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| Responsible Owner: Biomedical Research and Regulation Work Group | Standards Status : Informative | Compartments : Device , Group , Patient |
Raw XML ( canonical form + also see XML Format Specification )
StructureDefinition for researchsubject
<?xml version="1.0" encoding="UTF-8"?>vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=) data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg== data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAACC ElEQVQ4y4XTv2sUQRTA8e9Mzt3kjoOLSXFgZ6GJQlALCysLC89OsLTXv0VFxE4stRAEQUghSWEXuM4qMZpATsUD70dyMdnduZ15z2 IvMV5IfDDNm5nPm59GVTkpms1mTVXvhxDuichlEZn03m+KyJL3/mWj0fiKqp7YVlZWXrfbbR2PTqeji4uLn1WVEqdECKFRr9eP5Wd nZ/HeXwROB0TEA3S7XarVKiLC1tYW8/PzeO/5LxBCUABrLXEc02q1KJfLB30F0P144dPU9LVL1kwcrU06WP0ewhML4JwDYDgcHo7I 87wAjNq5ypU3Z8arT8F5u/xejw52zmGM+Rcg1wyIcc/BTYCdBlODyh3ElA1AHMekaUoURURRBECWZSNgaGzBxxAU9jfQ9jrJr2dcb bXobRYHlQAzo9X1gDR9+KUArE6CwLefZD9WCW6P0uRZKreXqADkHXZ3dshzjwRholJH397AOXcTwHTfzQ1n7q6NnYEAy+DWQVNwKW QJ6vcx557Se7HAzIN1M9rCwVteA/rAYDRRICQgSZEr7WLYO3bzJVJGQBu0D74PkoHkoBnIHvjfkO9AGABmDHCjFWgH8i7kPQh9yEe YH4DfLhBJgA2A7BBQJ9uwXWY3rhJqFo1AaiB1CBngwKZQcqAeSFSduL9Akj7qPF64jnALS5VTPwdgPwwJ+uog9Qcx4kRZiPKqxgAA AABJRU5ErkJggg== ResearchSubject : A physical entity which is the primary unit of operational and/or administrative interest in a study. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6 vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxPhysical entity which is the primary unit of interest in the study Elements defined in Ancestors: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.,<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="ResearchSubject"/> <meta> <lastUpdated value="2025-11-08T11:23:29.301+00:00"/> </meta> <text> <status value="generated"/> <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 class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px"> <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 class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px"> <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 class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px"> <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 class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px"> <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 alt="doco" src="data:(snipped in html view)" style="background-color: inherit"/> </a> </span> </th> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAg DsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Resource"/> <span title="ResearchSubject : A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.">ResearchSubject</span> <a name="ResearchSubject"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6; padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="domainresource.html">DomainResource</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Participant or object which is the recipient of investigative activities in a study <br/> <br/> Elements defined in Ancestors: <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.">id</a> , <a href="resource.html#Resource" title="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., 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., , 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., 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.,Changes to the content might not always be associated with version changes to the resource.">meta</a> , <a href="resource.html#Resource" title="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. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the [additionalImplicitRules](https://build.fhir.org/ig/HL7/fh ir-extensions/StructureDefinition-additionalImplicitRules.html) extension.">implicitRules</a> , <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , <a href="domainresource.html#DomainResource" title="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.">text</a> , <a href="domainresource.html#DomainResource" title="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.">contained</a> , <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definitionof 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.,of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.">extension</a> , <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definitionof 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. 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text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxBusiness Identifier for research subject in a study vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=) data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg== data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAR klEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4Ov TRgwAAAABJRU5ErkJggg== vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn ( ) vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data: image/png;base64,iV BORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6 EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg== data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data: image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQk ad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRP z58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPv szv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866O UPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6i f3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hY wbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iS FVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 ResearchSubject.period : The dates the subject began and ended their participation in the study. vertical-align: top; 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text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px ( ) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px Documentation for this format A physical entity which is the primary unit of operational and/or administrative interest in a study. A physical entity which is the primary unit of operational and/or administrative interest in a study. 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonica l) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(refer ence = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(c anonical) = '#').exists()).not()).trace('unmatched', id).empty() not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:refere nce/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])])) If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated 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. The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) -->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 managable, 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).">modifierExtension</a> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.identifier : Identifiers assigned to this research subject for a study.">identifier</span> <a name="ResearchSubject.identifier"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Identifier">Identifier</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Business Identifier for research subject in a study <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.status : The publication state of the resource (not of the subject).">status</span> <a