FHIR Release 3 (STU)
AdministrationThis page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
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| Regulated Clinical Research Information Management Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Patient |
StructureDefinition for researchsubject
{
"resourceType": "StructureDefinition",
"id": "ResearchSubject",
"meta": {
"lastUpdated": "2019-10-24T11:53:00+11:00"
},
"text": {
"status": "generated",
"div": "<div>!-- Snipped for Brevity --></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "rcrim"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
"name": "ResearchSubject",
"status": "draft",
"date": "2019-10-24T11:53:00+11:00",
"publisher": "Health Level Seven International (Regulated Clinical Research Information Management)",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org/fhir"
}
]
},
{
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}
]
}
],
"description": "Base StructureDefinition for ResearchSubject Resource",
"fhirVersion": "3.0.2",
"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/w5",
"name": "W5 Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "ResearchSubject",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation": "specialization",
"snapshot": {
"element": [
{
"id": "ResearchSubject",
"path": "ResearchSubject",
"short": "Investigation to increase healthcare-related patient-independent knowledge",
"definition": "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.",
"comment": "Need to make sure we encompass public health studies.",
"alias": [
"Study Subject"
],
"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": "DomainResource"
},
{
"key": "dom-1",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression": "contained.text.empty()",
"xpath": "not(parent::f:contained and f:text)",
"source": "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": "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",
"expression": "contained.where(('#'+id in %resource.descendants().reference).not()).empty()",
"xpath": "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))",
"source": "DomainResource"
}
],
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
},
{
"identity": "v2",
"map": "OBX"
},
{
"identity": "rim",
"map": "Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity": "w5",
"map": "clinical.diagnostics"
}
]
},
{
"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": [
{
"code": "id"
}
],
"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 may 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"
}
],
"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.",
"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. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"isModifier": true,
"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"
}
],
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueReference": {
"reference": "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": "extensible",
"description": "A human language.",
"valueSetReference": {
"reference": "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 may 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 in formation is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-1"
],
"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.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"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. In order 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.",
"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"
}
],
"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. Usually modifier elements provide negation or qualification. In order 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.",
"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.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchSubject.identifier",
"path": "ResearchSubject.identifier",
"short": "Business Identifier for research subject",
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
},
{
"identity": "w5",
"map": "id"
}
]
},
{
"id": "ResearchSubject.status",
"path": "ResearchSubject.status",
"short": "candidate | enrolled | active | suspended | withdrawn | completed",
"definition": "The current state of the subject.",
"comment": "This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"isModifier": true,
"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",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/research-subject-status"
}
},
"mapping": [
{
"identity": "rim",
"map": ".status"
},
{
"identity": "w5",
"map": "status"
}
]
},
{
"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": "w5",
"map": "when.planned"
}
]
},
{
"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
},
{
"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
},
{
"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.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"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"
}
]
},
{
"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"
}
]
}
]
},
"differential": {
"element": [
{
"id": "ResearchSubject",
"path": "ResearchSubject",
"short": "Investigation to increase healthcare-related patient-independent knowledge",
"definition": "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.",
"comment": "Need to make sure we encompass public health studies.",
"alias": [
"Study Subject"
],
"min": 0,
"max": "*",
"mapping": [
{
"identity": "v2",
"map": "OBX"
},
{
"identity": "rim",
"map": "Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity": "w5",
"map": "clinical.diagnostics"
}
]
},
{
"id": "ResearchSubject.identifier",
"path": "ResearchSubject.identifier",
"short": "Business Identifier for research subject",
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": ".identifier"
},
{
"identity": "w5",
"map": "id"
}
]
},
{
"id": "ResearchSubject.status",
"path": "ResearchSubject.status",
"short": "candidate | enrolled | active | suspended | withdrawn | completed",
"definition": "The current state of the subject.",
"comment": "This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"isModifier": true,
"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",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/research-subject-status"
}
},
"mapping": [
{
"identity": "rim",
"map": ".status"
},
{
"identity": "w5",
"map": "status"
}
]
},
{
"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": "w5",
"map": "when.planned"
}
]
},
{
"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
},
{
"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
},
{
"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.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"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"
}
]
},
{
"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"
}
]
}
]
}
}
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.
®© HL7.org 2011+. FHIR Release 3 (STU; v3.0.2-11200) generated on Thurs, Oct 24, 2019 11:53+1100. QA Page
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