Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.1.1 - ci-build
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.1.1 - ci-build
Publication Build: This will be filled in by the publication tooling
| Draft as of 2023-10-09 |
XML representation of the eclaire-researchstudy resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="eclaire-researchstudy"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><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 style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy">ResearchStudy</a><a name="ResearchStudy"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/researchstudy.html">ResearchStudy</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.extension:eclaire-review-date" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date">eclaire-review-date</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#instant">instant</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date de dernière modification substancielle<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-review-date.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.extension:eclaire-therapeutic-area" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area">eclaire-therapeutic-area</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Domaine thérapeutique concerné<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-therapeutic-area.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.extension:eclaire-recruitment-period" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period">eclaire-recruitment-period</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#Period">Period</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Période prévisionnelle de recrutement<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-recruitment-period.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.extension:eclaire-secondary-sponsor" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor">eclaire-secondary-sponsor</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="http://hl7.org/fhir/R4/organization.html">Organization</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Promoteur(s) secondaire(s) / Secondary Sponsor(s)<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-secondary-sponsor.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.extension:eclaire-label" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label">eclaire-label</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">autres titres et acronyme / Additional names for the study<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-label.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.identifier">Slices for identifier</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="opacity: 0.5; font-style: italic">0</span><span style="opacity: 0.5; font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Business Identifier for study</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:use</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.identifier:idPrimary" title="Slice idPrimary">identifier:idPrimary</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.identifier:idPrimary.use">use</a><a name="ResearchStudy.identifier.use"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">usual | official | temp | secondary | old (If known)</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">official</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.identifier:idSecondary" title="Slice idSecondary">identifier:idSecondary</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.identifier:idSecondary.use">use</a><a name="ResearchStudy.identifier.use"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">usual | official | temp | secondary | old (If known)</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">secondary</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.title">title</a><a name="ResearchStudy.title"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Nom scientifique de l'étude / Scientific Title</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.status">status</a><a name="ResearchStudy.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Statut de l'essai / Study Status</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.phase">phase</a><a name="ResearchStudy.phase"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Phase de l'essai / Study type : phase<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-eclaire-study-phase-vs.html">Value Set type de phase de l'essai clinique</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.category">category</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Type d'essai / Study type : type of study</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.condition">Slices for condition</a><a name="ResearchStudy.condition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="opacity: 0.5; font-style: italic">0</span><span style="opacity: 0.5; font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Sujet concerné / Problem(s) Studied exemple code MedDRA</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:id</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.condition:medDRACondition" title="Slice medDRACondition">condition:medDRACondition</a><a name="ResearchStudy.condition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">code MedDRA / MedDRA condition<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.condition:medDRACondition.id">id</a><a name="ResearchStudy.condition.id"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unique id for inter-element referencing</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">meddra-condition</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.condition:diseaseCondition" title="Slice diseaseCondition">condition:diseaseCondition</a><a name="ResearchStudy.condition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">condition de la pathologie / Disease Condition<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.condition:diseaseCondition.id">id</a><a name="ResearchStudy.condition.id"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Unique id for inter-element referencing</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">disease-condition</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.contact">contact</a><a name="ResearchStudy.contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/metadatatypes.html#ContactDetail">ContactDetail</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Contact (Contact for public / scientific queries)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck114.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.contact.extension:eclaire-contact-type" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type">eclaire-contact-type</a><a name="ResearchStudy.contact.