name="ResearchSubject.status"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</a> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#code">code</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">draft | active | retired | unknown <br/> Binding: <a href="valueset-publication-status.html">PublicationStatus</a> ( <a href="terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">Required</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.period : The dates the subject began and ended their participation in the study.">period</span> <a name="ResearchSubject.period"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Period">Period</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Start and end of participation <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.study : Reference to the study the subject is participating in.">study</span> <a name="ResearchSubject.study"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="researchstudy.html">ResearchStudy</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Study subject is part of <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.subject : The record of the person, animal or other entity involved in the study.">subject</span> <a name="ResearchSubject.subject"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null; padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="patient.html">Patient</a> | <a href="group.html">Group</a> | <a href="specimen.html">Specimen</a> | <a href="device.html">Device</a> | <a href="medication.html">Medication</a> | <a href="substance.html">Substance</a> | <a href="substancedefinition.html">SubstanceDefinition</a> | <a href="biologicallyderivedproduct.html">BiologicallyDerivedProduct</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Who or what is part of study <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Element"/> <span title="ResearchSubject.subjectState : A duration in the lifecycle of the ResearchSubject within a ResearchStudy.">subjectState</span> <a name="ResearchSubject.subjectState"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">A duration in the lifecycle of the ResearchSubject within a ResearchStudy <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.subjectState.code : Identifies the aspect of the subject's journey that the state refers to.">code</span> <a name="ResearchSubject.subjectState.code"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study <br/> Binding: <a href="http://terminology.hl7.org/6.5.0/ValueSet-research-subject-state.html">ResearchSubjectState</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.subjectState.startDate : The date a research subject entered the given state.">startDate</span> <a name="ResearchSubject.subjectState.startDate"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The date a research subject entered the given state <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.subjectState.endDate : The date a research subject exited or left the given state.">endDate</span> <a name="ResearchSubject.subjectState.endDate"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The date a research subject exited or left the given state <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.subjectState.reason : The reason for the state change. If coded it should follow the formal subject state model.">reason</span> <a name="ResearchSubject.subjectState.reason"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">State change reason <br/> Binding: <a href="http://terminology.hl7.org/6.5.0/ValueSet-state-change-reason.html">StateChangeReason</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Element"/> <span title="ResearchSubject.subjectMilestone : A significant event in the progress of a ResearchSubject.">subjectMilestone</span> <a name="ResearchSubject.subjectMilestone"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">A significant event in the progress of a ResearchSubject <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.subjectMilestone.milestone : A specific event in the research subject's journey through a research study.">milestone</span> <a name="ResearchSubject.subjectMilestone.milestone"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <br/> Binding: <a href="http://terminology.hl7.org/6.5.0/ValueSet-research-subject-milestone.html">ResearchSubjectMilestone</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.subjectMilestone.date : The date/time when this milestone event was completed.">date</span> <a name="ResearchSubject.subjectMilestone.date"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The date/time when this milestone event was completed <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.subjectMilestone.reason : A rationale that provides additional clarification for the milestone that was captured or documented.">reason</span> <a name="ResearchSubject.subjectMilestone.reason"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <br/> Binding: <a href="http://terminology.hl7.org/6.5.0/ValueSet-state-change-reason.html">StateChangeReason</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.comparisonGroup : A group to which the subject is assigned. This group assignment is used for administration or analysis.">comparisonGroup</span> <a name="ResearchSubject.comparisonGroup"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#CodeableReference">CodeableReference</a> ( <a href="group.html">Group</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">A group to which the subject is assigned <br/> Binding: <a href="valueset-example-comparison-group.html">Example Comparison Group</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAg DsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.consent : Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies.">consent</span> <a name="ResearchSubject.consent"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="consent.html">Consent</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Agreement to participate in study <br/> <br/> </td> </tr> <tr> <td class="hierarchy" colspan="5"> <br/> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"> <img alt="doco" src="data:(snipped in html view)" style="background-color: inherit"/> Documentation for this format </a> </td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="0"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category"> <valueCode value="patient"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> <version value="6.0.0-ballot3"/> <name value="ResearchSubject"/> <status value="draft"/> <experimental value="false"/> <date value="2025-11-08T11:23:29+00:00"/> <publisher value="HL7 International / Biomedical Research and Regulation"/> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/fiwg"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim"/> </telecom> </contact> <description value="A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <fhirVersion value="6.0.0-ballot3"/> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <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> <kind value="resource"/> <abstract value="false"/> <type value="ResearchSubject"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> <derivation value="specialization"/> <snapshot> <element id="ResearchSubject"> <path value="ResearchSubject"/> <short value="Participant or object which is the recipient of investigative activities in a study"/> <definition value="A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study."