Home > FHIR Artifacts > Profiles > SSRTreatmentStatus
SSRTreatmentStatus
| SSRTreatmentStatus (ResearchSubject) | I | ResearchSubject | |
| id | Σ | 0..1 | string |
| meta | Σ | 0..1 | Meta |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | I | 1..* | Extension |
| discontinueReason | I | 1..1 | Extension(CodeableConcept) |
| modifierExtension | ?! I | 0..* | Extension |
| identifier | Σ | 0..* | Identifier |
| status | Σ ?! | 1..1 | codeBinding |
| period | Σ | 0..1 | Period |
| study | Σ | 1..1 | Reference(SSRResearchStudy) |
| id | 0..1 | string | |
| extension | I | 0..* | Extension |
| reference | Σ I | 1..1 | string |
| type | Σ | 0..1 | uriBinding |
| identifier | Σ | 0..1 | Identifier |
| display | Σ | 0..1 | string |
| individual | Σ | 1..1 | Reference(SSRPatient) |
| id | 0..1 | string | |
| extension | I | 0..* | Extension |
| reference | Σ I | 1..1 | string |
| type | Σ | 0..1 | uriBinding |
| identifier | Σ | 0..1 | Identifier |
| display | Σ | 0..1 | string |
| assignedArm | 0..1 | string | |
| actualArm | 0..1 | string | |
| consent | 0..1 | Reference(Consent) |
{ "resourceType": "StructureDefinition", "url": "https://frbresearch.org/fhir/StructureDefinition/SSRTreatmentDiscontinued", "name": "SSRTreatmentStatus", "title": "SSR Treatment Status", "status": "draft", "description": "An indication of the discontinuation of one of the patient's eyes from the research study. If discontinued, a new baseline must be submitted if the eye is to be included in a subsequent visit.", "fhirVersion": "4.0.1", "kind": "resource", "abstract": false, "type": "ResearchSubject", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchSubject", "derivation": "constraint", "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-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-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" }, { "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" }, { "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" } ], "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", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isSummary": true }, { "id": "ResearchSubject.meta", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "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" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "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" } ], "condition": [ "ele-1" ], "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, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "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" } ], "condition": [ "ele-1" ], "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" } ], "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" }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchSubject.text", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "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" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" }, { "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" } ], "mapping": [ { "identity": "rim", "map": "Entity. Role, or Act" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.extension", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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": 1, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.extension:discontinueReason", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.extension", "sliceName": "discontinueReason", "short": "Optional Extensions Element", "definition": "Optional Extension Element - found in all resources.", "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": 1, "max": "1", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRDiscontinueReason" ] } ], "condition": [ "ele-1" ], "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, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.modifierExtension", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.modifierExtension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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" } ], "condition": [ "ele-1" ], "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", "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.identifier", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "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" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "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.", "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size", "min": 1, "max": "1", "base": { "path": "ResearchSubject.status", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "condition": [ "ele-1" ], "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 not be treated as valid", "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|4.0.1" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.status" }, { "identity": "BRIDG5.1", "map": "StudySubject.statusCode" }, { "identity": "rim", "map": ".status" } ] }, { "id": "ResearchSubject.period", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.period", "short": "Start and end of participation", "definition": "The dates the subject began and ended their participation in the study.", "comment": "A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "alias": [ "timing" ], "min": 0, "max": "1", "base": { "path": "ResearchSubject.period", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "condition": [ "ele-1" ], "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": "per-1", "severity": "error", "human": "If present, start SHALL have a lower value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start <= end)", "xpath": "not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL<TS>[lowClosed=\"true\" and highClosed=\"true\"] or URG<TS>[lowClosed=\"true\" and highClosed=\"true\"]" }, { "identity": "w5", "map": "FiveWs.planned" }, { "identity": "BRIDG5.1", "map": "PerformedStudySubjectMilestone.studyReferenceDateRange" } ] }, { "id": "ResearchSubject.study", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.study", "short": "Study subject is part of", "definition": "Reference to the study the subject is participating in.