{
"description": "Profil de ResearchStudy pour le projet ECLAIRE",
"_filename": "StructureDefinition-eclaire-researchstudy.json",
"package_name": "ans.fhir.fr.eclaire",
"date": "2023-10-24T08:16:05+00:00",
"derivation": "constraint",
"publisher": "ANS",
"fhirVersion": "4.0.1",
"jurisdiction": [ {
"coding": [ {
"code": "FR",
"system": "urn:iso:std:iso:3166",
"display": "FRANCE"
} ]
} ],
"name": "ECLAIREResearchStudy",
"mapping": [ {
"uri": "https://bridgmodel.nci.nih.gov",
"name": "BRIDG 5.1 Mapping",
"identity": "BRIDG5.1"
}, {
"uri": "http://hl7.org/v2",
"name": "HL7 v2 Mapping",
"identity": "v2"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
}, {
"uri": "http://clinicaltrials.gov",
"name": "ClinicalTrials.gov Mapping",
"identity": "clinicaltrials-gov"
}, {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
} ],
"abstract": false,
"type": "ResearchStudy",
"experimental": null,
"resourceType": "StructureDefinition",
"title": null,
"package_version": "0.2.0",
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"xpath": "not(parent::f:contained and f:contained)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"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",
"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",
"severity": "error",
"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()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"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",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"xpath": "not(exists(f:contained/*/f:meta/f:security))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"xpath": "exists(f:text/h:div)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"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."
} ],
"expression": "text.`div`.exists()"
} ],
"path": "ResearchStudy",
"min": 0,
"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.",
"isModifier": false,
"short": "Investigation to increase healthcare-related patient-independent knowledge",
"mapping": [ {
"map": "Entity. Role, or Act",
"identity": "rim"
}, {
"map": "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion",
"identity": "BRIDG5.1"
}, {
"map": "OBX",
"identity": "v2"
}, {
"map": "Observation[classCode=CLNTRL, moodCode=EVN]",
"identity": "rim"
} ],
"alias": [ "Clinical Trial", "Study" ],
"max": "*",
"id": "ResearchStudy",
"comment": "Need to make sure we encompass public health studies.",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy"
},
"isSummary": false
}, {
"path": "ResearchStudy.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"isModifier": false,
"short": "Logical id of this artifact",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"max": "1",
"id": "ResearchStudy.id",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.meta",
"min": 0,
"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.",
"isModifier": false,
"short": "Metadata about the resource",
"type": [ {
"code": "Meta"
} ],
"max": "1",
"id": "ResearchStudy.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.implicitRules",
"min": 0,
"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.",
"isModifier": true,
"short": "A set of rules under which this content was created",
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ResearchStudy.implicitRules",
"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.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.implicitRules"
},
"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
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/languages",
"extension": [ {
"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
} ],
"description": "A human language."
},
"max": "1",
"id": "ResearchStudy.language",
"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).",
"base": {
"max": "1",
"min": 0,
"path": "Resource.language"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.text",
"min": 0,
"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.",
"isModifier": false,
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "ResearchStudy.text",
"comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"base": {
"max": "1",
"min": 0,
"path": "DomainResource.text"
},
"isSummary": false
}, {
"path": "ResearchStudy.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"isModifier": false,
"short": "Contained, inline Resources",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "ResearchStudy.contained",
"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.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.contained"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "*",
"id": "ResearchStudy.extension",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout d'une date de révision fonctionnelle lorque que l'on souhaite indiquer la date de la dernière modification substancielle",
"isModifier": false,
"short": "Date de dernière modification substancielle",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-review-date",
"max": "1",
"id": "ResearchStudy.extension:eclaire-review-date",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout du domaine thérapeutique concerné par l'essai",
"isModifier": false,
"short": "Domaine thérapeutique concerné",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-therapeutic-area",
"max": "1",
"id": "ResearchStudy.extension:eclaire-therapeutic-area",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de la période prévisionnelle de recrutement l'essai",
"isModifier": false,
"short": "Période prévisionnelle de recrutement",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-recruitment-period",
"max": "1",
"id": "ResearchStudy.extension:eclaire-recruitment-period",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet API ECLAIRE afin de pouvoir renseigner le(s) promoteur(s) secondaire(s)",
"isModifier": false,
"short": "Promoteur(s) secondaire(s) / Secondary Sponsor(s)",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-secondary-sponsor",
"max": "*",
"id": "ResearchStudy.extension:eclaire-secondary-sponsor",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de plusieurs titres pour l'essai",
"isModifier": false,
"short": "autres titres et acronyme / Additional names for the study",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-label",
"max": "*",
"id": "ResearchStudy.extension:eclaire-label",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
}
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.modifierExtension",
"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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).",
"min": 0,
"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).",
"isModifier": true,
"short": "Extensions that cannot be ignored",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.modifierExtension",
"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.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier",
