FHIR for FAIR - FHIR Implementation Guide
1.0.0 - STU 1

FHIR for FAIR - FHIR Implementation Guide, published by Health Level Seven International - SOA Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-for-fair/ and changes regularly. See the Directory of published versions

## Resource Profile: ResearchStudyF4F - Detailed Descriptions

Active as of 2024-01-05

Definitions for the ResearchStudy-uv-f4f resource profile.

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

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

0. ResearchStudy
2. ResearchStudy.extension
Slicing | This element introduces a set of slices on `ResearchStudy.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
4. ResearchStudy.extension:copyright
Slice Name | copyright
Control | 0..1
Type | Extension(Copyright) (Extension Type: markdown)
6. ResearchStudy.extension:licenceAttachment
Slice Name | licenceAttachment
Control | 0..1
Type | Extension(Licence Terms as Attachment) (Extension Type: Attachment)
8. ResearchStudy.extension:licenceCodeable
Slice Name | licenceCodeable
Control | 0..1
Type | Extension(Licence Terms as CodeableConcept) (Extension Type: CodeableConcept)
10. ResearchStudy.extension:context
Slice Name | context
Control | 0..*
Type | Extension(Usage Context [ResearchStudy]) (Extension Type: UsageContext)
12. ResearchStudy.identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ system
14. ResearchStudy.identifier:url
Slice Name | url
Definition | Globally Unique, Persistent and Resolvable Identifier
Short | GUPRI (uri)
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
16. ResearchStudy.identifier:url.system
Control | 1..?
Pattern Value | urn:ietf:rfc:3986
18. ResearchStudy.identifier:url.value
Short | uri
20. ResearchStudy.title
Short | Name for this study.
22. ResearchStudy.status
Short | The current state of the study.
24. ResearchStudy.primaryPurposeType
Short | A classification of the intent of the study.
26. ResearchStudy.relatedArtifact
Type | RelatedArtifact(RelatedArtifact [FHIR for FAIR])
28. ResearchStudy.description
Short | What this is study doing.
30. ResearchStudy.objective
Short | A goal for the study.

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

0. ResearchStudy
Definition | A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Short | Investigation to increase healthcare-related patient-independent knowledge
Comments | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | 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.exists() and ('#'+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(uri) = '#').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
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
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
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ResearchStudy.extension
Definition | An Extension 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 | ExtensionAdditional content defined by implementations
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..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | 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())
Slicing | This element introduces a set of slices on `ResearchStudy.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
6. ResearchStudy.extension:copyright
Slice Name | copyright
Definition | This extension may be used to provide Copyright information about the set of data described by this resource
Short | Copyright
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Copyright) (Extension Type: markdown)
Is Modifier | false
Must Support | 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()`) 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())
8. ResearchStudy.extension:licenceAttachment
Slice Name | licenceAttachment
Definition | This extension may be used to provide detailed Licence information about the set of data described by this resource
Short | Licence Terms as Attachment
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Licence Terms as Attachment) (Extension Type: Attachment)
Is Modifier | false
Must Support | 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()`) 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())
10. ResearchStudy.extension:licenceCodeable
Slice Name | licenceCodeable
Definition | This extension may be used to provide machine-processable Licence information about the set of data described by this resource
Short | Licence Terms as CodeableConcept
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Licence Terms as CodeableConcept) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | 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()`) 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())
12. ResearchStudy.extension:context
Slice Name | context
Definition | This extension allows ResearchStudy to provide richer information about the context of the study, when not already covered by the already defined elements
Short | Usage Context [ResearchStudy]
Control | 0..* This element is affected by the following invariants: ele-1
Type | Extension(Usage Context [ResearchStudy]) (Extension Type: UsageContext)
Is Modifier | false
Must Support | 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()`) 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())
14. 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..*
Type | Extension
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
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.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..*
Type | 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()))
Slicing | This element introduces a set of slices on `ResearchStudy.identifier`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ system
18. ResearchStudy.identifier:url
Slice Name | url
Definition | Globally Unique, Persistent and Resolvable Identifier Identifiers assigned to this research study by the sponsor or other systems.
Short | GUPRI (uri)Business Identifier for study
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | 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()))
20. ResearchStudy.identifier:url.use
Definition | The purpose of this identifier.
Short | usual | official | temp | secondary | old (If known)
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Control | 0..1
Binding | The codes SHALL be taken from IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0
Type | code
Is Modifier | true because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ResearchStudy.identifier:url.system
Definition | Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Short | The namespace for the identifier value
Comments | Identifier.system is always case sensitive.
Control | 10..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Pattern Value | urn:ietf:rfc:3986
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ResearchStudy.identifier:url.value
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Short | uriThe value that is unique
Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Example | <br/><b>General</b>:123456
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. ResearchStudy.title
Definition | A short, descriptive user-friendly label for the study.
Short | Name for this study.
Control | 0..1
Type | string
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()))
28. ResearchStudy.status
Definition | The current state of the study.
Short | The current state of the study.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|4.3.0 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
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. ResearchStudy.primaryPurposeType
Definition | The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Short | A classification of the intent of the study.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 http://hl7.org/fhir/ValueSet/research-study-prim-purp-type Codes for the main intent of the study.
Type | CodeableConcept
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()))
32. ResearchStudy.relatedArtifact
Definition | Related artifacts such as additional documentation, justification, or bibliographic references. Citations, references and other related documents.
Short | Related artifacts for a knowledge resourceReferences and dependencies
Comments | Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.
Control | 0..* This element is affected by the following invariants: ele-1
Type | RelatedArtifact(RelatedArtifact [FHIR for FAIR])
Is Modifier | false
Must Support | 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`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ResearchStudy.description
Definition | 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
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. 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..*
Type | 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)
38. ResearchStudy.objective.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 | 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
Summary | 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())