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Type de contact : Public ou Scientific<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-contact-type.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type</a><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-eclaire-type-contact-vs.html">Type Contact Value Set</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck114.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.contact.extension:eclaire-contact-address" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address">eclaire-contact-address</a><a name="ResearchStudy.contact.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#Address">Address</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adresse du contact<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-contact-address.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck114.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.contact.extension:eclaire-contact-affiliation" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation">eclaire-contact-affiliation</a><a name="ResearchStudy.contact.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Affiliation du contact<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-contact-affiliation.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck104.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.contact.extension:eclaire-contact-name" title="Extension URL = https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name">eclaire-contact-name</a><a name="ResearchStudy.contact.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#HumanName">HumanName</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Nom du contact<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-eclaire-contact-name.html">https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.location">location</a><a name="ResearchStudy.location"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pays de recrutement / Countries of Recruitment</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.description">description</a><a name="ResearchStudy.description"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Résumé de l'essai / Summary Results</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.enrollment">enrollment</a><a name="ResearchStudy.enrollment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5" href="http://hl7.org/fhir/R4/group.html">Group</a>)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.sponsor">sponsor</a><a name="ResearchStudy.sponsor"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5" href="http://hl7.org/fhir/R4/organization.html">Organization</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Promoteur / primary Sponsor</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-eclaire-researchstudy-definitions.html#ResearchStudy.site">site</a><a name="ResearchStudy.site"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5" href="http://hl7.org/fhir/R4/location.html">Location</a>)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Lieux / Countries of Recruitment</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<url
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy"/>
<version value="0.1.1"/>
<name value="ECLAIREResearchStudy"/>
<status value="draft"/>
<date value="2023-10-09T08:51:32+00:00"/>
<publisher value="ANS"/>
<contact>
<name value="ANS"/>
<telecom>
<system value="url"/>
<value value="https://esante.gouv.fr"/>
</telecom>
</contact>
<description value="Profil de ResearchStudy pour le projet ECLAIRE"/>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="BRIDG5.1"/>
<uri value="https://bridgmodel.nci.nih.gov"/>
<name value="BRIDG 5.1 Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 v2 Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<uri value="http://clinicaltrials.gov"/>
<name value="ClinicalTrials.gov Mapping"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="ResearchStudy"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
<derivation value="constraint"/>
<snapshot>
<element id="ResearchStudy">
<path value="ResearchStudy"/>
<short
value="Investigation to increase healthcare-related patient-independent knowledge"/>
<definition
value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects."/>
<comment value="Need to make sure we encompass public health studies."/>
<alias value="Clinical Trial"/>
<alias value="Study"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<xpath value="not(parent::f:contained and f:contained)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<xpath
value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchStudy.id">
<path value="ResearchStudy.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isSummary value="true"/>
</element>
<element id="ResearchStudy.meta">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.implicitRules">
<path value="ResearchStudy.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.language">
<path value="ResearchStudy.language"/>
<short value="Language of the resource content"/>
<definition
value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="ResearchStudy.contained">
<path value="ResearchStudy.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.extension:eclaire-review-date">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-review-date"/>
<short value="Date de dernière modification substancielle"/>
<definition
value="Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout d'une date de révision fonctionnelle lorque que l'on souhaite indiquer la date de la dernière modification substancielle"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-therapeutic-area">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-therapeutic-area"/>
<short value="Domaine thérapeutique concerné"/>
<definition
value="Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout du domaine thérapeutique concerné par l'essai"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-recruitment-period">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-recruitment-period"/>
<short value="Période prévisionnelle de recrutement"/>
<definition
value="Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de la période prévisionnelle de recrutement l'essai"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-secondary-sponsor">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-secondary-sponsor"/>
<short value="Promoteur(s) secondaire(s) / Secondary Sponsor(s)"/>
<definition
value="Extension créée dans le cadre du projet API ECLAIRE afin de pouvoir renseigner le(s) promoteur(s) secondaire(s)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-label">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-label"/>
<short
value="autres titres et acronyme / Additional names for the study"/>
<definition
value="Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de plusieurs titres pour l'essai"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.modifierExtension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.modifierExtension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.identifier">