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 1, "max": "1", "base": { "path": "ResearchSubject.study", "min": 1, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy" ] } ], "condition": [ "ele-1" ], "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": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "BRIDG5.1", "map": "StudySubjectProtocolVersionRelationship" } ] }, { "id": "ResearchSubject.study.id", "path": "ResearchSubject.study.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", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchSubject.study.extension", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.study.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.study.reference", "path": "ResearchSubject.study.reference", "short": "Literal reference, Relative, internal or absolute URL", "definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.", "comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.", "min": 1, "max": "1", "base": { "path": "Reference.reference", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1", "ref-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.study.type", "path": "ResearchSubject.study.type", "short": "Type the reference refers to (e.g. \"Patient\")", "definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).", "comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.", "min": 0, "max": "1", "base": { "path": "Reference.type", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "FHIRResourceTypeExt" } ], "strength": "extensible", "description": "Aa resource (or, for logical models, the URI of the logical model).", "valueSet": "http://hl7.org/fhir/ValueSet/resource-types" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.study.identifier", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.study.identifier", "short": "Logical reference, when literal reference is not known", "definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.", "comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).", "min": 0, "max": "1", "base": { "path": "Reference.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "identity": "rim", "map": ".identifier" } ] }, { "id": "ResearchSubject.study.display", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true } ], "path": "ResearchSubject.study.display", "short": "Text alternative for the resource", "definition": "Plain text narrative that identifies the resource in addition to the resource reference.", "comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.", "min": 0, "max": "1", "base": { "path": "Reference.display", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.individual", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.individual", "short": "Who is part of study", "definition": "The record of the person or animal who is involved in the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 1, "max": "1", "base": { "path": "ResearchSubject.individual", "min": 1, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRPatient" ] } ], "condition": [ "ele-1" ], "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": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "BRIDG5.1", "map": "StudySubject" } ] }, { "id": "ResearchSubject.individual.id", "path": "ResearchSubject.individual.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", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchSubject.individual.extension", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.individual.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.individual.reference", "path": "ResearchSubject.individual.reference", "short": "Literal reference, Relative, internal or absolute URL", "definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.", "comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.", "min": 1, "max": "1", "base": { "path": "Reference.reference", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1", "ref-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.individual.type", "path": "ResearchSubject.individual.type", "short": "Type the reference refers to (e.g. \"Patient\")", "definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).", "comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.", "min": 0, "max": "1", "base": { "path": "Reference.type", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "FHIRResourceTypeExt" } ], "strength": "extensible", "description": "Aa resource (or, for logical models, the URI of the logical model).", "valueSet": "http://hl7.org/fhir/ValueSet/resource-types" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchSubject.individual.identifier", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.individual.identifier", "short": "Logical reference, when literal reference is not known", "definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.", "comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).", "min": 0, "max": "1", "base": { "path": "Reference.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "identity": "rim", "map": ".identifier" } ] }, { "id": "ResearchSubject.individual.display", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true } ], "path": "ResearchSubject.individual.display", "short": "Text alternative for the resource", "definition": "Plain text narrative that identifies the resource in addition to the resource reference.", "comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.", "min": 0, "max": "1", "base": { "path": "Reference.display", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "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": "Note that FHIR strings SHALL NOT exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "ResearchSubject.assignedArm", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "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.", "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "ResearchSubject.actualArm", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "BRIDG5.1", "map": "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject" } ] }, { "id": "ResearchSubject.consent", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "normative" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version", "valueCode": "4.0.0" } ], "path": "ResearchSubject.consent", "short": "Agreement