Complex
Primitive
ActivityDefinition
CapabilityStatement
CodeSystem
Composition
ConceptMap
Encounter
Library
List
Measure
MessageHeader
Observation
Patient
PlanDefinition
Questionnaire
Resource
ServiceDefinition
StructureDefinition
StructureMap
ValueSet
default
Base StructureDefinition for ResearchStudy Resource
ResearchStudy
Path
ResearchStudy
Id
ResearchStudy
Cardinality
0 - *
Definition
A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
Comment
Need to make sure we encompass public health studies.
Constraint
dom-2 [error]
If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-1 [error]
If the resource is contained in another resource, it SHALL NOT contain any narrative
dom-4 [error]
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-3 [error]
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
Path
ResearchStudy.identifier
Id
ResearchStudy.identifier
Type
Cardinality
0 - *
Definition
Identifiers assigned to this research study by the sponsor or other systems.
Comment
Requirements
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Path
ResearchStudy.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.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.
Path
ResearchStudy.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.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 - i.e. 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.
Path
ResearchStudy.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
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.
Path
ResearchStudy.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).
Path
ResearchStudy.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.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.
Condition
per-1
Path
ResearchStudy.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Condition
ref-1
Path
ResearchStudy.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.identifier.Identifier.assigner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.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.
Path
ResearchStudy.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
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.
Path
ResearchStudy.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).
Path
ResearchStudy.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
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.title
Id
ResearchStudy.title
Type
Cardinality
0 - 1
Definition
A short, descriptive user-friendly label for the study.
Comment
Path
ResearchStudy.protocol
Id
ResearchStudy.protocol
Type
Cardinality
0 - *
Definition
The set of steps expected to be performed as part of the execution of the study.
Comment
Path
ResearchStudy.protocol.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.
Condition
ref-1
Path
ResearchStudy.protocol.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.protocol.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.protocol.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.
Path
ResearchStudy.protocol.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.protocol.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
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.
Path
ResearchStudy.protocol.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).
Path
ResearchStudy.protocol.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.protocol.Reference.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.
Condition
per-1
Path
ResearchStudy.protocol.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.protocol.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.
Path
ResearchStudy.protocol.Reference.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.
Condition
ref-1
Path
ResearchStudy.protocol.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.protocol.Reference.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.
Path
ResearchStudy.protocol.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.
Path
ResearchStudy.partOf
Id
ResearchStudy.partOf
Type
Cardinality
0 - *
Definition
A larger research study of which this particular study is a component or step.
Comment
Requirements
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Path
ResearchStudy.partOf.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.
Condition
ref-1
Path
ResearchStudy.partOf.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.partOf.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.partOf.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.
Path
ResearchStudy.partOf.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.partOf.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
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.
Path
ResearchStudy.partOf.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).
Path
ResearchStudy.partOf.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.partOf.Reference.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.
Condition
per-1
Path
ResearchStudy.partOf.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.partOf.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.
Path
ResearchStudy.partOf.Reference.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.
Condition
ref-1
Path
ResearchStudy.partOf.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.partOf.Reference.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.
Path
ResearchStudy.partOf.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.
Path
ResearchStudy.status
Id
ResearchStudy.status
Type
Cardinality
1 - 1
Definition
The current state of the study.
Comment
This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Path
ResearchStudy.category
Id
ResearchStudy.category
Type
Cardinality
0 - *
Definition
Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Comment
Path
ResearchStudy.category.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.category.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.category.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.
Path
ResearchStudy.category.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.
Path
ResearchStudy.category.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.
Path
ResearchStudy.category.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.focus
Id
ResearchStudy.focus
Type
Cardinality
0 - *
Definition
The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Comment
Path
ResearchStudy.focus.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.focus.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.focus.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.
Path
ResearchStudy.focus.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.
Path
ResearchStudy.focus.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.
Path
ResearchStudy.focus.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.contact
Id
ResearchStudy.contact
Type
Cardinality
0 - *
Definition
Contact details to assist a user in learning more about or engaging with the study.
Comment
Path
ResearchStudy.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.
Path
ResearchStudy.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
Path
ResearchStudy.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
Condition
cpt-2
Path
ResearchStudy.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.
