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.

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

An Extension

R4: ResearchStudy.primaryPurposeType (new:CodeableConcept)

Element ResearchStudy.primaryPurposeType has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.primaryPurposeType has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.phase (new:CodeableConcept)

Element ResearchStudy.phase has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.phase has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.condition (new:CodeableConcept)

Element ResearchStudy.condition has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.condition has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.objective (new:BackboneElement)

Element ResearchStudy.objective has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.objective has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

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. Usually modifier elements provide negation or qualification. In order 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.

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.

The current state of the study.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

The codes SHALL be taken from ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|3.0.2
(required to http://hl7.org/fhir/ValueSet/research-study-status|3.0.2)

Codes that convey the current status of the research study

An Extension

R4: ResearchStudy.status

Element ResearchStudy.status is mapped to FHIR STU3 element ResearchStudy.status as SourceIsBroaderThanTarget. The target context ResearchStudy.status is a modifier element, so this extension does not need to be defined as a modifier.

R4: ResearchStudy.primaryPurposeType (new:CodeableConcept)

Element ResearchStudy.primaryPurposeType has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.primaryPurposeType has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.phase (new:CodeableConcept)

Element ResearchStudy.phase has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.phase has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.condition (new:CodeableConcept)

Element ResearchStudy.condition has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.condition has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.objective (new:BackboneElement)

Element ResearchStudy.objective has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.objective has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.status

Element ResearchStudy.status is mapped to FHIR STU3 element ResearchStudy.status as SourceIsBroaderThanTarget. The target context ResearchStudy.status is a modifier element, so this extension does not need to be defined as a modifier.

R4: ResearchStudy.principalInvestigator additional types from child elements (display, identifier, reference, type)

Element ResearchStudy.principalInvestigator is mapped to FHIR STU3 element ResearchStudy.principalInvestigator as SourceIsBroaderThanTarget. The mappings for ResearchStudy.principalInvestigator do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R4 element ResearchStudy.principalInvestigator with unmapped reference targets: PractitionerRole.

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 may 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.

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

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).

A human language.

A human-readable narrative that contains a summary of the resource, and may 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 in formation 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.

An Extension

R4: ResearchStudy.primaryPurposeType (new:CodeableConcept)

Element ResearchStudy.primaryPurposeType has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.primaryPurposeType has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.phase (new:CodeableConcept)

Element ResearchStudy.phase has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.phase has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.condition (new:CodeableConcept)

Element ResearchStudy.condition has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.condition has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R4: ResearchStudy.objective (new:BackboneElement)

Element ResearchStudy.objective has a context of ResearchStudy based on following the parent source element upwards and mapping to ResearchStudy. Element ResearchStudy.objective has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

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. Usually modifier elements provide negation or qualification. In order 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.

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.

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.

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.

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.

The current state of the study.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

The codes SHALL be taken from ResearchStudyStatus
(required to http://hl7.org/fhir/ValueSet/research-study-status|3.0.2)

Codes that convey the current status of the research study

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

An Extension

R4: ResearchStudy.status

Element ResearchStudy.status is mapped to FHIR STU3 element ResearchStudy.status as SourceIsBroaderThanTarget. The target context ResearchStudy.status is a modifier element, so this extension does not need to be defined as a modifier.

Primitive value for code

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 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.

Codes for medications, devices, conditions and other interventions

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

Citations, references and other related documents.

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.

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

[The list of types may be constrained as appropriate for the type of event].

The organization responsible for the execution of the study.

Indicates the individual who has primary oversite 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

R4: ResearchStudy.principalInvestigator additional types from child elements (display, identifier, reference, type)

Element ResearchStudy.principalInvestigator is mapped to FHIR STU3 element ResearchStudy.principalInvestigator as SourceIsBroaderThanTarget. The mappings for ResearchStudy.principalInvestigator do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R4 element ResearchStudy.principalInvestigator with unmapped reference targets: PractitionerRole.

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.

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.

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.

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.

Clinic, hospital or other healthcare location that is participating in the study.

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

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

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. In order 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.

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 that contains it. Usually modifier elements provide negation or qualification. In order 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.

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.

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.