/> <comment value="Need to make sure we encompass public health studies."/> <alias value="Study Subject"/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject"/> <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()"/> <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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmat ched', id).empty()"/> <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()"/> <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()"/> <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()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]"/> </mapping> <mapping> <identity value="w5"/> <map value="clinical.diagnostics"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> </element> <element id="ResearchSubject.id"> <path value="ResearchSubject.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="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.meta"> <path value="ResearchSubject.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. 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. 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.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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.implicitRules"> <path value="ResearchSubject.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. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the [additionalImplicitRules](https://build.fhir.org/ig/HL7/fh ir-extensions/StructureDefinition-additionalImplicitRules.html) extension."/> <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 its 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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additionalknowledge about the resource that modifies it's meaning or interpretation 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). 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. 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. 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. 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.knowledge about the resource that modifies its meaning or interpretation"/> <isSummary value="true"/> </element> <element id="ResearchSubject.language"> <path value="ResearchSubject.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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <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="required"/> <description value="IETF language tag for a human language"/> <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3"/> <additional> <purpose value="starter"/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </additional> </binding> </element> <element id="ResearchSubject.text"> <path value="ResearchSubject.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 a 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="dom-6"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="ResearchSubject.contained"> <path value="ResearchSubject.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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/> <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. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](resource.html#additional)."/> <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> <condition value="dom-2"/> <condition value="dom-4"/> <condition value="dom-3"/> <condition value="dom-5"/> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.extension"> <path value="ResearchSubject.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definitionof 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. 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.of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.modifierExtension"> <path value="ResearchSubject.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definitionof 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). 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. 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](extensibility.ht ml#modifierExtension). Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn 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 validof 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 managable, 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](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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.identifier"> <path value="ResearchSubject.identifier"/> <short value="Business Identifier for research subject in a study"/> <definition value="Identifiers assigned to this research subject for a study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject > Subject.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchSubject.status"> <path value="ResearchSubject.status"/> <short value="draft | active | retired | unknown"/> <definition value="The publication state of the resource (not of the subject)."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <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="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="required"/> <description value="Codes that convey the current publication status of the research study resource."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject.statusCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.period"> <path value="ResearchSubject.period"/> <short value="Start and end of participation"/> <definition value="The dates the subject began and ended their participation in the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="PerformedStudySubjectMilestone.studyReferenceDateRange"/> </mapping> </element> <element id="ResearchSubject.study"> <path value="ResearchSubject.study"/> <short value="Study subject is part of"/> <definition value="Reference to the study the subject is participating in."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.study"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubjectProtocolVersionRelationship"/> </mapping> </element> <element id="ResearchSubject.subject"> <path value="ResearchSubject.subject"/> <short value="Who or what is part of study"/> <definition value="The record of the person, animal or other entity involved in the study."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.subject"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Specimen"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject"/> </mapping> </element> <element id="ResearchSubject.subjectState"> <path value="ResearchSubject.subjectState"/> <short value="A duration in the lifecycle of the ResearchSubject within a ResearchStudy"/> <definition value="A duration in the lifecycle of the ResearchSubject within a ResearchStudy."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.subjectState"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children or both"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.id"> <path value="ResearchSubject.subjectState.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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchSubject.subjectState.extension"> <path value="ResearchSubject.subjectState.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchSubject.subjectState.modifierExtension"> <path value="ResearchSubject.subjectState.