path" : "url"
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          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
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        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 2,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
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        "type" : [
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        "max" : "1",
        "base" : {
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        ],
        "constraint" : [
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            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
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        ],
        "isModifier" : false,
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      {
        "id" : "Extension.extension:identifier.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
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        "base" : {
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        "slicing" : {
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          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
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        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
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          "max" : "*"
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        "type" : [
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        "path" : "Extension.extension.url",
        "representation" : [
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        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
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        "fixedUri" : "identifier",
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        "min" : 1,
        "max" : "1",
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          "max" : "1"
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        ]
      },
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        "path" : "Extension.extension.value[x]",
        "short" : "Statement regarding prior amendments",
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        "min" : 0,
        "max" : "1",
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        "max" : "1",
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        "base" : {
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        "condition" : [
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        ]
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      {
        "id" : "Extension.extension:scope.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scope.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "scope",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scope.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Global or Not Global",
        "definition" : "Global or Not Global (Country, Region, or Site).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:country",
        "path" : "Extension.extension",
        "sliceName" : "country",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:country.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:country.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:country.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "country",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:country.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Country",
        "definition" : "Country.",
        "comment" : "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:region",
        "path" : "Extension.extension",
        "sliceName" : "region",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:region.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:region.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:region.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "region",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:region.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Region",
        "definition" : "Region.",
        "comment" : "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:site",
        "path" : "Extension.extension",
        "sliceName" : "site",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:site.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:site.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:site.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "site",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:site.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Site",
        "definition" : "Site.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Identifier"
          },
          {
            "code" : "Reference"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:approvalDate",
        "path" : "Extension.extension",
        "sliceName" : "approvalDate",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:approvalDate.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:approvalDate.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:approvalDate.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "approvalDate",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:approvalDate.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Approval date",
        "definition" : "Approval date.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "date"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signature",
        "path" : "Extension.extension",
        "sliceName" : "signature",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signature.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:signature.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signature.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "signature",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signature.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Signature",
        "definition" : "Signature.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Signature"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureUrl",
        "path" : "Extension.extension",
        "sliceName" : "signatureUrl",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signatureUrl.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureUrl.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signatureUrl.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "signatureUrl",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureUrl.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Signature URL",
        "definition" : "Signature URL.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          },
          {
            "code" : "url"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureMethod",
        "path" : "Extension.extension",
        "sliceName" : "signatureMethod",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signatureMethod.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureMethod.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:signatureMethod.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "signatureMethod",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:signatureMethod.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Signature Method",
        "definition" : "Signature Method.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact",
        "path" : "Extension.extension",
        "sliceName" : "scopeImpact",
        "short" : "Provides number or percentage of each group affected by a single amendment",
        "definition" : "Provides number or percentage of each group affected by a single amendment.",
        "min" : 0,
        "max" : "3",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 2,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:number",
        "path" : "Extension.extension.extension",
