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; meta #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:meta 0..1 (Complex) STU3: meta additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.meta #xD; text #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:text 0..1 (Complex) STU3: text additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.text #xD; identifier #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:identifier 0..* Identifier STU3: identifier additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.identifier #xD; protocol #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:protocol 0..* Reference(Resource) STU3: 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..* Reference(Resource) STU3: partOf additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; contact #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:contact 0..* ContactDetail STU3: contact additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.contact #xD; relatedArtifact #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:relatedArtifact 0..* RelatedArtifact STU3: relatedArtifact additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.relatedArtifact #xD; enrollment #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:enrollment 0..* Reference(Resource) STU3: enrollment additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; period #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:period 0..1 Period STU3: period additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.period #xD; sponsor #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:sponsor 0..1 Reference(Resource) STU3: Organization responsible for the study additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; principalInvestigator #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:principalInvestigator 0..1 Reference(Resource) STU3: The individual responsible for the study 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) STU3: Location involved in study execution additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference #xD; note #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:note 0..* Annotation STU3: Comments made about the event additional types URL: http://hl7.org/fhir/3.0/StructureDefinition/extension-ResearchStudy.note #xD; Documentation for this format
Cross-version Profile for STU3.ResearchStudy for use in FHIR R4B
This cross-version profile allows STU3 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())
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
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
STU3: `ResearchStudy.meta` additional types (Meta) additional types from child elements (lastUpdated, profile, security, tag, versionId)
Element `ResearchStudy.meta` is mapped to FHIR R4B element `ResearchStudy.meta` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.meta` do not cover the following types: Meta. The mappings for `ResearchStudy.meta` do not cover the following types based on type expansion: lastUpdated, profile, security, tag, versionId.
The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
When the resource last changed - e.g. when the version changed.
This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R4B/http.html#read) interaction.
Identifies where the resource comes from
A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R4B/provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
Profiles this resource claims to conform to
A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R4B/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R4B/structuredefinition-definitions.html#StructureDefinition.url).
It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
Security Labels applied to this resource
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Security Labels from the Healthcare Privacy and Security Classification System.
Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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.
STU3: `ResearchStudy.text` additional types (Narrative) additional types from child elements (div, status)
Element `ResearchStudy.text` is mapped to FHIR R4B element `ResearchStudy.text` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.text` do not cover the following types: Narrative. The mappings for `ResearchStudy.text` do not cover the following types based on type expansion: div, status. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.
generated | extensions | additional | empty
The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.
The actual narrative content, a stripped down version of XHTML.
The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.
The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, elements (either name or href), images and internally contained style attributes
not(descendant-or-self::*[not(local-name(.)=('a', 'abbr', 'acronym', 'b', 'big', 'blockquote', 'br', 'caption', 'cite', 'code', 'col', 'colgroup', 'dd', 'dfn', 'div', 'dl', 'dt', 'em', 'h1', 'h2', 'h3', 'h4', 'h5', 'h6', 'hr', 'i', 'img', 'li', 'ol', 'p', 'pre', 'q', 'samp', 'small', 'span', 'strong', 'sub', 'sup', 'table', 'tbody', 'td', 'tfoot', 'th', 'thead', 'tr', 'tt', 'ul', 'var'))]) and not(descendant-or-self::*/@*[not(name(.)=('abbr', 'accesskey', 'align', 'alt', 'axis', 'bgcolor', 'border', 'cellhalign', 'cellpadding', 'cellspacing', 'cellvalign', 'char', 'charoff', 'charset', 'cite', 'class', 'colspan', 'compact', 'coords', 'dir', 'frame', 'headers', 'height', 'href', 'hreflang', 'hspace', 'id', 'lang', 'longdesc', 'name', 'nowrap', 'rel', 'rev', 'rowspan', 'rules', 'scope', 'shape', 'span', 'src', 'start', 'style', 'summary', 'tabindex', 'title', 'type', 'valign', 'value', 'vspace', 'width'))])
The narrative SHALL have some non-whitespace content
descendant::text()[normalize-space(.)!=''] or descendant::h:img[@src]
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)
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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)
STU3: `ResearchStudy.identifier` additional types (Identifier) additional types from child elements (assigner, period, system, type, use, value)
Element `ResearchStudy.identifier` is mapped to FHIR R4B element `ResearchStudy.identifier` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.identifier` do not cover the following types: Identifier. The mappings for `ResearchStudy.identifier` do not cover the following types based on type expansion: assigner, period, system, type, use, value.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4B/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
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
STU3: `ResearchStudy.protocol` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.protocol` is mapped to FHIR R4B element `ResearchStudy.protocol` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.protocol` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.protocol` with unmapped reference targets: PlanDefinition.