to participate in study", "definition": "A record of the patient's informed agreement to participate in the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "1", "base": { "path": "ResearchSubject.consent", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Consent" ] } ], "condition": [ "ele-1" ], "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": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "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.extension", "path": "ResearchSubject.extension", "min": 1 }, { "id": "ResearchSubject.extension:discontinueReason", "path": "ResearchSubject.extension", "sliceName": "discontinueReason", "type": [ { "code": "Extension", "profile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRDiscontinueReason" ] } ], "isModifier": false }, { "id": "ResearchSubject.study", "path": "ResearchSubject.study", "type": [ { "code": "Reference", "targetProfile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy" ] } ] }, { "id": "ResearchSubject.study.reference", "path": "ResearchSubject.study.reference", "min": 1 }, { "id": "ResearchSubject.individual", "path": "ResearchSubject.individual", "type": [ { "code": "Reference", "targetProfile": [ "https://frbresearch.org/fhir/StructureDefinition/SSRPatient" ] } ] }, { "id": "ResearchSubject.individual.reference", "path": "ResearchSubject.individual.reference", "min": 1 } ] } }
<StructureDefinition xmlns="http://hl7.org/fhir"> <url value="https://frbresearch.org/fhir/StructureDefinition/SSRTreatmentDiscontinued" /> <name value="SSRTreatmentStatus" /> <title value="SSR Treatment Status" /> <status value="draft" /> <description value="An indication of the discontinuation of one of the patient's eyes from the research study. If discontinued, a new baseline must be submitted if the eye is to be included in a subsequent visit." /> <fhirVersion value="4.0.1" /> <kind value="resource" /> <abstract value="false" /> <type value="ResearchSubject" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchSubject" /> <derivation value="constraint" /> <snapshot> <element id="ResearchSubject"> <path value="ResearchSubject" /> <short value="Physical entity which is the primary unit of interest in the study" /> <definition value="A physical entity which is the primary unit of operational and/or administrative interest in a study." /> <comment value="Need to make sure we encompass public health studies." /> <alias value="Study Subject" /> <min value="0" /> <max value="*" /> <base> <path value="ResearchSubject" /> <min value="0" /> <max value="*" /> </base> <constraint> <key value="dom-2" /> <severity value="error" /> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" /> <expression value="contained.contained.empty()" /> <xpath value="not(parent::f:contained and f:contained)" /> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" /> </constraint> <constraint> <key value="dom-4" /> <severity value="error" /> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" /> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" /> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" /> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" /> </constraint> <constraint> <key value="dom-3" /> <severity value="error" /> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource" /> <expression value="contained.where((('#'+id 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 value="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 value="http://hl7.org/fhir/StructureDefinition/DomainResource" /> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." /> </extension> <key value="dom-6" /> <severity value="warning" /> <human value="A resource should have narrative for robust management" /> <expression value="text.`div`.exists()" /> <xpath value="exists(f:text/h:div)" /> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" /> </constraint> <constraint> <key value="dom-5" /> <severity value="error" /> <human value="If a resource is contained in another resource, it SHALL NOT have a security label" /> <expression value="contained.meta.security.empty()" /> <xpath value="not(exists(f:contained/*/f:meta/f:security))" /> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" /> </constraint> <mapping> <identity value="rim" /> <map value="Entity. Role, or Act" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="StudySubject" /> </mapping> <mapping> <identity value="v2" /> <map value="OBX" /> </mapping> <mapping> <identity value="rim" /> <map value="Observation[classCode=CLNTRL, moodCode=EVN]" /> </mapping> </element> <element id="ResearchSubject.id"> <path value="ResearchSubject.id" /> <short value="Logical id of this artifact" /> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." /> <comment value="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 value="0" /> <max value="1" /> <base> <path value="Resource.id" /> <min value="0" /> <max value="1" /> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string" /> </extension> <code value="http://hl7.org/fhirpath/System.String" /> </type> <isSummary value="true" /> </element> <element id="ResearchSubject.meta"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.meta" /> <short value="Metadata about the resource" /> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.meta" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Meta" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.implicitRules"> <path value="ResearchSubject.implicitRules" /> <short value="A set of rules under which this content was created" /> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc." /> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.implicitRules" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isModifier value="true" /> <isModifierReason 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" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchSubject.language"> <path value="ResearchSubject.language" /> <short value="Language of