Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Resource Profile: M11 Research Study Profile - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the m11-research-study-profile resource profile

- Key Elements Table
- Differential Table
- Snapshot Table

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

0. ResearchStudy
Definition | A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
Short | Investigation to increase healthcare-related patient-independent knowledge
Comments | The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | 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()) identifier-required: The identifier MUST be populated with at least a Sponsor identifier (`identifier.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 its 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 its 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.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
6. 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 managable, 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 | 10..*
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()))
Slicing | 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
8. ResearchStudy.extension:narrative
Slice Name | narrative
Definition | Narrative content for the ResearchStudy.
Short | Narrative Elements
Control | 0..*
Type | Extension(Narrative Elements) (Extension Type: Reference(Research Study Narratives))
Is Modifier | false
Must Support | true
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()`)
10. ResearchStudy.extension:amendment
Slice Name | amendment
Definition | Representation of amendments to a study protocol.
Short | Amendment to a protocol - from EBM
Comments | The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
Control | 0..1
Type | Extension(M11_ProtocolAmendment) (Complex Extension)
Is Modifier | false
Must Support | true
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()`)
12. ResearchStudy.extension:confidentialityStatement
Slice Name | confidentialityStatement
Definition | Sponsor Confidentiality Statement, if applicable.
Short | Sponsor Confidentiality Statement, if applicable.
Control | 0..1
Type | Extension(M11_ConfidentialityStatement) (Extension Type: string)
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()`)
14. ResearchStudy.extension:approval
Slice Name | approval
Definition | Signature and date for approval.
Short | Sign-off details
Comments | This may need transferring into the StudyDesign profile eventually.
Control | 0..1
Type | Extension(M11_Approval) (Complex Extension)
Is Modifier | false
Must Support | true
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()`) date-required: At least one of approvalDate or signatureUrl SHOULD be populated. (`extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`)
16. ResearchStudy.extension:m11-research-study
Slice Name | m11-research-study
Definition | Signature and date for approval.
Short | Additional concepts for M11
Comments | Additional concepts required by M11 that have no other obvious home.
Control | 1..1
Type | Extension(M11 Research Study Extension) (Complex Extension)
Is Modifier | false
Must Support | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. ResearchStudy.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 managable, 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 | 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
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. 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 | 10..*
Type | Identifier
Is Modifier | false
Must Support | true
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()))
22. ResearchStudy.identifier.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|6.0.0-ballot3 (required to `http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3` ) Identifies the purpose for this identifier, if known .
Type | code
Is Modifier | true because This is labeled as "Is Modifier" 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 | false
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()))
24. ResearchStudy.identifier.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 | 10..1
Binding | Unless not suitable, these codes SHALL be taken from UDP Identifier Type Value Set http://hl7.org/fhir/ValueSet/identifier-type|6.0.0-ballot3 (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
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()))
26. ResearchStudy.title
Definition | The human readable name of the research study.
Short | Human readable name of the study
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
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 | true
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 publication state of the resource (not of the study).
Short | draft | active | retired | unknown
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 (required to `http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3` ) Codes that convey the current publication status of the research study resource.
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.phase
Definition | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Short | Classifier used for clinical trials
Comments | M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding.
Control | 0..1
Binding | The codes SHALL be taken from The codes SHOULD be taken from ICH M11 Trial Phase Value Set Terminology http://hl7.org/fhir/ValueSet/research-study-trial-phase|6.0.0-ballot3 (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. 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
Comments | Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name
Control | 0..*
Binding | For example codes, see ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3 (example to `http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3` ) Some example codes of research study focus
Type | CodeableReference(Medication, MedicinalProductDefinition, SubstanceDefinition, DeviceDefinition, PlanDefinition)
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()))
34. ResearchStudy.associatedParty
Definition | Sponsors, collaborators, and other parties.