        "sliceName" : "number",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:number.id",
        "path" : "Extension.extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:number.extension",
        "path" : "Extension.extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:number.url",
        "path" : "Extension.extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "number",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:number.value[x]",
        "path" : "Extension.extension.extension.value[x]",
        "short" : "Number of participants, or % of participants",
        "definition" : "Number of participants, or % of participants.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "positiveInt"
          },
          {
            "code" : "Quantity"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:scope",
        "path" : "Extension.extension.extension",
        "sliceName" : "scope",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:scope.id",
        "path" : "Extension.extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:scope.extension",
        "path" : "Extension.extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:scope.url",
        "path" : "Extension.extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "scope",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.extension:scope.value[x]",
        "path" : "Extension.extension.extension.value[x]",
        "short" : "Global, Locally, or By Cohort",
        "definition" : "Global, Locally, or By Cohort.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope-enrollment"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "scopeImpact",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:scopeImpact.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Value of extension",
        "definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "base64Binary"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "canonical"
          },
          {
            "code" : "code"
          },
          {
            "code" : "date"
          },
          {
            "code" : "dateTime"
          },
          {
            "code" : "decimal"
          },
          {
            "code" : "id"
          },
          {
            "code" : "instant"
          },
          {
            "code" : "integer"
          },
          {
            "code" : "integer64"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "oid"
          },
          {
            "code" : "positiveInt"
          },
          {
            "code" : "string"
          },
          {
            "code" : "time"
          },
          {
            "code" : "unsignedInt"
          },
          {
            "code" : "uri"
          },
          {
            "code" : "url"
          },
          {
            "code" : "uuid"
          },
          {
            "code" : "Address"
          },
          {
            "code" : "Age"
          },
          {
            "code" : "Annotation"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "CodeableReference"
          },
          {
            "code" : "Coding"
          },
          {
            "code" : "ContactPoint"
          },
          {
            "code" : "Count"
          },
          {
            "code" : "Distance"
          },
          {
            "code" : "Duration"
          },
          {
            "code" : "HumanName"
          },
          {
            "code" : "Identifier"
          },
          {
            "code" : "Money"
          },
          {
            "code" : "Period"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "Range"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "RatioRange"
          },
          {
            "code" : "Reference"
          },
          {
            "code" : "SampledData"
          },
          {
            "code" : "Signature"
          },
          {
            "code" : "Timing"
          },
          {
            "code" : "ContactDetail"
          },
          {
            "code" : "DataRequirement"
          },
          {
            "code" : "Expression"
          },
          {
            "code" : "ParameterDefinition"
          },
          {
            "code" : "RelatedArtifact"
          },
          {
            "code" : "TriggerDefinition"
          },
          {
            "code" : "UsageContext"
          },
          {
            "code" : "Availability"
          },
          {
            "code" : "ExtendedContactDetail"
          },
          {
            "code" : "VirtualServiceDetail"
          },
          {
            "code" : "Dosage"
          },
          {
            "code" : "Meta"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:primaryReason",
        "path" : "Extension.extension",
        "sliceName" : "primaryReason",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:primaryReason.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:primaryReason.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:primaryReason.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "primaryReason",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:primaryReason.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Reason for amendment, e.g. Safety",
        "definition" : "Reason for amendment, e.g. Safety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "extensible",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:secondaryReason",
        "path" : "Extension.extension",
        "sliceName" : "secondaryReason",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:secondaryReason.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:secondaryReason.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:secondaryReason.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "secondaryReason",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:secondaryReason.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Reason for amendment, e.g. Safety",
        "definition" : "Reason for amendment, e.g. Safety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "extensible",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:summary",
        "path" : "Extension.extension",
        "sliceName" : "summary",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:summary.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:summary.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:summary.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "summary",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:summary.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Summary of changes",
        "definition" : "Summary of changes.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafety",
        "path" : "Extension.extension",
        "sliceName" : "substantialImpactSafety",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactSafety.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafety.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactSafety.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "substantialImpactSafety",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafety.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Substantial impact on safety",
        "definition" : "Substantial impact on safety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafetyComment",
        "path" : "Extension.extension",
        "sliceName" : "substantialImpactSafetyComment",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactSafetyComment.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafetyComment.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactSafetyComment.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "substantialImpactSafetyComment",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactSafetyComment.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Comment on substantial impact on safety",