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.
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.
STU3: `ResearchStudy.partOf` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.partOf` is mapped to FHIR R4B element `ResearchStudy.partOf` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.partOf` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.partOf` with unmapped reference targets: ResearchStudy.
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.
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.
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
STU3: `ResearchStudy.contact` additional types (ContactDetail) additional types from child elements (name, telecom)
Element `ResearchStudy.contact` is mapped to FHIR R4B element `ResearchStudy.contact` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.contact` do not cover the following types: ContactDetail. The mappings for `ResearchStudy.contact` do not cover the following types based on type expansion: name, telecom.
If there is no named individual, the telecom information is for the organization as a whole.
Contact details for individual or organization
The contact details for the individual (if a name was provided) or the organization.
Citations, references and other related documents.
Citations, Links, Available Study Data/Documents
StudyProtocolDocument, StudyProtocolDocumentVersion
STU3: `ResearchStudy.relatedArtifact` additional types (RelatedArtifact) additional types from child elements (citation, display, document, resource, type, url)
Element `ResearchStudy.relatedArtifact` is mapped to FHIR R4B element `ResearchStudy.relatedArtifact` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.relatedArtifact` do not cover the following types: RelatedArtifact. The mappings for `ResearchStudy.relatedArtifact` do not cover the following types based on type expansion: citation, display, document, resource, type, url.
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of
The type of relationship to the related artifact.
A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.
Brief description of the related artifact
A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.
A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.
Additional structured information about citations should be captured as extensions.
A url for the artifact that can be followed to access the actual content.
If a document or resource element is present, this element SHALL NOT be provided (use the url or reference in the Attachment or resource reference).
The document being referenced, represented as an attachment. This is exclusive with the resource element.
The related resource, such as a library, value set, profile, or other knowledge resource.
If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.
Key terms to aid in searching for or filtering the study.
Words associated with the study that may be useful in discovery.
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)
STU3: `ResearchStudy.enrollment` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.enrollment` is mapped to FHIR R4B element `ResearchStudy.enrollment` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.enrollment` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.enrollment` with unmapped reference targets: Group. The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
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
STU3: `ResearchStudy.period` additional types (Period) additional types from child elements (end, start)
Element `ResearchStudy.period` is mapped to FHIR R4B element `ResearchStudy.period` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.period` do not cover the following types: Period. The mappings for `ResearchStudy.period` do not cover the following types based on type expansion: end, start.
The start of the period. The boundary is inclusive.
If the low element is missing, the meaning is that the low boundary is not known.
End time with inclusive boundary, if not ongoing
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
If the end of the period is missing, it means that the period is ongoing
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
STU3: Organization responsible for the study additional types
STU3: `ResearchStudy.sponsor` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.sponsor` is mapped to FHIR R4B element `ResearchStudy.sponsor` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.sponsor` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.sponsor` with unmapped reference targets: Organization.
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.
STU3: The individual responsible for the study additional types
STU3: `ResearchStudy.principalInvestigator` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.principalInvestigator` is mapped to FHIR R4B element `ResearchStudy.principalInvestigator` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.principalInvestigator` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.principalInvestigator` with unmapped reference targets: Practitioner.
Facility where study activities are conducted
A facility in which study activities are conducted.
STU3: Location involved in study execution additional types
STU3: `ResearchStudy.site` additional types from child elements (display, identifier, reference)
Element `ResearchStudy.site` is mapped to FHIR R4B element `ResearchStudy.site` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.site` do not cover the following types based on type expansion: display, identifier, reference. The standard extension `alternate-reference` has been mapped as the representation of FHIR STU3 element `ResearchStudy.site` with unmapped reference targets: Location.
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]
STU3: Comments made about the event additional types
STU3: `ResearchStudy.note` additional types (Annotation) additional types from child elements (author[x], text, time)
Element `ResearchStudy.note` is mapped to FHIR R4B element `ResearchStudy.note` as `SourceIsBroaderThanTarget`. The mappings for `ResearchStudy.note` do not cover the following types: Annotation. The mappings for `ResearchStudy.note` do not cover the following types based on type expansion: author[x], text, time.
Individual responsible for the annotation
The individual responsible for making the annotation.
Organization is used when there's no need for specific attribution as to who made the comment.
Indicates when this particular annotation was made.
The annotation - text content (as markdown)
The text of the annotation in markdown format.
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.
All FHIR elements must have a @value or children unless an empty Parameters resource
hasValue() or (children().count() > id.count()) or $this is Parameters
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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.
Unique, human-readable label for this objective of the study.
No BRIDG mapping (BRIDG has a description, but not a name)