NCPI FHIR Implementation Guide v2
0.1.0 - ci-build
NCPI FHIR Implementation Guide v2 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Draft as of 2024-03-21 |
TTL representation of the research-study-subject resource profile.
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:StructureDefinition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "research-study-subject"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-research-study-subject-definitions.html#ResearchStudy\">ResearchStudy</a><a name=\"ResearchStudy\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-ncpi-research-study.html\">NcpiResearchStudy</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_extension_simple.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Simple Extension\" class=\"hierarchy\"/> <a href=\"StructureDefinition-research-study-subject-definitions.html#ResearchStudy.extension\">extension</a><a name=\"ResearchStudy.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R4B/extensibility.html#Extension\">Extension</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Extension</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck14.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-research-study-subject-definitions.html#ResearchStudy.extension:consent\" title=\"Extension URL = https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent\">consent</a><a name=\"ResearchStudy.extension\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-ncpi-research-access-policy.html\">NCPI Research Access Policy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Research Study Subject Consent</span><br/><span style=\"font-weight:bold\">URL: </span>https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-research-study-subject-definitions.html#ResearchStudy.partOf\">partOf</a><a name=\"ResearchStudy.partOf\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R4B/researchstudy.html\">ResearchStudy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Part of larger study</span></td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>" ] ; # fhir:url [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject"^^xsd:anyURI] ; # fhir:version [ fhir:v "0.1.0"] ; # fhir:name [ fhir:v "ResearchStudySubject"] ; # fhir:title [ fhir:v "Research Study Subject"] ; # fhir:status [ fhir:v "draft"] ; # fhir:date [ fhir:v "2024-03-21T20:04:56+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "NCPI FHIR Working Group"] ; # fhir:contact ( [ fhir:name [ fhir:v "NCPI FHIR Working Group" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://example.org/example-publisher" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "ncpi-fhir-ig@googlegroups.com" ] ] ) ] ) ; # fhir:description [ fhir:v "A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions. This profile is an R4 proxy for the more flexible R5 ResearchSubject."] ; # fhir:fhirVersion [ fhir:v "4.3.0"] ; # fhir:mapping ( [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:uri [ fhir:v "https://bridgmodel.nci.nih.gov"^^xsd:anyURI ] ; fhir:name [ fhir:v "BRIDG 5.1 Mapping" ] ] [ fhir:identity [ fhir:v "v2" ] ; fhir:uri [ fhir:v "http://hl7.org/v2"^^xsd:anyURI ] ; fhir:name [ fhir:v "HL7 v2 Mapping" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:uri [ fhir:v "http://hl7.org/v3"^^xsd:anyURI ] ; fhir:name [ fhir:v "RIM Mapping" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:uri [ fhir:v "http://hl7.org/fhir/fivews"^^xsd:anyURI ] ; fhir:name [ fhir:v "FiveWs Pattern Mapping" ] ] [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:uri [ fhir:v "http://clinicaltrials.gov"^^xsd:anyURI ] ; fhir:name [ fhir:v "ClinicalTrials.gov Mapping" ] ] ) ; # fhir:kind [ fhir:v "resource"] ; # fhir:abstract [ fhir:v "false"^^xsd:boolean] ; # fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI] ; # fhir:baseDefinition [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-research-study"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-research-study> ] ; # fhir:derivation [ fhir:v "constraint"] ; # fhir:snapshot [ ( fhir:element [ fhir:id [ fhir:v "ResearchStudy" ] ; fhir:path [ fhir:v "ResearchStudy" ] ; fhir:short [ fhir:v "Investigation to increase healthcare-related patient-independent knowledge" ] ; fhir:definition [ fhir:v "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects." ] ; fhir:comment [ fhir:v "Need to make sure we encompass public health studies." ] ; ( fhir:alias [ fhir:v "Clinical Trial" ] [ fhir:v "Study" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:constraint [ fhir:key [ fhir:v "dom-2" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "If the resource is contained in another resource, it SHALL NOT contain nested Resources" ] ; fhir:expression [ fhir:v "contained.contained.empty()" ] ; fhir:xpath [ fhir:v "not(parent::f:contained and f:contained)" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/DomainResource"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/DomainResource> ] ] [ fhir:key [ fhir:v "dom-3" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "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" ] ; fhir:expression [ fhir:v "contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()" ] ; fhir:xpath [ fhir:v "not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/DomainResource"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/DomainResource> ] ] [ fhir:key [ fhir:v "dom-4" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" ] ; fhir:expression [ fhir:v "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" ] ; fhir:xpath [ fhir:v "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/DomainResource"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/DomainResource> ] ] [ fhir:key [ fhir:v "dom-5" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "If a resource is contained in another resource, it SHALL NOT have a security label" ] ; fhir:expression [ fhir:v "contained.meta.security.empty()" ] ; fhir:xpath [ fhir:v "not(exists(f:contained/*/f:meta/f:security))" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/DomainResource"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/DomainResource> ] ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"^^xsd:anyURI ] ; fhir:value [ fhir:v "true"^^xsd:boolean ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"^^xsd:anyURI ] ; fhir:value [ fhir:v "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." ] ] ) ; fhir:key [ fhir:v "dom-6" ] ; fhir:severity [ fhir:v "warning" ] ; fhir:human [ fhir:v "A resource should have narrative for robust management" ] ; fhir:expression [ fhir:v "text.