Release 5 Draft Ballot
AdministrationThis page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Practitioner |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for researchstudy
{
"resourceType" : "StructureDefinition",
"id" : "ResearchStudy",
"meta" : {
"lastUpdated" : "2021-04-15T12:25:09.461+10:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Public Health & Research"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "business"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"version" : "4.6.0",
"name" : "ResearchStudy",
"status" : "draft",
"date" : "2021-04-15T12:25:09+10:00",
"publisher" : "Health Level Seven International (Biomedical Research and Regulation)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
}]
},
{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}]
}],
"description" : "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.",
"fhirVersion" : "4.6.0",
"mapping" : [{
"identity" : "BRIDG5.1",
"uri" : "https://bridgmodel.nci.nih.gov",
"name" : "BRIDG 5.1 Mapping"
},
{
"identity" : "v2",
"uri" : "http://hl7.org/v2",
"name" : "HL7 v2 Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "clinicaltrials-gov",
"uri" : "http://clinicaltrials.gov",
"name" : "ClinicalTrials.gov Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "ResearchStudy",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "ResearchStudy",
"path" : "ResearchStudy",
"short" : "Investigation to increase healthcare-related patient-independent knowledge",
"definition" : "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 or stability data about drug products or drug substances.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Clinical Trial",
"Study"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "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",
"expression" : "contained.where((('#'+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(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath" : "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "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."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "BRIDG5.1",
"map" : "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity" : "w5",
"map" : "clinical.diagnostics"
}]
},
{
"id" : "ResearchStudy.id",
"path" : "ResearchStudy.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "Typically, the resource has an id except for cases like the create operation, conditional updates.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta",
"path" : "ResearchStudy.meta",
"short" : "Metadata about the resource",
"definition" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.implicitRules",
"path" : "ResearchStudy.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "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.",
"comment" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "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",
"isSummary" : true
},
{
"id" : "ResearchStudy.language",
"path" : "ResearchStudy.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "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).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/build/StructureDefinition/definition",
"valueString" : "A human language."
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "IETF language tag",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "ResearchStudy.text",
"path" : "ResearchStudy.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "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.",
"comment" : "Contained resources do not have a 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.",
"alias" : ["narrative",
"html",
"xhtml",
"display"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Narrative"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "ResearchStudy.contained",
"path" : "ResearchStudy.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope.",
"comment" : "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.",
"alias" : ["inline resources",
"anonymous resources",
"contained resources"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Resource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.extension",
"path" : "ResearchStudy.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.modifierExtension",
"path" : "ResearchStudy.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.url",
"path" : "ResearchStudy.url",
"short" : "Canonical identifier for this study resource",
"definition" : "Canonical identifier for this study resource, represented as a globally unique URI.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.url",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.identifier",
"path" : "ResearchStudy.identifier",
"short" : "Business Identifier for study",
"definition" : "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements" : "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Organization's Unique Protocol ID; Secondary IDs"
},
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchStudy.version",
"path" : "ResearchStudy.version",
"short" : "Business identifier for the study record",
"definition" : "Business identifier for the study record.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.version",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.name",
"path" : "ResearchStudy.name",
"short" : "Name for this study (computer friendly)",
"definition" : "Name for this study (computer friendly).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.name",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.title",
"path" : "ResearchStudy.title",
"short" : "Name for this study (for computers)",
"definition" : "A short, descriptive label for the study particularly for compouter use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.title",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Brief Title"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
}]
},
{
"id" : "ResearchStudy.label",
"path" : "ResearchStudy.label",
"short" : "Additional names for the study",
"definition" : "Additional names for the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.label",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.label.id",
"path" : "ResearchStudy.label.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.label.extension",
"path" : "ResearchStudy.label.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.label.modifierExtension",
"path" : "ResearchStudy.label.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.label.type",
"path" : "ResearchStudy.label.type",
"short" : "short | public | scientific",
"definition" : "Kind of name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.label.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyTitleType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-title-type"
}
},
{
"id" : "ResearchStudy.label.value",
"path" : "ResearchStudy.label.value",
"short" : "The name",
"definition" : "The name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.label.value",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.protocol",
"path" : "ResearchStudy.protocol",
"short" : "Steps followed in executing study",
"definition" : "The set of steps expected to be performed as part of the execution of the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.protocol",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/PlanDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Interventions; Arm/Intervention Cross-Reference"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersionPublicTitle.name"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=DEFN].target"
