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 |
JSON representation of the research-study-study-amendment extension.
{
"resourceType" : "StructureDefinition",
"id" : "research-study-study-amendment",
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition research-study-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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1350.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<tr class=\"xhtRowBorder0 xhtRowOdd\"><td style=\"background-image: url(tbl_bck1250.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<tr class=\"xhtRowBorder0 xhtRowEven\"><td style=\"background-image: url(tbl_bck1250.png)\" class=\"hierarchy xhtCellBorder0 xhtCellNoWrap\"><img src=\"tbl_spacer.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\"\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_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>\r\n<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>\r\n<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>\r\n<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>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
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{
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},
{
"id" : "Extension.extension:description.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "description",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:description.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Description",
"definition" : "Description.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:rationale",
"path" : "Extension.extension",
"sliceName" : "rationale",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:rationale.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:rationale.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:rationale.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "rationale",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:rationale.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Rationale",
"definition" : "Rationale.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafety",
"path" : "Extension.extension",
"sliceName" : "substantialImpactSafety",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactSafety.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafety.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactSafety.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "substantialImpactSafety",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafety.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Substantial impact on safety",
"definition" : "Substantial impact on safety.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafetyComment",
"path" : "Extension.extension",
"sliceName" : "substantialImpactSafetyComment",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "substantialImpactSafetyComment",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Comment on substantial impact on safety",
"definition" : "Comment on substantial impact on safety.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliability",
"path" : "Extension.extension",
"sliceName" : "substantialImpactReliability",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactReliability.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliability.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactReliability.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "substantialImpactReliability",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliability.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Substantial impact on reliability",
"definition" : "Substantial impact on reliability.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment",
"path" : "Extension.extension",
"sliceName" : "substantialImpactReliabilityComment",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "substantialImpactReliabilityComment",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Comment on substantial impact on reliability",
"definition" : "Comment on substantial impact on reliability.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:primaryReason",
"path" : "Extension.extension",
"sliceName" : "primaryReason",
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:primaryReason.id",
"path" : "Extension.extension.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"condition" : [
"ele-1"
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Extension.extension:primaryReason.extension",
"path" : "Extension.extension.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Extension.extension:primaryReason.url",
"path" : "Extension.extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "primaryReason",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.extension:primaryReason.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Reason for amendment, e.g. Safety",
"definition" : "Reason for amendment, e.g. Safety.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.url",
"path" : "Extension.url",
"representation" : [
"xmlAttr"
],
"short" : "identifies the meaning of the extension",
"definition" : "Source of the definition for the extension code - a logical name or a URL.",
"comment" : "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Extension.url",
"min" : 1,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "uri"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment",
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Extension.value[x]",
"path" : "Extension.value[x]",
"short" : "Value of extension",
"definition" : "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"min" : 0,
"max" : "0",
"base" : {
"path" : "Extension.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "base64Binary"
},
{
"code" : "boolean"
},
{
"code" : "canonical"
},
{
"code" : "code"
},
{
"code" : "date"
},
{
"code" : "dateTime"
},
{
"code" : "decimal"
},
{
"code" : "id"
},
{
"code" : "instant"
},
{
"code" : "integer"
},
{
"code" : "integer64"
},
{
"code" : "markdown"
},
{
"code" : "oid"
},
{
"code" : "positiveInt"
},
{
"code" : "string"
},
{
"code" : "time"
},
{
"code" : "unsignedInt"
},
{
"code" : "uri"
},
{
"code" : "url"
},
{
"code" : "uuid"
},
{
"code" : "Address"
},
{
"code" : "Age"
},
{
"code" : "Annotation"
},
{
"code" : "Attachment"
},
{
"code" : "CodeableConcept"
},
{
"code" : "CodeableReference"
},
{
"code" : "Coding"
},
{
"code" : "ContactPoint"
},
{
"code" : "Count"
},
{
"code" : "Distance"
},
{
"code" : "Duration"
},
{
"code" : "HumanName"
},
{
"code" : "Identifier"
},
{
"code" : "Money"
},
{
"code" : "Period"
},
{
"code" : "Quantity"
},
{
"code" : "Range"
},
{
"code" : "Ratio"
},
{
"code" : "RatioRange"
},
{
"code" : "Reference"
},
{
"code" : "SampledData"
},
{
"code" : "Signature"
},
{
"code" : "Timing"
},
{
"code" : "ContactDetail"
},
{
"code" : "DataRequirement"
},
{
"code" : "Expression"
},
{
"code" : "ParameterDefinition"
},
{
"code" : "RelatedArtifact"
},
{
"code" : "TriggerDefinition"
},
{
"code" : "UsageContext"
},
{
"code" : "Availability"
},
{
"code" : "ExtendedContactDetail"
},
{
"code" : "VirtualServiceDetail"
},
{
"code" : "Dosage"
},
{
"code" : "Meta"
}
],
"condition" : [
"ext-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
}
]
},
"differential" : {
"element" : [
{
"id" : "Extension",
"path" : "Extension",
"short" : "An amendment to a study protocol",
"definition" : "An amendment to a study protocol."