        "definition" : "Comment on substantial impact on safety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliability",
        "path" : "Extension.extension",
        "sliceName" : "substantialImpactReliability",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactReliability.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliability.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactReliability.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "substantialImpactReliability",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliability.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Substantial impact on reliability",
        "definition" : "Substantial impact on reliability.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliabilityComment",
        "path" : "Extension.extension",
        "sliceName" : "substantialImpactReliabilityComment",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactReliabilityComment.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliabilityComment.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:substantialImpactReliabilityComment.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "substantialImpactReliabilityComment",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:substantialImpactReliabilityComment.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Comment on substantial impact on reliability",
        "definition" : "Comment on substantial impact on reliability.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details",
        "path" : "Extension.extension",
        "sliceName" : "details",
        "short" : "Provides detail of a single change within an amendment",
        "definition" : "Provides detail of a single change within an amendment.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : [
              🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 3,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:detail",
        "path" : "Extension.extension.extension",
        "sliceName" : "detail",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:detail.id",
        "path" : "Extension.extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:detail.extension",
        "path" : "Extension.extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:detail.url",
        "path" : "Extension.extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "detail",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:detail.value[x]",
        "path" : "Extension.extension.extension.value[x]",
        "short" : "Detail",
        "definition" : "Detail of change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "base64Binary"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "canonical"
          },
          {
            "code" : "code"
          },
          {
            "code" : "date"
          },
          {
            "code" : "dateTime"
          },
          {
            "code" : "decimal"
          },
          {
            "code" : "id"
          },
          {
            "code" : "instant"
          },
          {
            "code" : "integer"
          },
          {
            "code" : "integer64"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "oid"
          },
          {
            "code" : "positiveInt"
          },
          {
            "code" : "string"
          },
          {
            "code" : "time"
          },
          {
            "code" : "unsignedInt"
          },
          {
            "code" : "uri"
          },
          {
            "code" : "url"
          },
          {
            "code" : "uuid"
          },
          {
            "code" : "Address"
          },
          {
            "code" : "Age"
          },
          {
            "code" : "Annotation"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "CodeableReference"
          },
          {
            "code" : "Coding"
          },
          {
            "code" : "ContactPoint"
          },
          {
            "code" : "Count"
          },
          {
            "code" : "Distance"
          },
          {
            "code" : "Duration"
          },
          {
            "code" : "HumanName"
          },
          {
            "code" : "Identifier"
          },
          {
            "code" : "Money"
          },
          {
            "code" : "Period"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "Range"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "RatioRange"
          },
          {
            "code" : "Reference"
          },
          {
            "code" : "SampledData"
          },
          {
            "code" : "Signature"
          },
          {
            "code" : "Timing"
          },
          {
            "code" : "ContactDetail"
          },
          {
            "code" : "DataRequirement"
          },
          {
            "code" : "Expression"
          },
          {
            "code" : "ParameterDefinition"
          },
          {
            "code" : "RelatedArtifact"
          },
          {
            "code" : "TriggerDefinition"
          },
          {
            "code" : "UsageContext"
          },
          {
            "code" : "Availability"
          },
          {
            "code" : "ExtendedContactDetail"
          },
          {
            "code" : "VirtualServiceDetail"
          },
          {
            "code" : "Dosage"
          },
          {
            "code" : "Meta"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:rationale",
        "path" : "Extension.extension.extension",
        "sliceName" : "rationale",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:rationale.id",
        "path" : "Extension.extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:rationale.extension",
        "path" : "Extension.extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:rationale.url",
        "path" : "Extension.extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "rationale",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:rationale.value[x]",
        "path" : "Extension.extension.extension.value[x]",
        "short" : "Rationale",
        "definition" : "Rationale for change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:section",
        "path" : "Extension.extension.extension",
        "sliceName" : "section",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:section.id",
        "path" : "Extension.extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:section.extension",
        "path" : "Extension.extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:details.extension:section.url",
        "path" : "Extension.extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "section",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.extension:section.value[x]",
        "path" : "Extension.extension.extension.value[x]",
        "short" : "Section where the amendment was made",
        "definition" : "Section where the amendment was made.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/limited-m11-section-codes"
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "details",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:details.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Value of extension",
        "definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "base64Binary"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "canonical"
          },
          {
            "code" : "code"
          },
          {
            "code" : "date"
          },
          {
            "code" : "dateTime"
          },
          {
            "code" : "decimal"
          },
          {
            "code" : "id"
          },
          {
            "code" : "instant"
          },
          {
            "code" : "integer"
          },
          {
            "code" : "integer64"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "oid"
