Summary
Diagnostics
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Medications
Workflow
Entities
Management
Individuals
General
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Support
Payment
Security
Other
Conformance
Documents
Terminology
Definitional Artifacts
Evidence-Based Medicine
Quality Reporting & Testing
Medication Definition
Public Health & Research
Complex
Primitive
ActivityDefinition
CapabilityStatement
ChargeItemDefinition
Claim
CodeSystem
Composition
ConceptMap
CoverageEligibilityRequest
Encounter
Group
Library
List
Measure
MedicinalProduct
MessageHeader
NamingSystem
Observation
Patient
PlanDefinition
Resource
StructureDefinition
StructureMap
ValueSet
default
The ResearchElementDefinition resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about.
ResearchElementDefinition
Path
ResearchElementDefinition
Id
ResearchElementDefinition
Cardinality
0 - *
Definition
The ResearchElementDefinition resource describes a "PICO" element that knowledge (evidence, assertion, recommendation) is about.
Comment
PICO stands for Population (the population within which exposures are being compared), Intervention (the conditional state or exposure state being described for its effect on outcomes), Comparison (the alternative conditional state or alternative exposure state being compared against), and Outcome (the result or effect of the intervention in the population).
Constraint
dom-2 [error]
If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3 [error]
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
dom-4 [error]
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5 [error]
If a resource is contained in another resource, it SHALL NOT have a security label
dom-6 [warning]
A resource should have narrative for robust management
red-0 [warning]
Name should be usable as an identifier for the module by machine processing applications such as code generation
url
Canonical identifier for this research element definition, represented as a URI (globally unique)
Path
ResearchElementDefinition.url
Id
ResearchElementDefinition.url
Type
Cardinality
0 - 1
Definition
An absolute URI that is used to identify this research element definition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which at which an authoritative instance of this research element definition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the research element definition is stored on different servers.
Comment
Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.
The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in [Technical and Business Versions](resource.html#versions).
In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the [meta.source](resource.html#meta) element to indicate where the current master source of the resource can be found.
Requirements
Allows the research element definition to be referenced by a single globally unique identifier.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier
Id
ResearchElementDefinition.identifier
Type
Cardinality
0 - *
Definition
A formal identifier that is used to identify this research element definition when it is represented in other formats, or referenced in a specification, model, design or an instance.
Comment
Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this research element definition outside of FHIR, where it is not possible to use the logical URI.
Requirements
Allows externally provided and/or usable business identifiers to be easily associated with the module.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.version
Id
ResearchElementDefinition.version
Type
Cardinality
0 - 1
Definition
The identifier that is used to identify this version of the research element definition when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the research element definition author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence. To provide a version consistent with the Decision Support Service specification, use the format Major.Minor.Revision (e.g. 1.0.0). For more information on versioning knowledge assets, refer to the Decision Support Service specification. Note that a version is required for non-experimental active artifacts.
Comment
There may be different research element definition instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the research element definition with the format [url]|[version].
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.name
Id
ResearchElementDefinition.name
Type
Cardinality
0 - 1
Definition
A natural language name identifying the research element definition. This name should be usable as an identifier for the module by machine processing applications such as code generation.
Comment
The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.
Requirements
Support human navigation and code generation.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
inv-0
Path
ResearchElementDefinition.title
Id
ResearchElementDefinition.title
Type
Cardinality
0 - 1
Definition
A short, descriptive, user-friendly title for the research element definition.
Comment
This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.shortTitle
Id
ResearchElementDefinition.shortTitle
Type
Cardinality
0 - 1
Definition
The short title provides an alternate title for use in informal descriptive contexts where the full, formal title is not necessary.
Comment
Requirements
Need to be able to reference the content by a short description, but still provide a longer, more formal title for the content.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subtitle
Id
ResearchElementDefinition.subtitle
Type
Cardinality
0 - 1
Definition
An explanatory or alternate title for the ResearchElementDefinition giving additional information about its content.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.status
Id
ResearchElementDefinition.status
Type
Cardinality
1 - 1
Definition
The status of this research element definition. Enables tracking the life-cycle of the content.
