Profile_R5_ResearchStudy_R4B - Definitions - Extensions for Using Data Elements from FHIR R5 in FHIR R4B v0.1.0

Is Modifier false

Must Support false

Summary true

4. ResearchStudy.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.

Short Metadata about the resource

Control 0..1

Meta

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

6. ResearchStudy.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.

Short A set of rules under which this content was created

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.

Control 0..1

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

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

8. ResearchStudy.language

Definition

The base language in which the resource is written.

Short Language of the resource content

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).

Control 0..1

The codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages|4.3.0)

IETF language tag

Additional Bindings

Purpose

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

10. ResearchStudy.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.

Short Text summary of the resource, for human interpretation

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.

Control 0..1

Narrative

Is Modifier false

Must Support false

Summary 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

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.

Short Contained, inline 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.

Control 0..*

Resource

Is Modifier false

Must Support false

Summary false

Alternate Names inline resources, anonymous resources, contained resources

Invariants dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))

14. ResearchStudy.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Must Support false

Summary false

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())

This element introduces a set of slices on ResearchStudy.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

16. ResearchStudy.extension:url

Slice Name url

Definition

R5: ResearchStudy.url (new:uri)

Short R5: Canonical identifier for this study resource (new)

Comments

Element ResearchStudy.url has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.url has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Canonical identifier for this study resource (new)) (Extension Type: uri)

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())

18. ResearchStudy.extension:version

Slice Name version

Definition

R5: ResearchStudy.version (new:string)

Short R5: The business version for the study record (new)

Comments

Element ResearchStudy.version has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.version has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: The business version for the study record (new)) (Extension Type: string)

Is Modifier false

Must Support false

Summary false

20. ResearchStudy.extension:name

Slice Name name

Definition

R5: ResearchStudy.name (new:string)

Short R5: Name for this study (computer friendly) (new)

Comments

Element ResearchStudy.name has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.name has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Name for this study (computer friendly) (new)) (Extension Type: string)

Is Modifier false

Must Support false

Summary false

22. ResearchStudy.extension:label

Slice Name label

Definition

R5: ResearchStudy.label (new:BackboneElement)

Short R5: Additional names for the study (new)

Comments

Element ResearchStudy.label has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.label has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Additional names for the study (new)) (Complex Extension)

Is Modifier false

Must Support false

24. ResearchStudy.extension:date

Slice Name date

Definition

R5: ResearchStudy.date (new:dateTime)

Short R5: Date the resource last changed (new)

Comments

Element ResearchStudy.date has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.date has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Date the resource last changed (new)) (Extension Type: dateTime)

Is Modifier false

Must Support false

Summary false

26. ResearchStudy.extension:studyDesign

Slice Name studyDesign

Definition

R5: ResearchStudy.studyDesign (new:CodeableConcept)

Short R5: Classifications of the study design characteristics (new)

Comments

Element ResearchStudy.studyDesign has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.studyDesign has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Classifications of the study design characteristics (new)) (Extension Type: CodeableConcept)

Is Modifier false

Must Support false

Summary false

28. ResearchStudy.extension:descriptionSummary

Slice Name descriptionSummary

Definition

R5: ResearchStudy.descriptionSummary (new:markdown)

Short R5: Brief text explaining the study (new)

Comments

Element ResearchStudy.descriptionSummary has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.descriptionSummary has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Brief text explaining the study (new)) (Extension Type: markdown)

Is Modifier false

Must Support false

Summary false

30. ResearchStudy.extension:classifier

Slice Name classifier

Definition

R5: ResearchStudy.classifier (new:CodeableConcept)

Short R5: Classification for the study (new)

Comments

Element ResearchStudy.classifier has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.classifier has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Classification for the study (new)) (Extension Type: CodeableConcept)

Is Modifier false

Must Support false

Summary false

32. ResearchStudy.extension:associatedParty

Slice Name associatedParty

Definition

R5: ResearchStudy.associatedParty (new:BackboneElement)

Short R5: Sponsors, collaborators, and other parties (new)

Comments

Element ResearchStudy.associatedParty has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.associatedParty has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element). For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Sponsors, collaborators, and other parties (new)) (Complex Extension)

