FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

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## Resource Profile: ClinicalTrialSubject - Detailed Descriptions

Draft as of 2025-04-03

Definitions for the clinical-trial-subject resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be found here

0. ResearchSubject
Définition | A physical entity which is the primary unit of operational and/or administrative interest in a study.
Short | Physical entity which is the primary unit of interest in the study
Commentaires | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Résumé | false
Alternate Names | Study Subject
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: 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 (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()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ResearchSubject.implicitRules
Définition | 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.
Short | A set of rules under which this content was created
Commentaires | 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.
Control | 0..1
Type | uri
Is Modifier | true because 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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ResearchSubject.modifierExtension
Définition | 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).
Short | Extensions that cannot be ignored
Commentaires | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résumé | false
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.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. ResearchSubject.status
Définition | The current state of the subject.
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
Control | 1..1
Binding | The codes SHALL be taken from ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` ) Indicates the progression of a study subject through a study.
Type | code
Is Modifier | true because 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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ResearchSubject.study
Définition | Reference to the study the subject is participating in.
Short | Study subject is part of
Control | 1..1
Type | Reference(Oncology Clinical Trial, ResearchStudy)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchSubject.individual
Définition | The record of the person or animal who is involved in the study.
Short | Who is part of study
Control | 1..1
Type | Reference(Oncology Patient, Patient)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. ResearchSubject
2. ResearchSubject.study
Type | Reference(Oncology Clinical Trial)
4. ResearchSubject.individual
Type | Reference(Oncology Patient)

Guidance on how to interpret the contents of this table can be found here

0. ResearchSubject
Définition | A physical entity which is the primary unit of operational and/or administrative interest in a study.
Short | Physical entity which is the primary unit of interest in the study
Commentaires | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Résumé | false
Alternate Names | Study Subject
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: 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 (`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()`) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. ResearchSubject.id
Définition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Commentaires | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Control | 0..1
Type | id
Is Modifier | false
Résumé | true
4. ResearchSubject.meta
Définition | 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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. ResearchSubject.implicitRules
Définition | 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.
Short | A set of rules under which this content was created
Commentaires | 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.
Control | 0..1
Type | uri
Is Modifier | true because 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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. ResearchSubject.language
Définition | The base language in which the resource is written.
Short | Language of the resource content
Commentaires | 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).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages` ) A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. ResearchSubject.text
Définition | 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.
Short | Text summary of the resource, for human interpretation
Commentaires | 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.
Control | 0..1
Type | Narrative
Is Modifier | false
Résumé | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. ResearchSubject.contained
Définition | 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.
Short | Contained, inline Resources
Commentaires | 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.
Control | 0..*
Type | Resource
Is Modifier | false
Résumé | false
Alternate Names | inline resources, anonymous resources, contained resources
14. ResearchSubject.extension
Définition | 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.
Short | Additional content defined by implementations
Commentaires | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Résumé | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. ResearchSubject.modifierExtension
Définition | 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).
Short | Extensions that cannot be ignored
Commentaires | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résumé | false
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.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. ResearchSubject.identifier
Définition | Identifiers assigned to this research subject for a study.
Short | Business Identifier for research subject in a study
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. ResearchSubject.status
Définition | The current state of the subject.
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
Control | 1..1
Binding | The codes SHALL be taken from ResearchSubjectStatus (required to `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` ) Indicates the progression of a study subject through a study.
Type | code
Is Modifier | true because 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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. ResearchSubject.period
Définition | The dates the subject began and ended their participation in the study.
Short | Start and end of participation
Control | 0..1
Type | Period
Is Modifier | false
Résumé | true
Alternate Names | timing
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. ResearchSubject.study
Définition | Reference to the study the subject is participating in.
Short | Study subject is part of
Control | 1..1
Type | Reference(Oncology Clinical Trial)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. ResearchSubject.individual
Définition | The record of the person or animal who is involved in the study.
Short | Who is part of study
Control | 1..1
Type | Reference(Oncology Patient)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. ResearchSubject.assignedArm
Définition | The name of the arm in the study the subject is expected to follow as part of this study.
Short | What path should be followed
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. ResearchSubject.actualArm
Définition | The name of the arm in the study the subject actually followed as part of this study.
Short | What path was followed
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. ResearchSubject.consent
Définition | A record of the patient's informed agreement to participate in the study.
Short | Agreement to participate in study
Control | 0..1
Type | Reference(Consent)
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)