Comment
Allows filtering of research element definitions that are appropriate for use versus not.
Binding
Strength
required
Description
The lifecycle status of an artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.experimental
Id
ResearchElementDefinition.experimental
Type
Cardinality
0 - 1
Definition
A Boolean value to indicate that this research element definition is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.
Comment
Allows filtering of research element definitions that are appropriate for use versus not.
Requirements
Enables experimental content to be developed following the same lifecycle that would be used for a production-level research element definition.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
subject[x]
E.g. Patient, Practitioner, RelatedPerson, Organization, Location, Device
Path
ResearchElementDefinition.subject[x]
Id
ResearchElementDefinition.subject[x]
Type
Cardinality
0 - 1
Definition
The intended subjects for the ResearchElementDefinition. If this element is not provided, a Patient subject is assumed, but the subject of the ResearchElementDefinition can be anything.
Comment
The subject of the ResearchElementDefinition is critical in interpreting the criteria definitions, as the logic in the ResearchElementDefinitions is evaluated with respect to a particular subject. This corresponds roughly to the notion of a Compartment in that it limits what content is available based on its relationship to the subject. In CQL, this corresponds to the context declaration.
Binding
Strength
extensible
Description
The possible types of subjects for a measure (E.g. Patient, Practitioner, Organization, Location, etc.).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.subject[x].CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.date
Id
ResearchElementDefinition.date
Type
Cardinality
0 - 1
Definition
The date (and optionally time) when the research element definition was published. 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 research element definition changes.
Comment
Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the research element definition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.publisher
Id
ResearchElementDefinition.publisher
Type
Cardinality
0 - 1
Definition
The name of the organization or individual that published the research element definition.
Comment
Usually an organization but may be an individual. The publisher (or steward) of the research element definition is the organization or individual primarily responsible for the maintenance and upkeep of the research element definition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the research element definition. This item SHOULD be populated unless the information is available from context.
Requirements
Helps establish the "authority/credibility" of the research element definition. May also allow for contact.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact
Id
ResearchElementDefinition.contact
Type
Cardinality
0 - *
Definition
Contact details to assist a user in finding and communicating with the publisher.
Comment
May be a web site, an email address, a telephone number, etc.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.name
Id
ContactDetail.name
Type
Cardinality
0 - 1
Definition
The name of an individual to contact.
Comment
If there is no named individual, the telecom information is for the organization as a whole.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom
Id
ContactDetail.telecom
Type
Cardinality
0 - *
Definition
The contact details for the individual (if a name was provided) or the organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.contact.ContactDetail.telecom.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.description
Id
ResearchElementDefinition.description
Type
Cardinality
0 - 1
Definition
A free text natural language description of the research element definition from a consumer's perspective.
Comment
This description can be used to capture details such as why the research element definition was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the research element definition as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the research element definition is presumed to be the predominant language in the place the research element definition was created).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.comment
Id
ResearchElementDefinition.comment
Type
Cardinality
0 - *
Definition
A human-readable string to clarify or explain concepts about the resource.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext
Id
ResearchElementDefinition.useContext
Type
Cardinality
0 - *
Definition
The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate research element definition instances.
Comment
When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.
Requirements
Assist in searching for appropriate content.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code
Id
UsageContext.code
Type
Cardinality
1 - 1
Definition
A code that identifies the type of context being specified by this usage context.
Comment
Binding
Strength
extensible
Description
A code that specifies a type of context being specified by a usage context.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.code.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x]
Id
UsageContext.value[x]
Type
Cardinality
1 - 1
Definition
A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.
Comment
Binding
Strength
example
Description
A code that defines the specific value for the context being specified.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.useContext.UsageContext.value[x].CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction
Id
ResearchElementDefinition.jurisdiction
Type
Cardinality
0 - *
Definition
A legal or geographic region in which the research element definition is intended to be used.
Comment
It may be possible for the research element definition to be used in jurisdictions other than those for which it was originally designed or intended.