}]
},
{
"id" : "ResearchStudy.partOf",
"path" : "ResearchStudy.partOf",
"short" : "Part of larger study",
"definition" : "A larger research study of which this particular study is a component or step.",
"requirements" : "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"alias" : ["container"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.partOf",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "CompanionStudyRelationship"
},
{
"identity" : "rim",
"map" : ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
}]
},
{
"id" : "ResearchStudy.relatedArtifact",
"path" : "ResearchStudy.relatedArtifact",
"short" : "References and dependencies",
"definition" : "Citations, references and other related documents.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.relatedArtifact",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "RelatedArtifact"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Citations, Links, Available Study Data/Documents"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocument, StudyProtocolDocumentVersion"
}]
},
{
"id" : "ResearchStudy.date",
"path" : "ResearchStudy.date",
"short" : "Date the resource last changed",
"definition" : "Date the resource last changed.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.date",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.status",
"path" : "ResearchStudy.status",
"short" : "draft | active | retired | unknown",
"definition" : "The publication state of the resource (not of the study).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.status",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "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",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "required",
"description" : "Codes that convey the current publication status of the research study resource.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|4.6.0"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.code"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchStudy.primaryPurposeType",
"path" : "ResearchStudy.primaryPurposeType",
"short" : "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"definition" : "The type of study based upon the intent of the study activities. A classification of the intent of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.primaryPurposeType",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPrimaryPurposeType"
}],
"strength" : "extensible",
"description" : "Codes for the main intent of the study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.primaryPurposeTypeCode"
}]
},
{
"id" : "ResearchStudy.phase",
"path" : "ResearchStudy.phase",
"short" : "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.phase",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPhase"
}],
"strength" : "example",
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Phase"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.phaseCode"
}]
},
{
"id" : "ResearchStudy.category",
"path" : "ResearchStudy.category",
"short" : "Classifications for the study",
"definition" : "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.category",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyCategory"
}],
"strength" : "example",
"description" : "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
}]
},
{
"id" : "ResearchStudy.focus",
"path" : "ResearchStudy.focus",
"short" : "Drugs, devices, etc. under study",
"definition" : "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.focus",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.focus.id",
"path" : "ResearchStudy.focus.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.focus.extension",
"path" : "ResearchStudy.focus.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.focus.modifierExtension",
"path" : "ResearchStudy.focus.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.focus.productCode",
"path" : "ResearchStudy.focus.productCode",
"short" : "Identification of product under study",
"definition" : "Identification of product under study. This may be any combination of code and/or name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.focus.productCode",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocus"
}],
"strength" : "example",
"description" : "Codes for medications, devices and other interventions."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Focus of Study"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionTypeCode"
}]
},
{
"id" : "ResearchStudy.focus.focusType",
"path" : "ResearchStudy.focus.focusType",
"short" : "medication | device | intervention | factor",
"definition" : "Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristic.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.focus.focusType",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocusType"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-focus-type"
}
},
{
"id" : "ResearchStudy.focus.factor",
"path" : "ResearchStudy.focus.factor",
"short" : "An independent variable manipulated by the experimentalist",
"definition" : "A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assay.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.focus.factor",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.condition",
"path" : "ResearchStudy.condition",
"short" : "Condition being studied",
"definition" : "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.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.condition",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ConditionCode"
}],
"strength" : "example",
"description" : "Identification of the condition or diagnosis.",
"valueSet" : "http://hl7.org/fhir/ValueSet/condition-code"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Conditions"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyCondition.code"
}]
},
{
"id" : "ResearchStudy.keyword",
"path" : "ResearchStudy.keyword",
"short" : "Used to search for the study",
"definition" : "Key terms to aid in searching for or filtering the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.keyword",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyKeyword"
}],
"strength" : "example",
"description" : "Words associated with the study that may be useful in discovery."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Keywords"
},
{
"identity" : "BRIDG5.1",
"map" : "DocumentVersion.keywordCode; DocumentVersion.keywordText"
}]
},
{
"id" : "ResearchStudy.location",
"path" : "ResearchStudy.location",
"short" : "Geographic region(s) for study",
"definition" : "Indicates a country, state or other region where the study is taking place.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.location",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "extensible",
"description" : "Countries and regions within which this artifact is targeted for use.",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.participatingLocationCode"
}]
},
{
"id" : "ResearchStudy.descriptionSummary",
"path" : "ResearchStudy.descriptionSummary",
"short" : "A brief summary of the study description",
"definition" : "A brief summary of the study description.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.descriptionSummary",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.description",
"path" : "ResearchStudy.description",
"short" : "What this is study doing",
