FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

Publication Build: This will be filled in by the publication tooling

## Resource Profile: ClinicalTrial - Detailed Descriptions

Draft as of 2025-04-03

Definitions for the clinical-trial 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. ResearchStudy
Définition | A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Short | Investigation to increase healthcare-related patient-independent knowledge
Commentaires | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Résumé | false
Alternate Names | Clinical Trial, Study
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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.identifier
Définition | The number in the EudraCT clinical trials database. Identifiers assigned to this research study by the sponsor or other systems.
Short | EudraCT number of the clinical trialBusiness Identifier for study
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 10..1*
Type | Identifier
Is Modifier | false
Résumé | true
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ResearchStudy.title
Définition | If the treatment is part of a clinical trial, its name is indicated. A short, descriptive user-friendly label for the study.
Short | Clinical trial nameName for this study
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchStudy.status
Définition | The current state of the study.
Short | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Control | 1..1
Binding | The codes SHALL be taken from ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/research-study-status|4.0.1` ) Codes that convey the current status of the research 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()))

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

0. ResearchStudy
2. ResearchStudy.identifier
Définition | The number in the EudraCT clinical trials database.
Short | EudraCT number of the clinical trial
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 1..1
4. ResearchStudy.title
Définition | If the treatment is part of a clinical trial, its name is indicated.
Short | Clinical trial name
Control | 1..?
Must Support | true

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

0. ResearchStudy
Définition | A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Short | Investigation to increase healthcare-related patient-independent knowledge
Commentaires | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Résumé | false
Alternate Names | Clinical Trial, Study
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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.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. ResearchStudy.identifier
Définition | The number in the EudraCT clinical trials database.
Short | EudraCT number of the clinical trial
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 1..1
Type | Identifier
Is Modifier | false
Résumé | true
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. ResearchStudy.title
Définition | If the treatment is part of a clinical trial, its name is indicated.
Short | Clinical trial name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. ResearchStudy.protocol
Définition | The set of steps expected to be performed as part of the execution of the study.
Short | Steps followed in executing study
Control | 0..*
Type | Reference(PlanDefinition)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. ResearchStudy.partOf
Définition | A larger research study of which this particular study is a component or step.
Short | Part of larger study
Control | 0..*
Type | Reference(ResearchStudy)
Is Modifier | false
Résumé | true
Requirements | Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Alternate Names | container
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. ResearchStudy.status
Définition | The current state of the study.
Short | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Control | 1..1
Binding | The codes SHALL be taken from ResearchStudyStatus (required to `http://hl7.org/fhir/ValueSet/research-study-status|4.0.1` ) Codes that convey the current status of the research 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())`)
28. ResearchStudy.primaryPurposeType
Définition | The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Short | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType (extensible to `http://hl7.org/fhir/ValueSet/research-study-prim-purp-type` ) Codes for the main intent of the study.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. ResearchStudy.phase
Définition | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Short | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Control | 0..1
Binding | For example codes, see ResearchStudyPhase (example to `http://hl7.org/fhir/ValueSet/research-study-phase` ) Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. ResearchStudy.category
Définition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Short | Classifications for the study
Control | 0..*
Binding | Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. ResearchStudy.focus
Définition | The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Short | Drugs, devices, etc. under study
Control | 0..*
Binding | Codes for medications, devices and other interventions.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. ResearchStudy.condition
Définition | The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
Short | Condition being studied
Control | 0..*
Binding | For example codes, see Condition/Problem/DiagnosisCodes (example to `http://hl7.org/fhir/ValueSet/condition-code` ) Identification of the condition or diagnosis.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. ResearchStudy.contact
Définition | Contact details to assist a user in learning more about or engaging with the study.
Short | Contact details for the study
Control | 0..*
Type | ContactDetail
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. ResearchStudy.relatedArtifact
Définition | Citations, references and other related documents.
Short | References and dependencies
Control | 0..*
Type | RelatedArtifact
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. ResearchStudy.keyword
Définition | Key terms to aid in searching for or filtering the study.
Short | Used to search for the study
Control | 0..*
Binding | Words associated with the study that may be useful in discovery.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. ResearchStudy.location
Définition | Indicates a country, state or other region where the study is taking place.
Short | Geographic region(s) for study
Control | 0..*
Binding | Unless not suitable, these codes SHALL be taken from Jurisdiction ValueSet (extensible to `http://hl7.org/fhir/ValueSet/jurisdiction` ) Countries and regions within which this artifact is targeted for use.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. ResearchStudy.description
Définition | A full description of how the study is being conducted.
Short | What this is study doing
Control | 0..1
Type | markdown
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())`)
48. ResearchStudy.enrollment
Définition | Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
Short | Inclusion & exclusion criteria
Commentaires | The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Control | 0..*
Type | Reference(Group)
Is Modifier | false
Résumé | true
Alternate Names | patient
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. ResearchStudy.period
Définition | Identifies the start date and the expected (or actual, depending on status) end date for the study.
Short | When the study began and ended
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())`)
52. ResearchStudy.sponsor
Définition | An organization that initiates the investigation and is legally responsible for the study.
Short | Organization that initiates and is legally responsible for the study
Control | 0..1
Type | Reference(Organization)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. ResearchStudy.principalInvestigator
Définition | A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Short | Researcher who oversees multiple aspects of the study
Control | 0..1
Type | Reference(Practitioner, PractitionerRole)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. ResearchStudy.site
Définition | A facility in which study activities are conducted.
Short | Facility where study activities are conducted
Control | 0..*
Type | Reference(Location)
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. ResearchStudy.reasonStopped
Définition | A description and/or code explaining the premature termination of the study.
Short | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Control | 0..1
Binding | For example codes, see ResearchStudyReasonStopped (example to `http://hl7.org/fhir/ValueSet/research-study-reason-stopped` ) Codes for why the study ended prematurely.
Type | CodeableConcept
Is Modifier | false
Résumé | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. ResearchStudy.note
Définition | Comments made about the study by the performer, subject or other participants.
Short | Comments made about the study
Control | 0..*
Type | Annotation
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. ResearchStudy.arm
Définition | Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
Short | Defined path through the study for a subject
Control | 0..*
Type | BackboneElement
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. ResearchStudy.arm.id
Définition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Résumé | false
66. ResearchStudy.arm.extension
Définition | 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.
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()`)
68. ResearchStudy.arm.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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 even if unrecognized
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 element that contains them
Résumé | true
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, modifiers
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()`)
70. ResearchStudy.arm.name
Définition | Unique, human-readable label for this arm of the study.
Short | Label for study arm
Control | 1..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())`)
72. ResearchStudy.arm.type
Définition | Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Short | Categorization of study arm
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. ResearchStudy.arm.description
Définition | A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Short | Short explanation of study path
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())`)
76. ResearchStudy.objective
Définition | A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
Short | A goal for the study
Control | 0..*
Type | BackboneElement
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. ResearchStudy.objective.id
Définition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Résumé | false
80. ResearchStudy.objective.extension
Définition | 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.
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()`)
82. ResearchStudy.objective.modifierExtension
Définition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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 even if unrecognized
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 element that contains them
Résumé | true
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, modifiers
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()`)
84. ResearchStudy.objective.name
Définition | Unique, human-readable label for this objective of the study.
Short | Label for the objective
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())`)
86. ResearchStudy.objective.type
Définition | The kind of study objective.
Short | primary | secondary | exploratory
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type` ) Codes for the kind of study objective.
Type | CodeableConcept
Is Modifier | false
Résumé | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)