Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
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
| Page standards status: Trial-use | Maturity Level: 1 |
XML representation of the research-study-study-amendment extension.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="research-study-study-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-study-amendment</b></p><a name="research-study-study-amendment"> </a><a name="hcresearch-study-study-amendment"> </a><table border="0" cellpadding="0" cellspacing="0" class="xhtTableBorder0"><tr class="xhtRowBorder1"><th scope="col" style="" class="hierarchy xhtCellBorder0"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th scope="col" style="" class="hierarchy xhtCellBorder0"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th scope="col" style="" class="hierarchy xhtCellBorder0"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th scope="col" style="; width: 100px" class="hierarchy xhtCellBorder0"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th scope="col" style="" class="hierarchy xhtCellBorder0"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension" title="An amendment to a study protocol.">Extension</a><a name="Extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">*</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension">Extension</a></td><td style="" class="hierarchy xhtCellBorder0">An amendment to a study protocol</td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck13.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.</span>Slices for extension<a name="Extension.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">Content/Rules for all slices</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:details" title="Slice details">extension:details</a><a name="Extension.extension:details"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:details.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:details.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:details.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:details.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:details.url">url</a><a name="Extension.extension:details.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"details"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:details.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:details.value[x]" title="Statement regarding prior amendments.">value[x]</a><a name="Extension.extension:details.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Statement regarding prior amendments</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:scope" title="Slice scope">extension:scope</a><a name="Extension.extension:scope"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:scope.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:scope.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:scope.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:scope.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:scope.url">url</a><a name="Extension.extension:scope.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"scope"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:scope.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:scope.value[x]" title="Global, Coutnry, Region, or Site.">value[x]</a><a name="Extension.extension:scope.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Global, Coutnry, Region, or Site</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:description" title="Slice description">extension:description</a><a name="Extension.extension:description"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:description.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:description.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:description.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:description.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:description.url">url</a><a name="Extension.extension:description.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"description"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:description.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:description.value[x]" title="Description.">value[x]</a><a name="Extension.extension:description.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Description</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:rationale" title="Slice rationale">extension:rationale</a><a name="Extension.extension:rationale"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:rationale.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:rationale.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:rationale.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:rationale.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:rationale.url">url</a><a name="Extension.extension:rationale.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"rationale"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:rationale.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:rationale.value[x]" title="Rationale.">value[x]</a><a name="Extension.extension:rationale.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Rationale</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafety" title="Slice substantialImpactSafety">extension:substantialImpactSafety</a><a name="Extension.extension:substantialImpactSafety"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafety.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:substantialImpactSafety.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafety.url">url</a><a name="Extension.extension:substantialImpactSafety.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"substantialImpactSafety"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafety.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafety.value[x]" title="Substantial impact on safety.">value[x]</a><a name="Extension.extension:substantialImpactSafety.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#boolean">boolean</a></td><td style="" class="hierarchy xhtCellBorder0">Substantial impact on safety</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment" title="Slice substantialImpactSafetyComment">extension:substantialImpactSafetyComment</a><a name="Extension.extension:substantialImpactSafetyComment"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:substantialImpactSafetyComment.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.url">url</a><a name="Extension.extension:substantialImpactSafetyComment.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"substantialImpactSafetyComment"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactSafetyComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactSafetyComment.value[x]" title="Comment on substantial impact on safety.">value[x]</a><a name="Extension.extension:substantialImpactSafetyComment.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Comment on substantial impact on safety</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliability" title="Slice substantialImpactReliability">extension:substantialImpactReliability</a><a name="Extension.extension:substantialImpactReliability"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliability.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:substantialImpactReliability.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliability.url">url</a><a name="Extension.extension:substantialImpactReliability.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"substantialImpactReliability"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliability.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliability.value[x]" title="Substantial impact on reliability.">value[x]</a><a name="Extension.extension:substantialImpactReliability.