This page is part of the FHIR Specification (v4.3.0: R4B - STU). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4
Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Practitioner |
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StructureDefinition for researchstudy
@prefix fhir: <http://hl7.org/fhir/> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . # - resource ------------------------------------------------------------------- [] a fhir:StructureDefinition; fhir:Resource.id [ fhir:value "ResearchStudy"]; fhir:Resource.meta [ fhir:Meta.lastUpdated [ fhir:value "2022-05-28T12:47:40.239+10:00" ] ]; fhir:DomainResource.text [ fhir:Narrative.status [ fhir:value "generated" ] ]; fhir:DomainResource.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-category" ]; fhir:Extension.value [ fhir:value "Specialized.Public Health & Research" ] ], [ fhir:index 1; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status" ]; fhir:Extension.value [ fhir:value "trial-use" ] ], [ fhir:index 2; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm" ]; fhir:Extension.value [ fhir:value "1" ] ], [ fhir:index 3; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category" ]; fhir:Extension.value [ fhir:value "business" ] ], [ fhir:index 4; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg" ]; fhir:Extension.value [ fhir:value "brr" ] ]; fhir:StructureDefinition.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/ResearchStudy"]; fhir:StructureDefinition.version [ fhir:value "4.3.0"]; fhir:StructureDefinition.name [ fhir:value "ResearchStudy"]; fhir:StructureDefinition.status [ fhir:value "draft"]; fhir:StructureDefinition.experimental [ fhir:value "false"]; fhir:StructureDefinition.date [ fhir:value "2022-05-28T12:47:40+10:00"]; fhir:StructureDefinition.publisher [ fhir:value "Health Level Seven International (Biomedical Research and Regulation)"]; fhir:StructureDefinition.contact [ fhir:index 0; fhir:ContactDetail.telecom [ fhir:index 0; fhir:ContactPoint.system [ fhir:value "url" ]; fhir:ContactPoint.value [ fhir:value "http://hl7.org/fhir" ] ] ], [ fhir:index 1; fhir:ContactDetail.telecom [ fhir:index 0; fhir:ContactPoint.system [ fhir:value "url" ]; fhir:ContactPoint.value [ fhir:value "http://www.hl7.org/Special/committees/rcrim/index.cfm" ] ] ]; fhir:StructureDefinition.description [ fhir:value "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects."]; fhir:StructureDefinition.fhirVersion [ fhir:value "4.3.0"]; fhir:StructureDefinition.mapping [ fhir:index 0; fhir:StructureDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:StructureDefinition.uri [ fhir:value "https://bridgmodel.nci.nih.gov" ]; fhir:StructureDefinition.name [ fhir:value "BRIDG 5.1 Mapping" ] ], [ fhir:index 1; fhir:StructureDefinition.identity [ fhir:value "v2" ]; fhir:StructureDefinition.uri [ fhir:value "http://hl7.org/v2" ]; fhir:StructureDefinition.name [ fhir:value "HL7 v2 Mapping" ] ], [ fhir:index 2; fhir:StructureDefinition.identity [ fhir:value "rim" ]; fhir:StructureDefinition.uri [ fhir:value "http://hl7.org/v3" ]; fhir:StructureDefinition.name [ fhir:value "RIM Mapping" ] ], [ fhir:index 3; fhir:StructureDefinition.identity [ fhir:value "w5" ]; fhir:StructureDefinition.uri [ fhir:value "http://hl7.org/fhir/fivews" ]; fhir:StructureDefinition.name [ fhir:value "FiveWs Pattern Mapping" ] ], [ fhir:index 4; fhir:StructureDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:StructureDefinition.uri [ fhir:value "http://clinicaltrials.gov" ]; fhir:StructureDefinition.name [ fhir:value "ClinicalTrials.gov Mapping" ] ]; fhir:StructureDefinition.kind [ fhir:value "resource"]; fhir:StructureDefinition.abstract [ fhir:value "false"]; fhir:StructureDefinition.type [ fhir:value "ResearchStudy"]; fhir:StructureDefinition.baseDefinition [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource"]; fhir:StructureDefinition.derivation [ fhir:value "specialization"]; fhir:StructureDefinition.snapshot [ fhir:StructureDefinition.element [ fhir:index 0; fhir:Element.id [ fhir:value "ResearchStudy" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy" ]; fhir:ElementDefinition.short [ fhir:value "Investigation to increase healthcare-related patient-independent knowledge" ]; fhir:ElementDefinition.definition [ fhir:value "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects." ]; fhir:ElementDefinition.comment [ fhir:value "Need to make sure we encompass public health studies." ]; fhir:ElementDefinition.alias [ fhir:value "Clinical Trial"; fhir:index 0 ], [ fhir:value "Study"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "dom-2" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "If the resource is contained in another resource, it SHALL NOT contain nested Resources" ]; fhir:ElementDefinition.expression [ fhir:value "contained.contained.empty()" ]; fhir:ElementDefinition.xpath [ fhir:value "not(parent::f:contained and f:contained)" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "dom-3" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource" ]; fhir:ElementDefinition.expression [ fhir:value "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:ElementDefinition.xpath [ fhir:value "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:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource" ] ], [ fhir:index 2; fhir:ElementDefinition.key [ fhir:value "dom-4" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" ]; fhir:ElementDefinition.expression [ fhir:value "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" ]; fhir:ElementDefinition.xpath [ fhir:value "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource" ] ], [ fhir:index 3; fhir:ElementDefinition.key [ fhir:value "dom-5" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "If a resource is contained in another resource, it SHALL NOT have a security label" ]; fhir:ElementDefinition.expression [ fhir:value "contained.meta.security.empty()" ]; fhir:ElementDefinition.xpath [ fhir:value "not(exists(f:contained/*/f:meta/f:security))" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource" ] ], [ fhir:index 4; fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice" ]; fhir:Extension.value [ fhir:value "true" ] ], [ fhir:index 1; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation" ]; fhir:Extension.value [ fhir:value "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." ] ]; fhir:ElementDefinition.key [ fhir:value "dom-6" ]; fhir:ElementDefinition.severity [ fhir:value "warning" ]; fhir:ElementDefinition.human [ fhir:value "A resource should have narrative for robust management" ]; fhir:ElementDefinition.expression [ fhir:value "text.`div`.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:text/h:div)" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/DomainResource" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "Entity. Role, or Act" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "v2" ]; fhir:ElementDefinition.map [ fhir:value "OBX" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "Observation[classCode=CLNTRL, moodCode=EVN]" ] ], [ fhir:index 4; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "clinical.diagnostics" ] ] ], [ fhir:index 1; fhir:Element.id [ fhir:value "ResearchStudy.id" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.id" ]; fhir:ElementDefinition.short [ fhir:value "Logical id of this artifact" ]; fhir:ElementDefinition.definition [ fhir:value "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." ]; fhir:ElementDefinition.comment [ fhir:value "The only time that a resource does not have an id is when it is being submitted to the server using a create operation." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Resource.id" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type" ]; fhir:Extension.value [ fhir:value "id" ] ]; fhir:ElementDefinition.code [ fhir:value "http://hl7.org/fhirpath/System.String" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ] ], [ fhir:index 2; fhir:Element.id [ fhir:value "ResearchStudy.meta" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.meta" ]; fhir:ElementDefinition.short [ fhir:value "Metadata about the resource" ]; fhir:ElementDefinition.definition [ fhir:value "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Resource.meta" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Meta" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ] ], [ fhir:index 3; fhir:Element.id [ fhir:value "ResearchStudy.implicitRules" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.implicitRules" ]; fhir:ElementDefinition.short [ fhir:value "A set of rules under which this content was created" ]; fhir:ElementDefinition.definition [ fhir:value "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc." ]; fhir:ElementDefinition.comment [ fhir:value "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Resource.implicitRules" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "uri" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ] ], [ fhir:index 4; fhir:Element.id [ fhir:value "ResearchStudy.language" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.language" ]; fhir:ElementDefinition.short [ fhir:value "Language of the resource content" ]; fhir:ElementDefinition.definition [ fhir:value "The base language in which the resource is written." ]; fhir:ElementDefinition.comment [ fhir:value "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Resource.language" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "code" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet" ]; fhir:Extension.value [ fhir:value "http://hl7.org/fhir/ValueSet/all-languages" ] ], [ fhir:index 1; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "Language" ] ], [ fhir:index 2; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding" ]; fhir:Extension.value [ fhir:value "true" ] ]; fhir:ElementDefinition.strength [ fhir:value "preferred" ]; fhir:ElementDefinition.description [ fhir:value "IETF language tag" ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/languages" ] ] ], [ fhir:index 5; fhir:Element.id [ fhir:value "ResearchStudy.text" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.text" ]; fhir:ElementDefinition.short [ fhir:value "Text summary of the resource, for human interpretation" ]; fhir:ElementDefinition.definition [ fhir:value "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." ]; fhir:ElementDefinition.comment [ fhir:value "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later." ]; fhir:ElementDefinition.alias [ fhir:value "narrative"; fhir:index 0 ], [ fhir:value "html"; fhir:index 1 ], [ fhir:value "xhtml"; fhir:index 2 ], [ fhir:value "display"; fhir:index 3 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "DomainResource.text" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Narrative" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "Act.text?" ] ] ], [ fhir:index 6; fhir:Element.id [ fhir:value "ResearchStudy.contained" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.contained" ]; fhir:ElementDefinition.short [ fhir:value "Contained, inline Resources" ]; fhir:ElementDefinition.definition [ fhir:value "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope." ]; fhir:ElementDefinition.comment [ fhir:value "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels." ]; fhir:ElementDefinition.alias [ fhir:value "inline resources"; fhir:index 0 ], [ fhir:value "anonymous resources"; fhir:index 1 ], [ fhir:value "contained resources"; fhir:index 2 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "DomainResource.contained" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Resource" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "dom-r4b" ]; fhir:ElementDefinition.severity [ fhir:value "warning" ]; fhir:ElementDefinition.human [ fhir:value "Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems" ]; fhir:ElementDefinition.expression [ fhir:value "($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:ElementDefinition.xpath [ fhir:value "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:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "N/A" ] ] ], [ fhir:index 7; fhir:Element.id [ fhir:value "ResearchStudy.extension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.extension" ]; fhir:ElementDefinition.short [ fhir:value "Additional content defined by implementations" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "DomainResource.extension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "N/A" ] ] ], [ fhir:index 8; fhir:Element.id [ fhir:value "ResearchStudy.modifierExtension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.modifierExtension" ]; fhir:ElementDefinition.short [ fhir:value "Extensions that cannot be ignored" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.requirements [ fhir:value "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "DomainResource.modifierExtension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "N/A" ] ] ], [ fhir:index 9; fhir:Element.id [ fhir:value "ResearchStudy.identifier" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.identifier" ]; fhir:ElementDefinition.short [ fhir:value "Business Identifier for study" ]; fhir:ElementDefinition.definition [ fhir:value "Identifiers assigned to this research study by the sponsor or other systems." ]; fhir:ElementDefinition.requirements [ fhir:value "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.identifier" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Identifier" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Organization's Unique Protocol ID; Secondary IDs" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.identifier" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".identifier" ] ] ], [ fhir:index 10; fhir:Element.id [ fhir:value "ResearchStudy.title" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.title" ]; fhir:ElementDefinition.short [ fhir:value "Name for this study" ]; fhir:ElementDefinition.definition [ fhir:value "A short, descriptive user-friendly label for the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.title" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Brief Title" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)" ] ] ], [ fhir:index 11; fhir:Element.id [ fhir:value "ResearchStudy.protocol" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.protocol" ]; fhir:ElementDefinition.short [ fhir:value "Steps followed in executing study" ]; fhir:ElementDefinition.definition [ fhir:value "The set