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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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](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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="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> </element> <element id="ResearchSubject.subjectState.code"> <path value="ResearchSubject.subjectState.code"/> <short value="candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study"/> <definition value="Identifies the aspect of the subject's journey that the state refers to."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.subjectState.code"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchSubjectState"/> </extension> <strength value="example"/> <description value="Indicates the progression of a study subject through a study."/> <valueSet value="http://terminology.hl7.org/ValueSet/research-subject-state"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject.statusCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.subjectState.startDate"> <path value="ResearchSubject.subjectState.startDate"/> <short value="The date a research subject entered the given state"/> <definition value="The date a research subject entered the given state."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.subjectState.startDate"/> <min value="1"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.endDate"> <path value="ResearchSubject.subjectState.endDate"/> <short value="The date a research subject exited or left the given state"/> <definition value="The date a research subject exited or left the given state."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.subjectState.endDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.reason"> <path value="ResearchSubject.subjectState.reason"/> <short value="State change reason"/> <definition value="The reason for the state change. If coded it should follow the formal subject state model."/> <comment value="Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated"."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.subjectState.reason"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="StateChangeReason"/> </extension> <strength value="example"/> <description value="Indicates why the state of the subject changed."/> <valueSet value="http://terminology.hl7.org/ValueSet/state-change-reason"/> </binding> </element> <element id="ResearchSubject.subjectMilestone"> <path value="ResearchSubject.subjectMilestone"/> <short value="A significant event in the progress of a ResearchSubject"/> <definition value="A significant event in the progress of a ResearchSubject."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.subjectMilestone"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children or both"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectMilestone.id"> <path value="ResearchSubject.subjectMilestone.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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchSubject.subjectMilestone.extension"> <path value="ResearchSubject.subjectMilestone.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchSubject.subjectMilestone.modifierExtension"> <path value="ResearchSubject.subjectMilestone.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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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](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> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="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> </element> <element id="ResearchSubject.subjectMilestone.milestone"> <path value="ResearchSubject.subjectMilestone.milestone"/> <definition value="A specific event in the research subject's journey through a research study."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.subjectMilestone.milestone"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchSubjectMilestone"/> </extension> <strength value="example"/> <description value="Indicates the progression of a study subject through a study."/> <valueSet value="http://terminology.hl7.org/ValueSet/research-subject-milestone"/> </binding> </element> <element id="ResearchSubject.subjectMilestone.date"> <path value="ResearchSubject.subjectMilestone.date"/> <short value="The date/time when this milestone event was completed"/> <definition value="The date/time when this milestone event was completed."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.subjectMilestone.date"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectMilestone.reason"> <path value="ResearchSubject.subjectMilestone.reason"/> <definition value="A rationale that provides additional clarification for the milestone that was captured or documented."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.subjectMilestone.reason"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="StateChangeReason"/> </extension> <strength value="example"/> <description value="Indicates why the state of the subject changed."/> <valueSet value="http://terminology.hl7.org/ValueSet/state-change-reason"/> </binding> </element> <element id="ResearchSubject.comparisonGroup"> <path value="ResearchSubject.comparisonGroup"/> <short value="A group to which the subject is assigned"/> <definition value="A group to which the subject is assigned. This group assignment is used for administration or analysis."/> <comment value="This grouping is used for study administration (such as assignment to arms in a trial) or study analysis (such as groupings for observational studies or sensitivity analyses)."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.comparisonGroup"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ExampleComparisonGroup"/> </extension> <strength value="example"/> <description value="Example values for defining comparison groups."/> <valueSet value="http://hl7.org/fhir/ValueSet/example-comparison-group"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/> </mapping> </element> <element id="ResearchSubject.consent"> <path value="ResearchSubject.consent"/> <short value="Agreement to participate in study"/> <definition value="Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.consent"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicatorin that the informedConsentIndicator can be derived from the data in the Consent resource. A physical entity which is the primary unit of operational and/or administrative interest in a study. candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn 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 validin that the informedConsentIndicator can be derived from the data in the Consent resource."/> </mapping> </element> </snapshot> <differential> <element id="ResearchSubject"> <path value="ResearchSubject"/> <short value="Participant or object which is the recipient of investigative activities in a study"/> <definition value="A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study."/> <comment value="Need to make sure we encompass public health studies."