Binding
Strength
extensible
Description
Countries and regions within which this artifact is targeted for use.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.jurisdiction.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.purpose
Id
ResearchElementDefinition.purpose
Type
Cardinality
0 - 1
Definition
Explanation of why this research element definition is needed and why it has been designed as it has.
Comment
This element does not describe the usage of the research element definition. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this research element definition.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.usage
Id
ResearchElementDefinition.usage
Type
Cardinality
0 - 1
Definition
A detailed description, from a clinical perspective, of how the ResearchElementDefinition is used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.copyright
Id
ResearchElementDefinition.copyright
Type
Cardinality
0 - 1
Definition
A copyright statement relating to the research element definition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the research element definition.
Comment
Requirements
Consumers must be able to determine any legal restrictions on the use of the research element definition and/or its content.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.approvalDate
Id
ResearchElementDefinition.approvalDate
Type
Cardinality
0 - 1
Definition
The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.
Comment
The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.lastReviewDate
Id
ResearchElementDefinition.lastReviewDate
Type
Cardinality
0 - 1
Definition
The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.
Comment
If specified, this date follows the original approval date.
Requirements
Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.effectivePeriod
Id
ResearchElementDefinition.effectivePeriod
Type
Cardinality
0 - 1
Definition
The period during which the research element definition content was or is planned to be in active use.
Comment
The effective period for a research element definition determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015.
Requirements
Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the research element definition are or are expected to be used instead.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.effectivePeriod.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.effectivePeriod.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
topic
The category of the ResearchElementDefinition, such as Education, Treatment, Assessment, etc.
Path
ResearchElementDefinition.topic
Id
ResearchElementDefinition.topic
Type
Cardinality
0 - *
Definition
Descriptive topics related to the content of the ResearchElementDefinition. Topics provide a high-level categorization grouping types of ResearchElementDefinitions that can be useful for filtering and searching.
Comment
Requirements
Repositories must be able to determine how to categorize the ResearchElementDefinition so that it can be found by topical searches.
Binding
Strength
example
Description
High-level categorization of the definition, used for searching, sorting, and filtering.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.topic.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author
Id
ResearchElementDefinition.author
Type
Cardinality
0 - *
Definition
An individiual or organization primarily involved in the creation and maintenance of the content.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.name
Id
ContactDetail.name
Type
Cardinality
0 - 1
Definition
The name of an individual to contact.
Comment
If there is no named individual, the telecom information is for the organization as a whole.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom
Id
ContactDetail.telecom
Type
Cardinality
0 - *
Definition
The contact details for the individual (if a name was provided) or the organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.author.ContactDetail.telecom.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.editor
Id
ResearchElementDefinition.editor
Type
Cardinality
0 - *
Definition
An individual or organization primarily responsible for internal coherence of the content.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.name
Id
ContactDetail.name
Type
Cardinality
0 - 1
Definition
The name of an individual to contact.
Comment
If there is no named individual, the telecom information is for the organization as a whole.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom
Id
ContactDetail.telecom
Type
Cardinality
0 - *
Definition
The contact details for the individual (if a name was provided) or the organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.editor.ContactDetail.telecom.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.reviewer
Id
ResearchElementDefinition.reviewer
Type
Cardinality
0 - *
Definition
An individual or organization primarily responsible for review of some aspect of the content.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.name
Id
ContactDetail.name
Type
Cardinality
0 - 1
Definition
The name of an individual to contact.
Comment
If there is no named individual, the telecom information is for the organization as a whole.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom
Id
ContactDetail.telecom
Type
Cardinality
0 - *
Definition
The contact details for the individual (if a name was provided) or the organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.reviewer.ContactDetail.telecom.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.endorser
Id
ResearchElementDefinition.endorser
Type
Cardinality
0 - *
Definition
An individual or organization responsible for officially endorsing the content for use in some setting.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.name
Id
ContactDetail.name
Type
Cardinality
0 - 1
Definition
The name of an individual to contact.