<path value="ResearchStudy.identifier"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="use"/>
</discriminator>
<description
value="Slicing pour les différents identifiants de l'essai clinique"/>
<rules value="open"/>
</slicing>
<short value="Business Identifier for study"/>
<definition
value="Identifiers assigned to this research study by the sponsor or other systems."/>
<requirements
value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map
value="CX / EI (occasionally, more often EI maps to a resource id or a URL)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="Identifier"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Organization's Unique Protocol ID; Secondary IDs"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary">
<path value="ResearchStudy.identifier"/>
<sliceName value="idPrimary"/>
<short
value="Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number"/>
<definition
value="Identifiers assigned to this research study by the sponsor or other systems."/>
<requirements
value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map
value="CX / EI (occasionally, more often EI maps to a resource id or a URL)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="Identifier"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Organization's Unique Protocol ID; Secondary IDs"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.id">
<path value="ResearchStudy.identifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.use">
<path value="ResearchStudy.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="official"/>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.type">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.system">
<path value="ResearchStudy.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</example>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.value">
<path value="ResearchStudy.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.period">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<comment
value="A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="per-1"/>
<severity value="error"/>
<human value="If present, start SHALL have a lower value than end"/>
<expression
value="start.hasValue().not() or end.hasValue().not() or (start <= end)"/>
<xpath
value="not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="DR"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idPrimary.assigner">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary">
<path value="ResearchStudy.identifier"/>
<sliceName value="idSecondary"/>
<short
value="identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided."/>
<definition
value="Identifiers assigned to this research study by the sponsor or other systems."/>
<requirements
value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map
value="CX / EI (occasionally, more often EI maps to a resource id or a URL)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="Identifier"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Organization's Unique Protocol ID; Secondary IDs"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.id">
<path value="ResearchStudy.identifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.use">
<path value="ResearchStudy.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<patternCode value="secondary"/>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.type">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.system">
<path value="ResearchStudy.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</example>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.value">
<path value="ResearchStudy.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.period">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<comment
value="A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="per-1"/>
<severity value="error"/>
<human value="If present, start SHALL have a lower value than end"/>
<expression
value="start.hasValue().not() or end.hasValue().not() or (start <= end)"/>
<xpath
value="not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="DR"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="ResearchStudy.identifier:idSecondary.assigner">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="ResearchStudy.title">
<path value="ResearchStudy.title"/>
<short value="Nom scientifique de l'étude / Scientific Title"/>
<definition
value="A short, descriptive user-friendly label for the study."/>
<comment value="Note that FHIR strings SHALL NOT exceed 1MB in size"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Brief Title"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/>
</mapping>
</element>
<element id="ResearchStudy.protocol">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.protocol"/>
<short value="Steps followed in executing study"/>
<definition
value="The set of steps expected to be performed as part of the execution of the study."/>
<comment
value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.protocol"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Interventions; Arm/Intervention Cross-Reference"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocumentVersionPublicTitle.name"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".outboundRelationship[typeCode=DEFN].target"/>
</mapping>
</element>
<element id="ResearchStudy.partOf">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.partOf"/>
<short value="Part of larger study"/>
<definition
value="A larger research study of which this particular study is a component or step."/>
<comment
value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository."/>
<requirements
value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/>
<alias value="container"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.partOf"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="CompanionStudyRelationship"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchStudy.status">
<path value="ResearchStudy.status"/>
<short value="Statut de l'essai / Study Status"/>
<definition value="The current state of the study."/>
<comment value="Note that FHIR strings SHALL NOT exceed 1MB in size"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchStudy.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyStatus"/>
</extension>
<strength value="required"/>
<description
value="Codes that convey the current status of the research study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyOverallStatus.code"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
</element>
<element id="ResearchStudy.primaryPurposeType">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.primaryPurposeType"/>
<short
value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/>
<definition
