ResearchStudyM11ProtocolAmendment - XML 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 - XML Profile

Page standards status: Trial-use
Maturity Level: 1
XML representation of the research-study-m11-protocol-amendment extension.
Raw xml | Download

<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="research-study-m11-protocol-amendment"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
<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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics">
    <valueCode value="can-bind"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="cds"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.42.163"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name value="ResearchStudyM11ProtocolAmendment"/>
  <status value="active"/>
  <date value="2026-11-05T14:34:28+00:00"/>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <description
               value="An amendment to a study protocol matching M11 template."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <fhirVersion value="6.0.0-snapshot1"/>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <kind value="complex-type"/>
  <abstract value="false"/>
  <context>
    <type value="element"/>
    <expression value="ResearchStudy"/>
  </context>
  <type value="Extension"/>
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension"/>
  <derivation value="constraint"/>
  <snapshot>
    <extension
               url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
      <valueString value="6.0.0-snapshot1"/>
    </extension>
    <element id="Extension">
      <path value="Extension"/>
      <short value="An amendment to a study protocol"/>
      <definition value="An amendment to a study protocol."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
    </element>
    <element id="Extension.id">
      <path value="Extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension">
      <path value="Extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="2"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:identifier">
      <path value="Extension.extension"/>
      <sliceName value="identifier"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:identifier.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:identifier.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:identifier.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="identifier"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:identifier.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Amendment identifier"/>
      <definition value="Amendment identifier."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:previous">
      <path value="Extension.extension"/>
      <sliceName value="previous"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:previous.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:previous.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:previous.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="previous"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:previous.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Statement regarding prior amendments"/>
      <definition value="Statement regarding prior amendments."/>
      <comment
               value="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)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scope">
      <path value="Extension.extension"/>
      <sliceName value="scope"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scope.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:scope.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scope.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="scope"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scope.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Global or Not Global"/>
      <definition value="Global or Not Global (Country, Region, or Site)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:country">
      <path value="Extension.extension"/>
      <sliceName value="country"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:country.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:country.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:country.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="country"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:country.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Country"/>
      <definition value="Country."/>
      <comment
               value="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 value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:region">
      <path value="Extension.extension"/>
      <sliceName value="region"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:region.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:region.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:region.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="region"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:region.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Region"/>
      <definition value="Region."/>
      <comment
               value="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 value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:site">
      <path value="Extension.extension"/>
      <sliceName value="site"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:site.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:site.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:site.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="site"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:site.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Site"/>
      <definition value="Site."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:approvalDate">
      <path value="Extension.extension"/>
      <sliceName value="approvalDate"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:approvalDate.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:approvalDate.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:approvalDate.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="approvalDate"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:approvalDate.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Approval date"/>
      <definition value="Approval date."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="date"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signature">
      <path value="Extension.extension"/>
      <sliceName value="signature"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signature.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:signature.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signature.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="signature"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signature.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Signature"/>
      <definition value="Signature."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Signature"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureUrl">
      <path value="Extension.extension"/>
      <sliceName value="signatureUrl"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signatureUrl.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureUrl.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signatureUrl.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="signatureUrl"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureUrl.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Signature URL"/>
      <definition value="Signature URL."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureMethod">
      <path value="Extension.extension"/>
      <sliceName value="signatureMethod"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signatureMethod.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureMethod.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:signatureMethod.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="signatureMethod"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:signatureMethod.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Signature Method"/>
      <definition value="Signature Method."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact">
      <path value="Extension.extension"/>
      <sliceName value="scopeImpact"/>
      <short
             value="Provides number or percentage of each group affected by a single amendment"/>
      <definition
                  value="Provides number or percentage of each group affected by a single amendment."/>
      <min value="0"/>
      <max value="3"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="2"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.extension:number">
      <path value="Extension.extension.extension"/>
      <sliceName value="number"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.extension:number.id">