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

0. ResearchStudy
Definition | A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Short | Investigation to increase healthcare-related patient-independent knowledge
Comments | Need to make sure we encompass public health studies.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | 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.exists() and ('#'+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(uri) = '#').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
Definition | 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
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Control | 0..1
Type | id
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
Type | 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
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
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
Binding | The codes SHOULD be taken from CommonLanguages IETF language tag
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
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
Type | 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..*
Type | 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..*
Type | Extension
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()`)
Slicing | This element introduces a set of slices on `ResearchStudy.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
16. ResearchStudy.extension:copyright
Slice Name | copyright
Definition | This extension may be used to provide Copyright information about the set of data described by this resource
Short | Copyright
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Copyright) (Extension Type: markdown)
Is Modifier | false
Must Support | 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:licenceAttachment
Slice Name | licenceAttachment
Definition | This extension may be used to provide detailed Licence information about the set of data described by this resource
Short | Licence Terms as Attachment
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Licence Terms as Attachment) (Extension Type: Attachment)
Is Modifier | false
Must Support | 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()`)
20. ResearchStudy.extension:licenceCodeable
Slice Name | licenceCodeable
Definition | This extension may be used to provide machine-processable Licence information about the set of data described by this resource
Short | Licence Terms as CodeableConcept
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Extension(Licence Terms as CodeableConcept) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | 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()`)
22. ResearchStudy.extension:context
Slice Name | context
Definition | This extension allows ResearchStudy to provide richer information about the context of the study, when not already covered by the already defined elements
Short | Usage Context [ResearchStudy]
Control | 0..* This element is affected by the following invariants: ele-1
Type | Extension(Usage Context [ResearchStudy]) (Extension Type: UsageContext)
Is Modifier | false
Must Support | 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()`)
24. 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..*
Type | Extension
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
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()`)
26. 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..*
Type | 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())`)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ system
28. ResearchStudy.identifier:url
Slice Name | url
Definition | Globally Unique, Persistent and Resolvable Identifier
Short | GUPRI (uri)
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | 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())`)
30. ResearchStudy.identifier:url.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
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
32. ResearchStudy.identifier:url.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
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..*
Type | Extension
Is Modifier | false
Summary | 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()`)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
34. ResearchStudy.identifier:url.use
Definition | The purpose of this identifier.
Short | usual | official | temp | secondary | old (If known)
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Control | 0..1
Binding | The codes SHALL be taken from IdentifierUse
Type | code
Is Modifier | true because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. ResearchStudy.identifier:url.type
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Short | Description of identifier
Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from Identifier Type Codes
Type | CodeableConcept
Is Modifier | false
Summary | true
Requirements | Allows users to make use of identifiers when the identifier system is not known.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. ResearchStudy.identifier:url.system
Definition | Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Short | The namespace for the identifier value
Comments | Identifier.system is always case sensitive.
Control | 1..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Pattern Value | urn:ietf:rfc:3986
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. ResearchStudy.identifier:url.value
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Short | uri
Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Example | <br/><b>General</b>:123456
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. ResearchStudy.identifier:url.period
Definition | Time period during which identifier is/was valid for use.
Short | Time period when id is/was valid for use
Control | 0..1
Type | Period
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. ResearchStudy.identifier:url.assigner
Definition | Organization that issued/manages the identifier.
Short | Organization that issued id (may be just text)
Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Control | 0..1