Short | Sponsors, collaborators, and other parties
Comments | For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Requirements | While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()))
36. ResearchStudy.associatedParty.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 managable, 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()))
38. ResearchStudy.associatedParty.role
Definition | Type of association.
Short | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Comments | NCI has study roles defined - M11 only requires a limited set of these
Control | 1..1
Binding | Unless not suitable, these codes SHALL be taken from UDP Party Role Type Value Set http://hl7.org/fhir/ValueSet/research-study-party-role|6.0.0-ballot3 (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs` )
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()))
40. ResearchStudy.associatedParty.party
Definition | Individual or organization associated with study (use practitionerRole to specify their organisation).
Short | Individual or organization associated with study (use practitionerRole to specify their organisation)
Comments | Suggestions of a better attribute name are appreciated
Control | 0..1
Type | Reference(Practitioner, PractitionerRole, Organization)
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()))
42. ResearchStudy.associatedParty.party.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-2, ref-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

0. ResearchStudy
Invariants | identifier-required: The identifier MUST be populated with at least a Sponsor identifier (`identifier.exists()`)
2. ResearchStudy.extension
Control | 1..?
Slicing | 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
4. ResearchStudy.extension:narrative
Slice Name | narrative
Control | 0..*
Type | Extension(Narrative Elements) (Extension Type: Reference(Research Study Narratives))
Must Support | true
6. ResearchStudy.extension:amendment
Slice Name | amendment
Control | 0..1
Type | Extension(M11_ProtocolAmendment) (Complex Extension)
Must Support | true
8. ResearchStudy.extension:confidentialityStatement
Slice Name | confidentialityStatement
Control | 0..1
Type | Extension(M11_ConfidentialityStatement) (Extension Type: string)
10. ResearchStudy.extension:approval
Slice Name | approval
Control | 0..1
Type | Extension(M11_Approval) (Complex Extension)
Must Support | true
12. ResearchStudy.extension:m11-research-study
Slice Name | m11-research-study
Control | 1..1
Type | Extension(M11 Research Study Extension) (Complex Extension)
Must Support | true
14. ResearchStudy.identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 1..?
Must Support | true
16. ResearchStudy.identifier.type
Control | 1..?
Binding | Unless not suitable, these codes SHALL be taken from UDP Identifier Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs` )
Is Modifier | true because Protocols may have multiple business identifers from a given system - only with a type can they be distinguished.
Must Support | true
18. ResearchStudy.identifier.type.coding
20. ResearchStudy.identifier.type.coding.code
Control | 1..?
22. ResearchStudy.title
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
Must Support | true
24. ResearchStudy.label
26. ResearchStudy.label.type
Comments | The value set used here is defined by CDISC/DDF
Binding | Unless not suitable, these codes SHALL be taken from UDP Study Title Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs` )
28. ResearchStudy.relatesTo
30. ResearchStudy.relatesTo.type
Comments | Set to a value of predecessor to indicate the target is the previous version of the protocol or to C218694 to indicate the target is the amendment details that have been incorporated
32. ResearchStudy.phase
Comments | M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding.
Binding | The codes SHALL be taken from ICH M11 Trial Phase Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs` )
Must Support | true
34. ResearchStudy.focus
Comments | Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name
36. ResearchStudy.associatedParty
38. ResearchStudy.associatedParty.role
Comments | NCI has study roles defined - M11 only requires a limited set of these
Binding | Unless not suitable, these codes SHALL be taken from UDP Party Role Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs` )
40. ResearchStudy.associatedParty.party
42. ResearchStudy.associatedParty.party.reference
Must Support | true

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

0. ResearchStudy
Definition | A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
Short | Investigation to increase healthcare-related patient-independent knowledge
Comments | The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | 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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | 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()`) identifier-required: The identifier MUST be populated with at least a Sponsor identifier (`identifier.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 | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
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 its 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 its 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 SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3` ) IETF language tag for a human language
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 a 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 This element is affected by the following invariants: dom-6
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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. ResearchStudy.extension
Definition | An Extension
Short | Extension
Control | 1..*
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())`)
Slicing | 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:narrative
Slice Name | narrative
Definition | Narrative content for the ResearchStudy.