value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.primaryPurposeType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyPrimaryPurposeType"/>
</extension>
<strength value="extensible"/>
<description value="Codes for the main intent of the study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.primaryPurposeTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.phase">
<path value="ResearchStudy.phase"/>
<short value="Phase de l'essai / Study type : phase"/>
<definition
value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.phase"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Study Phase"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.phaseCode"/>
</mapping>
</element>
<element id="ResearchStudy.category">
<path value="ResearchStudy.category"/>
<short value="Type d'essai / Study type : type of study"/>
<definition
value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.category"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyCategory"/>
</extension>
<strength value="example"/>
<description
value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.focus">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.focus"/>
<short value="Drugs, devices, etc. under study"/>
<definition
value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.focus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyFocus"/>
</extension>
<strength value="example"/>
<description
value="Codes for medications, devices and other interventions."/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Focus of Study"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="InterventionalStudyProtocol.interventionTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.condition">
<path value="ResearchStudy.condition"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="id"/>
</discriminator>
<description
value="Slicing pour apporter des précisions sur le sujet / Health Condition(s) or Problem(s) Studied"/>
<rules value="open"/>
</slicing>
<short
value="Sujet concerné / Problem(s) Studied exemple code MedDRA"/>
<definition
value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.condition"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ConditionCode"/>
</extension>
<strength value="example"/>
<description value="Identification of the condition or diagnosis."/>
<valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Conditions"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyCondition.code"/>
</mapping>
</element>
<element id="ResearchStudy.condition:medDRACondition">
<path value="ResearchStudy.condition"/>
<sliceName value="medDRACondition"/>
<short value="code MedDRA / MedDRA condition"/>
<definition
value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.condition"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ConditionCode"/>
</extension>
<strength value="example"/>
<description value="Identification of the condition or diagnosis."/>
<valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Conditions"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyCondition.code"/>
</mapping>
</element>
<element id="ResearchStudy.condition:medDRACondition.id">
<path value="ResearchStudy.condition.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<patternString value="meddra-condition"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.condition:medDRACondition.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.condition.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.condition:medDRACondition.coding">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.condition.coding"/>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map
value="CE/CNE/CWE subset one of the sets of component 1-3 or 4-6"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CV"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:Coding rdfs:subClassOf dt:CDCoding"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="ResearchStudy.condition:medDRACondition.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="ResearchStudy.condition.text"/>
<short value="Plain text representation of the concept"/>
<definition
value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
<comment
value="Very often the text is the same as a displayName of one of the codings."/>
<requirements
value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="CodeableConcept.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="C*E.9. But note many systems use C*E.2 for this"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./originalText[mediaType/code="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="ResearchStudy.condition:diseaseCondition">
<path value="ResearchStudy.condition"/>
<sliceName value="diseaseCondition"/>
<short value="condition de la pathologie / Disease Condition"/>
<definition
value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.condition"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ConditionCode"/>
</extension>
<strength value="example"/>
<description value="Identification of the condition or diagnosis."/>
<valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Conditions"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyCondition.code"/>
</mapping>
</element>
<element id="ResearchStudy.condition:diseaseCondition.id">
<path value="ResearchStudy.condition.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<patternString value="disease-condition"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.condition:diseaseCondition.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.condition.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.condition:diseaseCondition.coding">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.condition.coding"/>
<short value="Code defined by a terminology system"/>
<definition
value="A reference to a code defined by a terminology system."/>
<comment
value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
<requirements
value="Allows for alternative encodings within a code system, and translations to other code systems."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="CodeableConcept.coding"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Coding"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map
value="CE/CNE/CWE subset one of the sets of component 1-3 or 4-6"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CV"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:Coding rdfs:subClassOf dt:CDCoding"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="C*E.1-8, C*E.10-22"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="union(., ./translation)"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
</mapping>
</element>
<element id="ResearchStudy.condition:diseaseCondition.text">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="ResearchStudy.condition.text"/>
<short value="Plain text representation of the concept"/>
<definition
value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
<comment
