Release 5 Preview #2
AdministrationThis page is part of the FHIR Specification (v4.4.0: R5 Preview #2). 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 R3
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Patient |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for researchsubject
{
"resourceType" : "StructureDefinition",
"id" : "ResearchSubject",
"meta" : {
"lastUpdated" : "2020-05-03T08:43:35.811+10:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Public Health & Research"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "patient"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
"version" : "4.4.0",
"name" : "ResearchSubject",
"status" : "draft",
"date" : "2020-05-03T08:43:35+10:00",
"publisher" : "Health Level Seven International (Biomedical Research and Regulation)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
}]
},
{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}]
}],
"description" : "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
"fhirVersion" : "4.4.0",
"mapping" : [{
"identity" : "BRIDG5.1",
"uri" : "https://bridgmodel.nci.nih.gov",
"name" : "BRIDG 5.1 Mapping"
},
{
"identity" : "v2",
"uri" : "http://hl7.org/v2",
"name" : "HL7 v2 Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "ResearchSubject",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "ResearchSubject",
"path" : "ResearchSubject",
"short" : "Physical entity which is the primary unit of interest in the study",
"definition" : "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Study Subject"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath" : "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "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."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
}]
},
{
"id" : "ResearchSubject.id",
"path" : "ResearchSubject.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchSubject.meta",
"path" : "ResearchSubject.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchSubject.implicitRules",
"path" : "ResearchSubject.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
"isSummary" : true
},
{
"id" : "ResearchSubject.language",
"path" : "ResearchSubject.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "A human language.",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "ResearchSubject.text",
"path" : "ResearchSubject.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment" : "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"alias" : ["narrative",
"html",
"xhtml",
"display"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Narrative"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "ResearchSubject.contained",
"path" : "ResearchSubject.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.",
"alias" : ["inline resources",
"anonymous resources",
"contained resources"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Resource"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.extension",
"path" : "ResearchSubject.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.modifierExtension",
"path" : "ResearchSubject.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "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).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.identifier",
"path" : "ResearchSubject.identifier",
"short" : "Business Identifier for research subject in a study",
"definition" : "Identifiers assigned to this research subject for a study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject > Subject.identifier"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchSubject.status",
"path" : "ResearchSubject.status",
"short" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
"definition" : "The current state of the subject.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.status",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : true,
"isModifierReason" : "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 be treated as invalid",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectStatus"
}],
"strength" : "required",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-status|4.4.0"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.progress",
"path" : "ResearchSubject.progress",
"short" : "Subject status",
"definition" : "The current state (status) of the subject and resons for status change where appropriate.",
"comment" : "This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance \"Randomised\" and \"Visit 1\" may be different milestones but the state remains at \"on study\" after each of them. \n\nIt is likely that more than one \"state\" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.progress",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.progress.id",
"path" : "ResearchSubject.progress.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.progress.extension",
"path" : "ResearchSubject.progress.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.progress.modifierExtension",
"path" : "ResearchSubject.progress.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.progress.type",
"path" : "ResearchSubject.progress.type",
"short" : "Kind of state that is being described",
"definition" : "Identifies the aspect of the subject's journey that the state refers to.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.progress.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectStateType"
}],
"strength" : "example",
"description" : "Identifies the kind of state being refered to.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state-type"
}
},
{
"id" : "ResearchSubject.progress.state",
"path" : "ResearchSubject.progress.state",
"short" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
"definition" : "The current state of the subject.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.progress.state",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectState"
}],
"strength" : "example",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.progress.milestone",
"path" : "ResearchSubject.progress.milestone",
"short" : "SignedUp | Screened | Randomized",
"definition" : "The milestones the subject has passed through.",
"comment" : "There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.progress.milestone",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectMilestone"
}],
"strength" : "example",
"description" : "Indicates the progression of a study subject through the study milestones.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-milestone"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
}]
},
{
"id" : "ResearchSubject.progress.reason",
"path" : "ResearchSubject.progress.reason",
"short" : "State change reason",
"definition" : "The reason for the state change. If coded it should follow the formal subject state model.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.progress.reason",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "StateChangeReason"
}],
"strength" : "example",
"description" : "Indicates why the state of the subject changed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/state-change-reason"
}
},
{
"id" : "ResearchSubject.progress.startDate",
"path" : "ResearchSubject.progress.startDate",
"short" : "State change date",
"definition" : "The date when the change in status occurred.",
"comment" : "This is NOT the date the change in state was recorded.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.progress.startDate",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.period",
"path" : "ResearchSubject.period",
"short" : "Start and end of participation",
"definition" : "The dates the subject began and ended their participation in the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.period",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "PerformedStudySubjectMilestone.studyReferenceDateRange"