      <path value="Extension.extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension:number.extension">
      <path value="Extension.extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.extension:number.url">
      <path value="Extension.extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="number"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension:number.value[x]">
      <path value="Extension.extension.extension.value[x]"/>
      <short value="Number of participants, or % of participants"/>
      <definition value="Number of participants, or % of participants."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension:scope">
      <path value="Extension.extension.extension"/>
      <sliceName value="scope"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.extension:scope.id">
      <path value="Extension.extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension:scope.extension">
      <path value="Extension.extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scopeImpact.extension:scope.url">
      <path value="Extension.extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="scope"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.extension:scope.value[x]">
      <path value="Extension.extension.extension.value[x]"/>
      <short value="Global, Locally, or By Cohort"/>
      <definition value="Global, Locally, or By Cohort."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope-enrollment"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="scopeImpact"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scopeImpact.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="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 value="0"/>
      <max value="0"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="VirtualServiceDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:primaryReason">
      <path value="Extension.extension"/>
      <sliceName value="primaryReason"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:primaryReason.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:primaryReason.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:primaryReason.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="primaryReason"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:primaryReason.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Reason for amendment, e.g. Safety"/>
      <definition value="Reason for amendment, e.g. Safety."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:secondaryReason">
      <path value="Extension.extension"/>
      <sliceName value="secondaryReason"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:secondaryReason.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:secondaryReason.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:secondaryReason.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="secondaryReason"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:secondaryReason.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Reason for amendment, e.g. Safety"/>
      <definition value="Reason for amendment, e.g. Safety."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:summary">
      <path value="Extension.extension"/>
      <sliceName value="summary"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:summary.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:summary.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:summary.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="summary"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:summary.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Summary of changes"/>
      <definition value="Summary of changes."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactSafety">
      <path value="Extension.extension"/>
      <sliceName value="substantialImpactSafety"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactSafety.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactSafety.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactSafety.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="substantialImpactSafety"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactSafety.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Substantial impact on safety"/>
      <definition value="Substantial impact on safety."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactSafetyComment">
      <path value="Extension.extension"/>
      <sliceName value="substantialImpactSafetyComment"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactSafetyComment.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:substantialImpactSafetyComment.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactSafetyComment.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="substantialImpactSafetyComment"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:substantialImpactSafetyComment.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Comment on substantial impact on safety"/>
      <definition value="Comment on substantial impact on safety."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactReliability">
      <path value="Extension.extension"/>
      <sliceName value="substantialImpactReliability"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactReliability.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactReliability.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactReliability.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="substantialImpactReliability"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactReliability.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Substantial impact on reliability"/>
      <definition value="Substantial impact on reliability."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-yes-no"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:substantialImpactReliabilityComment">
      <path value="Extension.extension"/>
      <sliceName value="substantialImpactReliabilityComment"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:substantialImpactReliabilityComment.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:substantialImpactReliabilityComment.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:substantialImpactReliabilityComment.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="substantialImpactReliabilityComment"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:substantialImpactReliabilityComment.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Comment on substantial impact on reliability"/>
      <definition value="Comment on substantial impact on reliability."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details">
      <path value="Extension.extension"/>
      <sliceName value="details"/>
      <short value="Provides detail of a single change within an amendment"/>
      <definition
                  value="Provides detail of a single change within an amendment."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-detail"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="3"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:detail">
      <path value="Extension.extension.extension"/>
      <sliceName value="detail"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:detail.id">
      <path value="Extension.extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:detail.extension">
      <path value="Extension.extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:detail.url">
      <path value="Extension.extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="detail"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:detail.value[x]">
      <path value="Extension.extension.extension.value[x]"/>
      <short value="Detail"/>
      <definition value="Detail of change."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="VirtualServiceDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:rationale">
      <path value="Extension.extension.extension"/>
      <sliceName value="rationale"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:rationale.id">
      <path value="Extension.extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:rationale.extension">
      <path value="Extension.extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:rationale.url">
      <path value="Extension.extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="rationale"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:rationale.value[x]">
      <path value="Extension.extension.extension.value[x]"/>
      <short value="Rationale"/>
      <definition value="Rationale for change."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:section">
      <path value="Extension.extension.extension"/>
      <sliceName value="section"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:section.id">