"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,
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"isModifier": false,
"short": "Business Identifier for study",
"mapping": [ {
"map": "Organization's Unique Protocol ID; Secondary IDs",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
}, {
"map": "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)",
"identity": "BRIDG5.1"
}, {
"map": ".identifier",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Slicing pour les différents identifiants de l'essai clinique",
"discriminator": [ {
"path": "use",
"type": "value"
} ]
},
"type": [ {
"code": "Identifier"
} ],
"max": "*",
"id": "ResearchStudy.identifier",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier",
"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,
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"isModifier": false,
"short": "Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number",
"mapping": [ {
"map": "Organization's Unique Protocol ID; Secondary IDs",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
}, {
"map": "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)",
"identity": "BRIDG5.1"
}, {
"map": ".identifier",
"identity": "rim"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": true,
"sliceName": "idPrimary",
"max": "1",
"id": "ResearchStudy.identifier:idPrimary",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.identifier"
},
"isSummary": true
}, {
"path": "ResearchStudy.identifier.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.identifier.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.identifier:idPrimary.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.use",
"requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min": 1,
"definition": "The purpose of this identifier.",
"isModifier": true,
"short": "usual | official | temp | secondary | old (If known)",
"mapping": [ {
"map": "N/A",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"patternCode": "official",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-use|4.0.1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierUse"
} ],
"description": "Identifies the purpose for this identifier, if known ."
},
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.use",
"comment": "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.use"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.type",
"requirements": "Allows users to make use of identifiers when the identifier system is not known.",
"min": 0,
"definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"isModifier": false,
"short": "Description of identifier",
"mapping": [ {
"map": "CX.5",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierType"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."
},
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.type",
"comment": "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.system",
"requirements": "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
"min": 0,
"definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
"isModifier": false,
"short": "The namespace for the identifier value",
"mapping": [ {
"map": "CX.4 / EI-2-4",
"identity": "v2"
}, {
"map": "II.root or Role.id.root",
"identity": "rim"
}, {
"map": "./IdentifierType",
"identity": "servd"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.system",
"comment": "Identifier.system is always case sensitive.",
"example": [ {
"label": "General",
"valueUri": "http://www.acme.com/identifiers/patient"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.value",
"min": 0,
"definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"isModifier": false,
"short": "The value that is unique",
"mapping": [ {
"map": "CX.1 / EI.1",
"identity": "v2"
}, {
"map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
"identity": "rim"
}, {
"map": "./Value",
"identity": "servd"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.value",
"comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.",
"example": [ {
"label": "General",
"valueString": "123456"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.period",
"min": 0,
"definition": "Time period during which identifier is/was valid for use.",
"isModifier": false,
"short": "Time period when id is/was valid for use",
"mapping": [ {
"map": "CX.7 + CX.8",
"identity": "v2"
}, {
"map": "Role.effectiveTime or implied by context",
"identity": "rim"
}, {
"map": "./StartDate and ./EndDate",
"identity": "servd"
} ],
"type": [ {
"code": "Period"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.period",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.period"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.assigner",
"min": 0,
"definition": "Organization that issued/manages the identifier.",
"isModifier": false,
"short": "Organization that issued id (may be just text)",
"mapping": [ {
"map": "CX.4 / (CX.4,CX.9,CX.10)",
"identity": "v2"
}, {
"map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper",
"identity": "rim"
}, {
"map": "./IdentifierIssuingAuthority",
"identity": "servd"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"max": "1",
"id": "ResearchStudy.identifier:idPrimary.assigner",
"comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.assigner"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier",
"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,
"definition": "Identifiers assigned to this research study by the sponsor or other systems.",
"isModifier": false,
"short": "identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.",
"mapping": [ {
"map": "Organization's Unique Protocol ID; Secondary IDs",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
}, {
"map": "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)",
"identity": "BRIDG5.1"
}, {
"map": ".identifier",
"identity": "rim"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": true,
"sliceName": "idSecondary",
"max": "*",
"id": "ResearchStudy.identifier:idSecondary",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.identifier"
},
"isSummary": true
}, {
"path": "ResearchStudy.identifier.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.identifier.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.identifier:idSecondary.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.use",
"requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min": 1,
"definition": "The purpose of this identifier.",
"isModifier": true,
"short": "usual | official | temp | secondary | old (If known)",
"mapping": [ {
"map": "N/A",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"patternCode": "secondary",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-use|4.0.1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierUse"
} ],
"description": "Identifies the purpose for this identifier, if known ."