Short | Narrative Elements
Control | 0..*
Type | Extension(Narrative Elements) (Extension Type: Reference(Research Study Narratives))
Is Modifier | false
Must Support | true
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()`)
18. ResearchStudy.extension:amendment
Slice Name | amendment
Definition | Representation of amendments to a study protocol.
Short | Amendment to a protocol - from EBM
Comments | The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
Control | 0..1
Type | Extension(M11_ProtocolAmendment) (Complex Extension)
Is Modifier | false
Must Support | true
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()`)
20. ResearchStudy.extension:confidentialityStatement
Slice Name | confidentialityStatement
Definition | Sponsor Confidentiality Statement, if applicable.
Short | Sponsor Confidentiality Statement, if applicable.
Control | 0..1
Type | Extension(M11_ConfidentialityStatement) (Extension Type: string)
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()`)
22. ResearchStudy.extension:approval
Slice Name | approval
Definition | Signature and date for approval.
Short | Sign-off details
Comments | This may need transferring into the StudyDesign profile eventually.
Control | 0..1
Type | Extension(M11_Approval) (Complex Extension)
Is Modifier | false
Must Support | true
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()`) date-required: At least one of approvalDate or signatureUrl SHOULD be populated. (`extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()`)
24. ResearchStudy.extension:m11-research-study
Slice Name | m11-research-study
Definition | Signature and date for approval.
Short | Additional concepts for M11
Comments | Additional concepts required by M11 that have no other obvious home.
Control | 1..1
Type | Extension(M11 Research Study Extension) (Complex Extension)
Is Modifier | false
Must Support | true
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.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 managable, 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 | 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
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. ResearchStudy.url
Definition | Canonical identifier for this study resource, represented as a globally unique URI.
Short | Canonical identifier for this study resource
Control | 0..1
Type | uri
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())`)
30. 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 | 1..*
Type | Identifier
Is Modifier | false
Must Support | true
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())`)
32. ResearchStudy.identifier.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 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
34. ResearchStudy.identifier.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 managable, 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())`)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
36. ResearchStudy.identifier.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 (required to `http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3` ) Identifies the purpose for this identifier, if known .
Type | code
Is Modifier | true because This is labeled as "Is Modifier" 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 | false
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())`)
38. ResearchStudy.identifier.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 | 1..1
Binding | Unless not suitable, these codes SHALL be taken from UDP Identifier Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
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())`)
40. ResearchStudy.identifier.type.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 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
42. ResearchStudy.identifier.type.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 managable, 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())`)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
44. ResearchStudy.identifier.type.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..*
Type | Coding
Is Modifier | false
Summary | false
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())`)
46. ResearchStudy.identifier.type.coding.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 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
48. ResearchStudy.identifier.type.coding.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 managable, 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())`)
Slicing | This element introduces a set of slices on `ResearchStudy.identifier.type.coding.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
50. ResearchStudy.identifier.type.coding.system
Definition | The identification of the code system that defines the meaning of the symbol in the code.
Short | Identity of the terminology system
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | Need to be unambiguous about the source of the definition of the symbol.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. ResearchStudy.identifier.type.coding.version
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Short | Version of the system - if relevant
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. ResearchStudy.identifier.type.coding.code
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Short | Symbol in syntax defined by the system
Control | 1..1 This element is affected by the following invariants: cod-1
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | Need to refer to a particular code in the system.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. ResearchStudy.identifier.type.coding.display
Definition | A representation of the meaning of the code in the system, following the rules of the system.
