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.

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.

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 study.

Codes that convey the current status of the research study.

STU3: ResearchStudy.meta additional types (Meta) additional types from child elements (lastUpdated, profile, security, tag, versionId)

Element ResearchStudy.meta is mapped to FHIR R4B element ResearchStudy.meta as SourceIsBroaderThanTarget. The mappings for ResearchStudy.meta do not cover the following types: Meta. The mappings for ResearchStudy.meta do not cover the following types based on type expansion: lastUpdated, profile, security, tag, versionId.

STU3: ResearchStudy.text additional types (Narrative) additional types from child elements (div, status)

Element ResearchStudy.text is mapped to FHIR R4B element ResearchStudy.text as SourceIsBroaderThanTarget. The mappings for ResearchStudy.text do not cover the following types: Narrative. The mappings for ResearchStudy.text do not cover the following types based on type expansion: div, status. 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 in formation is added later.

STU3: ResearchStudy.identifier additional types (Identifier) additional types from child elements (assigner, period, system, type, use, value)

Element ResearchStudy.identifier is mapped to FHIR R4B element ResearchStudy.identifier as SourceIsBroaderThanTarget. The mappings for ResearchStudy.identifier do not cover the following types: Identifier. The mappings for ResearchStudy.identifier do not cover the following types based on type expansion: assigner, period, system, type, use, value.

STU3: ResearchStudy.protocol additional types from child elements (display, identifier, reference)

Element ResearchStudy.protocol is mapped to FHIR R4B element ResearchStudy.protocol as SourceIsBroaderThanTarget. The mappings for ResearchStudy.protocol do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.protocol with unmapped reference targets: PlanDefinition.

STU3: ResearchStudy.partOf additional types from child elements (display, identifier, reference)

Element ResearchStudy.partOf is mapped to FHIR R4B element ResearchStudy.partOf as SourceIsBroaderThanTarget. The mappings for ResearchStudy.partOf do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.partOf with unmapped reference targets: ResearchStudy.

STU3: ResearchStudy.contact additional types (ContactDetail) additional types from child elements (name, telecom)

Element ResearchStudy.contact is mapped to FHIR R4B element ResearchStudy.contact as SourceIsBroaderThanTarget. The mappings for ResearchStudy.contact do not cover the following types: ContactDetail. The mappings for ResearchStudy.contact do not cover the following types based on type expansion: name, telecom.

STU3: ResearchStudy.relatedArtifact additional types (RelatedArtifact) additional types from child elements (citation, display, document, resource, type, url)

Element ResearchStudy.relatedArtifact is mapped to FHIR R4B element ResearchStudy.relatedArtifact as SourceIsBroaderThanTarget. The mappings for ResearchStudy.relatedArtifact do not cover the following types: RelatedArtifact. The mappings for ResearchStudy.relatedArtifact do not cover the following types based on type expansion: citation, display, document, resource, type, url.

STU3: ResearchStudy.enrollment additional types from child elements (display, identifier, reference)

Element ResearchStudy.enrollment is mapped to FHIR R4B element ResearchStudy.enrollment as SourceIsBroaderThanTarget. The mappings for ResearchStudy.enrollment do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.enrollment with unmapped reference targets: Group. The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

STU3: ResearchStudy.period additional types (Period) additional types from child elements (end, start)

Element ResearchStudy.period is mapped to FHIR R4B element ResearchStudy.period as SourceIsBroaderThanTarget. The mappings for ResearchStudy.period do not cover the following types: Period. The mappings for ResearchStudy.period do not cover the following types based on type expansion: end, start.

STU3: ResearchStudy.sponsor additional types from child elements (display, identifier, reference)

Element ResearchStudy.sponsor is mapped to FHIR R4B element ResearchStudy.sponsor as SourceIsBroaderThanTarget. The mappings for ResearchStudy.sponsor do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.sponsor with unmapped reference targets: Organization.

STU3: ResearchStudy.principalInvestigator additional types from child elements (display, identifier, reference)

Element ResearchStudy.principalInvestigator is mapped to FHIR R4B element ResearchStudy.principalInvestigator as SourceIsBroaderThanTarget. The mappings for ResearchStudy.principalInvestigator do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.principalInvestigator with unmapped reference targets: Practitioner.