/> <alias value="Study Subject"/> <min value="0"/> <max value="*"/> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="w5"/> <map value="clinical.diagnostics"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> <mapping> <identity value="rim"/> <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> </mapping> </element> <element id="ResearchSubject.identifier"> <path value="ResearchSubject.identifier"/> <short value="Business Identifier for research subject in a study"/> <definition value="Identifiers assigned to this research subject for a study."/> <min value="0"/> <max value="*"/> <type> <code value="Identifier"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject > Subject.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchSubject.status"> <path value="ResearchSubject.status"/> <short value="draft | active | retired | unknown"/> <definition value="The publication state of the resource (not of the subject)."/> <min value="1"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <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="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="required"/> <description value="Codes that convey the current publication status of the research study resource."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject.statusCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.period"> <path value="ResearchSubject.period"/> <short value="Start and end of participation"/> <definition value="The dates the subject began and ended their participation in the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <type> <code value="Period"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="PerformedStudySubjectMilestone.studyReferenceDateRange"/> </mapping> </element> <element id="ResearchSubject.study"> <path value="ResearchSubject.study"/> <short value="Study subject is part of"/> <definition value="Reference to the study the subject is participating in."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubjectProtocolVersionRelationship"/> </mapping> </element> <element id="ResearchSubject.subject"> <path value="ResearchSubject.subject"/> <short value="Who or what is part of study"/> <definition value="The record of the person, animal or other entity involved in the study."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Specimen"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject"/> </mapping> </element> <element id="ResearchSubject.subjectState"> <path value="ResearchSubject.subjectState"/> <short value="A duration in the lifecycle of the ResearchSubject within a ResearchStudy"/> <definition value="A duration in the lifecycle of the ResearchSubject within a ResearchStudy."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.code"> <path value="ResearchSubject.subjectState.code"/> <short value="candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study"/> <definition value="Identifies the aspect of the subject's journey that the state refers to."/> <min value="1"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchSubjectState"/> </extension> <strength value="example"/> <description value="Indicates the progression of a study subject through a study."/> <valueSet value="http://terminology.hl7.org/ValueSet/research-subject-state"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudySubject.statusCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.subjectState.startDate"> <path value="ResearchSubject.subjectState.startDate"/> <short value="The date a research subject entered the given state"/> <definition value="The date a research subject entered the given state."/> <min value="1"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.endDate"> <path value="ResearchSubject.subjectState.endDate"/> <short value="The date a research subject exited or left the given state"/> <definition value="The date a research subject exited or left the given state."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectState.reason"> <path value="ResearchSubject.subjectState.reason"/> <short value="State change reason"/> <definition value="The reason for the state change. If coded it should follow the formal subject state model."/> <comment value="Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated"."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="StateChangeReason"/> </extension> <strength value="example"/> <description value="Indicates why the state of the subject changed."/> <valueSet value="http://terminology.hl7.org/ValueSet/state-change-reason"/> </binding> </element> <element id="ResearchSubject.subjectMilestone"> <path value="ResearchSubject.subjectMilestone"/> <short value="A significant event in the progress of a ResearchSubject"/> <definition value="A significant event in the progress of a ResearchSubject."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectMilestone.milestone"> <path value="ResearchSubject.subjectMilestone.milestone"/> <definition value="A specific event in the research subject's journey through a research study."/> <min value="1"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchSubjectMilestone"/> </extension> <strength value="example"/> <description value="Indicates the progression of a study subject through a study."/> <valueSet value="http://terminology.hl7.org/ValueSet/research-subject-milestone"/> </binding> </element> <element id="ResearchSubject.subjectMilestone.date"> <path value="ResearchSubject.subjectMilestone.date"/> <short value="The date/time when this milestone event was completed"/> <definition value="The date/time when this milestone event was completed."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.subjectMilestone.reason"> <path value="ResearchSubject.subjectMilestone.reason"/> <definition value="A rationale that provides additional clarification for the milestone that was captured or documented."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="StateChangeReason"/> </extension> <strength value="example"/> <description value="Indicates why the state of the subject changed."/> <valueSet value="http://terminology.hl7.org/ValueSet/state-change-reason"/> </binding> </element> <element id="ResearchSubject.comparisonGroup"> <path value="ResearchSubject.comparisonGroup"/> <short value="A group to which the subject is assigned"/> <definition value="A group to which the subject is assigned. This group assignment is used for administration or analysis."/> <comment value="This grouping is used for study administration (such as assignment to arms in a trial) or study analysis (such as groupings for observational studies or sensitivity analyses)."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ExampleComparisonGroup"/> </extension> <strength value="example"/> <description value="Example values for defining comparison groups."/> <valueSet value="http://hl7.org/fhir/ValueSet/example-comparison-group"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/> </mapping> </element> <element id="ResearchSubject.consent"> <path value="ResearchSubject.consent"/> <short value="Agreement to participate in study"/> <definition value="Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicatorin that the informedConsentIndicator can be derived from the data in the Consent resource.in that the informedConsentIndicator can be derived from the data in the Consent resource."/> </mapping> </element> </differential> </ StructureDefinition >
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
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