"definition" : "A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.description.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Detailed Description"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersion.publicDescription"
}]
},
{
"id" : "ResearchStudy.period",
"path" : "ResearchStudy.period",
"short" : "When the study began and ended",
"definition" : "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.period",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Start Date (start); Study Completion Date (end)"
},
{
"identity" : "w5",
"map" : "FiveWs.done[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
},
{
"identity" : "rim",
"map" : ".effectiveTime"
}]
},
{
"id" : "ResearchStudy.contact",
"path" : "ResearchStudy.contact",
"short" : "Contact details for the study",
"definition" : "Contact details to assist a user in learning more about or engaging with the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.contact",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "ContactDetail"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"
},
{
"identity" : "BRIDG5.1",
"map" : "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"
}]
},
{
"id" : "ResearchStudy.sponsor",
"path" : "ResearchStudy.sponsor",
"short" : "Organization that initiates and is legally responsible for the study",
"definition" : "An organization that initiates the investigation and is legally responsible for the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.sponsor",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Sponsor"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"
}]
},
{
"id" : "ResearchStudy.principalInvestigator",
"path" : "ResearchStudy.principalInvestigator",
"short" : "Researcher who oversees multiple aspects of the study",
"definition" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.principalInvestigator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Principal Investigator"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyInvestigator"
}]
},
{
"id" : "ResearchStudy.site",
"path" : "ResearchStudy.site",
"short" : "Facility where study activities are conducted",
"definition" : "A facility in which study activities are conducted.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.site",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Location",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Facility"
},
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "PlannedStudySite; StudySite"
}]
},
{
"id" : "ResearchStudy.note",
"path" : "ResearchStudy.note",
"short" : "Comments made about the study",
"definition" : "Comments made about the study by the performer, subject or other participants.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.note",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Annotation"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping"
},
{
"identity" : "rim",
"map" : ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
}]
},
{
"id" : "ResearchStudy.classification",
"path" : "ResearchStudy.classification",
"short" : "Classification for the study",
"definition" : "Classification for the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.classification",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.classification.id",
"path" : "ResearchStudy.classification.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.classification.extension",
"path" : "ResearchStudy.classification.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.classification.modifierExtension",
"path" : "ResearchStudy.classification.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.classification.type",
"path" : "ResearchStudy.classification.type",
"short" : "phase | category | keyword ",
"definition" : "Type of classifier.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.classification.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyCLassificationType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classification-type"
}
},
{
"id" : "ResearchStudy.classification.classifier",
"path" : "ResearchStudy.classification.classifier",
"short" : "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "Value of classifier.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.classification.classifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyClassificationClassifier"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classification-classifier"
}
},
{
"id" : "ResearchStudy.associatedParty",
"path" : "ResearchStudy.associatedParty",
"short" : "Sponsors, collaborators, and other parties",
"definition" : "Sponsors, collaborators, and other parties.",
"comment" : "For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.",
"requirements" : "While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.associatedParty",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.associatedParty.id",
"path" : "ResearchStudy.associatedParty.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.associatedParty.extension",
"path" : "ResearchStudy.associatedParty.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.associatedParty.modifierExtension",
"path" : "ResearchStudy.associatedParty.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.associatedParty.name",
"path" : "ResearchStudy.associatedParty.name",
"short" : "Name of associated party",
"definition" : "Name of associated party.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.associatedParty.name",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.associatedParty.role",
"path" : "ResearchStudy.associatedParty.role",
"short" : "sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair",
"definition" : "Type of association.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.associatedParty.role",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPartyType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-type"
}
},
{
"id" : "ResearchStudy.associatedParty.classifier",
"path" : "ResearchStudy.associatedParty.classifier",
"short" : "nih | fda",
"definition" : "Organisational type of association.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.associatedParty.classifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPartyOrganizationType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-org-type"
}
},
{
"id" : "ResearchStudy.associatedParty.party",
"path" : "ResearchStudy.associatedParty.party",
"short" : "Individual or organization associated with study (use practitionerRole to specify their organisation)",
"definition" : "Individual or organization associated with study (use practitionerRole to specify their organisation).",
"comment" : "Suggestions of a better attribute name are appreciated",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.associatedParty.party",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.currentState",
"path" : "ResearchStudy.currentState",
"short" : "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",
"definition" : "Current status of the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.currentState",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyStudyStatus"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status"
}
},
{
"id" : "ResearchStudy.statusDate",
"path" : "ResearchStudy.statusDate",
"short" : "Status of study with time for that status",
"definition" : "Status of study with time for that status.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.statusDate",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.statusDate.id",