value="Very often the text is the same as a displayName of one of the codings."/>
<requirements
value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="CodeableConcept.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="C*E.9. But note many systems use C*E.2 for this"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="./originalText[mediaType/code="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="ResearchStudy.contact">
<path value="ResearchStudy.contact"/>
<short value="Contact (Contact for public / scientific queries)"/>
<definition
value="Contact details to assist a user in learning more about or engaging with the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.contact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"/>
</mapping>
</element>
<element id="ResearchStudy.contact.id">
<path value="ResearchStudy.contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.contact.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-type">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-type"/>
<short value="Type de contact : Public ou Scientific"/>
<definition
value="Extension créée dans le cadre du projet ECLAIRE qui indique le type de Contact : Public ou Scientific"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-address">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-address"/>
<short value="Adresse du contact"/>
<definition
value="Extension créée dans le cadre du projet ECLAIRE pour indiquer l'adresse du contact"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element
id="ResearchStudy.contact.extension:eclaire-contact-affiliation">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-affiliation"/>
<short value="Affiliation du contact"/>
<definition
value="Extension créée dans le cadre du projet ECLAIRE pour indiquer l'affiliation du contact"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-name">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-name"/>
<short value="Nom du contact"/>
<definition
value="Extension créée dans le cadre du projet ECLAIRE pour indiquer le nom de contact"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
</element>
<element id="ResearchStudy.contact.name">
<path value="ResearchStudy.contact.name"/>
<short value="Name of an individual to contact"/>
<definition value="The name of an individual to contact."/>
<comment
value="If there is no named individual, the telecom information is for the organization as a whole."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ContactDetail.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.contact.telecom">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.contact.telecom"/>
<short value="Contact details for individual or organization"/>
<definition
value="The contact details for the individual (if a name was provided) or the organization."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ContactDetail.telecom"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactPoint"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="cpt-2"/>
<severity value="error"/>
<human value="A system is required if a value is provided."/>
<expression value="value.empty() or system.exists()"/>
<xpath value="not(exists(f:value)) or exists(f:system)"/>
<source value="http://hl7.org/fhir/StructureDefinition/Device"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="XTN"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="TEL"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="ContactPoint"/>
</mapping>
</element>
<element id="ResearchStudy.relatedArtifact">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="trial-use"/>
</extension>
<path value="ResearchStudy.relatedArtifact"/>
<short value="References and dependencies"/>
<definition value="Citations, references and other related documents."/>
<comment
value="Each related artifact is either an attachment, or a reference to another knowledge resource, but not both."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.relatedArtifact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="RelatedArtifact"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Citations, Links, Available Study Data/Documents"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/>
</mapping>
</element>
<element id="ResearchStudy.keyword">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.keyword"/>
<short value="Used to search for the study"/>
<definition
value="Key terms to aid in searching for or filtering the study."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.keyword"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyKeyword"/>
</extension>
<strength value="example"/>
<description
value="Words associated with the study that may be useful in discovery."/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Keywords"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/>
</mapping>
</element>
<element id="ResearchStudy.location">
<path value="ResearchStudy.location"/>
<short value="Pays de recrutement / Countries of Recruitment"/>
<definition
value="Indicates a country, state or other region where the study is taking place."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.location"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Jurisdiction"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="extensible"/>
<description
value="Countries and regions within which this artifact is targeted for use."/>
<valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.participatingLocationCode"/>
</mapping>
</element>
<element id="ResearchStudy.description">
<path value="ResearchStudy.description"/>
<short value="Résumé de l'essai / Summary Results"/>
<definition
value="A full description of how the study is being conducted."/>
<comment
value="Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Detailed Description"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocumentVersion.publicDescription"/>
</mapping>
</element>
<element id="ResearchStudy.enrollment">
<path value="ResearchStudy.enrollment"/>
<short
value="Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria"/>
<definition
value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"."/>
<comment
value="The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource."/>
<alias value="patient"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.enrollment"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="InterventionalStudyProtocol.interventionGroupQuantity"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".participation[typeCode=SBJ].role"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject"/>
</mapping>
</element>
<element id="ResearchStudy.period">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.period"/>
<short value="When the study began and ended"/>
<definition
value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/>
<comment
value="A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").