Is Modifier false

Must Support false

34. ResearchStudy.extension:progressStatus

Slice Name progressStatus

Definition

R5: ResearchStudy.progressStatus (new:BackboneElement)

Short R5: Status of study with time for that status (new)

Comments

Element ResearchStudy.progressStatus has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.progressStatus has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Status of study with time for that status (new)) (Complex Extension)

Is Modifier false

Must Support false

36. ResearchStudy.extension:targetNumber

Slice Name targetNumber

Definition

R5: ResearchStudy.recruitment.targetNumber (new:unsignedInt)

Short R5: Estimated total number of participants to be enrolled (new)

Comments

Element ResearchStudy.recruitment.targetNumber has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.recruitment.targetNumber has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Estimated total number of participants to be enrolled (new)) (Extension Type: unsignedInt)

Is Modifier false

Must Support false

Summary false

38. ResearchStudy.extension:actualNumber

Slice Name actualNumber

Definition

R5: ResearchStudy.recruitment.actualNumber (new:unsignedInt)

Short R5: Actual total number of participants enrolled in study (new)

Comments

Element ResearchStudy.recruitment.actualNumber has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.recruitment.actualNumber has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Actual total number of participants enrolled in study (new)) (Extension Type: unsignedInt)

Is Modifier false

Must Support false

Summary false

40. ResearchStudy.extension:actualGroup

Slice Name actualGroup

Definition

R5: ResearchStudy.recruitment.actualGroup (new:Reference(Group))

Short R5: Group of participants who were enrolled in study (new)

Comments

Element ResearchStudy.recruitment.actualGroup has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.recruitment.actualGroup has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Group of participants who were enrolled in study (new)) (Extension Type: Reference(Cross-version Profile for R5.Group for use in FHIR R4B, Group))

Is Modifier false

Must Support false

Summary false

42. ResearchStudy.extension:outcomeMeasure

Slice Name outcomeMeasure

Definition

R5: ResearchStudy.outcomeMeasure (new:BackboneElement)

Short R5: A variable measured during the study (new)

Comments

Element ResearchStudy.outcomeMeasure has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.outcomeMeasure has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element). A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: A variable measured during the study (new)) (Complex Extension)

Is Modifier false

Must Support false

44. ResearchStudy.extension:result

Slice Name result

Definition

R5: ResearchStudy.result (new:Reference(EvidenceReport,Citation,DiagnosticReport))

Short R5: Link to results generated during the study (new)

Comments

Element ResearchStudy.result has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.result has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Link to results generated during the study (new)) (Extension Type: Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B, EvidenceReport, Cross-version Profile for R5.Citation for use in FHIR R4B, Citation, Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B, DiagnosticReport))

Is Modifier false

Must Support false

Summary false

46. ResearchStudy.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).

Short Extensions that cannot be ignored

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.

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them

Must Support false

Summary 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

48. ResearchStudy.identifier

Definition

Identifiers assigned to this research study by the sponsor or other systems.

Short Business Identifier for study

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..*

Identifier

Is Modifier false

Must Support false

Summary 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()))

50. ResearchStudy.title

Definition

A short, descriptive user-friendly label for the study.

Short Name for this study

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

52. ResearchStudy.protocol

Definition

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

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

54. ResearchStudy.partOf

Definition

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

Must Support false

Summary 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()))

56. ResearchStudy.status

Definition

The current state of the study.

Control 1..1

The codes SHALL be taken from ResearchStudyStatus
(required to http://hl7.org/fhir/ValueSet/research-study-status|4.3.0)

Codes that convey the current status of the research study.

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

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

58. ResearchStudy.status.id

Definition

unique id for the element within a resource (for internal references)

Short xml:id (or equivalent in JSON)

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

60. ResearchStudy.status.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.status.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

62. ResearchStudy.status.extension:status

Slice Name status

Definition

R5: ResearchStudy.status additional codes

Short R5: draft | active | retired | unknown additional codes

Comments

Element ResearchStudy.status is mapped to FHIR R4B element ResearchStudy.status as RelatedTo. The mappings for ResearchStudy.status do not allow expression of the necessary codes, per the bindings on the source and target. The target context ResearchStudy.status is a modifier element, so this extension does not need to be defined as a modifier.