Short | Representation defined by the system
Control | 0..1 This element is affected by the following invariants: cod-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. ResearchStudy.identifier.type.coding.userSelected
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Short | If this coding was chosen directly by the user
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. ResearchStudy.identifier.type.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
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
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())`)
62. ResearchStudy.identifier.system
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Short | The namespace for the identifier value
Comments | Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found here.
Control | 0..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
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.
Example | General: http://www.acme.com/identifiers/patient
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. ResearchStudy.identifier.value
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Short | The 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 http://hl7.org/fhir/StructureDefinition/rendered-value). 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 This element is affected by the following invariants: ident-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Example | General: 123456
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. ResearchStudy.identifier.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 | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. ResearchStudy.identifier.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 | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. ResearchStudy.version
Definition | The business version for the study record.
Short | The business version for the study record
Note | This is a business version Id, not a resource version Id (see discussion)
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())`)
72. ResearchStudy.name
Definition | Name for this study (computer friendly).
Short | Name for this study (computer friendly)
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())`)
74. ResearchStudy.title
Definition | The human readable name of the research study.
Short | Human readable name of the study
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. ResearchStudy.label
Definition | Additional names for the study.
Short | Additional names 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 or both (`hasValue() or (children().count() > id.count())`)
78. ResearchStudy.label.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
80. ResearchStudy.label.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 managable, 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())`)
82. ResearchStudy.label.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 managable, 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())`)
84. ResearchStudy.label.type
Definition | Kind of name.
Short | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Comments | The value set used here is defined by CDISC/DDF
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from UDP Study Title Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs` )
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())`)
86. ResearchStudy.label.value
Definition | The name.
Short | The name
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())`)
88. 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())`)
90. 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())`)
92. ResearchStudy.citeAs
Definition | Display of the bibliographic citation of this ResearchStudy.
Short | How to cite this ResearchStudy
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())`)
94. ResearchStudy.relatesTo
Definition | Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist.
Short | Relationships to other Resources
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
96. ResearchStudy.relatesTo.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
98. ResearchStudy.relatesTo.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 managable, 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())`)
100. ResearchStudy.relatesTo.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 managable, 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())`)
102. ResearchStudy.relatesTo.type
Definition | The type of relationship to the related artifact.
Short | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Comments | Set to a value of predecessor to indicate the target is the previous version of the protocol or to C218694 to indicate the target is the amendment details that have been incorporated
Control | 1..1
Binding | The codes SHALL be taken from ArtifactRelationshipType (required to `http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3` ) The type of relationship to the related artifact.
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())`)
104. ResearchStudy.relatesTo.target[x]
Definition | The artifact that is related to this ResearchStudy Resource.
Short | The artifact that is related to this ResearchStudy
Control | 1..1
Type | Choice of: uri, Attachment, canonical(Resource), Reference(Resource), markdown
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
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())`)
106. ResearchStudy.date
Definition | The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.
Short | Date the resource last changed
Control | 0..1
Type | dateTime
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())`)
108. ResearchStudy.status
Definition | The publication state of the resource (not of the study).
Short | draft | active | retired | unknown
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus (required to `http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3` ) Codes that convey the current publication status of the research study resource.
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())`)
110. ResearchStudy.primaryPurposeType
Definition | The type of study based upon the intent of the study activities. A classification of the intent of the study.
Short | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyPrimaryPurposeType (preferred to `http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|6.0.0-ballot3` ) 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())`)
112. 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 | Classifier used for clinical trials
Comments | M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding.
Control | 0..1
Binding | The codes SHALL be taken from ICH M11 Trial Phase Value Set Terminology (required to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. ResearchStudy.studyDesign
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Short | Classifications of the study design characteristics
Control | 0..*
Binding | The codes SHOULD be taken from StudyDesign (preferred to `http://hl7.org/fhir/ValueSet/study-design|6.0.0-ballot3` ) This is a set of terms for study design characteristics.