"path" : "ResearchStudy.statusDate.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.statusDate.extension",
"path" : "ResearchStudy.statusDate.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.statusDate.modifierExtension",
"path" : "ResearchStudy.statusDate.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.statusDate.activity",
"path" : "ResearchStudy.statusDate.activity",
"short" : "Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting",
"definition" : "Label for status or state.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.statusDate.activity",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyStatusActivity"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-statusDate-activity"
}
},
{
"id" : "ResearchStudy.statusDate.actual",
"path" : "ResearchStudy.statusDate.actual",
"short" : "Actual if true else anticipated",
"definition" : "Actual if true else anticipated.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.statusDate.actual",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "boolean"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.statusDate.period",
"path" : "ResearchStudy.statusDate.period",
"short" : "Date range",
"definition" : "Date range.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.statusDate.period",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.whyStopped",
"path" : "ResearchStudy.whyStopped",
"short" : "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
"definition" : "A description and/or code explaining the premature termination of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.whyStopped",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyReasonStopped"
}],
"strength" : "example",
"description" : "Codes for why the study ended prematurely.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Why Study Stopped"
},
{
"identity" : "w5",
"map" : "FiveWs.why[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.studyStoppedReasonCode"
}]
},
{
"id" : "ResearchStudy.recruitment",
"path" : "ResearchStudy.recruitment",
"short" : "Target or actual group of participants enrolled in study",
"definition" : "Target or actual group of participants enrolled in study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.recruitment",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=SBJ].role"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}]
},
{
"id" : "ResearchStudy.recruitment.id",
"path" : "ResearchStudy.recruitment.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.recruitment.extension",
"path" : "ResearchStudy.recruitment.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.recruitment.modifierExtension",
"path" : "ResearchStudy.recruitment.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.recruitment.targetNumber",
"path" : "ResearchStudy.recruitment.targetNumber",
"short" : "Estimated total number of participants to be enrolled",
"definition" : "Estimated total number of participants to be enrolled.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.recruitment.targetNumber",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "unsignedInt"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.actualNumber",
"path" : "ResearchStudy.recruitment.actualNumber",
"short" : "Actual total number of participants enrolled in study",
"definition" : "Actual total number of participants enrolled in study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.recruitment.actualNumber",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "unsignedInt"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.eligibility",
"path" : "ResearchStudy.recruitment.eligibility",
"short" : "Inclusion and exclusion criteria",
"definition" : "Inclusion and exclusion criteria.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.recruitment.eligibility",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.actualGroup",
"path" : "ResearchStudy.recruitment.actualGroup",
"short" : "Group of participants who were enrolled in study",
"definition" : "Group of participants who were enrolled in study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.recruitment.actualGroup",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=SBJ].role"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}]
},
{
"id" : "ResearchStudy.comparisonGroup",
"path" : "ResearchStudy.comparisonGroup",
"short" : "Defined path through the study for a subject",
"definition" : "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.",
"comment" : "In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.",
"alias" : ["arm"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.comparisonGroup",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arms"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.id",
"path" : "ResearchStudy.comparisonGroup.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.extension",
"path" : "ResearchStudy.comparisonGroup.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.modifierExtension",
"path" : "ResearchStudy.comparisonGroup.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.identifier[x]",
"path" : "ResearchStudy.comparisonGroup.identifier[x]",
"short" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily",
"definition" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.comparisonGroup.identifier[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
},
{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.comparisonGroup.name",
"path" : "ResearchStudy.comparisonGroup.name",
"short" : "Label for study comparisonGroup",
"definition" : "Unique, human-readable label for this comparisonGroup of the study.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.comparisonGroup.name",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Label"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.name"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.type",
"path" : "ResearchStudy.comparisonGroup.type",
"short" : "Categorization of study comparisonGroup",
"definition" : "Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.comparisonGroup.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyArmType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-arm-type"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Type"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.typeCode"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.description",
"path" : "ResearchStudy.comparisonGroup.description",
"short" : "Short explanation of study path",
"definition" : "A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.comparisonGroup.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Description"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.description"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.intendedExposure",
"path" : "ResearchStudy.comparisonGroup.intendedExposure",
"short" : "Interventions or exposures in this comparisonGroup or cohort",
"definition" : "Interventions or exposures in this comparisonGroup or cohort.",
"requirements" : "this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.comparisonGroup.intendedExposure",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.comparisonGroup.observedGroup",
"path" : "ResearchStudy.comparisonGroup.observedGroup",
"short" : "Group of participants who were enrolled in study comparisonGroup",
"definition" : "Group of participants who were enrolled in study comparisonGroup.",