the resource content" /> <definition value="The base language in which the resource is written." /> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.language" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="preferred" /> <description value="A human language." /> <valueSet value="http://hl7.org/fhir/ValueSet/languages" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchSubject.text"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.text" /> <short value="Text summary of the resource, for human interpretation" /> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." /> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later." /> <alias value="narrative" /> <alias value="html" /> <alias value="xhtml" /> <alias value="display" /> <min value="0" /> <max value="1" /> <base> <path value="DomainResource.text" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Narrative" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Act.text?" /> </mapping> </element> <element id="ResearchSubject.contained"> <path value="ResearchSubject.contained" /> <short value="Contained, inline Resources" /> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope." /> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels." /> <alias value="inline resources" /> <alias value="anonymous resources" /> <alias value="contained resources" /> <min value="0" /> <max value="*" /> <base> <path value="DomainResource.contained" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Resource" /> </type> <mapping> <identity value="rim" /> <map value="Entity. Role, or Act" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.extension"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional content defined by implementations" /> <definition value="May be used to represent additional information that is not part of the basic definition of the 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 value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="1" /> <max value="*" /> <base> <path value="DomainResource.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Extension" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.extension:discontinueReason"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.extension" /> <sliceName value="discontinueReason" /> <short value="Optional Extensions Element" /> <definition value="Optional Extension Element - found in all resources." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="1" /> <max value="1" /> <base> <path value="DomainResource.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> <profile value="https://frbresearch.org/fhir/StructureDefinition/SSRDiscontinueReason" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Extension" /> </constraint> <isModifier value="false" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.modifierExtension"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.modifierExtension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Extensions that cannot be ignored" /> <definition 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)." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension)." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="DomainResource.modifierExtension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Extension" /> </constraint> <isModifier value="true" /> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.identifier"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.identifier" /> <short value="Business Identifier for research subject in a study" /> <definition value="Identifiers assigned to this research subject for a study." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchSubject.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="FiveWs.identifier" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="StudySubject > Subject.identifier" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> </element> <element id="ResearchSubject.status"> <path value="ResearchSubject.status" /> <short value="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 value="The current state of the subject." /> <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" /> <min value="1" /> <max value="1" /> <base> <path value="ResearchSubject.status" /> <min value="1" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isModifier value="true" /> <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchSubjectStatus" /> </extension> <strength value="required" /> <description value="Indicates the progression of a study subject through a study." /> <valueSet value="http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="w5" /> <map value="FiveWs.status" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="StudySubject.statusCode" /> </mapping> <mapping> <identity value="rim" /> <map value=".status" /> </mapping> </element> <element id="ResearchSubject.period"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.period" /> <short value="Start and end of participation" /> <definition value="The dates the subject began and ended their participation in the study." /> <comment value="A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration)." /> <alias value="timing" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchSubject.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.hasValue().not() or end.hasValue().not() or (start <= end)" /> <xpath value="not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))" /> <source value="http://hl7.org/fhir/StructureDefinition/Period" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="w5" /> <map value="FiveWs.planned" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="PerformedStudySubjectMilestone.studyReferenceDateRange" /> </mapping> </element> <element id="ResearchSubject.study"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.study" /> <short value="Study subject is part of" /> <definition value="Reference to the study the subject is participating in." /> <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchSubject.study" /> <min value="1" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" /> <xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Reference" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="StudySubjectProtocolVersionRelationship" /> </mapping> </element> <element id="ResearchSubject.study.id"> <path value="ResearchSubject.study.id" /> <representation value="xmlAttr" /> <short value="Unique id for inter-element referencing" /> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string" /> </extension> <code value="http://hl7.org/fhirpath/System.String" /> </type> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchSubject.study.extension"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.study.