STU3: ResearchStudy.site additional types from child elements (display, identifier, reference)

Element ResearchStudy.site is mapped to FHIR R4B element ResearchStudy.site as SourceIsBroaderThanTarget. The mappings for ResearchStudy.site do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.site with unmapped reference targets: Location.

STU3: ResearchStudy.note additional types (Annotation) additional types from child elements (author[x], text, time)

Element ResearchStudy.note is mapped to FHIR R4B element ResearchStudy.note as SourceIsBroaderThanTarget. The mappings for ResearchStudy.note do not cover the following types: Annotation. The mappings for ResearchStudy.note do not cover the following types based on type expansion: author[x], text, time.

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.

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.

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

An Extension

STU3: ResearchStudy.meta additional types (Meta) additional types from child elements (lastUpdated, profile, security, tag, versionId)

Element ResearchStudy.meta is mapped to FHIR R4B element ResearchStudy.meta as SourceIsBroaderThanTarget. The mappings for ResearchStudy.meta do not cover the following types: Meta. The mappings for ResearchStudy.meta do not cover the following types based on type expansion: lastUpdated, profile, security, tag, versionId.

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

When the resource last changed - e.g. when the version changed.

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

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).

IETF language tag

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.

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

An Extension

STU3: ResearchStudy.text additional types (Narrative) additional types from child elements (div, status)

Element ResearchStudy.text is mapped to FHIR R4B element ResearchStudy.text as SourceIsBroaderThanTarget. The mappings for ResearchStudy.text do not cover the following types: Narrative. The mappings for ResearchStudy.text do not cover the following types based on type expansion: div, status. 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 in formation is added later.

The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.

The actual narrative content, a stripped down version of XHTML.

The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.

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.

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

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.

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 study by the sponsor or other systems.

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

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

An Extension

STU3: ResearchStudy.identifier additional types (Identifier) additional types from child elements (assigner, period, system, type, use, value)

Element ResearchStudy.identifier is mapped to FHIR R4B element ResearchStudy.identifier as SourceIsBroaderThanTarget. The mappings for ResearchStudy.identifier do not cover the following types: Identifier. The mappings for ResearchStudy.identifier do not cover the following types based on type expansion: assigner, period, system, type, use, value.

The purpose of this identifier.

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

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.

Allows users to make use of identifiers when the identifier system is not known.

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Identifier.system is always case sensitive.

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.

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Time period during which identifier is/was valid for use.

Organization that issued/manages the identifier.

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.

A short, descriptive user-friendly label for the study.

The set of steps expected to be performed as part of the execution of 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

STU3: ResearchStudy.protocol additional types from child elements (display, identifier, reference)

Element ResearchStudy.protocol is mapped to FHIR R4B element ResearchStudy.protocol as SourceIsBroaderThanTarget. The mappings for ResearchStudy.protocol do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.protocol with unmapped reference targets: PlanDefinition.

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.

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.

A larger research study of which this particular study is a component or step.

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

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

An Extension

STU3: ResearchStudy.partOf additional types from child elements (display, identifier, reference)

Element ResearchStudy.partOf is mapped to FHIR R4B element ResearchStudy.partOf as SourceIsBroaderThanTarget. The mappings for ResearchStudy.partOf do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.partOf with unmapped reference targets: ResearchStudy.

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.

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 current state of the study.

Codes that convey the current status of the research study.

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Codes for the main intent of the study.

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

Codes for medications, devices and other interventions.

The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

Identification of the condition or diagnosis.

Contact details to assist a user in learning more about or engaging with 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

STU3: ResearchStudy.contact additional types (ContactDetail) additional types from child elements (name, telecom)

Element ResearchStudy.contact is mapped to FHIR R4B element ResearchStudy.contact as SourceIsBroaderThanTarget. The mappings for ResearchStudy.contact do not cover the following types: ContactDetail. The mappings for ResearchStudy.contact do not cover the following types based on type expansion: name, telecom.

The name of an individual to contact.

If there is no named individual, the telecom information is for the organization as a whole.

The contact details for the individual (if a name was provided) or the organization.

Citations, references and other related documents.