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: draft | active | retired | unknown additional codes) (Extension Type: code)

Is Modifier false

Summary false

64. ResearchStudy.status.value

Definition

Primitive value for code

Short Primitive value for code

Control 0..1

code

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

66. ResearchStudy.primaryPurposeType

Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Control 0..1

Unless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType
(extensible to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|4.3.0)

Codes for the main intent of the study.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

68. ResearchStudy.phase

Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Control 0..1

For example codes, see ResearchStudyPhase
(example to http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0)

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

70. ResearchStudy.category

Definition

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..*

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

72. ResearchStudy.focus

Definition

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..*

Codes for medications, devices and other interventions.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

74. ResearchStudy.focus.id

Definition

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

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

76. ResearchStudy.focus.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.focus.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

78. ResearchStudy.focus.extension:focus

Slice Name focus

Definition

R5: ResearchStudy.focus additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))

Short R5: focus additional types

Comments

Element ResearchStudy.focus is mapped to FHIR R4B element ResearchStudy.focus as SourceIsBroaderThanTarget. The mappings for ResearchStudy.focus do not cover the following types: CodeableReference.

Control 0..*

Type Extension(R5: focus additional types) (Extension Type: CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B, Medication, Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B, MedicinalProductDefinition, Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B, SubstanceDefinition, Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B, EvidenceVariable))

Is Modifier false

Summary false

80. ResearchStudy.focus.coding

Definition

A reference to a code defined by a terminology system.

Short Code defined by a terminology system

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control 0..*

Coding

Is Modifier false

Summary true

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

82. ResearchStudy.focus.text

Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Short Plain text representation of the concept

Comments

Very often the text is the same as a displayName of one of the codings.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

84. ResearchStudy.condition

Definition

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..*

For example codes, see Condition/Problem/DiagnosisCodes
(example to http://hl7.org/fhir/ValueSet/condition-code|4.3.0)

Identification of the condition or diagnosis.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

86. ResearchStudy.contact

Definition

Contact details to assist a user in learning more about or engaging with the study.

Short Contact details for the study

Control 0..*

ContactDetail

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

88. ResearchStudy.relatedArtifact

Definition

Citations, references and other related documents.

Short References and dependencies

Control 0..*

RelatedArtifact

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

90. ResearchStudy.keyword

Definition

Key terms to aid in searching for or filtering the study.

Short Used to search for the study

Control 0..*

Words associated with the study that may be useful in discovery.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

92. ResearchStudy.location

Definition

Indicates a country, state or other region where the study is taking place.

Short Geographic region(s) for study

Control 0..*

Unless not suitable, these codes SHALL be taken from Jurisdiction ValueSet
(extensible to http://hl7.org/fhir/ValueSet/jurisdiction|4.3.0)

Countries and regions within which this artifact is targeted for use.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

94. ResearchStudy.description

Definition

A full description of how the study is being conducted.

Short What this is study doing

Control 0..1

markdown

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

96. ResearchStudy.enrollment

Definition

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

Comments

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

Must Support false

Summary true

Alternate Names patient

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

98. ResearchStudy.enrollment.id

Definition

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

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

100. ResearchStudy.enrollment.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.enrollment.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

102. ResearchStudy.enrollment.extension:eligibility

Slice Name eligibility

Definition

R5: ResearchStudy.recruitment.eligibility additional types from child elements (display, identifier, reference, type)

Short R5: Inclusion and exclusion criteria additional types

Comments

Element ResearchStudy.recruitment.eligibility is mapped to FHIR R4B element ResearchStudy.enrollment as RelatedTo. The mappings for ResearchStudy.recruitment.eligibility do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element ResearchStudy.recruitment.eligibility with unmapped reference targets: EvidenceVariable.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

104. ResearchStudy.enrollment.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.

Short Literal reference, Relative, internal or absolute URL

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.

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

106. ResearchStudy.enrollment.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).

Short Type the reference refers to (e.g. "Patient")

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.

Control 0..1

Binding Unless not suitable, these codes SHALL be taken from ResourceType
(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.3.0)

uri

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

108. ResearchStudy.enrollment.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.

Short Logical reference, when literal reference is not known

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).