},
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.use",
"comment": "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.use"
},
"isModifierReason": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.type",
"requirements": "Allows users to make use of identifiers when the identifier system is not known.",
"min": 0,
"definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"isModifier": false,
"short": "Description of identifier",
"mapping": [ {
"map": "CX.5",
"identity": "v2"
}, {
"map": "Role.code or implied by context",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/identifier-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "IdentifierType"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."
},
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.type",
"comment": "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.system",
"requirements": "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
"min": 0,
"definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
"isModifier": false,
"short": "The namespace for the identifier value",
"mapping": [ {
"map": "CX.4 / EI-2-4",
"identity": "v2"
}, {
"map": "II.root or Role.id.root",
"identity": "rim"
}, {
"map": "./IdentifierType",
"identity": "servd"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.system",
"comment": "Identifier.system is always case sensitive.",
"example": [ {
"label": "General",
"valueUri": "http://www.acme.com/identifiers/patient"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.system"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.value",
"min": 0,
"definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"isModifier": false,
"short": "The value that is unique",
"mapping": [ {
"map": "CX.1 / EI.1",
"identity": "v2"
}, {
"map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
"identity": "rim"
}, {
"map": "./Value",
"identity": "servd"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.value",
"comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.",
"example": [ {
"label": "General",
"valueString": "123456"
} ],
"base": {
"max": "1",
"min": 0,
"path": "Identifier.value"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.period",
"min": 0,
"definition": "Time period during which identifier is/was valid for use.",
"isModifier": false,
"short": "Time period when id is/was valid for use",
"mapping": [ {
"map": "CX.7 + CX.8",
"identity": "v2"
}, {
"map": "Role.effectiveTime or implied by context",
"identity": "rim"
}, {
"map": "./StartDate and ./EndDate",
"identity": "servd"
} ],
"type": [ {
"code": "Period"
} ],
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.period",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.period"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.identifier.assigner",
"min": 0,
"definition": "Organization that issued/manages the identifier.",
"isModifier": false,
"short": "Organization that issued id (may be just text)",
"mapping": [ {
"map": "CX.4 / (CX.4,CX.9,CX.10)",
"identity": "v2"
}, {
"map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper",
"identity": "rim"
}, {
"map": "./IdentifierIssuingAuthority",
"identity": "servd"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"max": "1",
"id": "ResearchStudy.identifier:idSecondary.assigner",
"comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
"base": {
"max": "1",
"min": 0,
"path": "Identifier.assigner"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.title",
"min": 0,
"definition": "A short, descriptive user-friendly label for the study.",
"isModifier": false,
"short": "Nom scientifique de l'étude / Scientific Title",
"mapping": [ {
"map": "Brief Title",
"identity": "clinicaltrials-gov"
}, {
"map": "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "ResearchStudy.title",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.title"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.protocol",
"min": 0,
"definition": "The set of steps expected to be performed as part of the execution of the study.",
"isModifier": false,
"short": "Steps followed in executing study",
"mapping": [ {
"map": "Interventions; Arm/Intervention Cross-Reference",
"identity": "clinicaltrials-gov"
}, {
"map": "StudyProtocolDocumentVersionPublicTitle.name",
"identity": "BRIDG5.1"
}, {
"map": ".outboundRelationship[typeCode=DEFN].target",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/PlanDefinition" ]
} ],
"max": "*",
"id": "ResearchStudy.protocol",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.protocol"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.partOf",
"requirements": "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"min": 0,
"definition": "A larger research study of which this particular study is a component or step.",
"isModifier": false,
"short": "Part of larger study",
"mapping": [ {
"map": "CompanionStudyRelationship",
"identity": "BRIDG5.1"
}, {
"map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ]
} ],
"alias": [ "container" ],
"max": "*",
"id": "ResearchStudy.partOf",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.partOf"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.status",
"min": 1,
"definition": "The current state of the study.",
"isModifier": true,
"short": "Statut de l'essai / Study Status",
"mapping": [ {
"map": "FiveWs.status",
"identity": "w5"
}, {
"map": "StudyOverallStatus.code",
"identity": "BRIDG5.1"
}, {
"map": ".status",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-status|4.0.1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyStatus"
} ],
"description": "Codes that convey the current status of the research study."