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())`)
116. 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
Comments | Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name
Control | 0..*
Binding | For example codes, see ResearchStudyFocusType (example to `http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3` ) Some example codes of research study focus
Type | CodeableReference(Medication, MedicinalProductDefinition, SubstanceDefinition, DeviceDefinition, PlanDefinition)
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())`)
118. 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 ConditionProblemDiagnosisCodes (example to `http://hl7.org/fhir/ValueSet/condition-code|6.0.0-ballot3` ) 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())`)
120. ResearchStudy.keyword
Definition | Key terms to aid in searching for or filtering the study.
Short | Used to search for the study
Control | 0..*
Binding | For example codes, see ResearchStudyFocusType (example to `http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3` ) Some example codes.
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())`)
122. ResearchStudy.region
Definition | A country, state or other area where the study is taking place rather than its precise geographic location or address.
Short | Geographic area for the study
Control | 0..*
Binding | Unless not suitable, these codes SHALL be taken from JurisdictionValueSet (extensible to `http://hl7.org/fhir/ValueSet/jurisdiction|6.0.0-ballot3` ) 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())`)
124. ResearchStudy.descriptionSummary
Definition | A brief text for explaining the study.
Short | Brief text explaining the study
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())`)
126. ResearchStudy.description
Definition | A detailed and human-readable narrative of the study. E.g., study abstract.
Short | Detailed narrative of the study
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())`)
128. 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())`)
130. ResearchStudy.site
Definition | A facility in which study activities are conducted.
Short | Facility where study activities are conducted
Control | 0..*
Type | Reference(Location, ResearchStudy, 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())`)
132. 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())`)
134. ResearchStudy.classifier
Definition | Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.
Short | Classification for the study
Control | 0..*
Binding | For example codes, see ResearchStudyClassifiers (example to `http://hl7.org/fhir/ValueSet/research-study-classifiers|6.0.0-ballot3` ) desc.
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())`)
136. ResearchStudy.associatedParty
Definition | Sponsors, collaborators, and other parties.
Short | Sponsors, collaborators, and other parties
Comments | For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Requirements | While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
138. ResearchStudy.associatedParty.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
140. ResearchStudy.associatedParty.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 managable, 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())`)
142. ResearchStudy.associatedParty.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 managable, 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())`)
144. ResearchStudy.associatedParty.name
Definition | Name of associated party.
Short | Name of associated party
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())`)
146. ResearchStudy.associatedParty.role
Definition | Type of association.
Short | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Comments | NCI has study roles defined - M11 only requires a limited set of these
Control | 1..1
Binding | Unless not suitable, these codes SHALL be taken from UDP Party Role Type Value Set (extensible to `http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs` )
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())`)
148. ResearchStudy.associatedParty.period
Definition | Identifies the start date and the end date of the associated party in the role.
Short | When active in the role
Comments | The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.
Control | 0..*
Type | Period
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())`)
150. ResearchStudy.associatedParty.classifier
Definition | A categorization other than role for the associated party.
Short | nih | fda | government | nonprofit | academic | industry
Control | 0..*
Binding | For example codes, see ResearchStudyPartyOrgType (example to `http://hl7.org/fhir/ValueSet/research-study-party-organization-type|6.0.0-ballot3` ) A characterization or type of the entity.
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())`)
152. ResearchStudy.associatedParty.party
Definition | Individual or organization associated with study (use practitionerRole to specify their organisation).
Short | Individual or organization associated with study (use practitionerRole to specify their organisation)
Comments | Suggestions of a better attribute name are appreciated
Control | 0..1
Type | Reference(Practitioner, PractitionerRole, Organization)
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())`)
154. ResearchStudy.associatedParty.party.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 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
156. ResearchStudy.associatedParty.party.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 managable, 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())`)
Slicing | This element introduces a set of slices on `ResearchStudy.associatedParty.party.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
158. ResearchStudy.associatedParty.party.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-2, ref-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
160. ResearchStudy.associatedParty.party.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") - must be a resource in resources
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 known RESTful URL) or by resolving the target of the reference.