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#boolean">boolean</a></td><td style="" class="hierarchy xhtCellBorder0">Substantial impact on reliability</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck135.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment" title="Slice substantialImpactReliabilityComment">extension:substantialImpactReliabilityComment</a><a name="Extension.extension:substantialImpactReliabilityComment"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:substantialImpactReliabilityComment.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1350.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.url">url</a><a name="Extension.extension:substantialImpactReliabilityComment.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"substantialImpactReliabilityComment"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1340.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:substantialImpactReliabilityComment.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:substantialImpactReliabilityComment.value[x]" title="Comment on substantial impact on reliability.">value[x]</a><a name="Extension.extension:substantialImpactReliabilityComment.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#string">string</a></td><td style="" class="hierarchy xhtCellBorder0">Comment on substantial impact on reliability</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck125.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="" style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:primaryReason" title="Slice primaryReason">extension:primaryReason</a><a name="Extension.extension:primaryReason"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0">0..1</td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/extensibility.html#Extension" class="xhtPieceDeEmphasized">Extension</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1250.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:primaryReason.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:primaryReason.extension" class="xhtPieceStrikeout">extension</a><a name="Extension.extension:primaryReason.extension"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Extension</span></td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck1250.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:primaryReason.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:primaryReason.url">url</a><a name="Extension.extension:primaryReason.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"primaryReason"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck1240.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.Slices for extension.extension:primaryReason.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.extension:primaryReason.value[x]" title="Reason for amendment, e.g. Safety.">value[x]</a><a name="Extension.extension:primaryReason.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">0</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="" class="hierarchy xhtCellBorder0">Reason for amendment, e.g. Safety</td></tr>
<tr class="xhtRowBorder0 xhtRowEven"><td style="background-image: url(tbl_bck10.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.url">url</a><a name="Extension.url"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDeEmphasized">1</span><span class="xhtPieceDeEmphasized">..</span><span class="xhtPieceDeEmphasized">1</span></td><td style="" class="hierarchy xhtCellBorder0"><a href="http://hl7.org/fhir/6.0.0-ballot5/datatypes.html#uri" class="xhtPieceDeEmphasized">uri</a></td><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceDarkGreen">"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"</span></td></tr>
<tr class="xhtRowBorder0 xhtRowOdd"><td style="background-image: url(tbl_bck00.png)" class="hierarchy xhtCellBorder0 xhtCellNoWrap"><img src="tbl_spacer.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="" style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="" style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <span style="position: absolute; width: 1px; height: 1px; padding: 0; margin: -1px; overflow: hidden; clip: rect(0, 0, 0, 0); white-space: nowrap; border: 0" class="sr-only">Extension.</span><a href="StructureDefinition-research-study-study-amendment-definitions.html#Extension.value[x]" class="xhtPieceStrikeout">value[x]</a><a name="Extension.value_x_"> </a></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceStrikeout"/><span class="xhtPieceStrikeout xhtPieceDeEmphasized">0</span><span class="xhtPieceStrikeout">..</span><span class="xhtPieceStrikeout">0</span></td><td style="" class="hierarchy xhtCellBorder0"/><td style="" class="hierarchy xhtCellBorder0"><span class="xhtPieceItalic xhtPieceDeEmphasized">Value of extension</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics">
<valueCode value="can-bind"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="1"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="cds"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="trial-use"/>
</extension>
<url
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.44.42.97"/>
</identifier>
<version value="1.0.0-ballot3"/>
<name value="ResearchStudyStudyAmendment"/>
<status value="active"/>
<date value="2026-11-05T14:34:28+00:00"/>
<publisher value="HL7 International / Clinical Decision Support"/>
<contact>
<name value="HL7 International / Clinical Decision Support"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/dss"/>
</telecom>
</contact>
<description value="An amendment to a study protocol."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<fhirVersion value="6.0.0-snapshot1"/>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<kind value="complex-type"/>
<abstract value="false"/>
<context>
<type value="element"/>
<expression value="ResearchStudy"/>
</context>
<type value="Extension"/>
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension"/>
<derivation value="constraint"/>
<snapshot>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
<valueString value="6.0.0-snapshot1"/>
</extension>
<element id="Extension">
<path value="Extension"/>
<short value="An amendment to a study protocol"/>
<definition value="An amendment to a study protocol."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Extension"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
</element>
<element id="Extension.id">
<path value="Extension.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Extension.extension">
<path value="Extension.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Extension.extension:details">
<path value="Extension.extension"/>
<sliceName value="details"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="Extension.extension:details.id">
<path value="Extension.extension.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<condition value="ele-1"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="Extension.extension:details.extension">
<path value="Extension.extension.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="Extension.extension:details.url">
<path value="Extension.extension.url"/>
<representation value="xmlAttr"/>
<short value="identifies the meaning of the extension"/>
<definition
value="Source of the definition for the extension code - a logical name or a URL."/>
<comment
value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Extension.url"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="uri"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<fixedUri value="details"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Extension.extension:details.value[x]">
<path value="Extension.extension.value[x]"/>
<short value="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="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() > 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:scope">
<path value="Extension.extension"/>