Path
ResearchStudy.contact.ContactDetail.telecom.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one. 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.
Path
ResearchStudy.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. Contacts are ranked with lower values coming before higher values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Path
ResearchStudy.contact.ContactDetail.telecom.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Path
ResearchStudy.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.
Condition
per-1
Path
ResearchStudy.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.relatedArtifact
Id
ResearchStudy.relatedArtifact
Type
Cardinality
0 - *
Definition
Citations, references and other related documents.
Comment
type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of
Path
ResearchStudy.relatedArtifact.RelatedArtifact.type
Id
RelatedArtifact.type
Type
Cardinality
1 - 1
Definition
The type of relationship to the related artifact.
Comment
Path
ResearchStudy.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
Path
ResearchStudy.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.
Path
ResearchStudy.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).
Path
ResearchStudy.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
Path
ResearchStudy.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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.document.Attachment.data
Id
Attachment.data
Type
Cardinality
0 - 1
Definition
The actual data of the attachment - a sequence of bytes. In XML, represented using base64.
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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.document.Attachment.url
Id
Attachment.url
Type
Cardinality
0 - 1
Definition
An alternative 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.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Requirements
Included so that applications can verify that the contents of a location have not changed and so that a signature of the content can implicitly sign the content of an image without having to include the data in the instance or reference the url in the signature.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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.
Condition
ref-1
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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
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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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).
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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.
Path
ResearchStudy.relatedArtifact.RelatedArtifact.resource.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.
Path
ResearchStudy.keyword
Id
ResearchStudy.keyword
Type
Cardinality
0 - *
Definition
Key terms to aid in searching for or filtering the study.
Comment
Path
ResearchStudy.keyword.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.keyword.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.keyword.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.
Path
ResearchStudy.keyword.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.
Path
ResearchStudy.keyword.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.
Path
ResearchStudy.keyword.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.jurisdiction
Id
ResearchStudy.jurisdiction
Type
Cardinality
0 - *
Definition
Indicates a country, state or other region where the study is taking place.
Comment
Path
ResearchStudy.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.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.
Path
ResearchStudy.jurisdiction.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.description
Id
ResearchStudy.description
Type
Cardinality
0 - 1
Definition
A full description of how the study is being conducted.
Comment
Path
ResearchStudy.enrollment
Id
ResearchStudy.enrollment
Type
Cardinality
0 - *
Definition
Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
Comment
The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Path
ResearchStudy.enrollment.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.
Condition
ref-1
Path
ResearchStudy.enrollment.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.enrollment.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.enrollment.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.
Path
ResearchStudy.enrollment.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.enrollment.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
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.
Path
ResearchStudy.enrollment.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).
Path
ResearchStudy.enrollment.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.enrollment.Reference.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.
Condition
per-1
Path
ResearchStudy.enrollment.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.enrollment.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.
Path
ResearchStudy.enrollment.Reference.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.
Condition
ref-1
Path
ResearchStudy.enrollment.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.enrollment.Reference.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.
Path
ResearchStudy.enrollment.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.
Path
ResearchStudy.period
Id
ResearchStudy.period
Type
Cardinality
0 - 1
Definition
Identifies the start date and the expected (or actual, depending on status) end date for the study.
Comment
Requirements
[The list of types may be constrained as appropriate for the type of event].
Path
ResearchStudy.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.
Condition
per-1
Path
ResearchStudy.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.sponsor
Id
ResearchStudy.sponsor
Type
Cardinality
0 - 1
Definition
The organization responsible for the execution of the study.
Comment
Path
ResearchStudy.sponsor.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.
Condition
ref-1
Path
ResearchStudy.sponsor.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.sponsor.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.sponsor.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.
Path
ResearchStudy.sponsor.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.sponsor.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
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.
Path
ResearchStudy.sponsor.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).
Path
ResearchStudy.sponsor.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.sponsor.Reference.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.
Condition
per-1
Path
ResearchStudy.sponsor.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.sponsor.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.
Path
ResearchStudy.sponsor.Reference.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.
Condition
ref-1
Path
ResearchStudy.sponsor.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.sponsor.Reference.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.
Path
ResearchStudy.sponsor.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.