},
"max": "1",
"id": "ResearchStudy.status",
"base": {
"max": "1",
"min": 1,
"path": "ResearchStudy.status"
},
"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
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.primaryPurposeType",
"min": 0,
"definition": "The type of study based upon the intent of the study's activities. A classification of the intent of the study.",
"isModifier": false,
"short": "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"mapping": [ {
"map": "StudyProtocolVersion.primaryPurposeTypeCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyPrimaryPurposeType"
} ],
"description": "Codes for the main intent of the study."
},
"max": "1",
"id": "ResearchStudy.primaryPurposeType",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.primaryPurposeType"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.phase",
"min": 0,
"definition": "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"isModifier": false,
"short": "Phase de l'essai / Study type : phase",
"mapping": [ {
"map": "Study Phase",
"identity": "clinicaltrials-gov"
}, {
"map": "StudyProtocolVersion.phaseCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "extensible",
"valueSet": "https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs"
},
"max": "1",
"id": "ResearchStudy.phase",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.phase"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.category",
"min": 0,
"definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"isModifier": false,
"short": "Type d'essai / Study type : type of study",
"mapping": [ {
"map": "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention",
"identity": "clinicaltrials-gov"
}, {
"map": "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "extensible",
"valueSet": "https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs"
},
"max": "*",
"id": "ResearchStudy.category",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.category"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.focus",
"min": 0,
"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.",
"isModifier": false,
"short": "Drugs, devices, etc. under study",
"mapping": [ {
"map": "Focus of Study",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": "InterventionalStudyProtocol.interventionTypeCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "example",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyFocus"
} ],
"description": "Codes for medications, devices and other interventions."
},
"max": "*",
"id": "ResearchStudy.focus",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.focus"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition",
"min": 0,
"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.",
"isModifier": false,
"short": "Sujet concerné / Problem(s) Studied exemple code MedDRA",
"mapping": [ {
"map": "Conditions",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": "StudyCondition.code",
"identity": "BRIDG5.1"
} ],
"slicing": {
"rules": "open",
"description": "Slicing pour apporter des précisions sur le sujet / Health Condition(s) or Problem(s) Studied. Dans le CTIS, il y a un champ texte ouvert (obligatoire) pour indiquer la pathologie et éventuellement des précisons. Un code MedDRA peut-être ajouté mais il est optionnel.\nAinsi la slice medDRACondition contient un code meddra, la slice diseaseCondition contient un texte libre. "
},
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/condition-code",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ConditionCode"
} ],
"description": "Identification of the condition or diagnosis."
},
"max": "*",
"id": "ResearchStudy.condition",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.condition"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition",
"min": 0,
"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.",
"isModifier": false,
"short": "code MedDRA / MedDRA condition",
"mapping": [ {
"map": "Conditions",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": "StudyCondition.code",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "medDRACondition",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/condition-code",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ConditionCode"
} ],
"description": "Identification of the condition or diagnosis."