},
{
"id" : "Extension.extension:details",
"path" : "Extension.extension",
"sliceName" : "details",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:details.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:details.url",
"path" : "Extension.extension.url",
"fixedUri" : "details"
},
{
"id" : "Extension.extension:details.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Statement regarding prior amendments",
"definition" : "Statement regarding prior amendments.",
"comment" : "State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).",
"type" : [
{
"code" : "string"
}
]
},
{
"id" : "Extension.extension:scope",
"path" : "Extension.extension",
"sliceName" : "scope",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:scope.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:scope.url",
"path" : "Extension.extension.url",
"fixedUri" : "scope"
},
{
"id" : "Extension.extension:scope.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Global, Coutnry, Region, or Site",
"definition" : "Global, Coutnry, Region, or Site.",
"comment" : "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" : "string"
}
]
},
{
"id" : "Extension.extension:description",
"path" : "Extension.extension",
"sliceName" : "description",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:description.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:description.url",
"path" : "Extension.extension.url",
"fixedUri" : "description"
},
{
"id" : "Extension.extension:description.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Description",
"definition" : "Description.",
"type" : [
{
"code" : "string"
}
]
},
{
"id" : "Extension.extension:rationale",
"path" : "Extension.extension",
"sliceName" : "rationale",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:rationale.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:rationale.url",
"path" : "Extension.extension.url",
"fixedUri" : "rationale"
},
{
"id" : "Extension.extension:rationale.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Rationale",
"definition" : "Rationale.",
"type" : [
{
"code" : "string"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafety",
"path" : "Extension.extension",
"sliceName" : "substantialImpactSafety",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:substantialImpactSafety.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:substantialImpactSafety.url",
"path" : "Extension.extension.url",
"fixedUri" : "substantialImpactSafety"
},
{
"id" : "Extension.extension:substantialImpactSafety.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Substantial impact on safety",
"definition" : "Substantial impact on safety.",
"type" : [
{
"code" : "boolean"
}
]
},
{
"id" : "Extension.extension:substantialImpactSafetyComment",
"path" : "Extension.extension",
"sliceName" : "substantialImpactSafetyComment",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.url",
"path" : "Extension.extension.url",
"fixedUri" : "substantialImpactSafetyComment"
},
{
"id" : "Extension.extension:substantialImpactSafetyComment.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Comment on substantial impact on safety",
"definition" : "Comment on substantial impact on safety.",
"type" : [
{
"code" : "string"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliability",
"path" : "Extension.extension",
"sliceName" : "substantialImpactReliability",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:substantialImpactReliability.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:substantialImpactReliability.url",
"path" : "Extension.extension.url",
"fixedUri" : "substantialImpactReliability"
},
{
"id" : "Extension.extension:substantialImpactReliability.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Substantial impact on reliability",
"definition" : "Substantial impact on reliability.",
"type" : [
{
"code" : "boolean"
}
]
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment",
"path" : "Extension.extension",
"sliceName" : "substantialImpactReliabilityComment",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.url",
"path" : "Extension.extension.url",
"fixedUri" : "substantialImpactReliabilityComment"
},
{
"id" : "Extension.extension:substantialImpactReliabilityComment.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Comment on substantial impact on reliability",
"definition" : "Comment on substantial impact on reliability.",
"type" : [
{
"code" : "string"
}
]
},
{
"id" : "Extension.extension:primaryReason",
"path" : "Extension.extension",
"sliceName" : "primaryReason",
"min" : 0,
"max" : "1"
},
{
"id" : "Extension.extension:primaryReason.extension",
"path" : "Extension.extension.extension",
"max" : "0"
},
{
"id" : "Extension.extension:primaryReason.url",
"path" : "Extension.extension.url",
"fixedUri" : "primaryReason"
},
{
"id" : "Extension.extension:primaryReason.value[x]",
"path" : "Extension.extension.value[x]",
"short" : "Reason for amendment, e.g. Safety",
"definition" : "Reason for amendment, e.g. Safety.",
"type" : [
{
"code" : "CodeableConcept"
}
]
},
{
"id" : "Extension.url",
"path" : "Extension.url",
"fixedUri" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"
},
{
"id" : "Extension.value[x]",
"path" : "Extension.value[x]",
"max" : "0"
}
]
}
}
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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