Path
ResearchStudy.principalInvestigator
Id
ResearchStudy.principalInvestigator
Type
Cardinality
0 - 1
Definition
Indicates the individual who has primary oversite of the execution of the study.
Comment
Path
ResearchStudy.principalInvestigator.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.
Condition
ref-1
Path
ResearchStudy.principalInvestigator.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.principalInvestigator.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.principalInvestigator.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.
Path
ResearchStudy.principalInvestigator.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.principalInvestigator.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
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.
Path
ResearchStudy.principalInvestigator.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).
Path
ResearchStudy.principalInvestigator.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.principalInvestigator.Reference.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.
Condition
per-1
Path
ResearchStudy.principalInvestigator.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.principalInvestigator.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.
Path
ResearchStudy.principalInvestigator.Reference.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.
Condition
ref-1
Path
ResearchStudy.principalInvestigator.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.principalInvestigator.Reference.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.
Path
ResearchStudy.principalInvestigator.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.
Path
ResearchStudy.site
Id
ResearchStudy.site
Type
Cardinality
0 - *
Definition
Clinic, hospital or other healthcare location that is participating in the study.
Comment
Path
ResearchStudy.site.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.
Condition
ref-1
Path
ResearchStudy.site.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.site.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.site.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.
Path
ResearchStudy.site.Reference.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.site.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
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.
Path
ResearchStudy.site.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).
Path
ResearchStudy.site.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.site.Reference.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.
Condition
per-1
Path
ResearchStudy.site.Reference.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 that the period is ongoing. 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 a end value of 2012-02-03.
Condition
per-1
Path
ResearchStudy.site.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.
Path
ResearchStudy.site.Reference.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.
Condition
ref-1
Path
ResearchStudy.site.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.site.Reference.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.
Path
ResearchStudy.site.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.
Path
ResearchStudy.reasonStopped
Id
ResearchStudy.reasonStopped
Type
Cardinality
0 - 1
Definition
A description and/or code explaining the premature termination of the study.
Comment
Path
ResearchStudy.reasonStopped.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.reasonStopped.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.reasonStopped.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.
Path
ResearchStudy.reasonStopped.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.
Path
ResearchStudy.reasonStopped.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.
Path
ResearchStudy.reasonStopped.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.note
Id
ResearchStudy.note
Type
Cardinality
0 - *
Definition
Comments made about the event by the performer, subject or other participants.
Comment
Path
ResearchStudy.note.Annotation.author[x]
Id
Annotation.author[x]
Type
Cardinality
0 - 1
Definition
The individual responsible for making the annotation.
Comment
Path
ResearchStudy.note.Annotation.author[x].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.
Condition
ref-1
Path
ResearchStudy.note.Annotation.author[x].Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.
Path
ResearchStudy.note.Annotation.author[x].Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. 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.
Path
ResearchStudy.note.Annotation.author[x].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.
Path
ResearchStudy.note.Annotation.author[x].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
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.
Path
ResearchStudy.note.Annotation.author[x].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).
Path
ResearchStudy.note.Annotation.author[x].Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Path
ResearchStudy.note.Annotation.author[x].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.
Path
ResearchStudy.note.Annotation.author[x].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.
Path
ResearchStudy.note.Annotation.time
Id
Annotation.time
Type
Cardinality
0 - 1
Definition
Indicates when this particular annotation was made.
Comment
Path
ResearchStudy.arm
Id
ResearchStudy.arm
Type
Cardinality
0 - *
Definition
Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ResearchStudy.arm.name
Id
ResearchStudy.arm.name
Type
Cardinality
1 - 1
Definition
Unique, human-readable label for this arm of the study.
Comment
Path
ResearchStudy.arm.code
Id
ResearchStudy.arm.code
Type
Cardinality
0 - 1
Definition
Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Comment
Path
ResearchStudy.arm.code.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 translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
Path
ResearchStudy.arm.code.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 de-reference to some definition that establish the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Path
ResearchStudy.arm.code.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.
Path
ResearchStudy.arm.code.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.
Path
ResearchStudy.arm.code.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.
Path
ResearchStudy.arm.code.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - i.e. 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.
Path
ResearchStudy.arm.description
Id
ResearchStudy.arm.description
Type
Cardinality
0 - 1
Definition
A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Comment