}]
},
{
"id" : "ResearchSubject.study",
"path" : "ResearchSubject.study",
"short" : "Study subject is part of",
"definition" : "Reference to the study the subject is participating in.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.study",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubjectProtocolVersionRelationship"
}]
},
{
"id" : "ResearchSubject.individual",
"path" : "ResearchSubject.individual",
"short" : "Who is part of study",
"definition" : "The record of the person or animal who is involved in the study.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.individual",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
}]
},
{
"id" : "ResearchSubject.assignedArm",
"path" : "ResearchSubject.assignedArm",
"short" : "What path should be followed",
"definition" : "The name of the arm in the study the subject is expected to follow as part of this study.",
"comment" : "Maybe this is really PlanDefinition.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.assignedArm",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.actualArm",
"path" : "ResearchSubject.actualArm",
"short" : "What path was followed",
"definition" : "The name of the arm in the study the subject actually followed as part of this study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.actualArm",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.consent",
"path" : "ResearchSubject.consent",
"short" : "Agreement to participate in study",
"definition" : "A record of the patient's informed agreement to participate in the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.consent",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Consent"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
}]
}]
},
"differential" : {
"element" : [{
"id" : "ResearchSubject",
"path" : "ResearchSubject",
"short" : "Physical entity which is the primary unit of interest in the study",
"definition" : "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Study Subject"],
"min" : 0,
"max" : "*",
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
}]
},
{
"id" : "ResearchSubject.identifier",
"path" : "ResearchSubject.identifier",
"short" : "Business Identifier for research subject in a study",
"definition" : "Identifiers assigned to this research subject for a study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject > Subject.identifier"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchSubject.status",
"path" : "ResearchSubject.status",
"short" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
"definition" : "The current state of the subject.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "code"
}],
"isModifier" : true,
"isModifierReason" : "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 be treated as invalid",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectStatus"
}],
"strength" : "required",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-status|4.4.0"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.progress",
"path" : "ResearchSubject.progress",
"short" : "Subject status",
"definition" : "The current state (status) of the subject and resons for status change where appropriate.",
"comment" : "This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance \"Randomised\" and \"Visit 1\" may be different milestones but the state remains at \"on study\" after each of them. \n\nIt is likely that more than one \"state\" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}]
},
{
"id" : "ResearchSubject.progress.type",
"path" : "ResearchSubject.progress.type",
"short" : "Kind of state that is being described",
"definition" : "Identifies the aspect of the subject's journey that the state refers to.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectStateType"
}],
"strength" : "example",
"description" : "Identifies the kind of state being refered to.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state-type"
}
},
{
"id" : "ResearchSubject.progress.state",
"path" : "ResearchSubject.progress.state",
"short" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
"definition" : "The current state of the subject.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectState"
}],
"strength" : "example",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.progress.milestone",
"path" : "ResearchSubject.progress.milestone",
"short" : "SignedUp | Screened | Randomized",
"definition" : "The milestones the subject has passed through.",
"comment" : "There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectMilestone"
}],
"strength" : "example",
"description" : "Indicates the progression of a study subject through the study milestones.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-milestone"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
}]
},
{
"id" : "ResearchSubject.progress.reason",
"path" : "ResearchSubject.progress.reason",
"short" : "State change reason",
"definition" : "The reason for the state change. If coded it should follow the formal subject state model.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "StateChangeReason"
}],
"strength" : "example",
"description" : "Indicates why the state of the subject changed.",
"valueSet" : "http://hl7.org/fhir/ValueSet/state-change-reason"
}
},
{
"id" : "ResearchSubject.progress.startDate",
"path" : "ResearchSubject.progress.startDate",
"short" : "State change date",
"definition" : "The date when the change in status occurred.",
"comment" : "This is NOT the date the change in state was recorded.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "dateTime"
}]
},
{
"id" : "ResearchSubject.period",
"path" : "ResearchSubject.period",
"short" : "Start and end of participation",
"definition" : "The dates the subject began and ended their participation in the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "PerformedStudySubjectMilestone.studyReferenceDateRange"
}]
},
{
"id" : "ResearchSubject.study",
"path" : "ResearchSubject.study",
"short" : "Study subject is part of",
"definition" : "Reference to the study the subject is participating in.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubjectProtocolVersionRelationship"
}]
},
{
"id" : "ResearchSubject.individual",
"path" : "ResearchSubject.individual",
"short" : "Who is part of study",
"definition" : "The record of the person or animal who is involved in the study.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient"]
}],
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
}]
},
{
"id" : "ResearchSubject.assignedArm",
"path" : "ResearchSubject.assignedArm",
"short" : "What path should be followed",
"definition" : "The name of the arm in the study the subject is expected to follow as part of this study.",
"comment" : "Maybe this is really PlanDefinition.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.actualArm",
"path" : "ResearchSubject.actualArm",
"short" : "What path was followed",
"definition" : "The name of the arm in the study the subject actually followed as part of this study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.consent",
"path" : "ResearchSubject.consent",
"short" : "Agreement to participate in study",
"definition" : "A record of the patient's informed agreement to participate in the study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Consent"]
}],
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
}]
}]
}
}
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.
FHIR ®© HL7.org 2011+. FHIR CI Build hl7.fhir.core#4.4.0 generated on Sun, May 3, 2020 08:48+1000.
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