"requirements" : "This is necessary to relate comparisonGroups to actual groups",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.comparisonGroup.observedGroup",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.objective",
"path" : "ResearchStudy.objective",
"short" : "A goal for the study",
"definition" : "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.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.objective",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyObjective"
}]
},
{
"id" : "ResearchStudy.objective.id",
"path" : "ResearchStudy.objective.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.objective.extension",
"path" : "ResearchStudy.objective.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.objective.modifierExtension",
"path" : "ResearchStudy.objective.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.objective.name",
"path" : "ResearchStudy.objective.name",
"short" : "Label for the objective",
"definition" : "Unique, human-readable label for this objective of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.objective.name",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (BRIDG has a description, but not a name)"
}]
},
{
"id" : "ResearchStudy.objective.type",
"path" : "ResearchStudy.objective.type",
"short" : "primary | secondary | exploratory",
"definition" : "The kind of study objective.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.objective.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyObjectiveType"
}],
"strength" : "preferred",
"description" : "Codes for the kind of study objective.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyObjective.typeCode"
}]
},
{
"id" : "ResearchStudy.objective.description",
"path" : "ResearchStudy.objective.description",
"short" : "Description of the objective",
"definition" : "Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.objective.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure",
"path" : "ResearchStudy.outcomeMeasure",
"short" : "An outcome or planned variable to measure during the study",
"definition" : "An outcome or planned variable to measure during the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.outcomeMeasure",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.id",
"path" : "ResearchStudy.outcomeMeasure.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.outcomeMeasure.extension",
"path" : "ResearchStudy.outcomeMeasure.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.outcomeMeasure.modifierExtension",
"path" : "ResearchStudy.outcomeMeasure.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.outcomeMeasure.name",
"path" : "ResearchStudy.outcomeMeasure.name",
"short" : "Label for the outcome",
"definition" : "Label for the outcome.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.outcomeMeasure.name",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.type",
"path" : "ResearchStudy.outcomeMeasure.type",
"short" : "primary | secondary | exploratory",
"definition" : "The parameter or characteristic being assessed as one of the values by which the study is assessed.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.outcomeMeasure.type",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyObjectiveType"
}],
"strength" : "preferred",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
}
},
{
"id" : "ResearchStudy.outcomeMeasure.description",
"path" : "ResearchStudy.outcomeMeasure.description",
"short" : "Description of the outcome",
"definition" : "Description of the outcome.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.outcomeMeasure.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.reference",
"path" : "ResearchStudy.outcomeMeasure.reference",
"short" : "Structured outcome definition",
"definition" : "Structured outcome definition.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.outcomeMeasure.reference",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.result",
"path" : "ResearchStudy.result",
"short" : "Link to results generated during the study",
"definition" : "Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.result",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceReport",
"http://hl7.org/fhir/StructureDefinition/Citation",
"http://hl7.org/fhir/StructureDefinition/DiagnosticReport"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.webLocation",
"path" : "ResearchStudy.webLocation",
"short" : "Archive location for the study",
"definition" : "A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.webLocation",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.webLocation.id",
"path" : "ResearchStudy.webLocation.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUri" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.webLocation.extension",
"path" : "ResearchStudy.webLocation.extension",
"short" : "Additional content defined by implementations",
"definition" : "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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchStudy.webLocation.modifierExtension",
"path" : "ResearchStudy.webLocation.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"requirements" : "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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchStudy.webLocation.type",
"path" : "ResearchStudy.webLocation.type",
"short" : "registry-page|recruitment-page|contact-page",
"definition" : "Describes the nature of the location being specified.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.webLocation.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyUrlType"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-url-type"
}
},
{
"id" : "ResearchStudy.webLocation.url",
"path" : "ResearchStudy.webLocation.url",
"short" : "The location address",
"definition" : "The location address.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.webLocation.url",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
}]
},
"differential" : {
"element" : [{
"id" : "ResearchStudy",
"path" : "ResearchStudy",
"short" : "Investigation to increase healthcare-related patient-independent knowledge",
"definition" : "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 or stability data about drug products or drug substances.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Clinical Trial",
"Study"],
"min" : 0,
"max" : "*",
"mustSupport" : false,
"isModifier" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity" : "w5",
"map" : "clinical.diagnostics"
}]
},
{
"id" : "ResearchStudy.url",
"path" : "ResearchStudy.url",
"short" : "Canonical identifier for this study resource",
"definition" : "Canonical identifier for this study resource, represented as a globally unique URI.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.identifier",
"path" : "ResearchStudy.identifier",
"short" : "Business Identifier for study",
"definition" : "Identifiers assigned to this research study by the sponsor or other systems.",
"requirements" : "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Organization's Unique Protocol ID; Secondary IDs"
},
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchStudy.version",
"path" : "ResearchStudy.version",
"short" : "Business identifier for the study record",
"definition" : "Business identifier for the study record.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.name",
"path" : "ResearchStudy.name",
"short" : "Name for this study (computer friendly)",
"definition" : "Name for this study (computer friendly).",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.title",