},
"max": "*",
"id": "ResearchStudy.condition:medDRACondition",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.condition"
},
"isSummary": true
}, {
"path": "ResearchStudy.condition.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"patternString": "meddra-condition",
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.condition.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.condition:medDRACondition.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "ResearchStudy.condition:medDRACondition.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"path": "ResearchStudy.condition.coding.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.condition.coding.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.condition:medDRACondition.coding.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding.system",
"requirements": "Need to be unambiguous about the source of the definition of the symbol.",
"min": 0,
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"isModifier": false,
"short": "Identity of the terminology system",
"mapping": [ {
"map": "C*E.3",
"identity": "v2"
}, {
"map": "./codeSystem",
"identity": "rim"
}, {
"map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
"identity": "orim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.system",
"comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.system"
},
"patternUri": "http://terminology.hl7.org/CodeSystem/mdr",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding.version",
"min": 0,
"definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"isModifier": false,
"short": "Version of the system - if relevant",
"mapping": [ {
"map": "C*E.7",
"identity": "v2"
}, {
"map": "./codeSystemVersion",
"identity": "rim"
}, {
"map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.version",
"comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding.code",
"requirements": "Need to refer to a particular code in the system.",
"min": 0,
"definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"isModifier": false,
"short": "Symbol in syntax defined by the system",
"mapping": [ {
"map": "C*E.1",
"identity": "v2"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
"identity": "orim"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.code",
"base": {
"max": "1",
"min": 0,
"path": "Coding.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding.display",
"requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min": 0,
"definition": "A representation of the meaning of the code in the system, following the rules of the system.",
"isModifier": false,
"short": "Representation defined by the system",
"mapping": [ {
"map": "C*E.2 - but note this is not well followed",
"identity": "v2"
}, {
"map": "CV.displayName",
"identity": "rim"
}, {
"map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.display",
"base": {
"max": "1",
"min": 0,
"path": "Coding.display"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding.userSelected",
"requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min": 0,
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"isModifier": false,
"short": "If this coding was chosen directly by the user",
"mapping": [ {
"map": "Sometimes implied by being first",
"identity": "v2"
}, {
"map": "CD.codingRationale",
"identity": "rim"
}, {
"map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]",
"identity": "orim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.coding.userSelected",
"comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.userSelected"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ResearchStudy.condition:medDRACondition.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition",
"min": 0,
"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.",
"isModifier": false,
"short": "condition de la pathologie / Disease Condition",
"mapping": [ {
"map": "Conditions",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": "StudyCondition.code",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"sliceName": "diseaseCondition",
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/condition-code",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ConditionCode"
} ],
"description": "Identification of the condition or diagnosis."
},
"max": "*",
"id": "ResearchStudy.condition:diseaseCondition",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.condition"
},
"isSummary": true
}, {
"path": "ResearchStudy.condition.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"patternString": "disease-condition",
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.condition:diseaseCondition.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.condition.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.condition:diseaseCondition.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "ResearchStudy.condition:diseaseCondition.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.condition.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 1,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "ResearchStudy.condition:diseaseCondition.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.contact",
"min": 0,
"definition": "Contact details to assist a user in learning more about or engaging with the study.",
"isModifier": false,
"short": "Contact (Contact for public / scientific queries)",
"mapping": [ {
"map": "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators",
"identity": "clinicaltrials-gov"
}, {
"map": "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "ContactDetail"
} ],
"mustSupport": true,
"max": "*",
"id": "ResearchStudy.contact",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.contact"
},
"isSummary": true
}, {
"path": "ResearchStudy.contact.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.contact.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.contact.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.contact.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.contact.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet ECLAIRE qui indique le type de Contact : Public ou Scientific",
"isModifier": false,
"short": "Type de contact : Public ou Scientific",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-contact-type",
"max": "1",
"id": "ResearchStudy.contact.extension:eclaire-contact-type",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.contact.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet ECLAIRE pour indiquer l'adresse du contact",