Comment
If there is no named individual, the telecom information is for the organization as a whole.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom
Id
ContactDetail.telecom
Type
Cardinality
0 - *
Definition
The contact details for the individual (if a name was provided) or the organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.endorser.ContactDetail.telecom.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
ResearchElementDefinition.relatedArtifact
Id
ResearchElementDefinition.relatedArtifact
Type
Cardinality
0 - *
Definition
Related artifacts such as additional documentation, justification, or bibliographic references.
Comment
Each related artifact is either an attachment, or a reference to another resource, but not both.
Requirements
ResearchElementDefinitions must be able to provide enough information for consumers of the content (and/or interventions or results produced by the content) to be able to determine and understand the justification for and evidence in support of the content.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.type
Id
RelatedArtifact.type
Type
Cardinality
1 - 1
Definition
The type of relationship to the related artifact.
Comment
Binding
Strength
required
Description
The type of relationship to the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.label
Id
RelatedArtifact.label
Type
Cardinality
0 - 1
Definition
A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.display
Id
RelatedArtifact.display
Type
Cardinality
0 - 1
Definition
A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.citation
Id
RelatedArtifact.citation
Type
Cardinality
0 - 1
Definition
A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.
Comment
Additional structured information about citations should be captured as extensions.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.url
Id
RelatedArtifact.url
Type
Cardinality
0 - 1
Definition
A url for the artifact that can be followed to access the actual content.
Comment
If a document or resource element is present, this element SHALL NOT be provided (use the url or reference in the Attachment or resource reference).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document
Id
RelatedArtifact.document
Type
Cardinality
0 - 1
Definition
The document being referenced, represented as an attachment. This is exclusive with the resource element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.contentType
Id
Attachment.contentType
Type
Cardinality
0 - 1
Definition
Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.
Comment
Requirements
Processors of the data need to be able to know how to interpret the data.
Binding
Strength
required
Description
The mime type of an attachment. Any valid mime type is allowed.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.data
Id
Attachment.data
Type
Cardinality
0 - 1
Definition
The actual data of the attachment - a sequence of bytes, base64 encoded.
Comment
The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.
Requirements
The data needs to able to be transmitted inline.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.url
Id
Attachment.url
Type
Cardinality
0 - 1
Definition
A location where the data can be accessed.
Comment
If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.
Requirements
The data needs to be transmitted by reference.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.size
Id
Attachment.size
Type
Cardinality
0 - 1
Definition
The number of bytes of data that make up this attachment (before base64 encoding, if that is done).
Comment
The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.
Requirements
Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.hash
Id
Attachment.hash
Type
Cardinality
0 - 1
Definition
The calculated hash of the data using SHA-1. Represented using base64.
Comment
The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature.
Requirements
Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.title
Id
Attachment.title
Type
Cardinality
0 - 1
Definition
A label or set of text to display in place of the data.
Comment
Requirements
Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.document.Attachment.creation
Id
Attachment.creation
Type
Cardinality
0 - 1
Definition
The date that the attachment was first created.
Comment
Requirements
This is often tracked as an integrity issue for use of the attachment.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.relatedArtifact.RelatedArtifact.resource
Id
RelatedArtifact.resource
Type
Cardinality
0 - 1
Definition
The related resource, such as a library, value set, profile, or other knowledge resource.
Comment
If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.library
Id
ResearchElementDefinition.library
Type
Cardinality
0 - *
Definition
A reference to a Library resource containing the formal logic used by the ResearchElementDefinition.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.type
Id
ResearchElementDefinition.type
Type
Cardinality
1 - 1
Definition
The type of research element, a population, an exposure, or an outcome.
Comment
Binding
Strength
required
Description
The possible types of research elements (E.g. Population, Exposure, Outcome).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.variableType
Id
ResearchElementDefinition.variableType
Type
Cardinality
0 - 1
Definition
The type of the outcome (e.g. Dichotomous, Continuous, or Descriptive).
