Generated Narrative: StructureDefinition profile-ResearchStudy Name Flags Card. Type Description & Constraints ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:url 0..1 uri R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url #xD; extension:version 0..1 string R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version #xD; extension:name 0..1 string R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name #xD; extension:label 0..* (Complex) R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label #xD; extension:date 0..1 dateTime R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date #xD; extension:primaryPurposeType 0..1 CodeableConcept R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType Binding: R5ResearchStudyPrimPurpTypeForR3 (0.1.0) (preferred): Codes for the main intent of the study. #xD; extension:phase 0..1 CodeableConcept R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase Binding: R5ResearchStudyPhaseForR3 (0.1.0) (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. #xD; extension:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR3 (0.1.0) (preferred): This is a set of terms for study design characteristics. #xD; extension:condition 0..* CodeableConcept R5: Condition being studied (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition #xD; extension:descriptionSummary 0..1 markdown R5: Brief text explaining the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary #xD; extension:classifier 0..* CodeableConcept R5: Classification for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier Binding: R5ResearchStudyClassifiersForR3 (0.1.0) (example): desc. #xD; extension:associatedParty 0..* (Complex) R5: Sponsors, collaborators, and other parties (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty #xD; extension:progressStatus 0..* (Complex) R5: Status of study with time for that status (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus #xD; extension:targetNumber 0..1 unsignedInt R5: Estimated total number of participants to be enrolled (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber #xD; extension:actualNumber 0..1 unsignedInt R5: Actual total number of participants enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber #xD; extension:actualGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) R5: Group of participants who were enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup #xD; extension:objective 0..* (Complex) R5: A goal for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective #xD; extension:outcomeMeasure 0..* (Complex) R5: A variable measured during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure #xD; extension:result 0..* Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.Citation for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.DiagnosticReport for use in FHIR STU3(0.1.0) | DiagnosticReport) R5: Link to results generated during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result #xD; protocol #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:protocol 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] R5: protocol additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; partOf #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:partOf 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] R5: partOf additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; status #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:status 0..1 code R5: draft | active | retired | unknown additional codes URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. #xD; focus #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:focus 0..* (Complex) R5: Drugs, devices, etc. under study additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus #xD; enrollment #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:eligibility 0..1 ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] R5: Inclusion and exclusion criteria additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; site #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:site 0..* ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] R5: Facility where study activities are conducted URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; arm #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:linkId 0..1 id R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId #xD; extension:intendedExposure 0..* Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR STU3(0.1.0) | Basic) R5: Interventions or exposures in this comparisonGroup or cohort (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure #xD; extension:observedGroup 0..1 Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) R5: Group of participants who were enrolled in study comparisonGroup (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup #xD; Documentation for this format
Cross-version Profile for R5.ResearchStudy for use in FHIR STU3
This cross-version profile allows R5 ResearchStudy content to be represented via FHIR STU3 ResearchStudy resources.
Investigation to increase healthcare-related patient-independent knowledge
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.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
If the resource is contained in another resource, it SHALL NOT contain any narrative
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))
Observation[classCode=CLNTRL, moodCode=EVN]
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 set of rules under which this content was created
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).
Text summary of the resource, for human interpretation
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.
R5: Canonical identifier for this study resource (new)
Element `ResearchStudy.url` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.url` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
All FHIR elements must have a @value or children
hasValue() | (children().count() > id.count())
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
R5: The business version for the study record (new)
R5: `ResearchStudy.version` (new:string)
Element `ResearchStudy.version` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.version` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Name for this study (computer friendly) (new)
Element `ResearchStudy.name` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.name` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Additional names for the study (new)
R5: `ResearchStudy.label` (new:BackboneElement)
Element `ResearchStudy.label` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.label` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Date the resource last changed (new)
Element `ResearchStudy.date` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.date` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)
R5: `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).
R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)
R5: `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).
R5: Classifications of the study design characteristics (new)
R5: `ResearchStudy.studyDesign` (new:CodeableConcept)
Element `ResearchStudy.studyDesign` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.studyDesign` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: `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).
