Generated Narrative: StructureDefinition profile-ResearchStudy Name Flags Card. Type Description & Constraints ResearchStudy 0..* ResearchStudy(4.3.0) 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:studyDesign 0..* CodeableConcept R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics. #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: R5ResearchStudyClassifiersForR4B (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 R4B(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: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 R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(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; 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..* CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) R5: focus additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus #xD; enrollment #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:eligibility 0..1 Reference(Resource) 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..* Reference(Resource) R5: site 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 R4B(0.1.0) | EvidenceVariable) 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 R4B(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; objective #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:description 0..1 markdown R5: Description of the objective (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description #xD; Documentation for this format
Cross-version Profile for R5.ResearchStudy for use in FHIR R4B
This cross-version profile allows R5 ResearchStudy content to be represented via FHIR R4B 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 be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))
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 a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
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 might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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. 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.
This element is labeled 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 can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:PackagedProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedAuthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citation|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDefinition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingredient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic)
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
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 R4B. Typically, this is because the element has been added (is a new element).
All FHIR elements must have a @value or children unless an empty Parameters resource
hasValue() or (children().count() > id.count()) or $this is Parameters
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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 R4B. 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 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](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
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
No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
A short, descriptive user-friendly label for the study.
No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
The set of steps expected to be performed as part of the execution of the study.
Interventions; Arm/Intervention Cross-Reference
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.
active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as 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 R4B 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.
treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
The type of study based upon the intent of the study's activities. A classification of the intent of the study.
n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
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.
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
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.
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.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 R4B 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 alternative encodings within a code system, and translations to other code systems.
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
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.
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
Citations, references and other related documents.
Citations, Links, Available Study Data/Documents
StudyProtocolDocument, StudyProtocolDocumentVersion
Key terms to aid in searching for or filtering the study.
Words associated with the study that may be useful in discovery.
DocumentVersion.keywordCode; DocumentVersion.keywordText
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 R4B 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.
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.
Type the reference refers to (e.g. "Patient")
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.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
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.
Study Start Date (start); Study Completion Date (end)
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
Organization that initiates and is legally responsible for the study
An organization that initiates the investigation and is legally responsible for the study.
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
Researcher who oversees multiple aspects of the study
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.
Facility where study activities are conducted
A facility in which study activities are conducted.
Element `ResearchStudy.site` is mapped to FHIR R4B 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: Organization, ResearchStudy.
accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
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.
.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
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 R4B. 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 R4B. 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 R4B. Typically, this is because the element has been added (is a new element).
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
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.
R5: `ResearchStudy.objective.description` (new:markdown)
Element `ResearchStudy.objective.description` has a context of ResearchStudy.objective based on following the parent source element upwards and mapping to `ResearchStudy`. Element `ResearchStudy.objective.description` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).
Unique, human-readable label for this objective of the study.
No BRIDG mapping (BRIDG has a description, but not a name)