Comment
Binding
Strength
required
Description
The possible types of variables for exposures or outcomes (E.g. Dichotomous, Continuous, Descriptive).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic
Id
ResearchElementDefinition.characteristic
Type
Cardinality
1 - *
Definition
A characteristic that defines the members of the research element. Multiple characteristics are applied with "and" semantics.
Comment
Characteristics can be defined flexibly to accommodate different use cases for membership criteria, ranging from simple codes, all the way to using an expression language to express the criteria.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x]
Id
ResearchElementDefinition.characteristic.definition[x]
Type
Cardinality
1 - 1
Definition
Define members of the research element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).
Comment
Requirements
Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.definition[x].CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext
Id
ResearchElementDefinition.characteristic.usageContext
Type
Cardinality
0 - *
Definition
Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings.
Comment
Requirements
Need to be able to define members more structurally when more information can be communicated such as age range.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code
Id
UsageContext.code
Type
Cardinality
1 - 1
Definition
A code that identifies the type of context being specified by this usage context.
Comment
Binding
Strength
extensible
Description
A code that specifies a type of context being specified by a usage context.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.code.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.value[x]
Id
UsageContext.value[x]
Type
Cardinality
1 - 1
Definition
A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.
Comment
Binding
Strength
example
Description
A code that defines the specific value for the context being specified.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.usageContext.UsageContext.value[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.exclude
Id
ResearchElementDefinition.characteristic.exclude
Type
Cardinality
0 - 1
Definition
When true, members with this characteristic are excluded from the element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure
Id
ResearchElementDefinition.characteristic.unitOfMeasure
Type
Cardinality
0 - 1
Definition
Specifies the UCUM unit for the outcome.
Comment
Binding
Strength
required
Description
Unified Code for Units of Measure (UCUM).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.unitOfMeasure.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveDescription
Id
ResearchElementDefinition.characteristic.studyEffectiveDescription
Type
Cardinality
0 - 1
Definition
A narrative description of the time period the study covers.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffective[x]
Id
ResearchElementDefinition.characteristic.studyEffective[x]
Type
Cardinality
0 - 1
Definition
Indicates what effective period the study covers.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Id
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart
Type
Cardinality
0 - 1
Definition
Indicates duration from the study initiation.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart.Duration.value
Id
Duration.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart.Duration.comparator
Id
Duration.comparator
Type
Cardinality
0 - 1
Definition
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart.Duration.unit
Id
Duration.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart.Duration.system
Id
Duration.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
ResearchElementDefinition.characteristic.studyEffectiveTimeFromStart.Duration.code
Id
Duration.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Requirements
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
studyEffectiveGroupMeasure
mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median
Path
ResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Id
ResearchElementDefinition.characteristic.studyEffectiveGroupMeasure
Type
Cardinality
0 - 1
Definition
Indicates how elements are aggregated within the study effective period.
Comment
Binding
Strength
required
Description
Possible group measure aggregates (E.g. Mean, Median).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveDescription
Id
ResearchElementDefinition.characteristic.participantEffectiveDescription
Type
Cardinality
0 - 1
Definition
A narrative description of the time period the study covers.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffective[x]
Id
ResearchElementDefinition.characteristic.participantEffective[x]
Type
Cardinality
0 - 1
Definition
Indicates what effective period the study covers.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Id
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart
Type
Cardinality
0 - 1
Definition
Indicates duration from the participant's study entry.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart.Duration.value
Id
Duration.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart.Duration.comparator
Id
Duration.comparator
Type
Cardinality
0 - 1
Definition
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart.Duration.unit
Id
Duration.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart.Duration.system
Id
Duration.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
ResearchElementDefinition.characteristic.participantEffectiveTimeFromStart.Duration.code
Id
Duration.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Requirements
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
participantEffectiveGroupMeasure
mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median
Path
ResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Id
ResearchElementDefinition.characteristic.participantEffectiveGroupMeasure
Type
Cardinality
0 - 1
Definition
Indicates how elements are aggregated within the study effective period.
Comment
Binding
Strength
required
Description
Possible group measure aggregates (E.g. Mean, Median).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children