"path" : "ResearchStudy.title",
"short" : "Name for this study (for computers)",
"definition" : "A short, descriptive label for the study particularly for compouter use.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Brief Title"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
}]
},
{
"id" : "ResearchStudy.label",
"path" : "ResearchStudy.label",
"short" : "Additional names for the study",
"definition" : "Additional names for the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.label.type",
"path" : "ResearchStudy.label.type",
"short" : "short | public | scientific",
"definition" : "Kind of name.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyTitleType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-title-type"
}
},
{
"id" : "ResearchStudy.label.value",
"path" : "ResearchStudy.label.value",
"short" : "The name",
"definition" : "The name.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.protocol",
"path" : "ResearchStudy.protocol",
"short" : "Steps followed in executing study",
"definition" : "The set of steps expected to be performed as part of the execution of the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/PlanDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Interventions; Arm/Intervention Cross-Reference"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersionPublicTitle.name"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=DEFN].target"
}]
},
{
"id" : "ResearchStudy.partOf",
"path" : "ResearchStudy.partOf",
"short" : "Part of larger study",
"definition" : "A larger research study of which this particular study is a component or step.",
"requirements" : "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"alias" : ["container"],
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "CompanionStudyRelationship"
},
{
"identity" : "rim",
"map" : ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
}]
},
{
"id" : "ResearchStudy.relatedArtifact",
"path" : "ResearchStudy.relatedArtifact",
"short" : "References and dependencies",
"definition" : "Citations, references and other related documents.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "RelatedArtifact"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Citations, Links, Available Study Data/Documents"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocument, StudyProtocolDocumentVersion"
}]
},
{
"id" : "ResearchStudy.date",
"path" : "ResearchStudy.date",
"short" : "Date the resource last changed",
"definition" : "Date the resource last changed.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.status",
"path" : "ResearchStudy.status",
"short" : "draft | active | retired | unknown",
"definition" : "The publication state of the resource (not of the study).",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "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",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "required",
"description" : "Codes that convey the current publication status of the research study resource.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|4.6.0"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.code"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchStudy.primaryPurposeType",
"path" : "ResearchStudy.primaryPurposeType",
"short" : "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"definition" : "The type of study based upon the intent of the study activities. A classification of the intent of the study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPrimaryPurposeType"
}],
"strength" : "extensible",
"description" : "Codes for the main intent of the study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.primaryPurposeTypeCode"
}]
},
{
"id" : "ResearchStudy.phase",
"path" : "ResearchStudy.phase",
"short" : "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPhase"
}],
"strength" : "example",
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Phase"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.phaseCode"
}]
},
{
"id" : "ResearchStudy.category",
"path" : "ResearchStudy.category",
"short" : "Classifications for the study",
"definition" : "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyCategory"
}],
"strength" : "example",
"description" : "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
}]
},
{
"id" : "ResearchStudy.focus",
"path" : "ResearchStudy.focus",
"short" : "Drugs, devices, etc. under study",
"definition" : "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.focus.productCode",
"path" : "ResearchStudy.focus.productCode",
"short" : "Identification of product under study",
"definition" : "Identification of product under study. This may be any combination of code and/or name.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocus"
}],
"strength" : "example",
"description" : "Codes for medications, devices and other interventions."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Focus of Study"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionTypeCode"
}]
},
{
"id" : "ResearchStudy.focus.focusType",
"path" : "ResearchStudy.focus.focusType",
"short" : "medication | device | intervention | factor",
"definition" : "Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristic.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocusType"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-focus-type"
}
},
{
"id" : "ResearchStudy.focus.factor",
"path" : "ResearchStudy.focus.factor",
"short" : "An independent variable manipulated by the experimentalist",
"definition" : "A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assay.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.condition",
"path" : "ResearchStudy.condition",
"short" : "Condition being studied",
"definition" : "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.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ConditionCode"
}],
"strength" : "example",
"description" : "Identification of the condition or diagnosis.",
"valueSet" : "http://hl7.org/fhir/ValueSet/condition-code"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Conditions"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyCondition.code"
}]
},
{
"id" : "ResearchStudy.keyword",
"path" : "ResearchStudy.keyword",
"short" : "Used to search for the study",
"definition" : "Key terms to aid in searching for or filtering the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyKeyword"
}],
"strength" : "example",
"description" : "Words associated with the study that may be useful in discovery."
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Keywords"
},
{
"identity" : "BRIDG5.1",
"map" : "DocumentVersion.keywordCode; DocumentVersion.keywordText"
}]
},
{
"id" : "ResearchStudy.location",
"path" : "ResearchStudy.location",
"short" : "Geographic region(s) for study",
"definition" : "Indicates a country, state or other region where the study is taking place.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "extensible",
"description" : "Countries and regions within which this artifact is targeted for use.",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.participatingLocationCode"
}]
},
{
"id" : "ResearchStudy.descriptionSummary",
"path" : "ResearchStudy.descriptionSummary",
"short" : "A brief summary of the study description",
"definition" : "A brief summary of the study description.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.description",
"path" : "ResearchStudy.description",
"short" : "What this is study doing",