Period is not used for a duration (a measure of elapsed time). See [Duration](http://hl7.org/fhir/R4/datatypes.html#Duration)."/>
<alias value="timing"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="per-1"/>
<severity value="error"/>
<human value="If present, start SHALL have a lower value than end"/>
<expression
value="start.hasValue().not() or end.hasValue().not() or (start <= end)"/>
<xpath
value="not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="DR"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Study Start Date (start); Study Completion Date (end)"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.done[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".effectiveTime"/>
</mapping>
</element>
<element id="ResearchStudy.sponsor">
<path value="ResearchStudy.sponsor"/>
<short value="Promoteur / primary Sponsor"/>
<definition
value="An organization that initiates the investigation and is legally responsible for the study."/>
<comment
value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.sponsor"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Sponsor"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.actor"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.principalInvestigator"/>
<short value="Researcher who oversees multiple aspects of the study"/>
<definition
value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/>
<comment
value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.principalInvestigator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Principal Investigator"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.actor"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyInvestigator"/>
</mapping>
</element>
<element id="ResearchStudy.site">
<path value="ResearchStudy.site"/>
<short value="Lieux / Countries of Recruitment"/>
<definition
value="A facility in which study activities are conducted."/>
<comment
value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.site"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Location"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ref-1"/>
<severity value="error"/>
<human
value="SHALL have a contained resource if a local reference is provided"/>
<expression
value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))"/>
<xpath
value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/RequestGroup"/>
</constraint>
<mustSupport value="true"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Facility"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.where[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="PlannedStudySite; StudySite"/>
</mapping>
</element>
<element id="ResearchStudy.reasonStopped">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.reasonStopped"/>
<short
value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design"/>
<definition
value="A description and/or code explaining the premature termination of the study."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.reasonStopped"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyReasonStopped"/>
</extension>
<strength value="example"/>
<description value="Codes for why the study ended prematurely."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Why Study Stopped"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.why[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyOverallStatus.studyStoppedReasonCode"/>
</mapping>
</element>
<element id="ResearchStudy.note">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.note"/>
<short value="Comments made about the study"/>
<definition
value="Comments made about the study by the performer, subject or other participants."/>
<comment
value="For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. *Annotations SHOULD NOT* be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.note"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Annotation"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Act"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="No BRIDG mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/>
</mapping>
</element>
<element id="ResearchStudy.arm">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.arm"/>
<short value="Defined path through the study for a subject"/>
<definition
value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.arm"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arms"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm"/>
</mapping>
</element>
<element id="ResearchStudy.arm.id">
<path value="ResearchStudy.arm.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.arm.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.arm.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.arm.modifierExtension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.arm.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.arm.name">
<path value="ResearchStudy.arm.name"/>
<short value="Label for study arm"/>
<definition
value="Unique, human-readable label for this arm of the study."/>
<comment value="Note that FHIR strings SHALL NOT exceed 1MB in size"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Label"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.name"/>
</mapping>
</element>
<element id="ResearchStudy.arm.type">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.arm.type"/>
<short value="Categorization of study arm"/>
<definition
value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Type"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.typeCode"/>
</mapping>
</element>
<element id="ResearchStudy.arm.description">
<path value="ResearchStudy.arm.description"/>
<short value="Short explanation of study path"/>
<definition
value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/>
<comment value="Note that FHIR strings SHALL NOT exceed 1MB in size"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Description"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.description"/>
</mapping>
</element>
<element id="ResearchStudy.objective">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.objective"/>
<short value="A goal for the study"/>
<definition
value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.objective"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyObjective"/>
</mapping>
</element>
<element id="ResearchStudy.objective.id">
<path value="ResearchStudy.objective.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.objective.extension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.objective.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.objective.modifierExtension">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.objective.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.objective.name">
<path value="ResearchStudy.objective.name"/>
<short value="Label for the objective"/>
<definition
value="Unique, human-readable label for this objective of the study."/>
<comment value="Note that FHIR strings SHALL NOT exceed 1MB in size"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.objective.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (BRIDG has a description, but not a name)"/>
</mapping>