R5: Brief text explaining the study (new)
R5: `ResearchStudy.descriptionSummary` (new:markdown)
Element `ResearchStudy.descriptionSummary` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.descriptionSummary` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: `ResearchStudy.classifier` (new:CodeableConcept)
Element `ResearchStudy.classifier` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.classifier` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Sponsors, collaborators, and other parties (new)
R5: `ResearchStudy.associatedParty` (new:BackboneElement)
Element `ResearchStudy.associatedParty` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.associatedParty` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
R5: Status of study with time for that status (new)
R5: `ResearchStudy.progressStatus` (new:BackboneElement)
Element `ResearchStudy.progressStatus` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.progressStatus` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Estimated total number of participants to be enrolled (new)
R5: `ResearchStudy.recruitment.targetNumber` (new:unsignedInt)
Element `ResearchStudy.recruitment.targetNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.targetNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Actual total number of participants enrolled in study (new)
R5: `ResearchStudy.recruitment.actualNumber` (new:unsignedInt)
Element `ResearchStudy.recruitment.actualNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualNumber` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Group of participants who were enrolled in study (new)
R5: `ResearchStudy.recruitment.actualGroup` (new:Reference(Group))
Element `ResearchStudy.recruitment.actualGroup` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.recruitment.actualGroup` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: `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).
R5: A variable measured during the study (new)
R5: `ResearchStudy.outcomeMeasure` (new:BackboneElement)
Element `ResearchStudy.outcomeMeasure` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.outcomeMeasure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element). A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP
R5: Link to results generated during the study (new)
R5: `ResearchStudy.result` (new:Reference(EvidenceReport,Citation,DiagnosticReport))
Element `ResearchStudy.result` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.result` 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.
Organization's Unique Protocol ID; Secondary IDs
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.
Interventions; Arm/Intervention Cross-Reference
unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
R5: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference, type)
Element `ResearchStudy.protocol` is mapped to FHIR STU3 element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.protocol` 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 R5 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.
Literal reference, Relative, internal or absolute URL
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.
Logical reference, when literal reference is not known
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.
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.
R5: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference, type)
Element `ResearchStudy.partOf` is mapped to FHIR STU3 element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.partOf` 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 R5 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.
draft | in-progress | suspended | stopped | completed | entered-in-error
This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Codes that convey the current status of the research study
unique id for the element within a resource (for internal references)
R5: draft | active | retired | unknown additional codes
R5: `ResearchStudy.status` additional codes
Element `ResearchStudy.status` is mapped to FHIR STU3 element `ResearchStudy.status` as `RelatedTo`. The mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target. The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier.
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.
Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
Drugs, devices, conditions, etc. under study
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
R5: Drugs, devices, etc. under study additional types
R5: `ResearchStudy.focus` additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))
Element `ResearchStudy.focus` is mapped to FHIR STU3 element `ResearchStudy.focus` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.focus` do not cover the following types: CodeableReference.
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
Contact details to assist a user in learning more about or engaging with the study.
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
Citations, references and other related documents.
Citations, Links, Available Study Data/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.
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
R5: Inclusion and exclusion criteria additional types
R5: `ResearchStudy.recruitment.eligibility` additional types from child elements (display, identifier, reference, type)
Element `ResearchStudy.recruitment.eligibility` is mapped to FHIR STU3 element `ResearchStudy.enrollment` as `RelatedTo`. The mappings for `ResearchStudy.recruitment.eligibility` 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 R5 element `ResearchStudy.recruitment.eligibility` with unmapped reference targets: EvidenceVariable, Group.
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].
Study Start Date (start); Study Completion Date (end)
The organization responsible for the execution of the study.
The individual responsible for the study
Indicates the individual who has primary oversite of the execution of the study.
Clinic, hospital or other healthcare location that is participating in the study.
R5: Facility where study activities are conducted
Element `ResearchStudy.site` is mapped to FHIR STU3 element `ResearchStudy.site` as `SourceIsBroaderThanTarget`. The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.site` with unmapped reference targets: Location, Organization, ResearchStudy.
A description and/or code explaining the premature termination of the study.
Comments made about the event by the performer, subject or other participants.
Defined path through the study for a subject
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.
R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)
R5: `ResearchStudy.comparisonGroup.linkId` (new:id)
Element `ResearchStudy.comparisonGroup.linkId` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.linkId` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Interventions or exposures in this comparisonGroup or cohort (new)
R5: `ResearchStudy.comparisonGroup.intendedExposure` (new:Reference(EvidenceVariable))
Element `ResearchStudy.comparisonGroup.intendedExposure` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.intendedExposure` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).
R5: Group of participants who were enrolled in study comparisonGroup (new)
R5: `ResearchStudy.comparisonGroup.observedGroup` (new:Reference(Group))
Element `ResearchStudy.comparisonGroup.observedGroup` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.comparisonGroup.observedGroup` 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 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.
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.