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.
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<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" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension" title="An amendment to a study protocol.">Extension</a><a name="Extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">An amendment to a study protocol</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension">extension</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> Slices for extension<a name="Extension.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier.extension">extension</a><a name="Extension.extension:identifier.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:identifier.url">url</a><a name="Extension.extension:identifier.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;identifier&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Amendment identifier</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous.extension">extension</a><a name="Extension.extension:previous.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:previous.url">url</a><a name="Extension.extension:previous.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;previous&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Statement regarding prior amendments<br class="binding"/><span style="font-weight:bold" title="null" class="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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope.extension">extension</a><a name="Extension.extension:scope.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scope.url">url</a><a name="Extension.extension:scope.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;scope&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Global or Not Global<br class="binding"/><span style="font-weight:bold" title="null" class="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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country.extension">extension</a><a name="Extension.extension:country.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:country.url">url</a><a name="Extension.extension:country.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;country&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Country</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region.extension">extension</a><a name="Extension.extension:region.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:region.url">url</a><a name="Extension.extension:region.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;region&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Region</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site.extension">extension</a><a name="Extension.extension:site.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:site.url">url</a><a name="Extension.extension:site.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;site&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: white; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Identifier Type: An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.">valueIdentifier</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> valueReference</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/references.html#Reference">Reference</a>(Any)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.extension">extension</a><a name="Extension.extension:approvalDate.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:approvalDate.url">url</a><a name="Extension.extension:approvalDate.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;approvalDate&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#date">date</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Approval date</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature.extension">extension</a><a name="Extension.extension:signature.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signature.url">url</a><a name="Extension.extension:signature.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;signature&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#Signature">Signature</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Signature</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.extension">extension</a><a name="Extension.extension:signatureUrl.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureUrl.url">url</a><a name="Extension.extension:signatureUrl.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;signatureUrl&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: white; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Signature URL</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="string Type: A sequence of Unicode characters">valueString</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="url type: A URI that is a literal reference">valueUrl</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#url">url</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.extension">extension</a><a name="Extension.extension:signatureMethod.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:signatureMethod.url">url</a><a name="Extension.extension:signatureMethod.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;signatureMethod&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Signature Method</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:scopeImpact" title="Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact">extension:scopeImpact</a><a name="Extension.extension:scopeImpact"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..3</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Provides number or percentage of each group affected by a single amendment</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-research-study-m11-amendment-scope-impact.html">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-scope-impact</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.extension">extension</a><a name="Extension.extension:primaryReason.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:primaryReason.url">url</a><a name="Extension.extension:primaryReason.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;primaryReason&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reason for amendment, e.g. Safety<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.extension">extension</a><a name="Extension.extension:secondaryReason.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:secondaryReason.url">url</a><a name="Extension.extension:secondaryReason.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;secondaryReason&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reason for amendment, e.g. Safety<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary.extension">extension</a><a name="Extension.extension:summary.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:summary.url">url</a><a name="Extension.extension:summary.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;summary&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Summary of changes</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.extension">extension</a><a name="Extension.extension:substantialImpactSafety.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafety.url">url</a><a name="Extension.extension:substantialImpactSafety.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;substantialImpactSafety&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Substantial impact on safety<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.extension">extension</a><a name="Extension.extension:substantialImpactSafetyComment.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.url">url</a><a name="Extension.extension:substantialImpactSafetyComment.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;substantialImpactSafetyComment&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Comment on substantial impact on safety</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.extension">extension</a><a name="Extension.extension:substantialImpactReliability.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliability.url">url</a><a name="Extension.extension:substantialImpactReliability.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;substantialImpactReliability&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Substantial impact on reliability<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-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 title="null" 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 title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.extension">extension</a><a name="Extension.extension:substantialImpactReliabilityComment.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.url">url</a><a name="Extension.extension:substantialImpactReliabilityComment.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;substantialImpactReliabilityComment&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Comment on substantial impact on reliability</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:details" title="Extension URL = http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail">extension:details</a><a name="Extension.extension:details"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Provides detail of a single change within an amendment</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-research-study-m11-amendment-detail.html">http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-amendment-detail</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale.extension">extension</a><a name="Extension.extension:rationale.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:rationale.url">url</a><a name="Extension.extension:rationale.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;rationale&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Rationale</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description.extension">extension</a><a name="Extension.extension:description.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.extension:description.url">url</a><a name="Extension.extension:description.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;description&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: white; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-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="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="markdown type: A string that may contain Github Flavored Markdown syntax for optional processing by a mark down presentation engine">valueMarkdown</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="string Type: A sequence of Unicode characters">valueString</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.url">url</a><a name="Extension.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-research-study-m11-protocol-amendment-definitions.html#Extension.value[x]">value[x]</a><a name="Extension.value_x_"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Value of extension</span></td></tr>
<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="2026-10-02T12:47:35+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-ballot5"/>
  <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-ballot5"/>
    </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
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          <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/research-study-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: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/research-study-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: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">
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</StructureDefinition>