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional content defined by implementations" /> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Extension" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.study.reference"> <path value="ResearchSubject.study.reference" /> <short value="Literal reference, Relative, internal or absolute URL" /> <definition value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources." /> <comment value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server." /> <min value="1" /> <max value="1" /> <base> <path value="Reference.reference" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <condition value="ref-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.study.type"> <path value="ResearchSubject.study.type" /> <short value="Type the reference refers to (e.g. "Patient")" /> <definition value="The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources)." /> <comment value="This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="FHIRResourceTypeExt" /> </extension> <strength value="extensible" /> <description value="Aa resource (or, for logical models, the URI of the logical model)." /> <valueSet value="http://hl7.org/fhir/ValueSet/resource-types" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.study.identifier"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.study.identifier" /> <short value="Logical reference, when literal reference is not known" /> <definition value="An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference." /> <comment value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any)." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.identifier" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> </element> <element id="ResearchSubject.study.display"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="ResearchSubject.study.display" /> <short value="Text alternative for the resource" /> <definition value="Plain text narrative that identifies the resource in addition to the resource reference." /> <comment value="This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.display" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.individual"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.individual" /> <short value="Who is part of study" /> <definition value="The record of the person or animal who is involved in the study." /> <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchSubject.individual" /> <min value="1" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="https://frbresearch.org/fhir/StructureDefinition/SSRPatient" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" /> <xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Reference" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="StudySubject" /> </mapping> </element> <element id="ResearchSubject.individual.id"> <path value="ResearchSubject.individual.id" /> <representation value="xmlAttr" /> <short value="Unique id for inter-element referencing" /> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string" /> </extension> <code value="http://hl7.org/fhirpath/System.String" /> </type> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchSubject.individual.extension"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.individual.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional content defined by implementations" /> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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 value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Extension" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.individual.reference"> <path value="ResearchSubject.individual.reference" /> <short value="Literal reference, Relative, internal or absolute URL" /> <definition value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources." /> <comment value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server." /> <min value="1" /> <max value="1" /> <base> <path value="Reference.reference" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <condition value="ref-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.individual.type"> <path value="ResearchSubject.individual.type" /> <short value="Type the reference refers to (e.g. "Patient")" /> <definition value="The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources)." /> <comment value="This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="FHIRResourceTypeExt" /> </extension> <strength value="extensible" /> <description value="Aa resource (or, for logical models, the URI of the logical model)." /> <valueSet value="http://hl7.org/fhir/ValueSet/resource-types" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.individual.identifier"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.individual.identifier" /> <short value="Logical reference, when literal reference is not known" /> <definition value="An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference." /> <comment value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any)." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.identifier" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> </element> <element id="ResearchSubject.individual.display"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="ResearchSubject.individual.display" /> <short value="Text alternative for the resource" /> <definition value="Plain text narrative that identifies the resource in addition to the resource reference." /> <comment value="This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it." /> <min value="0" /> <max value="1" /> <base> <path value="Reference.display" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchSubject.assignedArm"> <path value="ResearchSubject.assignedArm" /> <short value="What path should be followed" /> <definition value="The name of the arm in the study the subject is expected to follow as part of this study." /> <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchSubject.assignedArm" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject" /> </mapping> </element> <element id="ResearchSubject.actualArm"> <path value="ResearchSubject.actualArm" /> <short value="What path was followed" /> <definition value="The name of the arm in the study the subject actually followed as part of this study." /> <comment value="Note that FHIR strings SHALL NOT exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchSubject.actualArm" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject" /> </mapping> </element> <element id="ResearchSubject.consent"> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="normative" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version"> <valueCode value="4.0.0" /> </extension> <path value="ResearchSubject.consent" /> <short value="Agreement to participate in study" /> <definition value="A record of the patient's informed agreement to participate in the study." /> <comment value="References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchSubject.consent" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() or (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> <source value="http://hl7.org/fhir/StructureDefinition/Element" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))" /> <xpath value="not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])" /> <source value="http://hl7.org/fhir/StructureDefinition/Reference" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="BRIDG5.1" /> <map value="ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource." /> </mapping> </element> </snapshot> <differential> <element id="ResearchSubject.extension"> <path value="ResearchSubject.extension" /> <min value="1" /> </element> <element id="ResearchSubject.extension:discontinueReason"> <path value="ResearchSubject.extension" /> <sliceName value="discontinueReason" /> <type> <code value="Extension" /> <profile value="https://frbresearch.org/fhir/StructureDefinition/SSRDiscontinueReason" /> </type> <isModifier value="false" /> </element> <element id="ResearchSubject.study"> <path value="ResearchSubject.study" /> <type> <code value="Reference" /> <targetProfile value="https://frbresearch.org/fhir/StructureDefinition/SSRResearchStudy" /> </type> </element> <element id="ResearchSubject.study.reference"> <path value="ResearchSubject.study.reference" /> <min value="1" /> </element> <element id="ResearchSubject.individual"> <path value="ResearchSubject.individual" /> <type> <code value="Reference" /> <targetProfile value="https://frbresearch.org/fhir/StructureDefinition/SSRPatient" /> </type> </element> <element id="ResearchSubject.individual.reference"> <path value="ResearchSubject.individual.reference" /> <min value="1" /> </element> </differential> </StructureDefinition>
| ResearchSubject | |
| Definition | A physical entity which is the primary unit of operational and/or administrative interest in a study. |
| Cardinality | 0...* |
| Alias | Study Subject |
| Comments | Need to make sure we encompass public health studies. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.id | |
| Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
| Cardinality | 0...1 |
| Type | string |
| Summary | True |
| Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
| ResearchSubject.meta | |
| 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. |
| Cardinality | 0...1 |
| Type | Meta |
| Summary | True |
| Invariants |
|
| ResearchSubject.implicitRules | |
| 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. |
| Cardinality | 0...1 |
| Type | uri |
| Modifier | True |
| Summary | True |
| Comments | 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. |
| Invariants |
|
| ResearchSubject.language | |
| Definition | The base language in which the resource is written. |
| Cardinality | 0...1 |
| Type | code |
| Binding | A human language. |
| Comments | 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). |
| Invariants |
|
| ResearchSubject.text | |
| 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. |
| Cardinality | 0...1 |
| Type | Narrative |
| Alias | narrative, html, xhtml, display |
| Comments | 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. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.contained | |
| 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. |
| Cardinality | 0...* |
| Type | Resource |
| Alias | inline resources, anonymous resources, contained resources |
| Comments | 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. |
| Mappings |
|
| ResearchSubject.extension | |
| 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. |
| Cardinality | 1...* |
| Type | Extension |
| Alias | extensions, user content |
| Comments | 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. |
| Slicing | Unordered, Open, by url(Value) |
| Invariants |
|
| Mappings |
|
| ResearchSubject.extension:discontinueReason | |
| Definition | Optional Extension Element - found in all resources. |
| Cardinality | 1...1 |
| Type | Extension(CodeableConcept) |
| Alias | extensions, user content |
| Comments | 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. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.modifierExtension | |
| 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Cardinality | 0...* |
| Type | Extension |
| Modifier | True |
| Alias | extensions, user content |
| 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. |
| Comments | 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. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.identifier | |
| Definition | Identifiers assigned to this research subject for a study. |
| Cardinality | 0...* |