"definition" : "A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.description.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Detailed Description"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersion.publicDescription"
}]
},
{
"id" : "ResearchStudy.period",
"path" : "ResearchStudy.period",
"short" : "When the study began and ended",
"definition" : "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Study Start Date (start); Study Completion Date (end)"
},
{
"identity" : "w5",
"map" : "FiveWs.done[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
},
{
"identity" : "rim",
"map" : ".effectiveTime"
}]
},
{
"id" : "ResearchStudy.contact",
"path" : "ResearchStudy.contact",
"short" : "Contact details for the study",
"definition" : "Contact details to assist a user in learning more about or engaging with the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "ContactDetail"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"
},
{
"identity" : "BRIDG5.1",
"map" : "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"
}]
},
{
"id" : "ResearchStudy.sponsor",
"path" : "ResearchStudy.sponsor",
"short" : "Organization that initiates and is legally responsible for the study",
"definition" : "An organization that initiates the investigation and is legally responsible for the study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Sponsor"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"
}]
},
{
"id" : "ResearchStudy.principalInvestigator",
"path" : "ResearchStudy.principalInvestigator",
"short" : "Researcher who oversees multiple aspects of the study",
"definition" : "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.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Principal Investigator"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyInvestigator"
}]
},
{
"id" : "ResearchStudy.site",
"path" : "ResearchStudy.site",
"short" : "Facility where study activities are conducted",
"definition" : "A facility in which study activities are conducted.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Location",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Facility"
},
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "PlannedStudySite; StudySite"
}]
},
{
"id" : "ResearchStudy.note",
"path" : "ResearchStudy.note",
"short" : "Comments made about the study",
"definition" : "Comments made about the study by the performer, subject or other participants.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Annotation"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping"
},
{
"identity" : "rim",
"map" : ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
}]
},
{
"id" : "ResearchStudy.classification",
"path" : "ResearchStudy.classification",
"short" : "Classification for the study",
"definition" : "Classification for the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.classification.type",
"path" : "ResearchStudy.classification.type",
"short" : "phase | category | keyword ",
"definition" : "Type of classifier.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyCLassificationType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classification-type"
}
},
{
"id" : "ResearchStudy.classification.classifier",
"path" : "ResearchStudy.classification.classifier",
"short" : "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "Value of classifier.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyClassificationClassifier"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classification-classifier"
}
},
{
"id" : "ResearchStudy.associatedParty",
"path" : "ResearchStudy.associatedParty",
"short" : "Sponsors, collaborators, and other parties",
"definition" : "Sponsors, collaborators, and other parties.",
"comment" : "For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.",
"requirements" : "While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.associatedParty.name",
"path" : "ResearchStudy.associatedParty.name",
"short" : "Name of associated party",
"definition" : "Name of associated party.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.associatedParty.role",
"path" : "ResearchStudy.associatedParty.role",
"short" : "sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair",
"definition" : "Type of association.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPartyType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-type"
}
},
{
"id" : "ResearchStudy.associatedParty.classifier",
"path" : "ResearchStudy.associatedParty.classifier",
"short" : "nih | fda",
"definition" : "Organisational type of association.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPartyOrganizationType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-org-type"
}
},
{
"id" : "ResearchStudy.associatedParty.party",
"path" : "ResearchStudy.associatedParty.party",
"short" : "Individual or organization associated with study (use practitionerRole to specify their organisation)",
"definition" : "Individual or organization associated with study (use practitionerRole to specify their organisation).",
"comment" : "Suggestions of a better attribute name are appreciated",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.currentState",
"path" : "ResearchStudy.currentState",
"short" : "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",
"definition" : "Current status of the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyStudyStatus"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status"
}
},
{
"id" : "ResearchStudy.statusDate",
"path" : "ResearchStudy.statusDate",
"short" : "Status of study with time for that status",
"definition" : "Status of study with time for that status.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.statusDate.activity",
"path" : "ResearchStudy.statusDate.activity",
"short" : "Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting",
"definition" : "Label for status or state.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyStatusActivity"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-statusDate-activity"
}
},
{
"id" : "ResearchStudy.statusDate.actual",
"path" : "ResearchStudy.statusDate.actual",
"short" : "Actual if true else anticipated",
"definition" : "Actual if true else anticipated.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "boolean"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.statusDate.period",
"path" : "ResearchStudy.statusDate.period",
"short" : "Date range",
"definition" : "Date range.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.whyStopped",
"path" : "ResearchStudy.whyStopped",
"short" : "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
"definition" : "A description and/or code explaining the premature termination of the study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyReasonStopped"
}],
"strength" : "example",
"description" : "Codes for why the study ended prematurely.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Why Study Stopped"
},
{
"identity" : "w5",
"map" : "FiveWs.why[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.studyStoppedReasonCode"
}]
},
{
"id" : "ResearchStudy.recruitment",
"path" : "ResearchStudy.recruitment",
"short" : "Target or actual group of participants enrolled in study",
"definition" : "Target or actual group of participants enrolled in study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=SBJ].role"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}]
},
{
"id" : "ResearchStudy.recruitment.targetNumber",
"path" : "ResearchStudy.recruitment.targetNumber",