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Identifier

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

110. ResearchStudy.enrollment.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

112. ResearchStudy.period

Definition

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

Period

Is Modifier false

Must Support false

Summary true

Alternate Names timing

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

114. ResearchStudy.sponsor

Definition

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

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

116. ResearchStudy.principalInvestigator

Definition

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

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

118. ResearchStudy.site

Definition

A facility in which study activities are conducted.

Short Facility where study activities are conducted

Control 0..*

Type Reference(Location)

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

120. ResearchStudy.site.id

Definition

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

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

122. ResearchStudy.site.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.site.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

124. ResearchStudy.site.extension:site

Slice Name site

Definition

R5: ResearchStudy.site

Short R5: site

Comments

Element ResearchStudy.site is mapped to FHIR R4B element ResearchStudy.site as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element ResearchStudy.site with unmapped reference targets: Organization, ResearchStudy.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

126. ResearchStudy.site.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

128. ResearchStudy.site.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.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Binding Unless not suitable, these codes SHALL be taken from ResourceType
(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.3.0)

uri

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

130. ResearchStudy.site.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Identifier

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

132. ResearchStudy.site.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

134. ResearchStudy.reasonStopped

Definition

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

For example codes, see ResearchStudyReasonStopped
(example to http://hl7.org/fhir/ValueSet/research-study-reason-stopped|4.3.0)

Codes for why the study ended prematurely.

Is Modifier false

Must Support false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

136. ResearchStudy.note

Definition

Comments made about the study by the performer, subject or other participants.

Short Comments made about the study

Control 0..*

Annotation

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

138. ResearchStudy.arm

Definition

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..*

BackboneElement

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)

140. ResearchStudy.arm.id

Definition

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

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

142. ResearchStudy.arm.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.arm.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

144. ResearchStudy.arm.extension:linkId

Slice Name linkId

Definition

R5: ResearchStudy.comparisonGroup.linkId (new:id)

Short R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)

Comments

Element ResearchStudy.comparisonGroup.linkId has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.comparisonGroup.linkId has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)) (Extension Type: id)

Is Modifier false

Summary false

146. ResearchStudy.arm.extension:intendedExposure

Slice Name intendedExposure

Definition

R5: ResearchStudy.comparisonGroup.intendedExposure (new:Reference(EvidenceVariable))

Short R5: Interventions or exposures in this comparisonGroup or cohort (new)

Comments

Element ResearchStudy.comparisonGroup.intendedExposure has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.comparisonGroup.intendedExposure has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Interventions or exposures in this comparisonGroup or cohort (new)) (Extension Type: Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B, EvidenceVariable))

Is Modifier false

Summary false

148. ResearchStudy.arm.extension:observedGroup

Slice Name observedGroup

Definition

R5: ResearchStudy.comparisonGroup.observedGroup (new:Reference(Group))

Short R5: Group of participants who were enrolled in study comparisonGroup (new)

Comments

Element ResearchStudy.comparisonGroup.observedGroup has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.comparisonGroup.observedGroup has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Group of participants who were enrolled in study comparisonGroup (new)) (Extension Type: Reference(Cross-version Profile for R5.Group for use in FHIR R4B, Group))

Is Modifier false

Summary false

150. ResearchStudy.arm.modifierExtension

Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

152. ResearchStudy.arm.name

Definition

Unique, human-readable label for this arm of the study.

Short Label for study arm

Control 1..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

154. ResearchStudy.arm.type

Definition

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

Short Categorization of study arm

Control 0..1

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

156. ResearchStudy.arm.description

Definition

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

158. ResearchStudy.objective

Definition

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..*

BackboneElement

Is Modifier false

Must Support false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)

160. ResearchStudy.objective.id

Definition

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

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

162. ResearchStudy.objective.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on ResearchStudy.objective.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

164. ResearchStudy.objective.extension:description

Slice Name description

Definition

R5: ResearchStudy.objective.description (new:markdown)

Short R5: Description of the objective (new)

Comments

Element ResearchStudy.objective.description has a context of ResearchStudy.objective based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.objective.description has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Description of the objective (new)) (Extension Type: markdown)

Is Modifier false

Summary false

166. ResearchStudy.objective.modifierExtension

Definition

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

Comments

Control 0..*