          },
          {
            "code" : "positiveInt"
          },
          {
            "code" : "string"
          },
          {
            "code" : "time"
          },
          {
            "code" : "unsignedInt"
          },
          {
            "code" : "uri"
          },
          {
            "code" : "url"
          },
          {
            "code" : "uuid"
          },
          {
            "code" : "Address"
          },
          {
            "code" : "Age"
          },
          {
            "code" : "Annotation"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "CodeableReference"
          },
          {
            "code" : "Coding"
          },
          {
            "code" : "ContactPoint"
          },
          {
            "code" : "Count"
          },
          {
            "code" : "Distance"
          },
          {
            "code" : "Duration"
          },
          {
            "code" : "HumanName"
          },
          {
            "code" : "Identifier"
          },
          {
            "code" : "Money"
          },
          {
            "code" : "Period"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "Range"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "RatioRange"
          },
          {
            "code" : "Reference"
          },
          {
            "code" : "SampledData"
          },
          {
            "code" : "Signature"
          },
          {
            "code" : "Timing"
          },
          {
            "code" : "ContactDetail"
          },
          {
            "code" : "DataRequirement"
          },
          {
            "code" : "Expression"
          },
          {
            "code" : "ParameterDefinition"
          },
          {
            "code" : "RelatedArtifact"
          },
          {
            "code" : "TriggerDefinition"
          },
          {
            "code" : "UsageContext"
          },
          {
            "code" : "Availability"
          },
          {
            "code" : "ExtendedContactDetail"
          },
          {
            "code" : "VirtualServiceDetail"
          },
          {
            "code" : "Dosage"
          },
          {
            "code" : "Meta"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:rationale",
        "path" : "Extension.extension",
        "sliceName" : "rationale",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:rationale.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:rationale.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:rationale.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "rationale",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:rationale.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Rationale",
        "definition" : "Rationale.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:description",
        "path" : "Extension.extension",
        "sliceName" : "description",
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:description.id",
        "path" : "Extension.extension.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Extension.extension:description.extension",
        "path" : "Extension.extension.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Extension.extension:description.url",
        "path" : "Extension.extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "description",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.extension:description.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Description",
        "definition" : "Description.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "markdown"
          },
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.url",
        "path" : "Extension.url",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "identifies the meaning of the extension",
        "definition" : "Source of the definition for the extension code - a logical name or a URL.",
        "comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Extension.url",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "uri"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment",
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Extension.value[x]",
        "path" : "Extension.value[x]",
        "short" : "Value of extension",
        "definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min" : 0,
        "max" : "0",
        "base" : {
          "path" : "Extension.value[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "base64Binary"
          },
          {
            "code" : "boolean"
          },
          {
            "code" : "canonical"
          },
          {
            "code" : "code"
          },
          {
            "code" : "date"
          },
          {
            "code" : "dateTime"
          },
          {
            "code" : "decimal"
          },
          {
            "code" : "id"
          },
          {
            "code" : "instant"
          },
          {
            "code" : "integer"
          },
          {
            "code" : "integer64"
          },
          {
            "code" : "markdown"
          },
          {
            "code" : "oid"
          },
          {
            "code" : "positiveInt"
          },
          {
            "code" : "string"
          },
          {
            "code" : "time"
          },
          {
            "code" : "unsignedInt"
          },
          {
            "code" : "uri"
          },
          {
            "code" : "url"
          },
          {
            "code" : "uuid"
          },
          {
            "code" : "Address"
          },
          {
            "code" : "Age"
          },
          {
            "code" : "Annotation"
          },
          {
            "code" : "Attachment"
          },
          {
            "code" : "CodeableConcept"
          },
          {
            "code" : "CodeableReference"
          },
          {
            "code" : "Coding"
          },
          {
            "code" : "ContactPoint"
          },
          {
            "code" : "Count"
          },
          {
            "code" : "Distance"
          },
          {
            "code" : "Duration"
          },
          {
            "code" : "HumanName"
          },
          {
            "code" : "Identifier"
          },
          {
            "code" : "Money"
          },
          {
            "code" : "Period"
          },
          {
            "code" : "Quantity"
          },
          {
            "code" : "Range"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "RatioRange"
          },
          {
            "code" : "Reference"
          },
          {
            "code" : "SampledData"
          },
          {
            "code" : "Signature"
          },
          {
            "code" : "Timing"
          },
          {
            "code" : "ContactDetail"
          },
          {
            "code" : "DataRequirement"
          },
          {
            "code" : "Expression"
          },
          {
            "code" : "ParameterDefinition"
          },
          {
            "code" : "RelatedArtifact"
          },
          {
            "code" : "TriggerDefinition"
          },
          {
            "code" : "UsageContext"
          },
          {
            "code" : "Availability"
          },
          {
            "code" : "ExtendedContactDetail"
          },
          {
            "code" : "VirtualServiceDetail"
          },
          {
            "code" : "Dosage"
          },
          {
            "code" : "Meta"
          }
        ],
        "condition" : [
          "ext-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "Extension",
        "path" : "Extension",
        "short" : "An amendment to a study protocol",
        "definition" : "An amendment to a study protocol."