| Type | Identifier |
| Summary | True |
| Invariants |
|
| Mappings |
|
| ResearchSubject.status | |
| Definition | The current state of the subject. |
| Cardinality | 1...1 |
| Type | code |
| Binding | Indicates the progression of a study subject through a study. |
| Modifier | True |
| Summary | True |
| Invariants |
|
| Mappings |
|
| ResearchSubject.period | |
| Definition | The dates the subject began and ended their participation in the study. |
| Cardinality | 0...1 |
| Type | Period |
| Summary | True |
| Alias | timing |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study | |
| Definition | Reference to the study the subject is participating in. |
| Cardinality | 1...1 |
| Type | Reference(SSRResearchStudy) |
| Summary | True |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Cardinality | 0...1 |
| Type | string |
| Mappings |
|
| ResearchSubject.study.extension | |
| 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. |
| Cardinality | 0...* |
| Type | Extension |
| Alias | extensions, user content |
| Comments | 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. |
| Slicing | Unordered, Open, by url(Value) |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study.reference | |
| Definition | A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. |
| Cardinality | 1...1 |
| Type | string |
| Summary | True |
| Comments | Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study.type | |
| Definition | The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). |
| Cardinality | 0...1 |
| Type | uri |
| Binding | Aa resource (or, for logical models, the URI of the logical model). |
| Summary | True |
| Comments | This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study.identifier | |
| Definition | An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. |
| Cardinality | 0...1 |
| Type | Identifier |
| Summary | True |
| Comments | When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). |
| Invariants |
|
| Mappings |
|
| ResearchSubject.study.display | |
| Definition | Plain text narrative that identifies the resource in addition to the resource reference. |
| Cardinality | 0...1 |
| Type | string |
| Summary | True |
| Comments | This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual | |
| Definition | The record of the person or animal who is involved in the study. |
| Cardinality | 1...1 |
| Type | Reference(SSRPatient) |
| Summary | True |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Cardinality | 0...1 |
| Type | string |
| Mappings |
|
| ResearchSubject.individual.extension | |
| 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. |
| Cardinality | 0...* |
| Type | Extension |
| Alias | extensions, user content |
| Comments | 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. |
| Slicing | Unordered, Open, by url(Value) |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual.reference | |
| Definition | A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. |
| Cardinality | 1...1 |
| Type | string |
| Summary | True |
| Comments | Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual.type | |
| Definition | The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). |
| Cardinality | 0...1 |
| Type | uri |
| Binding | Aa resource (or, for logical models, the URI of the logical model). |
| Summary | True |
| Comments | This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual.identifier | |
| Definition | An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. |
| Cardinality | 0...1 |
| Type | Identifier |
| Summary | True |
| Comments | When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). |
| Invariants |
|
| Mappings |
|
| ResearchSubject.individual.display | |
| Definition | Plain text narrative that identifies the resource in addition to the resource reference. |
| Cardinality | 0...1 |
| Type | string |
| Summary | True |
| Comments | This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. |
| Invariants |
|
| Mappings |
|
| ResearchSubject.assignedArm | |
| Definition | The name of the arm in the study the subject is expected to follow as part of this study. |
| Cardinality | 0...1 |
| Type | string |
| Invariants |
|
| Mappings |
|
| ResearchSubject.actualArm | |
| Definition | The name of the arm in the study the subject actually followed as part of this study. |
| Cardinality | 0...1 |
| Type | string |
| Invariants |
|
| Mappings |
|
| ResearchSubject.consent | |
| Definition | A record of the patient's informed agreement to participate in the study. |
| Cardinality | 0...1 |
| Type | Reference(Consent) |
| Invariants |
|
| Mappings |
|
| ResearchSubject | 0..* | |
| ResearchSubject.id | string | 0..1 |
| ResearchSubject.meta | Meta | 0..1 |
| ResearchSubject.implicitRules | uri | 0..1 |
| ResearchSubject.language | code | 0..1 |
| ResearchSubject.text | Narrative | 0..1 |
| ResearchSubject.contained | Resource | 0..* |
| ResearchSubject.extension | Extension | 1..* |
| ResearchSubject.extension | Extension | 1..1 |
| ResearchSubject.modifierExtension | Extension | 0..* |
| ResearchSubject.identifier | Identifier | 0..* |
| ResearchSubject.status | code | 1..1 |
| ResearchSubject.period | Period | 0..1 |
| ResearchSubject.study | Reference(SSRResearchStudy) | 1..1 |
| ResearchSubject.study.id | string | 0..1 |
| ResearchSubject.study.extension | Extension | 0..* |
| ResearchSubject.study.reference | string | 1..1 |
| ResearchSubject.study.type | uri | 0..1 |
| ResearchSubject.study.identifier | Identifier | 0..1 |
| ResearchSubject.study.display | string | 0..1 |
| ResearchSubject.individual | Reference(SSRPatient) | 1..1 |
| ResearchSubject.individual.id | string | 0..1 |
| ResearchSubject.individual.extension | Extension | 0..* |
| ResearchSubject.individual.reference | string | 1..1 |
| ResearchSubject.individual.type | uri | 0..1 |
| ResearchSubject.individual.identifier | Identifier | 0..1 |
| ResearchSubject.individual.display | string | 0..1 |
| ResearchSubject.assignedArm | string | 0..1 |
| ResearchSubject.actualArm | string | 0..1 |
| ResearchSubject.consent | Reference(Consent) | 0..1 |