`div`.exists()" ] ; fhir:xpath [ fhir:v "exists(f:text/h:div)" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/DomainResource"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/DomainResource> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "Entity. Role, or Act" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion" ] ] [ fhir:identity [ fhir:v "v2" ] ; fhir:map [ fhir:v "OBX" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "Observation[classCode=CLNTRL, moodCode=EVN]" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "clinical.diagnostics" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.id" ] ; fhir:path [ fhir:v "ResearchStudy.id" ] ; fhir:short [ fhir:v "Logical id of this artifact" ] ; fhir:definition [ fhir:v "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." ] ; fhir:comment [ fhir:v "The only time that a resource does not have an id is when it is being submitted to the server using a create operation." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Resource.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ] ; fhir:value [ fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.meta" ] ; fhir:path [ fhir:v "ResearchStudy.meta" ] ; fhir:short [ fhir:v "Metadata about the resource" ] ; fhir:definition [ fhir:v "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." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Resource.meta" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Meta"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.implicitRules" ] ; fhir:path [ fhir:v "ResearchStudy.implicitRules" ] ; fhir:short [ fhir:v "A set of rules under which this content was created" ] ; fhir:definition [ fhir:v "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." ] ; fhir:comment [ fhir:v "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." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Resource.implicitRules" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "uri"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "true"^^xsd:boolean ] ; fhir:isModifierReason [ fhir:v "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.language" ] ; fhir:path [ fhir:v "ResearchStudy.language" ] ; fhir:short [ fhir:v "Language of the resource content" ] ; fhir:definition [ fhir:v "The base language in which the resource is written." ] ; fhir:comment [ fhir:v "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)." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Resource.language" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "code"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"^^xsd:anyURI ] ; fhir:value [ fhir:v "http://hl7.org/fhir/ValueSet/all-languages"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/all-languages> ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "Language" ] ] ) ; fhir:strength [ fhir:v "preferred" ] ; fhir:description [ fhir:v "IETF language tag" ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/languages"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/languages> ] ] ] [ fhir:id [ fhir:v "ResearchStudy.text" ] ; fhir:path [ fhir:v "ResearchStudy.text" ] ; fhir:short [ fhir:v "Text summary of the resource, for human interpretation" ] ; fhir:definition [ fhir:v "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." ] ; fhir:comment [ fhir:v "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." ] ; ( fhir:alias [ fhir:v "narrative" ] [ fhir:v "html" ] [ fhir:v "xhtml" ] [ fhir:v "display" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.text" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Narrative"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "Act.text?" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.contained" ] ; fhir:path [ fhir:v "ResearchStudy.contained" ] ; fhir:short [ fhir:v "Contained, inline Resources" ] ; fhir:definition [ fhir:v "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." ] ; fhir:comment [ fhir:v "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." ] ; ( fhir:alias [ fhir:v "inline resources" ] [ fhir:v "anonymous resources" ] [ fhir:v "contained resources" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.contained" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Resource"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "dom-r4b" ] ; fhir:severity [ fhir:v "warning" ] ; fhir:human [ fhir:v "Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems" ] ; fhir:expression [ fhir:v "($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)" ] ; fhir:xpath [ fhir:v "not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:PackagedProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedAuthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citation|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDefinition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingredient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic)" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/ResearchStudy"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/ResearchStudy> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.extension" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:slicing [ ( fhir:discriminator [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:ordered [ fhir:v "false"^^xsd:boolean ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Extension" ] ; fhir:definition [ fhir:v "An Extension" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:studyDesign" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "studyDesign" ] ; fhir:short [ fhir:v "Study Design and Study Type" ] ; fhir:definition [ fhir:v "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-design> ] ) ] ) ; ( fhir:condition [ fhir:v "ele-1" ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:result" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "result" ] ; fhir:short [ fhir:v "Link to results generated during the study." ] ; fhir:definition [ fhir:v "Link to citations associated with the study's publications." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-result> ] ) ] ) ; ( fhir:condition [ fhir:v "ele-1" ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:associatedParty" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "associatedParty" ] ; fhir:short [ fhir:v "Research Study Associated Party" ] ; fhir:definition [ fhir:v "Sponsors, collaborators, and other parties affiliated with a research study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-associated-party> ] ) ] ) ; ( fhir:condition [ fhir:v "ele-1" ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:acknowledgement" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "acknowledgement" ] ; fhir:short [ fhir:v "URL describing the policy restrictions in detail." ] ; fhir:definition [ fhir:v "Provides an informative description of acknowledgement expectations for those using data from the research study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-acknowledgement> ] ) ] ) ; ( fhir:condition [ fhir:v "ele-1" ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:consent" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "consent" ] ; fhir:short [ fhir:v "Research Study Subject Consent" ] ; fhir:definition [ fhir:v "ResearchStudySubjectConsent provides link to a consent through which participants were enrolled." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ] [ fhir:id [ fhir:v "ResearchStudy.modifierExtension" ] ; fhir:path [ fhir:v "ResearchStudy.modifierExtension" ] ; fhir:short [ fhir:v "Extensions that cannot be ignored" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ] ; fhir:comment [ fhir:v "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." ] ; fhir:requirements [ fhir:v "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "DomainResource.modifierExtension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "true"^^xsd:boolean ] ; fhir:isModifierReason [ fhir:v "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.identifier" ] ; fhir:path [ fhir:v "ResearchStudy.identifier" ] ; fhir:short [ fhir:v "External facing, globally unique identifiers. When providing more than one identifier, researchers should indicate the 'official' identifier by assigning 'official' to that identifier's use property." ] ; fhir:definition [ fhir:v "Identifiers assigned to this research study by the sponsor or other systems." ] ; fhir:requirements [ fhir:v "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.identifier" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Identifier"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Organization's Unique Protocol ID; Secondary IDs" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.identifier" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".identifier" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.title" ] ; fhir:path [ fhir:v "ResearchStudy.title" ] ; fhir:short [ fhir:v "Study's formal title." ] ; fhir:definition [ fhir:v "A short, descriptive user-friendly label for the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.title" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Brief Title" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.protocol" ] ; fhir:path [ fhir:v "ResearchStudy.protocol" ] ; fhir:short [ fhir:v "Steps followed in executing study" ] ; fhir:definition [ fhir:v "The set of steps expected to be performed as part of the execution of the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.protocol" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/PlanDefinition"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/PlanDefinition> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Interventions; Arm/Intervention Cross-Reference" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolDocumentVersionPublicTitle.name" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".outboundRelationship[typeCode=DEFN].target" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.partOf" ] ; fhir:path [ fhir:v "ResearchStudy.partOf" ] ; fhir:short [ fhir:v "Part of larger study" ] ; fhir:definition [ fhir:v "A larger research study of which this particular study is a component or step." ] ; fhir:requirements [ fhir:v "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc." ] ; ( fhir:alias [ fhir:v "container" ] ) ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.partOf" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/ResearchStudy"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/ResearchStudy> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "CompanionStudyRelationship" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.status" ] ; fhir:path [ fhir:v "ResearchStudy.status" ] ; fhir:short [ fhir:v "active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn" ] ; fhir:definition [ fhir:v "The current state of the study." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.status" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "code"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "true"^^xsd:boolean ] ; fhir:isModifierReason [ fhir:v "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" ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyStatus" ] ] ) ; fhir:strength [ fhir:v "required" ] ; fhir:description [ fhir:v "Codes that convey the current status of the research study." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/research-study-status|4.3.0"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/research-study-status|4.3.0> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.status" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyOverallStatus.code" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".status" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.primaryPurposeType" ] ; fhir:path [ fhir:v "ResearchStudy.primaryPurposeType" ] ; fhir:short [ fhir:v "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility" ] ; fhir:definition [ fhir:v "The type of study based upon the intent of the study's activities. A classification of the intent of the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.primaryPurposeType" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyPrimaryPurposeType" ] ] ) ; fhir:strength [ fhir:v "extensible" ] ; fhir:description [ fhir:v "Codes for the main intent of the study." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/research-study-prim-purp-type> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolVersion.primaryPurposeTypeCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.phase" ] ; fhir:path [ fhir:v "ResearchStudy.phase" ] ; fhir:short [ fhir:v "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4" ] ; fhir:definition [ fhir:v "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.phase" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyPhase" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/research-study-phase"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/research-study-phase> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Study Phase" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolVersion.phaseCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.category" ] ; fhir:path [ fhir:v "ResearchStudy.category" ] ; fhir:short [ fhir:v "Classifications for the study" ] ; fhir:definition [ fhir:v "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.category" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyCategory" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.category.id" ] ; fhir:path [ fhir:v "ResearchStudy.category.id" ] ; ( fhir:representation [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ] ; fhir:value [ fhir:v "id"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.category.extension" ] ; fhir:path [ fhir:v "ResearchStudy.category.extension" ] ; fhir:slicing [ ( fhir:discriminator [ fhir:type [ fhir:v "value" ] ; fhir:path [ fhir:v "url" ] ] ) ; fhir:description [ fhir:v "Extensions are always sliced by (at least) url" ] ; fhir:rules [ fhir:v "open" ] ] ; fhir:short [ fhir:v "Additional content defined by implementations" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ] ; fhir:comment [ fhir:v "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." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.category.coding" ] ; fhir:path [ fhir:v "ResearchStudy.category.coding" ] ; fhir:short [ fhir:v "Indicate this is an NCPI Research Study" ] ; fhir:definition [ fhir:v "A reference to a code defined by a terminology system." ] ; fhir:comment [ fhir:v "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true." ] ; fhir:requirements [ fhir:v "Allows for alternative encodings within a code system, and translations to other code systems." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "CodeableConcept.coding" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Coding"^^xsd:anyURI ] ] ) ; fhir:pattern [ a fhir:Coding ; fhir:system [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/CodeSystem/ncpi"^^xsd:anyURI ] ; fhir:code [ fhir:v "StudyCohort" ] ; fhir:display [ fhir:v "Study Cohort" ] ] ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "v2" ] ; fhir:map [ fhir:v "C*E.1-8, C*E.10-22" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "union(., ./translation)" ] ] [ fhir:identity [ fhir:v "orim" ] ; fhir:map [ fhir:v "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.category.text" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"^^xsd:anyURI ] ; fhir:value [ fhir:v "true"^^xsd:boolean ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"^^xsd:anyURI ] ; fhir:value [ fhir:v "true"^^xsd:boolean ] ] ) ; fhir:path [ fhir:v "ResearchStudy.category.text" ] ; fhir:short [ fhir:v "Plain text representation of the concept" ] ; fhir:definition [ fhir:v "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user." ] ; fhir:comment [ fhir:v "Very often the text is the same as a displayName of one of the codings." ] ; fhir:requirements [ fhir:v "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "CodeableConcept.text" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "v2" ] ; fhir:map [ fhir:v "C*E.9. But note many systems use C*E.2 for this" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "./originalText[mediaType/code=\"text/plain\"]/data" ] ] [ fhir:identity [ fhir:v "orim" ] ; fhir:map [ fhir:v "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.focus" ] ; fhir:path [ fhir:v "ResearchStudy.focus" ] ; fhir:short [ fhir:v "The primary, non-disease focus(es) of the study. This can include terms related to intervention, drug, device, or other focus." ] ; fhir:definition [ fhir:v "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about." ] ; fhir:comment [ fhir:v "Researcher specified foci that are not specific to disease/phenotype codes." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.focus" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyFocus" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Codes for medications, devices and other interventions." ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Focus of Study" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.what[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "InterventionalStudyProtocol.interventionTypeCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.condition" ] ; fhir:path [ fhir:v "ResearchStudy.condition" ] ; fhir:short [ fhir:v "The primary focus(es) of the study. This is specific to the disease. MeSH terms are preferred." ] ; fhir:definition [ fhir:v "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code." ] ; fhir:comment [ fhir:v "Disease and phenotype codes identified in the CDM study's 'focus'." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.condition" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ConditionCode" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Identification of the condition or diagnosis." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/condition-code"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/condition-code> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Conditions" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.what[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyCondition.code" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.contact" ] ; fhir:path [ fhir:v "ResearchStudy.contact" ] ; fhir:short [ fhir:v "Contact details for the study" ] ; fhir:definition [ fhir:v "Contact details to assist a user in learning more about or engaging with the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.contact" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "ContactDetail"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.relatedArtifact" ] ; fhir:path [ fhir:v "ResearchStudy.relatedArtifact" ] ; fhir:short [ fhir:v "Attribution, Study Weblinks, Citation, Study Documents, etc." ] ; fhir:definition [ fhir:v "Citations, references and other related documents." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.relatedArtifact" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "RelatedArtifact"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Citations, Links, Available Study Data/Documents" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolDocument, StudyProtocolDocumentVersion" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.keyword" ] ; fhir:path [ fhir:v "ResearchStudy.keyword" ] ; fhir:short [ fhir:v "Used to search for the study" ] ; fhir:definition [ fhir:v "Key terms to aid in searching for or filtering the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.keyword" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyKeyword" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Words associated with the study that may be useful in discovery." ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Keywords" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "DocumentVersion.keywordCode; DocumentVersion.keywordText" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.location" ] ; fhir:path [ fhir:v "ResearchStudy.location" ] ; fhir:short [ fhir:v "Geographic region(s) for study" ] ; fhir:definition [ fhir:v "Indicates a country, state or other region where the study is taking place." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.location" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "Jurisdiction" ] ] ) ; fhir:strength [ fhir:v "extensible" ] ; fhir:description [ fhir:v "Countries and regions within which this artifact is targeted for use." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/jurisdiction"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/jurisdiction> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolVersion.participatingLocationCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.description" ] ; fhir:path [ fhir:v "ResearchStudy.description" ] ; fhir:short [ fhir:v "Study Description (Recommended)" ] ; fhir:definition [ fhir:v "A full description of how the study is being conducted." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.description" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "markdown"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Detailed Description" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyProtocolDocumentVersion.publicDescription" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.enrollment" ] ; fhir:path [ fhir:v "ResearchStudy.enrollment" ] ; fhir:short [ fhir:v "Inclusion & exclusion criteria" ] ; fhir:definition [ fhir:v "Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\"." ] ; fhir:comment [ fhir:v "The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource." ] ; ( fhir:alias [ fhir:v "patient" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.enrollment" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/Group"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Group> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.subject[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "InterventionalStudyProtocol.interventionGroupQuantity" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".participation[typeCode=SBJ].role" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.subject" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.period" ] ; fhir:path [ fhir:v "ResearchStudy.period" ] ; fhir:short [ fhir:v "When the study began and ended" ] ; fhir:definition [ fhir:v "Identifies the start date and the expected (or actual, depending on status) end date for the study." ] ; ( fhir:alias [ fhir:v "timing" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.period" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Period"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Study Start Date (start); Study Completion Date (end)" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.done[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".effectiveTime" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.sponsor" ] ; fhir:path [ fhir:v "ResearchStudy.sponsor" ] ; fhir:short [ fhir:v "Organization that initiates and is legally responsible for the study" ] ; fhir:definition [ fhir:v "An organization that initiates the investigation and is legally responsible for the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.sponsor" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/Organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Organization> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Sponsor" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.actor" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.principalInvestigator" ] ; fhir:path [ fhir:v "ResearchStudy.principalInvestigator" ] ; fhir:short [ fhir:v "Researcher who oversees multiple aspects of the study" ] ; fhir:definition [ fhir:v "A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.principalInvestigator" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/Practitioner"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Practitioner> ] [ fhir:v "http://hl7.org/fhir/StructureDefinition/PractitionerRole"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/PractitionerRole> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Principal Investigator" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.actor" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyInvestigator" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.site" ] ; fhir:path [ fhir:v "ResearchStudy.site" ] ; fhir:short [ fhir:v "Facility where study activities are conducted" ] ; fhir:definition [ fhir:v "A facility in which study activities are conducted." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.site" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Reference"^^xsd:anyURI ] ; ( fhir:targetProfile [ fhir:v "http://hl7.org/fhir/StructureDefinition/Location"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Location> ] ) ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Facility" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.where[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "PlannedStudySite; StudySite" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.reasonStopped" ] ; fhir:path [ fhir:v "ResearchStudy.reasonStopped" ] ; fhir:short [ fhir:v "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design" ] ; fhir:definition [ fhir:v "A description and/or code explaining the premature termination of the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.reasonStopped" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyReasonStopped" ] ] ) ; fhir:strength [ fhir:v "example" ] ; fhir:description [ fhir:v "Codes for why the study ended prematurely." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/research-study-reason-stopped> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Why Study Stopped" ] ] [ fhir:identity [ fhir:v "w5" ] ; fhir:map [ fhir:v "FiveWs.why[x]" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyOverallStatus.studyStoppedReasonCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.note" ] ; fhir:path [ fhir:v "ResearchStudy.note" ] ; fhir:short [ fhir:v "Comments made about the study" ] ; fhir:definition [ fhir:v "Comments made about the study by the performer, subject or other participants." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.note" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Annotation"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "No BRIDG mapping" ] ] [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm" ] ; fhir:path [ fhir:v "ResearchStudy.arm" ] ; fhir:short [ fhir:v "Defined path through the study for a subject" ] ; fhir:definition [ fhir:v "Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.arm" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "BackboneElement"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Arms" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "Arm" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.id" ] ; fhir:path [ fhir:v "ResearchStudy.arm.id" ] ; ( fhir:representation [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ] ; fhir:value [ fhir:v "string"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.extension" ] ; fhir:path [ fhir:v "ResearchStudy.arm.extension" ] ; fhir:short [ fhir:v "Additional content defined by implementations" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ] ; fhir:comment [ fhir:v "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." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.modifierExtension" ] ; fhir:path [ fhir:v "ResearchStudy.arm.modifierExtension" ] ; fhir:short [ fhir:v "Extensions that cannot be ignored even if unrecognized" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ] ; fhir:comment [ fhir:v "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." ] ; fhir:requirements [ fhir:v "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] [ fhir:v "modifiers" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "BackboneElement.modifierExtension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:isModifier [ fhir:v "true"^^xsd:boolean ] ; fhir:isModifierReason [ fhir:v "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.name" ] ; fhir:path [ fhir:v "ResearchStudy.arm.name" ] ; fhir:short [ fhir:v "Label for study arm" ] ; fhir:definition [ fhir:v "Unique, human-readable label for this arm of the study." ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.arm.name" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Arm Label" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "Arm.name" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.type" ] ; fhir:path [ fhir:v "ResearchStudy.arm.type" ] ; fhir:short [ fhir:v "Categorization of study arm" ] ; fhir:definition [ fhir:v "Categorization of study arm, e.g. experimental, active comparator, placebo comparater." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.arm.type" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Arm Type" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "Arm.typeCode" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.arm.description" ] ; fhir:path [ fhir:v "ResearchStudy.arm.description" ] ; fhir:short [ fhir:v "Short explanation of study path" ] ; fhir:definition [ fhir:v "A succinct description of the path through the study that would be followed by a subject adhering to this arm." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.arm.description" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "clinicaltrials-gov" ] ; fhir:map [ fhir:v "Arm Description" ] ] [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "Arm.description" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective" ] ; fhir:path [ fhir:v "ResearchStudy.objective" ] ; fhir:short [ fhir:v "A goal for the study" ] ; fhir:definition [ fhir:v "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.objective" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "BackboneElement"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children unless an empty Parameters resource" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count()) or $this is Parameters" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div|self::f:Parameters" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyObjective" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective.id" ] ; fhir:path [ fhir:v "ResearchStudy.objective.id" ] ; ( fhir:representation [ fhir:v "xmlAttr" ] ) ; fhir:short [ fhir:v "Unique id for inter-element referencing" ] ; fhir:definition [ fhir:v "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "Element.id" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"^^xsd:anyURI ] ; fhir:value [ fhir:v "string"^^xsd:anyURI ] ] ) ; fhir:code [ fhir:v "http://hl7.org/fhirpath/System.String"^^xsd:anyURI ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective.extension" ] ; fhir:path [ fhir:v "ResearchStudy.objective.extension" ] ; fhir:short [ fhir:v "Additional content defined by implementations" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ] ; fhir:comment [ fhir:v "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." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "Element.extension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "n/a" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective.modifierExtension" ] ; fhir:path [ fhir:v "ResearchStudy.objective.modifierExtension" ] ; fhir:short [ fhir:v "Extensions that cannot be ignored even if unrecognized" ] ; fhir:definition [ fhir:v "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ] ; fhir:comment [ fhir:v "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." ] ; fhir:requirements [ fhir:v "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)." ] ; ( fhir:alias [ fhir:v "extensions" ] [ fhir:v "user content" ] [ fhir:v "modifiers" ] ) ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ; fhir:base [ fhir:path [ fhir:v "BackboneElement.modifierExtension" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "*" ] ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] [ fhir:key [ fhir:v "ext-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "Must have either extensions or value[x], not both" ] ; fhir:expression [ fhir:v "extension.exists() != value.exists()" ] ; fhir:xpath [ fhir:v "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Extension"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Extension> ] ] ) ; fhir:isModifier [ fhir:v "true"^^xsd:boolean ] ; fhir:isModifierReason [ fhir:v "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" ] ; fhir:isSummary [ fhir:v "true"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "rim" ] ; fhir:map [ fhir:v "N/A" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective.name" ] ; fhir:path [ fhir:v "ResearchStudy.objective.name" ] ; fhir:short [ fhir:v "Label for the objective" ] ; fhir:definition [ fhir:v "Unique, human-readable label for this objective of the study." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.objective.name" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "string"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "No BRIDG mapping (BRIDG has a description, but not a name)" ] ] ) ] [ fhir:id [ fhir:v "ResearchStudy.objective.type" ] ; fhir:path [ fhir:v "ResearchStudy.objective.type" ] ; fhir:short [ fhir:v "primary | secondary | exploratory" ] ; fhir:definition [ fhir:v "The kind of study objective." ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; fhir:base [ fhir:path [ fhir:v "ResearchStudy.objective.type" ] ; fhir:min [ fhir:v "0"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ; ( fhir:type [ fhir:code [ fhir:v "CodeableConcept"^^xsd:anyURI ] ] ) ; ( fhir:constraint [ fhir:key [ fhir:v "ele-1" ] ; fhir:severity [ fhir:v "error" ] ; fhir:human [ fhir:v "All FHIR elements must have a @value or children" ] ; fhir:expression [ fhir:v "hasValue() or (children().count() > id.count())" ] ; fhir:xpath [ fhir:v "@value|f:*|h:div" ] ; fhir:source [ fhir:v "http://hl7.org/fhir/StructureDefinition/Element"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/Element> ] ] ) ; fhir:mustSupport [ fhir:v "false"^^xsd:boolean ] ; fhir:isModifier [ fhir:v "false"^^xsd:boolean ] ; fhir:isSummary [ fhir:v "false"^^xsd:boolean ] ; fhir:binding [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"^^xsd:anyURI ] ; fhir:value [ fhir:v "ResearchStudyObjectiveType" ] ] ) ; fhir:strength [ fhir:v "preferred" ] ; fhir:description [ fhir:v "Codes for the kind of study objective." ] ; fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/research-study-objective-type"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/research-study-objective-type> ] ] ; ( fhir:mapping [ fhir:identity [ fhir:v "BRIDG5.1" ] ; fhir:map [ fhir:v "StudyObjective.typeCode" ] ] ) ] ) ] ; # fhir:differential [ ( fhir:element [ fhir:id [ fhir:v "ResearchStudy" ] ; fhir:path [ fhir:v "ResearchStudy" ] ] [ fhir:id [ fhir:v "ResearchStudy.extension" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ] [ fhir:id [ fhir:v "ResearchStudy.extension:consent" ] ; fhir:path [ fhir:v "ResearchStudy.extension" ] ; fhir:sliceName [ fhir:v "consent" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ; ( fhir:type [ fhir:code [ fhir:v "Extension"^^xsd:anyURI ] ; ( fhir:profile [ fhir:v "https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent"^^xsd:anyURI ; fhir:link <https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-subject-consent> ] ) ] ) ] [ fhir:id [ fhir:v "ResearchStudy.partOf" ] ; fhir:path [ fhir:v "ResearchStudy.partOf" ] ; fhir:min [ fhir:v "1"^^xsd:nonNegativeInteger ] ; fhir:max [ fhir:v "1" ] ] ) ] . #
IG © 2023+ NCPI FHIR Working Group. Package ncpi-fhir-implementation-guide-v2#0.1.0 based on FHIR 4.3.0. Generated 2024-03-21
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