      },
      {
        "id" : "Extension.extension",
        "path" : "Extension.extension",
        "min" : 2
      },
      {
        "id" : "Extension.extension:identifier",
        "path" : "Extension.extension",
        "sliceName" : "identifier",
        "min" : 1,
        "max" : "1"
      },
      {
        "id" : "Extension.extension:identifier.extension",
        "path" : "Extension.extension.extension",
        "max" : "0"
      },
      {
        "id" : "Extension.extension:identifier.url",
        "path" : "Extension.extension.url",
        "fixedUri" : "identifier"
      },
      {
        "id" : "Extension.extension:identifier.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Amendment identifier",
        "definition" : "Amendment identifier.",
        "type" : [
          {
            "code" : "Identifier"
          }
        ]
      },
      {
        "id" : "Extension.extension:previous",
        "path" : "Extension.extension",
        "sliceName" : "previous",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "Extension.extension:previous.extension",
        "path" : "Extension.extension.extension",
        "max" : "0"
      },
      {
        "id" : "Extension.extension:previous.url",
        "path" : "Extension.extension.url",
        "fixedUri" : "previous"
      },
      {
        "id" : "Extension.extension:previous.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Statement regarding prior amendments",
        "definition" : "Statement regarding prior amendments.",
        "comment" : "State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).",
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement"
        }
      },
      {
        "id" : "Extension.extension:scope",
        "path" : "Extension.extension",
        "sliceName" : "scope",
        "min" : 1,
        "max" : "1"
      },
      {
        "id" : "Extension.extension:scope.extension",
        "path" : "Extension.extension.extension",
        "max" : "0"
      },
      {
        "id" : "Extension.extension:scope.url",
        "path" : "Extension.extension.url",
        "fixedUri" : "scope"
      },
      {
        "id" : "Extension.extension:scope.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Global or Not Global",
        "definition" : "Global or Not Global (Country, Region, or Site).",
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"
        }
      },
      {
        "id" : "Extension.extension:country",
        "path" : "Extension.extension",
        "sliceName" : "country",
        "min" : 0,
        "max" : "*"
      },
      {
        "id" : "Extension.extension:country.extension",
        "path" : "Extension.extension.extension",
        "max" : "0"
      },
      {
        "id" : "Extension.extension:country.url",
        "path" : "Extension.extension.url",
        "fixedUri" : "country"
      },
      {
        "id" : "Extension.extension:country.value[x]",
        "path" : "Extension.extension.value[x]",
        "short" : "Country",
        "definition" : "Country.",
        "comment" : "Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. ICH M11 Study Amendment Country Value Set posted at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-country-region-vs.html.",
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ]
      },
      {
        "id" : "Extension.extension:region",
        "path" : "Extension.extension",
        "sliceName" : "region",
        "min" : 0,
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}