      <path value="Extension.extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:section.extension">
      <path value="Extension.extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:details.extension:section.url">
      <path value="Extension.extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="section"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.extension:section.value[x]">
      <path value="Extension.extension.extension.value[x]"/>
      <short value="Section where the amendment was made"/>
      <definition value="Section where the amendment was made."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/limited-m11-section-codes"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="details"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:details.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="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 value="0"/>
      <max value="0"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="VirtualServiceDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:rationale">
      <path value="Extension.extension"/>
      <sliceName value="rationale"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:rationale.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:rationale.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:rationale.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="rationale"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:rationale.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Rationale"/>
      <definition value="Rationale."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:description">
      <path value="Extension.extension"/>
      <sliceName value="description"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:description.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:description.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:description.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="description"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:description.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Description"/>
      <definition value="Description."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.url">
      <path value="Extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="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 value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri
                value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.value[x]">
      <path value="Extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="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 value="0"/>
      <max value="0"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="VirtualServiceDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
  </snapshot>
  <differential>
    <element id="Extension">
      <path value="Extension"/>
      <short value="An amendment to a study protocol"/>
      <definition value="An amendment to a study protocol."/>
    </element>
    <element id="Extension.extension">
      <path value="Extension.extension"/>
      <min value="2"/>
    </element>
    <element id="Extension.extension:identifier">
      <path value="Extension.extension"/>
      <sliceName value="identifier"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:identifier.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:identifier.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="identifier"/>
    </element>
    <element id="Extension.extension:identifier.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Amendment identifier"/>
      <definition value="Amendment identifier."/>
      <type>
        <code value="Identifier"/>
      </type>
    </element>
    <element id="Extension.extension:previous">
      <path value="Extension.extension"/>
      <sliceName value="previous"/>
      <min value="0"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:previous.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:previous.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="previous"/>
    </element>
    <element id="Extension.extension:previous.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Statement regarding prior amendments"/>
      <definition value="Statement regarding prior amendments."/>
      <comment
               value="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 value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement"/>
      </binding>
    </element>
    <element id="Extension.extension:scope">
      <path value="Extension.extension"/>
      <sliceName value="scope"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:scope.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:scope.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="scope"/>
    </element>
    <element id="Extension.extension:scope.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Global or Not Global"/>
      <definition value="Global or Not Global (Country, Region, or Site)."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"/>
      </binding>
    </element>
    <element id="Extension.extension:country">
      <path value="Extension.extension"/>
      <sliceName value="country"/>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="Extension.extension:country.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:country.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="country"/>
    </element>
    <element id="Extension.extension:country.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Country"/>
      <definition value="Country."/>
      <comment
               value="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 value="CodeableConcept"/>
      </type>
    </element>
    <element id="Extension.extension:region">
      <path value="Extension.extension"/>
      <sliceName value="region"/>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="Extension.extension:region.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:region.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="region"/>
    </element>
    <element id="Extension.extension:region.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Region"/>
      <definition value="Region."/>
      <comment
               value="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 value="CodeableConcept"/>
      </type>
    </element>
    <element id="Extension.extension:site">
      <path value="Extension.extension"/>
      <sliceName value="site"/>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="Extension.extension:site.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:site.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="site"/>
    </element>
    <element id="Extension.extension:site.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Site"/>
      <definition value="Site."/>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
    </element>
    <element id="Extension.extension:approvalDate">
      <path value="Extension.extension"/>
      <sliceName value="approvalDate"/>
      <min value="0"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:approvalDate.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:approvalDate.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="approvalDate"/>
    </element>
    <element id="Extension.extension:approvalDate.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Approval date"/>
      <definition value="Approval date."/>
      <type>
        <code value="date"/>
      </type>
    </element>
    <element id="Extension.extension:signature">
      <path value="Extension.extension"/>
      <sliceName value="signature"/>
      <min value="0"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:signature.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:signature.url">
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      <short value="Signature"/>
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        <code value="Signature"/>
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      <fixedUri value="signatureUrl"/>
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      <short value="Signature URL"/>
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        <code value="string"/>
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        <code value="url"/>
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      <path value="Extension.extension.value[x]"/>
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        <code value="string"/>
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        <strength value="extensible"/>
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        <code value="markdown"/>
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        <code value="string"/>
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</StructureDefinition>