</element>
<element id="ResearchStudy.objective.type">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="normative"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
<valueCode value="4.0.0"/>
</extension>
<path value="ResearchStudy.objective.type"/>
<short value="primary | secondary | exploratory"/>
<definition value="The kind of study objective."/>
<comment
value="Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.objective.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyObjectiveType"/>
</extension>
<strength value="preferred"/>
<description value="Codes for the kind of study objective."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/>
</binding>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="CE/CNE/CWE"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="CD"/>
</mapping>
<mapping>
<identity value="orim"/>
<map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyObjective.typeCode"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="ResearchStudy">
<path value="ResearchStudy"/>
</element>
<element id="ResearchStudy.extension:eclaire-review-date">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-review-date"/>
<short value="Date de dernière modification substancielle"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-therapeutic-area">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-therapeutic-area"/>
<short value="Domaine thérapeutique concerné"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-recruitment-period">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-recruitment-period"/>
<short value="Période prévisionnelle de recrutement"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-secondary-sponsor">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-secondary-sponsor"/>
<short value="Promoteur(s) secondaire(s) / Secondary Sponsor(s)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.extension:eclaire-label">
<path value="ResearchStudy.extension"/>
<sliceName value="eclaire-label"/>
<short
value="autres titres et acronyme / Additional names for the study"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.identifier">
<path value="ResearchStudy.identifier"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="use"/>
</discriminator>
<description
value="Slicing pour les différents identifiants de l'essai clinique"/>
<rules value="open"/>
</slicing>
</element>
<element id="ResearchStudy.identifier:idPrimary">
<path value="ResearchStudy.identifier"/>
<sliceName value="idPrimary"/>
<short
value="Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number"/>
<min value="0"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.identifier:idPrimary.use">
<path value="ResearchStudy.identifier.use"/>
<min value="1"/>
<patternCode value="official"/>
</element>
<element id="ResearchStudy.identifier:idSecondary">
<path value="ResearchStudy.identifier"/>
<sliceName value="idSecondary"/>
<short
value="identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided."/>
<min value="0"/>
<max value="*"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.identifier:idSecondary.use">
<path value="ResearchStudy.identifier.use"/>
<min value="1"/>
<patternCode value="secondary"/>
</element>
<element id="ResearchStudy.title">
<path value="ResearchStudy.title"/>
<short value="Nom scientifique de l'étude / Scientific Title"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.status">
<path value="ResearchStudy.status"/>
<short value="Statut de l'essai / Study Status"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.phase">
<path value="ResearchStudy.phase"/>
<short value="Phase de l'essai / Study type : phase"/>
<mustSupport value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs"/>
</binding>
</element>
<element id="ResearchStudy.category">
<path value="ResearchStudy.category"/>
<short value="Type d'essai / Study type : type of study"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.condition">
<path value="ResearchStudy.condition"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="id"/>
</discriminator>
<description
value="Slicing pour apporter des précisions sur le sujet / Health Condition(s) or Problem(s) Studied"/>
<rules value="open"/>
</slicing>
<short
value="Sujet concerné / Problem(s) Studied exemple code MedDRA"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.condition:medDRACondition">
<path value="ResearchStudy.condition"/>
<sliceName value="medDRACondition"/>
<short value="code MedDRA / MedDRA condition"/>
<min value="0"/>
<max value="*"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.condition:medDRACondition.id">
<path value="ResearchStudy.condition.id"/>
<min value="1"/>
<patternString value="meddra-condition"/>
</element>
<element id="ResearchStudy.condition:diseaseCondition">
<path value="ResearchStudy.condition"/>
<sliceName value="diseaseCondition"/>
<short value="condition de la pathologie / Disease Condition"/>
<min value="0"/>
<max value="*"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.condition:diseaseCondition.id">
<path value="ResearchStudy.condition.id"/>
<min value="1"/>
<patternString value="disease-condition"/>
</element>
<element id="ResearchStudy.contact">
<path value="ResearchStudy.contact"/>
<short value="Contact (Contact for public / scientific queries)"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-type">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-type"/>
<short value="Type de contact : Public ou Scientific"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-address">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-address"/>
<short value="Adresse du contact"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address"/>
</type>
<mustSupport value="true"/>
</element>
<element
id="ResearchStudy.contact.extension:eclaire-contact-affiliation">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-affiliation"/>
<short value="Affiliation du contact"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.contact.extension:eclaire-contact-name">
<path value="ResearchStudy.contact.extension"/>
<sliceName value="eclaire-contact-name"/>
<short value="Nom du contact"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name"/>
</type>
</element>
<element id="ResearchStudy.location">
<path value="ResearchStudy.location"/>
<short value="Pays de recrutement / Countries of Recruitment"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.description">
<path value="ResearchStudy.description"/>
<short value="Résumé de l'essai / Summary Results"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.enrollment">
<path value="ResearchStudy.enrollment"/>
<short
value="Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.sponsor">
<path value="ResearchStudy.sponsor"/>
<short value="Promoteur / primary Sponsor"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.site">
<path value="ResearchStudy.site"/>
<short value="Lieux / Countries of Recruitment"/>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2020+ ANS. Package ans.fhir.fr.eclaire#0.1.1 based on FHIR 4.0.1. Generated 2023-10-09
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