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from ResourceType (extensible to `http://hl7.org/fhir/ValueSet/resource-types|6.0.0-ballot3` ) Aa resource (or, for logical models, the URI of the logical model).
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
162. ResearchStudy.associatedParty.party.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). This element only allows for a single identifier. In the case where additional identifiers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1 This element is affected by the following invariants: ref-2
Type | Identifier
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
164. ResearchStudy.associatedParty.party.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 This element is affected by the following invariants: ref-2
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
166. ResearchStudy.progressStatus
Definition | Status of study with time for that status.
Short | Status of study with time for that status
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
168. ResearchStudy.progressStatus.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
170. ResearchStudy.progressStatus.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 managable, 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())`)
172. ResearchStudy.progressStatus.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 managable, 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())`)
174. ResearchStudy.progressStatus.state
Definition | Label for status or state (e.g. recruitment status).
Short | Label for status or state (e.g. recruitment status)
Control | 1..1
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyStatus (extensible to `http://hl7.org/fhir/ValueSet/research-study-status|6.0.0-ballot3` ) defn.
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())`)
176. ResearchStudy.progressStatus.actual
Definition | An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.
Short | Actual if true else anticipated
Control | 0..1
Type | boolean
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())`)
178. ResearchStudy.progressStatus.period
Definition | Date range.
Short | Date range
Control | 0..1
Type | Period
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())`)
180. ResearchStudy.whyStopped
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 (example to `http://hl7.org/fhir/ValueSet/research-study-reason-stopped|6.0.0-ballot3` ) 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())`)
182. ResearchStudy.recruitment
Definition | Target or actual group of participants enrolled in study.
Short | Target or actual group of participants enrolled in study
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
184. ResearchStudy.recruitment.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
186. ResearchStudy.recruitment.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 managable, 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())`)
188. ResearchStudy.recruitment.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 managable, 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())`)
190. ResearchStudy.recruitment.targetNumber
Definition | Estimated total number of participants to be enrolled.
Short | Estimated total number of participants to be enrolled
Control | 0..1
Type | unsignedInt
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())`)
192. ResearchStudy.recruitment.actualNumber
Definition | Actual total number of participants enrolled in study.
Short | Actual total number of participants enrolled in study
Control | 0..1
Type | unsignedInt
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())`)
194. ResearchStudy.recruitment.eligibility
Definition | Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Short | Inclusion and exclusion criteria
Control | 0..1
Type | Reference(Group)
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())`)
196. ResearchStudy.recruitment.actualGroup
Definition | Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.
Short | Group of participants who were enrolled in study
Control | 0..1
Type | Reference(Group)
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())`)
198. ResearchStudy.comparisonGroup
Definition | Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.
Short | Defined path through the study for a subject
Comments | In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | arm
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
200. ResearchStudy.comparisonGroup.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
202. ResearchStudy.comparisonGroup.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 managable, 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())`)
204. ResearchStudy.comparisonGroup.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 managable, 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())`)
206. ResearchStudy.comparisonGroup.targetNumber
Definition | Estimated total number of participants to be enrolled in the comparison group.
Short | Estimated total number of participants to be enrolled in the comparison group
Control | 0..1
Type | unsignedInt
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())`)
208. ResearchStudy.comparisonGroup.actualNumber
Definition | Actual total number of participants enrolled in the comparison group.
Short | Actual total number of participants enrolled in the comparison group
Control | 0..1
Type | unsignedInt
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())`)
210. ResearchStudy.comparisonGroup.eligibility
Definition | Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Short | Inclusion and exclusion criteria for the comparison group
Control | 0..1
Type | Reference(Group)
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())`)
212. ResearchStudy.comparisonGroup.observedGroup
Definition | Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.