Type | Reference(Organization)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. ResearchStudy.title
Definition | A short, descriptive user-friendly label for the study.
Short | Name for this study.
Control | 0..1
Type | string
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())`)
48. 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())`)
50. 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())`)
52. ResearchStudy.status
Definition | The current state of the study.
Short | The current state of the study.
Control | 1..1
Binding | The codes SHALL be taken from ResearchStudyStatus 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
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.primaryPurposeType
Definition | The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Short | A classification of the intent of the study.
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType Codes for the main intent of the study.
Type | CodeableConcept
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())`)
56. ResearchStudy.phase
Definition | 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 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
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.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..*
Binding | Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
Type | CodeableConcept
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())`)
60. 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..*
Binding | Codes for medications, devices and other interventions.
Type | CodeableConcept
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())`)
62. 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..*
Binding | For example codes, see Condition/Problem/DiagnosisCodes Identification of the condition or diagnosis.
Type | CodeableConcept
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())`)
64. 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..*
Type | 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())`)
66. ResearchStudy.relatedArtifact
Definition | Related artifacts such as additional documentation, justification, or bibliographic references.
Short | Related artifacts for a knowledge resource
Comments | Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.
Control | 0..* This element is affected by the following invariants: ele-1
Type | RelatedArtifact(RelatedArtifact [FHIR for FAIR])
Is Modifier | false
Must Support | 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`)
68. ResearchStudy.keyword
Definition | 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
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.location
Definition | 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 Countries and regions within which this artifact is targeted for use.
Type | CodeableConcept
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.description
Definition | 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
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. 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())`)
76. 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
Type | 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())`)
78. 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())`)
80. 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())`)
82. 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())`)
84. 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
Binding | For example codes, see ResearchStudyReasonStopped Codes for why the study ended prematurely.
Type | CodeableConcept
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.note
Definition | 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
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. 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..*
Type | 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`)
90. 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
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
92. ResearchStudy.arm.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
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..*
Type | Extension
Is Modifier | false
Summary | 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()`)
94. 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 | 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
Summary | 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()`)
96. ResearchStudy.arm.name
Definition | 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
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. ResearchStudy.arm.type
Definition | Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Short | Categorization of study arm
Control | 0..1
Type | CodeableConcept
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())`)
100. 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
Type | string
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())`)
102. 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..*
Type | 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`)
104. 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
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
106. ResearchStudy.objective.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
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..*
Type | Extension
Is Modifier | false
Summary | 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()`)
108. ResearchStudy.objective.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 | 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
Summary | 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()`)
110. ResearchStudy.objective.name
Definition | 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
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. ResearchStudy.objective.type
Definition | The kind of study objective.
Short | primary | secondary | exploratory
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType Codes for the kind of study objective.
Type | CodeableConcept
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())`)