<sliceName value="scope"/>
<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() > 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() > 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, Coutnry, Region, or Site"/>
<definition value="Global, Coutnry, Region, or Site."/>
<comment
value="If an amendment applies to all sites in the trial, enter “global” and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter “global”. If the amendment does not apply to all sites in the trial, select “Not Global” and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU)."/>
<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() > 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() > 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() > 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="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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Extension.extension:rationale">
<path value="Extension.extension"/>
<sliceName value="rationale"/>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > 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() > 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() > 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() > 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() > 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="boolean"/>
</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() > 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: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() > 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() > 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() > 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() > 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() > 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="boolean"/>
</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() > 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: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() > 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() > 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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="Extension.extension:primaryReason">
<path value="Extension.extension"/>
<sliceName value="primaryReason"/>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > 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() > 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() > 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-study-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() > 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:details">
<path value="Extension.extension"/>
<sliceName value="details"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:details.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:details.url">
<path value="Extension.extension.url"/>
<fixedUri value="details"/>
</element>
<element id="Extension.extension:details.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="string"/>
</type>
</element>
<element id="Extension.extension:scope">
<path value="Extension.extension"/>
<sliceName value="scope"/>
<min value="0"/>
<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, Coutnry, Region, or Site"/>
<definition value="Global, Coutnry, Region, or Site."/>
<comment
value="If an amendment applies to all sites in the trial, enter “global” and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter “global”. If the amendment does not apply to all sites in the trial, select “Not Global” and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU)."/>
<type>
<code value="string"/>
</type>
</element>
<element id="Extension.extension:description">
<path value="Extension.extension"/>
<sliceName value="description"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:description.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:description.url">
<path value="Extension.extension.url"/>
<fixedUri value="description"/>
</element>
<element id="Extension.extension:description.value[x]">
<path value="Extension.extension.value[x]"/>
<short value="Description"/>
<definition value="Description."/>
<type>
<code value="string"/>
</type>
</element>
<element id="Extension.extension:rationale">
<path value="Extension.extension"/>
<sliceName value="rationale"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:rationale.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:rationale.url">
<path value="Extension.extension.url"/>
<fixedUri value="rationale"/>
</element>
<element id="Extension.extension:rationale.value[x]">
<path value="Extension.extension.value[x]"/>
<short value="Rationale"/>
<definition value="Rationale."/>
<type>
<code value="string"/>
</type>
</element>
<element id="Extension.extension:substantialImpactSafety">
<path value="Extension.extension"/>
<sliceName value="substantialImpactSafety"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:substantialImpactSafety.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:substantialImpactSafety.url">
<path value="Extension.extension.url"/>
<fixedUri value="substantialImpactSafety"/>
</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."/>
<type>
<code value="boolean"/>
</type>
</element>
<element id="Extension.extension:substantialImpactSafetyComment">
<path value="Extension.extension"/>
<sliceName value="substantialImpactSafetyComment"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="Extension.extension:substantialImpactSafetyComment.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:substantialImpactSafetyComment.url">
<path value="Extension.extension.url"/>
<fixedUri value="substantialImpactSafetyComment"/>
</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."/>
<type>
<code value="string"/>
</type>
</element>
<element id="Extension.extension:substantialImpactReliability">
<path value="Extension.extension"/>
<sliceName value="substantialImpactReliability"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:substantialImpactReliability.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:substantialImpactReliability.url">
<path value="Extension.extension.url"/>
<fixedUri value="substantialImpactReliability"/>
</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."/>
<type>
<code value="boolean"/>
</type>
</element>
<element id="Extension.extension:substantialImpactReliabilityComment">
<path value="Extension.extension"/>
<sliceName value="substantialImpactReliabilityComment"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="Extension.extension:substantialImpactReliabilityComment.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element
id="Extension.extension:substantialImpactReliabilityComment.url">
<path value="Extension.extension.url"/>
<fixedUri value="substantialImpactReliabilityComment"/>
</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."/>
<type>
<code value="string"/>
</type>
</element>
<element id="Extension.extension:primaryReason">
<path value="Extension.extension"/>
<sliceName value="primaryReason"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="Extension.extension:primaryReason.extension">
<path value="Extension.extension.extension"/>
<max value="0"/>
</element>
<element id="Extension.extension:primaryReason.url">
<path value="Extension.extension.url"/>
<fixedUri value="primaryReason"/>
</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."/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="Extension.url">
<path value="Extension.url"/>
<fixedUri
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"/>
</element>
<element id="Extension.value[x]">
<path value="Extension.value[x]"/>
<max value="0"/>
</element>
</differential>
</StructureDefinition>
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-snapshot1.
Generated
2026-11-05
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