"short" : "Estimated total number of participants to be enrolled",
"definition" : "Estimated total number of participants to be enrolled.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "unsignedInt"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.actualNumber",
"path" : "ResearchStudy.recruitment.actualNumber",
"short" : "Actual total number of participants enrolled in study",
"definition" : "Actual total number of participants enrolled in study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "unsignedInt"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.eligibility",
"path" : "ResearchStudy.recruitment.eligibility",
"short" : "Inclusion and exclusion criteria",
"definition" : "Inclusion and exclusion criteria.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.recruitment.actualGroup",
"path" : "ResearchStudy.recruitment.actualGroup",
"short" : "Group of participants who were enrolled in study",
"definition" : "Group of participants who were enrolled in study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=SBJ].role"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}]
},
{
"id" : "ResearchStudy.comparisonGroup",
"path" : "ResearchStudy.comparisonGroup",
"short" : "Defined path through the study for a subject",
"definition" : "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.",
"comment" : "In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.",
"alias" : ["arm"],
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arms"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.identifier[x]",
"path" : "ResearchStudy.comparisonGroup.identifier[x]",
"short" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily",
"definition" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "uri"
},
{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.comparisonGroup.name",
"path" : "ResearchStudy.comparisonGroup.name",
"short" : "Label for study comparisonGroup",
"definition" : "Unique, human-readable label for this comparisonGroup of the study.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Label"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.name"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.type",
"path" : "ResearchStudy.comparisonGroup.type",
"short" : "Categorization of study comparisonGroup",
"definition" : "Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyArmType"
}],
"strength" : "extensible",
"description" : "desc.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-arm-type"
},
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Type"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.typeCode"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.description",
"path" : "ResearchStudy.comparisonGroup.description",
"short" : "Short explanation of study path",
"definition" : "A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "clinicaltrials-gov",
"map" : "Arm Description"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.description"
}]
},
{
"id" : "ResearchStudy.comparisonGroup.intendedExposure",
"path" : "ResearchStudy.comparisonGroup.intendedExposure",
"short" : "Interventions or exposures in this comparisonGroup or cohort",
"definition" : "Interventions or exposures in this comparisonGroup or cohort.",
"requirements" : "this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.comparisonGroup.observedGroup",
"path" : "ResearchStudy.comparisonGroup.observedGroup",
"short" : "Group of participants who were enrolled in study comparisonGroup",
"definition" : "Group of participants who were enrolled in study comparisonGroup.",
"requirements" : "This is necessary to relate comparisonGroups to actual groups",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.objective",
"path" : "ResearchStudy.objective",
"short" : "A goal for the study",
"definition" : "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.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyObjective"
}]
},
{
"id" : "ResearchStudy.objective.name",
"path" : "ResearchStudy.objective.name",
"short" : "Label for the objective",
"definition" : "Unique, human-readable label for this objective of the study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (BRIDG has a description, but not a name)"
}]
},
{
"id" : "ResearchStudy.objective.type",
"path" : "ResearchStudy.objective.type",
"short" : "primary | secondary | exploratory",
"definition" : "The kind of study objective.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyObjectiveType"
}],
"strength" : "preferred",
"description" : "Codes for the kind of study objective.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
},
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudyObjective.typeCode"
}]
},
{
"id" : "ResearchStudy.objective.description",
"path" : "ResearchStudy.objective.description",
"short" : "Description of the objective",
"definition" : "Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure",
"path" : "ResearchStudy.outcomeMeasure",
"short" : "An outcome or planned variable to measure during the study",
"definition" : "An outcome or planned variable to measure during the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.name",
"path" : "ResearchStudy.outcomeMeasure.name",
"short" : "Label for the outcome",
"definition" : "Label for the outcome.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.type",
"path" : "ResearchStudy.outcomeMeasure.type",
"short" : "primary | secondary | exploratory",
"definition" : "The parameter or characteristic being assessed as one of the values by which the study is assessed.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyObjectiveType"
}],
"strength" : "preferred",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
}
},
{
"id" : "ResearchStudy.outcomeMeasure.description",
"path" : "ResearchStudy.outcomeMeasure.description",
"short" : "Description of the outcome",
"definition" : "Description of the outcome.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.outcomeMeasure.reference",
"path" : "ResearchStudy.outcomeMeasure.reference",
"short" : "Structured outcome definition",
"definition" : "Structured outcome definition.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.result",
"path" : "ResearchStudy.result",
"short" : "Link to results generated during the study",
"definition" : "Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceReport",
"http://hl7.org/fhir/StructureDefinition/Citation",
"http://hl7.org/fhir/StructureDefinition/DiagnosticReport"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.webLocation",
"path" : "ResearchStudy.webLocation",
"short" : "Archive location for the study",
"definition" : "A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchStudy.webLocation.type",
"path" : "ResearchStudy.webLocation.type",
"short" : "registry-page|recruitment-page|contact-page",
"definition" : "Describes the nature of the location being specified.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyUrlType"
}],
"strength" : "extensible",
"description" : "defn.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-url-type"
}
},
{
"id" : "ResearchStudy.webLocation.url",
"path" : "ResearchStudy.webLocation.url",
"short" : "The location address",
"definition" : "The location address.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
}]
}
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 Draft Ballot hl7.fhir.core#4.6.0 generated on Thu, Apr 15, 2021 12:29+1000.
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