A physical entity which is the primary unit of operational and/or administrative interest in a study.

Need to make sure we encompass public health studies.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

An Extension

R5: ResearchSubject.progress (new:BackboneElement)

Element ResearchSubject.progress has a context of ResearchSubject based on following the parent source element upwards and mapping to ResearchSubject. Element ResearchSubject.progress has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them.

It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.

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

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The current state of the subject.

Indicates the progression of a study subject through a study.

An Extension

R5: ResearchSubject.status additional codes

Element ResearchSubject.status is mapped to FHIR R4 element ResearchSubject.status as RelatedTo. The mappings for ResearchSubject.status do not allow expression of the necessary codes, per the bindings on the source and target. The target context ResearchSubject.status is a modifier element, so this extension does not need to be defined as a modifier.

Reference to the study the subject is participating in.

The record of the person or animal who is involved in the study.

An Extension

R5: ResearchSubject.subject

Element ResearchSubject.subject is mapped to FHIR R4 element ResearchSubject.individual as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element ResearchSubject.subject with unmapped reference targets: BiologicallyDerivedProduct, Device, Group, Medication, Specimen, Substance.

R5: ResearchSubject.progress (new:BackboneElement)

Element ResearchSubject.progress has a context of ResearchSubject based on following the parent source element upwards and mapping to ResearchSubject. Element ResearchSubject.progress has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them.

It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.

R5: ResearchSubject.status additional codes

Element ResearchSubject.status is mapped to FHIR R4 element ResearchSubject.status as RelatedTo. The mappings for ResearchSubject.status do not allow expression of the necessary codes, per the bindings on the source and target. The target context ResearchSubject.status is a modifier element, so this extension does not need to be defined as a modifier.

R5: ResearchSubject.subject

Element ResearchSubject.subject is mapped to FHIR R4 element ResearchSubject.individual as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element ResearchSubject.subject with unmapped reference targets: BiologicallyDerivedProduct, Device, Group, Medication, Specimen, Substance.

A physical entity which is the primary unit of operational and/or administrative interest in a study.

Need to make sure we encompass public health studies.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

The codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

An Extension

R5: ResearchSubject.progress (new:BackboneElement)

Element ResearchSubject.progress has a context of ResearchSubject based on following the parent source element upwards and mapping to ResearchSubject. Element ResearchSubject.progress has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them.

It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.

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

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Identifiers assigned to this research subject for a study.

The current state of the subject.

Indicates the progression of a study subject through a study.

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

An Extension

R5: ResearchSubject.status additional codes

Element ResearchSubject.status is mapped to FHIR R4 element ResearchSubject.status as RelatedTo. The mappings for ResearchSubject.status do not allow expression of the necessary codes, per the bindings on the source and target. The target context ResearchSubject.status is a modifier element, so this extension does not need to be defined as a modifier.

Primitive value for code

The dates the subject began and ended their participation in the study.

Reference to the study the subject is participating in.

The record of the person or animal who is involved in the study.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

R5: ResearchSubject.subject

Element ResearchSubject.subject is mapped to FHIR R4 element ResearchSubject.individual as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element ResearchSubject.subject with unmapped reference targets: BiologicallyDerivedProduct, Device, Group, Medication, Specimen, Substance.

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.

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.

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Unless not suitable, these codes SHALL be taken from ResourceType
(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

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

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

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

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.

The name of the arm in the study the subject is expected to follow as part of this study.

The name of the arm in the study the subject actually followed as part of this study.

A record of the patient's informed agreement to participate in the study.