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

An Extension

STU3: ResearchStudy.relatedArtifact additional types (RelatedArtifact) additional types from child elements (citation, display, document, resource, type, url)

Element ResearchStudy.relatedArtifact is mapped to FHIR R4B element ResearchStudy.relatedArtifact as SourceIsBroaderThanTarget. The mappings for ResearchStudy.relatedArtifact do not cover the following types: RelatedArtifact. The mappings for ResearchStudy.relatedArtifact do not cover the following types based on type expansion: citation, display, document, resource, type, url.

The type of relationship to the related artifact.

A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.

A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.

A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.

Additional structured information about citations should be captured as extensions.

A url for the artifact that can be followed to access the actual content.

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).

The document being referenced, represented as an attachment. This is exclusive with the resource element.

The related resource, such as a library, value set, profile, or other knowledge resource.

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.

Key terms to aid in searching for or filtering the study.

Words associated with the study that may be useful in discovery.

Indicates a country, state or other region where the study is taking place.

Countries and regions within which this artifact is targeted for use.

A full description of how the study is being conducted.

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".

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

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

An Extension

STU3: ResearchStudy.enrollment additional types from child elements (display, identifier, reference)

Element ResearchStudy.enrollment is mapped to FHIR R4B element ResearchStudy.enrollment as SourceIsBroaderThanTarget. The mappings for ResearchStudy.enrollment do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.enrollment with unmapped reference targets: Group. The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

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.

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.

Identifies the start date and the expected (or actual, depending on status) end date for 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

STU3: ResearchStudy.period additional types (Period) additional types from child elements (end, start)

Element ResearchStudy.period is mapped to FHIR R4B element ResearchStudy.period as SourceIsBroaderThanTarget. The mappings for ResearchStudy.period do not cover the following types: Period. The mappings for ResearchStudy.period do not cover the following types based on type expansion: end, start.

The start of the period. The boundary is inclusive.

If the low element is missing, the meaning is that the low boundary is not known.

The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

An organization that initiates the investigation and is legally responsible for 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

STU3: ResearchStudy.sponsor additional types from child elements (display, identifier, reference)

Element ResearchStudy.sponsor is mapped to FHIR R4B element ResearchStudy.sponsor as SourceIsBroaderThanTarget. The mappings for ResearchStudy.sponsor do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.sponsor with unmapped reference targets: Organization.

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.

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.

A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.

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

An Extension

STU3: ResearchStudy.principalInvestigator additional types from child elements (display, identifier, reference)

Element ResearchStudy.principalInvestigator is mapped to FHIR R4B element ResearchStudy.principalInvestigator as SourceIsBroaderThanTarget. The mappings for ResearchStudy.principalInvestigator do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.principalInvestigator with unmapped reference targets: Practitioner.

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.

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.

A facility in which study activities are conducted.

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

An Extension

STU3: ResearchStudy.site additional types from child elements (display, identifier, reference)

Element ResearchStudy.site is mapped to FHIR R4B element ResearchStudy.site as SourceIsBroaderThanTarget. The mappings for ResearchStudy.site do not cover the following types based on type expansion: display, identifier, reference. The standard extension alternate-reference has been mapped as the representation of FHIR STU3 element ResearchStudy.site with unmapped reference targets: Location.

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.

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.

A description and/or code explaining the premature termination of the study.

Codes for why the study ended prematurely.

Comments made about the study by the performer, subject or other participants.

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

An Extension

STU3: ResearchStudy.note additional types (Annotation) additional types from child elements (author[x], text, time)

Element ResearchStudy.note is mapped to FHIR R4B element ResearchStudy.note as SourceIsBroaderThanTarget. The mappings for ResearchStudy.note do not cover the following types: Annotation. The mappings for ResearchStudy.note do not cover the following types based on type expansion: author[x], text, time.

The individual responsible for making the annotation.

Organization is used when there's no need for specific attribution as to who made the comment.

Indicates when this particular annotation was made.

The text of the annotation in markdown format.

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.

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

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

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.

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

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

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.

Unique, human-readable label for this arm of the study.

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

A succinct description of the path through the study that would be followed by a subject adhering to this arm.

A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

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

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

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.

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

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

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.

Unique, human-readable label for this objective of the study.

The kind of study objective.

Codes for the kind of study objective.