Short | Group of participants who were enrolled in the comparison group
Control | 0..1
Type | Reference(Group)
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())`)
214. 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 or both (`hasValue() or (children().count() > id.count())`)
216. 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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
218. 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 managable, 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())`)
220. 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 managable, 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())`)
222. 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())`)
224. ResearchStudy.objective.type
Definition | The kind of study objective.
Short | primary | secondary | exploratory
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type|6.0.0-ballot3` ) 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())`)
226. ResearchStudy.objective.description
Definition | Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).
Short | Description of the objective
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())`)
228. ResearchStudy.objective.outcomeMeasure
Definition | An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Short | A variable measured during the study
Comments | 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..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
230. ResearchStudy.objective.outcomeMeasure.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
232. ResearchStudy.objective.outcomeMeasure.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 managable, 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())`)
234. ResearchStudy.objective.outcomeMeasure.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 managable, 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())`)
236. ResearchStudy.objective.outcomeMeasure.name
Definition | Label for the outcome measure.
Short | Label for the outcome measure
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())`)
238. ResearchStudy.objective.outcomeMeasure.type
Definition | The kind of outcome measure.
Short | primary | secondary | exploratory
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to `http://hl7.org/fhir/ValueSet/research-study-objective-type|6.0.0-ballot3` ) defn.
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())`)
240. ResearchStudy.objective.outcomeMeasure.description
Definition | Description of the outcome measure.
Short | Description of the outcome measure
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())`)
242. ResearchStudy.objective.outcomeMeasure.endpoint
Definition | Definition of the outcome measure.
Short | Definition of the outcome measure
Control | 1..1
Type | Reference(EvidenceVariable)
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())`)
244. ResearchStudy.objective.outcomeMeasure.population
Definition | Population for this estimand.
Short | Population for this estimand
Control | 0..1
Type | Reference(Group)
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())`)
246. ResearchStudy.objective.outcomeMeasure.intervention
Definition | Comparison group of interest.
Short | Comparison group of interest
Comments | To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id
Control | 0..1
Type | Reference(Group)
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())`)
248. ResearchStudy.objective.outcomeMeasure.comparator
Definition | Comparison group for comparison.
Short | Comparison group for comparison
Comments | To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id
Control | 0..1
Type | Reference(Group)
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())`)
250. ResearchStudy.objective.outcomeMeasure.summaryMeasure
Definition | Statistical measure for treatment effect estimate.
Short | Statistical measure for treatment effect estimate
Control | 0..1
Binding | For example codes, see StatisticType (example to `http://hl7.org/fhir/ValueSet/statistic-type|6.0.0-ballot3` ) The type of a statistic, e.g. relative risk or mean.
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())`)
252. ResearchStudy.objective.outcomeMeasure.eventHandling
Definition | Handling of intercurrent event.
Short | Handling of intercurrent event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children or both (`hasValue() or (children().count() > id.count())`)
254. ResearchStudy.objective.outcomeMeasure.eventHandling.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 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
256. ResearchStudy.objective.outcomeMeasure.eventHandling.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 managable, 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())`)
258. ResearchStudy.objective.outcomeMeasure.eventHandling.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 managable, 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())`)
260. ResearchStudy.objective.outcomeMeasure.eventHandling.event
Definition | The event.
Short | The event
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())`)
262. ResearchStudy.objective.outcomeMeasure.eventHandling.group
Definition | The group that is affected by this event handling.
Short | The group that is affected by this event handling
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())`)
264. ResearchStudy.objective.outcomeMeasure.eventHandling.handling
Definition | How the data is handled.
Short | How the data is handled
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())`)
266. ResearchStudy.objective.outcomeMeasure.eventHandling.description
Definition | Text summary of event handling.
Short | Text summary of event handling
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())`)
268. ResearchStudy.result
Definition | Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.
Short | Link to results generated during the study
Control | 0..*
Type | Reference(Citation, Composition, DiagnosticReport, Evidence)
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())`)