of steps expected to be performed as part of the execution of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.protocol" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/PlanDefinition"; fhir:index 0 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Interventions; Arm/Intervention Cross-Reference" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocumentVersionPublicTitle.name" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".outboundRelationship[typeCode=DEFN].target" ] ] ], [ fhir:index 12; fhir:Element.id [ fhir:value "ResearchStudy.partOf" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.partOf" ]; fhir:ElementDefinition.short [ fhir:value "Part of larger study" ]; fhir:ElementDefinition.definition [ fhir:value "A larger research study of which this particular study is a component or step." ]; fhir:ElementDefinition.requirements [ fhir:value "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc." ]; fhir:ElementDefinition.alias [ fhir:value "container"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.partOf" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/ResearchStudy"; fhir:index 0 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "CompanionStudyRelationship" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" ] ] ], [ fhir:index 13; fhir:Element.id [ fhir:value "ResearchStudy.status" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.status" ]; fhir:ElementDefinition.short [ fhir:value "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:ElementDefinition.definition [ fhir:value "The current state of the study." ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.status" ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "code" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyStatus" ] ]; fhir:ElementDefinition.strength [ fhir:value "required" ]; fhir:ElementDefinition.description [ fhir:value "Codes that convey the current status of the research study." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-status|4.3.0" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.status" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyOverallStatus.code" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".status" ] ] ], [ fhir:index 14; fhir:Element.id [ fhir:value "ResearchStudy.primaryPurposeType" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.primaryPurposeType" ]; fhir:ElementDefinition.short [ fhir:value "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility" ]; fhir:ElementDefinition.definition [ fhir:value "The type of study based upon the intent of the study's activities. A classification of the intent of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.primaryPurposeType" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyPrimaryPurposeType" ] ]; fhir:ElementDefinition.strength [ fhir:value "extensible" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the main intent of the study." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.primaryPurposeTypeCode" ] ] ], [ fhir:index 15; fhir:Element.id [ fhir:value "ResearchStudy.phase" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.phase" ]; fhir:ElementDefinition.short [ fhir:value "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4" ]; fhir:ElementDefinition.definition [ fhir:value "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.phase" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyPhase" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-phase" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Phase" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.phaseCode" ] ] ], [ fhir:index 16; fhir:Element.id [ fhir:value "ResearchStudy.category" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.category" ]; fhir:ElementDefinition.short [ fhir:value "Classifications for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.category" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyCategory" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode" ] ] ], [ fhir:index 17; fhir:Element.id [ fhir:value "ResearchStudy.focus" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.focus" ]; fhir:ElementDefinition.short [ fhir:value "Drugs, devices, etc. under study" ]; fhir:ElementDefinition.definition [ fhir:value "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.focus" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyFocus" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for medications, devices and other interventions." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Focus of Study" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.what[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocol.interventionTypeCode" ] ] ], [ fhir:index 18; fhir:Element.id [ fhir:value "ResearchStudy.condition" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.condition" ]; fhir:ElementDefinition.short [ fhir:value "Condition being studied" ]; fhir:ElementDefinition.definition [ fhir:value "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.condition" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ConditionCode" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Identification of the condition or diagnosis." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/condition-code" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Conditions" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.what[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyCondition.code" ] ] ], [ fhir:index 19; fhir:Element.id [ fhir:value "ResearchStudy.contact" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.contact" ]; fhir:ElementDefinition.short [ fhir:value "Contact details for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Contact details to assist a user in learning more about or engaging with the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.contact" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "ContactDetail" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion" ] ] ], [ fhir:index 20; fhir:Element.id [ fhir:value "ResearchStudy.relatedArtifact" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.relatedArtifact" ]; fhir:ElementDefinition.short [ fhir:value "References and dependencies" ]; fhir:ElementDefinition.definition [ fhir:value "Citations, references and other related documents." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.relatedArtifact" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "RelatedArtifact" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Citations, Links, Available Study Data/Documents" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocument, StudyProtocolDocumentVersion" ] ] ], [ fhir:index 21; fhir:Element.id [ fhir:value "ResearchStudy.keyword" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.keyword" ]; fhir:ElementDefinition.short [ fhir:value "Used to search for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Key terms to aid in searching for or filtering the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.keyword" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyKeyword" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Words associated with the study that may be useful in discovery." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Keywords" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "DocumentVersion.keywordCode; DocumentVersion.keywordText" ] ] ], [ fhir:index 22; fhir:Element.id [ fhir:value "ResearchStudy.location" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.location" ]; fhir:ElementDefinition.short [ fhir:value "Geographic region(s) for study" ]; fhir:ElementDefinition.definition [ fhir:value "Indicates a country, state or other region where the study is taking place." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.location" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "Jurisdiction" ] ], [ fhir:index 1; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding" ]; fhir:Extension.value [ fhir:value "true" ] ]; fhir:ElementDefinition.strength [ fhir:value "extensible" ]; fhir:ElementDefinition.description [ fhir:value "Countries and regions within which this artifact is targeted for use." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/jurisdiction" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.participatingLocationCode" ] ] ], [ fhir:index 23; fhir:Element.id [ fhir:value "ResearchStudy.description" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.description" ]; fhir:ElementDefinition.short [ fhir:value "What this is study doing" ]; fhir:ElementDefinition.definition [ fhir:value "A full description of how the study is being conducted." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.description" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "markdown" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Detailed Description" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocumentVersion.publicDescription" ] ] ], [ fhir:index 24; fhir:Element.id [ fhir:value "ResearchStudy.enrollment" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.enrollment" ]; fhir:ElementDefinition.short [ fhir:value "Inclusion & exclusion criteria" ]; fhir:ElementDefinition.definition [ fhir:value "Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\"." ]; fhir:ElementDefinition.comment [ fhir:value "The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource." ]; fhir:ElementDefinition.alias [ fhir:value "patient"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.enrollment" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Group"; fhir:index 0 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.subject[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocol.interventionGroupQuantity" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".participation[typeCode=SBJ].role" ] ], [ fhir:index 4; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.subject" ] ] ], [ fhir:index 25; fhir:Element.id [ fhir:value "ResearchStudy.period" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.period" ]; fhir:ElementDefinition.short [ fhir:value "When the study began and ended" ]; fhir:ElementDefinition.definition [ fhir:value "Identifies the start date and the expected (or actual, depending on status) end date for the study." ]; fhir:ElementDefinition.alias [ fhir:value "timing"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.period" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Period" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Start Date (start); Study Completion Date (end)" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.done[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".effectiveTime" ] ] ], [ fhir:index 26; fhir:Element.id [ fhir:value "ResearchStudy.sponsor" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.sponsor" ]; fhir:ElementDefinition.short [ fhir:value "Organization that initiates and is legally responsible for the study" ]; fhir:ElementDefinition.definition [ fhir:value "An organization that initiates the investigation and is legally responsible for the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.sponsor" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Organization"; fhir:index 0 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Sponsor" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.actor" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" ] ] ], [ fhir:index 27; fhir:Element.id [ fhir:value "ResearchStudy.principalInvestigator" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.principalInvestigator" ]; fhir:ElementDefinition.short [ fhir:value "Researcher who oversees multiple aspects of the study" ]; fhir:ElementDefinition.definition [ fhir:value "A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.principalInvestigator" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Practitioner"; fhir:index 0 ], [ fhir:value "http://hl7.org/fhir/StructureDefinition/PractitionerRole"; fhir:index 1 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Principal Investigator" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.actor" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyInvestigator" ] ] ], [ fhir:index 28; fhir:Element.id [ fhir:value "ResearchStudy.site" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.site" ]; fhir:ElementDefinition.short [ fhir:value "Facility where study activities are conducted" ]; fhir:ElementDefinition.definition [ fhir:value "A facility in which study activities are conducted." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.site" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Location"; fhir:index 0 ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Facility" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.where[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "PlannedStudySite; StudySite" ] ] ], [ fhir:index 29; fhir:Element.id [ fhir:value "ResearchStudy.reasonStopped" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.reasonStopped" ]; fhir:ElementDefinition.short [ fhir:value "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design" ]; fhir:ElementDefinition.definition [ fhir:value "A description and/or code explaining the premature termination of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.reasonStopped" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyReasonStopped" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for why the study ended prematurely." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-reason-stopped" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Why Study Stopped" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.why[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyOverallStatus.studyStoppedReasonCode" ] ] ], [ fhir:index 30; fhir:Element.id [ fhir:value "ResearchStudy.note" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.note" ]; fhir:ElementDefinition.short [ fhir:value "Comments made about the study" ]; fhir:ElementDefinition.definition [ fhir:value "Comments made about the study by the performer, subject or other participants." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.note" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Annotation" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]" ] ] ], [ fhir:index 31; fhir:Element.id [ fhir:value "ResearchStudy.arm" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm" ]; fhir:ElementDefinition.short [ fhir:value "Defined path through the study for a subject" ]; fhir:ElementDefinition.definition [ fhir:value "Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "BackboneElement" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children unless an empty Parameters resource" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count()) or $this is Parameters" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div|self::f:Parameters" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arms" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm" ] ] ], [ fhir:index 32; fhir:Element.id [ fhir:value "ResearchStudy.arm.id" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.id" ]; fhir:ElementDefinition.representation [ fhir:value "xmlAttr"; fhir:index 0 ]; fhir:ElementDefinition.short [ fhir:value "Unique id for inter-element referencing" ]; fhir:ElementDefinition.definition [ fhir:value "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Element.id" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type" ]; fhir:Extension.value [ fhir:value "string" ] ]; fhir:ElementDefinition.code [ fhir:value "http://hl7.org/fhirpath/System.String" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "n/a" ] ] ], [ fhir:index 33; fhir:Element.id [ fhir:value "ResearchStudy.arm.extension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.extension" ]; fhir:ElementDefinition.short [ fhir:value "Additional content defined by implementations" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Element.extension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "n/a" ] ] ], [ fhir:index 34; fhir:Element.id [ fhir:value "ResearchStudy.arm.modifierExtension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.modifierExtension" ]; fhir:ElementDefinition.short [ fhir:value "Extensions that cannot be ignored even if unrecognized" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.requirements [ fhir:value "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ], [ fhir:value "modifiers"; fhir:index 2 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "BackboneElement.modifierExtension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "N/A" ] ] ], [ fhir:index 35; fhir:Element.id [ fhir:value "ResearchStudy.arm.name" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.name" ]; fhir:ElementDefinition.short [ fhir:value "Label for study arm" ]; fhir:ElementDefinition.definition [ fhir:value "Unique, human-readable label for this arm of the study." ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.name" ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Label" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.name" ] ] ], [ fhir:index 36; fhir:Element.id [ fhir:value "ResearchStudy.arm.type" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.type" ]; fhir:ElementDefinition.short [ fhir:value "Categorization of study arm" ]; fhir:ElementDefinition.definition [ fhir:value "Categorization of study arm, e.g. experimental, active comparator, placebo comparater." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.type" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Type" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.typeCode" ] ] ], [ fhir:index 37; fhir:Element.id [ fhir:value "ResearchStudy.arm.description" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.description" ]; fhir:ElementDefinition.short [ fhir:value "Short explanation of study path" ]; fhir:ElementDefinition.definition [ fhir:value "A succinct description of the path through the study that would be followed by a subject adhering to this arm." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.description" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Description" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.description" ] ] ], [ fhir:index 38; fhir:Element.id [ fhir:value "ResearchStudy.objective" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective" ]; fhir:ElementDefinition.short [ fhir:value "A goal for the study" ]; fhir:ElementDefinition.definition [ fhir:value "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "BackboneElement" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children unless an empty Parameters resource" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count()) or $this is Parameters" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div|self::f:Parameters" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyObjective" ] ] ], [ fhir:index 39; fhir:Element.id [ fhir:value "ResearchStudy.objective.id" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.id" ]; fhir:ElementDefinition.representation [ fhir:value "xmlAttr"; fhir:index 0 ]; fhir:ElementDefinition.short [ fhir:value "Unique id for inter-element referencing" ]; fhir:ElementDefinition.definition [ fhir:value "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Element.id" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type" ]; fhir:Extension.value [ fhir:value "string" ] ]; fhir:ElementDefinition.code [ fhir:value "http://hl7.org/fhirpath/System.String" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "n/a" ] ] ], [ fhir:index 40; fhir:Element.id [ fhir:value "ResearchStudy.objective.extension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.extension" ]; fhir:ElementDefinition.short [ fhir:value "Additional content defined by implementations" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "Element.extension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "n/a" ] ] ], [ fhir:index 41; fhir:Element.id [ fhir:value "ResearchStudy.objective.modifierExtension" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.modifierExtension" ]; fhir:ElementDefinition.short [ fhir:value "Extensions that cannot be ignored even if unrecognized" ]; fhir:ElementDefinition.definition [ fhir:value "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)." ]; fhir:ElementDefinition.comment [ fhir:value "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." ]; fhir:ElementDefinition.requirements [ fhir:value "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." ]; fhir:ElementDefinition.alias [ fhir:value "extensions"; fhir:index 0 ], [ fhir:value "user content"; fhir:index 1 ], [ fhir:value "modifiers"; fhir:index 2 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "BackboneElement.modifierExtension" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Extension" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ], [ fhir:index 1; fhir:ElementDefinition.key [ fhir:value "ext-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "Must have either extensions or value[x], not both" ]; fhir:ElementDefinition.expression [ fhir:value "extension.exists() != value.exists()" ]; fhir:ElementDefinition.xpath [ fhir:value "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Extension" ] ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "N/A" ] ] ], [ fhir:index 42; fhir:Element.id [ fhir:value "ResearchStudy.objective.name" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.name" ]; fhir:ElementDefinition.short [ fhir:value "Label for the objective" ]; fhir:ElementDefinition.definition [ fhir:value "Unique, human-readable label for this objective of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.name" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (BRIDG has a description, but not a name)" ] ] ], [ fhir:index 43; fhir:Element.id [ fhir:value "ResearchStudy.objective.type" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.type" ]; fhir:ElementDefinition.short [ fhir:value "primary | secondary | exploratory" ]; fhir:ElementDefinition.definition [ fhir:value "The kind of study objective." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.base [ fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.type" ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ] ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.constraint [ fhir:index 0; fhir:ElementDefinition.key [ fhir:value "ele-1" ]; fhir:ElementDefinition.severity [ fhir:value "error" ]; fhir:ElementDefinition.human [ fhir:value "All FHIR elements must have a @value or children" ]; fhir:ElementDefinition.expression [ fhir:value "hasValue() or (children().count() > id.count())" ]; fhir:ElementDefinition.xpath [ fhir:value "@value|f:*|h:div" ]; fhir:ElementDefinition.source [ fhir:value "http://hl7.org/fhir/StructureDefinition/Element" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyObjectiveType" ] ]; fhir:ElementDefinition.strength [ fhir:value "preferred" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the kind of study objective." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-objective-type" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyObjective.typeCode" ] ] ] ]; fhir:StructureDefinition.differential [ fhir:StructureDefinition.element [ fhir:index 0; fhir:Element.id [ fhir:value "ResearchStudy" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy" ]; fhir:ElementDefinition.short [ fhir:value "Investigation to increase healthcare-related patient-independent knowledge" ]; fhir:ElementDefinition.definition [ fhir:value "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects." ]; fhir:ElementDefinition.comment [ fhir:value "Need to make sure we encompass public health studies." ]; fhir:ElementDefinition.alias [ fhir:value "Clinical Trial"; fhir:index 0 ], [ fhir:value "Study"; fhir:index 1 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "v2" ]; fhir:ElementDefinition.map [ fhir:value "OBX" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value "Observation[classCode=CLNTRL, moodCode=EVN]" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "clinical.diagnostics" ] ] ], [ fhir:index 1; fhir:Element.id [ fhir:value "ResearchStudy.identifier" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.identifier" ]; fhir:ElementDefinition.short [ fhir:value "Business Identifier for study" ]; fhir:ElementDefinition.definition [ fhir:value "Identifiers assigned to this research study by the sponsor or other systems." ]; fhir:ElementDefinition.requirements [ fhir:value "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Identifier" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Organization's Unique Protocol ID; Secondary IDs" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.identifier" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".identifier" ] ] ], [ fhir:index 2; fhir:Element.id [ fhir:value "ResearchStudy.title" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.title" ]; fhir:ElementDefinition.short [ fhir:value "Name for this study" ]; fhir:ElementDefinition.definition [ fhir:value "A short, descriptive user-friendly label for the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Brief Title" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)" ] ] ], [ fhir:index 3; fhir:Element.id [ fhir:value "ResearchStudy.protocol" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.protocol" ]; fhir:ElementDefinition.short [ fhir:value "Steps followed in executing study" ]; fhir:ElementDefinition.definition [ fhir:value "The set of steps expected to be performed as part of the execution of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/PlanDefinition"; fhir:index 0 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Interventions; Arm/Intervention Cross-Reference" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocumentVersionPublicTitle.name" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".outboundRelationship[typeCode=DEFN].target" ] ] ], [ fhir:index 4; fhir:Element.id [ fhir:value "ResearchStudy.partOf" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.partOf" ]; fhir:ElementDefinition.short [ fhir:value "Part of larger study" ]; fhir:ElementDefinition.definition [ fhir:value "A larger research study of which this particular study is a component or step." ]; fhir:ElementDefinition.requirements [ fhir:value "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc." ]; fhir:ElementDefinition.alias [ fhir:value "container"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/ResearchStudy"; fhir:index 0 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "CompanionStudyRelationship" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" ] ] ], [ fhir:index 5; fhir:Element.id [ fhir:value "ResearchStudy.status" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.status" ]; fhir:ElementDefinition.short [ fhir:value "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:ElementDefinition.definition [ fhir:value "The current state of the study." ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "code" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "true" ]; fhir:ElementDefinition.isModifierReason [ fhir:value "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyStatus" ] ]; fhir:ElementDefinition.strength [ fhir:value "required" ]; fhir:ElementDefinition.description [ fhir:value "Codes that convey the current status of the research study." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-status|4.3.0" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.status" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyOverallStatus.code" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".status" ] ] ], [ fhir:index 6; fhir:Element.id [ fhir:value "ResearchStudy.primaryPurposeType" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.primaryPurposeType" ]; fhir:ElementDefinition.short [ fhir:value "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility" ]; fhir:ElementDefinition.definition [ fhir:value "The type of study based upon the intent of the study's activities. A classification of the intent of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyPrimaryPurposeType" ] ]; fhir:ElementDefinition.strength [ fhir:value "extensible" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the main intent of the study." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.primaryPurposeTypeCode" ] ] ], [ fhir:index 7; fhir:Element.id [ fhir:value "ResearchStudy.phase" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.phase" ]; fhir:ElementDefinition.short [ fhir:value "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4" ]; fhir:ElementDefinition.definition [ fhir:value "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyPhase" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-phase" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Phase" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.phaseCode" ] ] ], [ fhir:index 8; fhir:Element.id [ fhir:value "ResearchStudy.category" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.category" ]; fhir:ElementDefinition.short [ fhir:value "Classifications for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyCategory" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode" ] ] ], [ fhir:index 9; fhir:Element.id [ fhir:value "ResearchStudy.focus" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.focus" ]; fhir:ElementDefinition.short [ fhir:value "Drugs, devices, etc. under study" ]; fhir:ElementDefinition.definition [ fhir:value "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyFocus" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for medications, devices and other interventions." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Focus of Study" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.what[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocol.interventionTypeCode" ] ] ], [ fhir:index 10; fhir:Element.id [ fhir:value "ResearchStudy.condition" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.condition" ]; fhir:ElementDefinition.short [ fhir:value "Condition being studied" ]; fhir:ElementDefinition.definition [ fhir:value "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ConditionCode" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Identification of the condition or diagnosis." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/condition-code" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Conditions" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.what[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyCondition.code" ] ] ], [ fhir:index 11; fhir:Element.id [ fhir:value "ResearchStudy.contact" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.contact" ]; fhir:ElementDefinition.short [ fhir:value "Contact details for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Contact details to assist a user in learning more about or engaging with the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "ContactDetail" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion" ] ] ], [ fhir:index 12; fhir:Element.id [ fhir:value "ResearchStudy.relatedArtifact" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.relatedArtifact" ]; fhir:ElementDefinition.short [ fhir:value "References and dependencies" ]; fhir:ElementDefinition.definition [ fhir:value "Citations, references and other related documents." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "RelatedArtifact" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Citations, Links, Available Study Data/Documents" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocument, StudyProtocolDocumentVersion" ] ] ], [ fhir:index 13; fhir:Element.id [ fhir:value "ResearchStudy.keyword" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.keyword" ]; fhir:ElementDefinition.short [ fhir:value "Used to search for the study" ]; fhir:ElementDefinition.definition [ fhir:value "Key terms to aid in searching for or filtering the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyKeyword" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Words associated with the study that may be useful in discovery." ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Keywords" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "DocumentVersion.keywordCode; DocumentVersion.keywordText" ] ] ], [ fhir:index 14; fhir:Element.id [ fhir:value "ResearchStudy.location" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.location" ]; fhir:ElementDefinition.short [ fhir:value "Geographic region(s) for study" ]; fhir:ElementDefinition.definition [ fhir:value "Indicates a country, state or other region where the study is taking place." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "Jurisdiction" ] ], [ fhir:index 1; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding" ]; fhir:Extension.value [ fhir:value "true" ] ]; fhir:ElementDefinition.strength [ fhir:value "extensible" ]; fhir:ElementDefinition.description [ fhir:value "Countries and regions within which this artifact is targeted for use." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/jurisdiction" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolVersion.participatingLocationCode" ] ] ], [ fhir:index 15; fhir:Element.id [ fhir:value "ResearchStudy.description" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.description" ]; fhir:ElementDefinition.short [ fhir:value "What this is study doing" ]; fhir:ElementDefinition.definition [ fhir:value "A full description of how the study is being conducted." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "markdown" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Detailed Description" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyProtocolDocumentVersion.publicDescription" ] ] ], [ fhir:index 16; fhir:Element.id [ fhir:value "ResearchStudy.enrollment" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.enrollment" ]; fhir:ElementDefinition.short [ fhir:value "Inclusion & exclusion criteria" ]; fhir:ElementDefinition.definition [ fhir:value "Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\"." ]; fhir:ElementDefinition.comment [ fhir:value "The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource." ]; fhir:ElementDefinition.alias [ fhir:value "patient"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Group"; fhir:index 0 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.subject[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "InterventionalStudyProtocol.interventionGroupQuantity" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".participation[typeCode=SBJ].role" ] ], [ fhir:index 4; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.subject" ] ] ], [ fhir:index 17; fhir:Element.id [ fhir:value "ResearchStudy.period" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.period" ]; fhir:ElementDefinition.short [ fhir:value "When the study began and ended" ]; fhir:ElementDefinition.definition [ fhir:value "Identifies the start date and the expected (or actual, depending on status) end date for the study." ]; fhir:ElementDefinition.alias [ fhir:value "timing"; fhir:index 0 ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Period" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Study Start Date (start); Study Completion Date (end)" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.done[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".effectiveTime" ] ] ], [ fhir:index 18; fhir:Element.id [ fhir:value "ResearchStudy.sponsor" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.sponsor" ]; fhir:ElementDefinition.short [ fhir:value "Organization that initiates and is legally responsible for the study" ]; fhir:ElementDefinition.definition [ fhir:value "An organization that initiates the investigation and is legally responsible for the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Organization"; fhir:index 0 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Sponsor" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.actor" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode" ] ], [ fhir:index 3; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" ] ] ], [ fhir:index 19; fhir:Element.id [ fhir:value "ResearchStudy.principalInvestigator" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.principalInvestigator" ]; fhir:ElementDefinition.short [ fhir:value "Researcher who oversees multiple aspects of the study" ]; fhir:ElementDefinition.definition [ fhir:value "A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Practitioner"; fhir:index 0 ], [ fhir:value "http://hl7.org/fhir/StructureDefinition/PractitionerRole"; fhir:index 1 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Principal Investigator" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.actor" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyInvestigator" ] ] ], [ fhir:index 20; fhir:Element.id [ fhir:value "ResearchStudy.site" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.site" ]; fhir:ElementDefinition.short [ fhir:value "Facility where study activities are conducted" ]; fhir:ElementDefinition.definition [ fhir:value "A facility in which study activities are conducted." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Reference" ]; fhir:ElementDefinition.targetProfile [ fhir:value "http://hl7.org/fhir/StructureDefinition/Location"; fhir:index 0 ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Facility" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.where[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "PlannedStudySite; StudySite" ] ] ], [ fhir:index 21; fhir:Element.id [ fhir:value "ResearchStudy.reasonStopped" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.reasonStopped" ]; fhir:ElementDefinition.short [ fhir:value "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design" ]; fhir:ElementDefinition.definition [ fhir:value "A description and/or code explaining the premature termination of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "true" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyReasonStopped" ] ]; fhir:ElementDefinition.strength [ fhir:value "example" ]; fhir:ElementDefinition.description [ fhir:value "Codes for why the study ended prematurely." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-reason-stopped" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Why Study Stopped" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "w5" ]; fhir:ElementDefinition.map [ fhir:value "FiveWs.why[x]" ] ], [ fhir:index 2; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyOverallStatus.studyStoppedReasonCode" ] ] ], [ fhir:index 22; fhir:Element.id [ fhir:value "ResearchStudy.note" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.note" ]; fhir:ElementDefinition.short [ fhir:value "Comments made about the study" ]; fhir:ElementDefinition.definition [ fhir:value "Comments made about the study by the performer, subject or other participants." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "Annotation" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "rim" ]; fhir:ElementDefinition.map [ fhir:value ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]" ] ] ], [ fhir:index 23; fhir:Element.id [ fhir:value "ResearchStudy.arm" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm" ]; fhir:ElementDefinition.short [ fhir:value "Defined path through the study for a subject" ]; fhir:ElementDefinition.definition [ fhir:value "Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "BackboneElement" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arms" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm" ] ] ], [ fhir:index 24; fhir:Element.id [ fhir:value "ResearchStudy.arm.name" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.name" ]; fhir:ElementDefinition.short [ fhir:value "Label for study arm" ]; fhir:ElementDefinition.definition [ fhir:value "Unique, human-readable label for this arm of the study." ]; fhir:ElementDefinition.min [ fhir:value "1" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Label" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.name" ] ] ], [ fhir:index 25; fhir:Element.id [ fhir:value "ResearchStudy.arm.type" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.type" ]; fhir:ElementDefinition.short [ fhir:value "Categorization of study arm" ]; fhir:ElementDefinition.definition [ fhir:value "Categorization of study arm, e.g. experimental, active comparator, placebo comparater." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Type" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.typeCode" ] ] ], [ fhir:index 26; fhir:Element.id [ fhir:value "ResearchStudy.arm.description" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.arm.description" ]; fhir:ElementDefinition.short [ fhir:value "Short explanation of study path" ]; fhir:ElementDefinition.definition [ fhir:value "A succinct description of the path through the study that would be followed by a subject adhering to this arm." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "clinicaltrials-gov" ]; fhir:ElementDefinition.map [ fhir:value "Arm Description" ] ], [ fhir:index 1; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "Arm.description" ] ] ], [ fhir:index 27; fhir:Element.id [ fhir:value "ResearchStudy.objective" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective" ]; fhir:ElementDefinition.short [ fhir:value "A goal for the study" ]; fhir:ElementDefinition.definition [ fhir:value "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "*" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "BackboneElement" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyObjective" ] ] ], [ fhir:index 28; fhir:Element.id [ fhir:value "ResearchStudy.objective.name" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.name" ]; fhir:ElementDefinition.short [ fhir:value "Label for the objective" ]; fhir:ElementDefinition.definition [ fhir:value "Unique, human-readable label for this objective of the study." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "string" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "No BRIDG mapping (BRIDG has a description, but not a name)" ] ] ], [ fhir:index 29; fhir:Element.id [ fhir:value "ResearchStudy.objective.type" ]; fhir:ElementDefinition.path [ fhir:value "ResearchStudy.objective.type" ]; fhir:ElementDefinition.short [ fhir:value "primary | secondary | exploratory" ]; fhir:ElementDefinition.definition [ fhir:value "The kind of study objective." ]; fhir:ElementDefinition.min [ fhir:value "0" ]; fhir:ElementDefinition.max [ fhir:value "1" ]; fhir:ElementDefinition.type [ fhir:index 0; fhir:ElementDefinition.code [ fhir:value "CodeableConcept" ] ]; fhir:ElementDefinition.mustSupport [ fhir:value "false" ]; fhir:ElementDefinition.isModifier [ fhir:value "false" ]; fhir:ElementDefinition.isSummary [ fhir:value "false" ]; fhir:ElementDefinition.binding [ fhir:Element.extension [ fhir:index 0; fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName" ]; fhir:Extension.value [ fhir:value "ResearchStudyObjectiveType" ] ]; fhir:ElementDefinition.strength [ fhir:value "preferred" ]; fhir:ElementDefinition.description [ fhir:value "Codes for the kind of study objective." ]; fhir:ElementDefinition.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-study-objective-type" ] ]; fhir:ElementDefinition.mapping [ fhir:index 0; fhir:ElementDefinition.identity [ fhir:value "BRIDG5.1" ]; fhir:ElementDefinition.map [ fhir:value "StudyObjective.typeCode" ] ] ] ] . # -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.