"isModifier": false,
"short": "Adresse du contact",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-contact-address",
"max": "1",
"id": "ResearchStudy.contact.extension:eclaire-contact-address",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.contact.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet ECLAIRE pour indiquer l'affiliation du contact",
"isModifier": false,
"short": "Affiliation du contact",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation" ]
} ],
"mustSupport": true,
"sliceName": "eclaire-contact-affiliation",
"max": "1",
"id": "ResearchStudy.contact.extension:eclaire-contact-affiliation",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.contact.extension",
"min": 0,
"definition": "Extension créée dans le cadre du projet ECLAIRE pour indiquer le nom de contact",
"isModifier": false,
"short": "Nom du contact",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name" ]
} ],
"sliceName": "eclaire-contact-name",
"max": "1",
"id": "ResearchStudy.contact.extension:eclaire-contact-name",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.contact.name",
"min": 0,
"definition": "The name of an individual to contact.",
"isModifier": false,
"short": "Name of an individual to contact",
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.contact.name",
"comment": "If there is no named individual, the telecom information is for the organization as a whole.",
"base": {
"max": "1",
"min": 0,
"path": "ContactDetail.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.contact.telecom",
"min": 0,
"definition": "The contact details for the individual (if a name was provided) or the organization.",
"isModifier": false,
"short": "Contact details for individual or organization",
"type": [ {
"code": "ContactPoint"
} ],
"max": "*",
"id": "ResearchStudy.contact.telecom",
"base": {
"max": "*",
"min": 0,
"path": "ContactDetail.telecom"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.relatedArtifact",
"min": 0,
"definition": "Citations, references and other related documents.",
"isModifier": false,
"short": "References and dependencies",
"mapping": [ {
"map": "Citations, Links, Available Study Data/Documents",
"identity": "clinicaltrials-gov"
}, {
"map": "StudyProtocolDocument, StudyProtocolDocumentVersion",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "RelatedArtifact"
} ],
"max": "*",
"id": "ResearchStudy.relatedArtifact",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.relatedArtifact"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.keyword",
"min": 0,
"definition": "Key terms to aid in searching for or filtering the study.",
"isModifier": false,
"short": "Used to search for the study",
"mapping": [ {
"map": "Keywords",
"identity": "clinicaltrials-gov"
}, {
"map": "DocumentVersion.keywordCode; DocumentVersion.keywordText",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "example",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyKeyword"
} ],
"description": "Words associated with the study that may be useful in discovery."
},
"max": "*",
"id": "ResearchStudy.keyword",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.keyword"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.location",
"min": 0,
"definition": "Indicates a country, state or other region where the study is taking place.",
"isModifier": false,
"short": "Pays de recrutement / Countries of Recruitment",
"mapping": [ {
"map": "StudyProtocolVersion.participatingLocationCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Jurisdiction"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
} ],
"description": "Countries and regions within which this artifact is targeted for use."
},
"max": "*",
"id": "ResearchStudy.location",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.location"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.description",
"min": 0,
"definition": "A full description of how the study is being conducted.",
"isModifier": false,
"short": "Résumé de l'essai / Summary Results",
"mapping": [ {
"map": "Detailed Description",
"identity": "clinicaltrials-gov"
}, {
"map": "StudyProtocolDocumentVersion.publicDescription",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": true,
"max": "1",
"id": "ResearchStudy.description",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.description"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.enrollment",
"min": 0,
"definition": "Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\".",
"isModifier": false,
"short": "Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria",
"mapping": [ {
"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": "clinicaltrials-gov"
}, {
"map": "FiveWs.subject[x]",
"identity": "w5"
}, {
"map": "InterventionalStudyProtocol.interventionGroupQuantity",
"identity": "BRIDG5.1"
}, {
"map": ".participation[typeCode=SBJ].role",
"identity": "rim"
}, {
"map": "FiveWs.subject",
"identity": "w5"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ]
} ],
"mustSupport": true,
"alias": [ "patient" ],
"max": "*",
"id": "ResearchStudy.enrollment",
"comment": "The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.enrollment"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.period",
"min": 0,
"definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"isModifier": false,
"short": "When the study began and ended",
"mapping": [ {
"map": "Study Start Date (start); Study Completion Date (end)",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.done[x]",
"identity": "w5"
}, {
"map": "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration",
"identity": "BRIDG5.1"
}, {
"map": ".effectiveTime",
"identity": "rim"
} ],
"type": [ {
"code": "Period"
} ],
"alias": [ "timing" ],
"max": "1",
"id": "ResearchStudy.period",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.period"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.sponsor",
"min": 0,
"definition": "An organization that initiates the investigation and is legally responsible for the study.",
"isModifier": false,
"short": "Promoteur / primary Sponsor",
"mapping": [ {
"map": "Sponsor",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.actor",
"identity": "w5"
}, {
"map": "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode",
"identity": "BRIDG5.1"
}, {
"map": ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ]
} ],
"mustSupport": true,
"max": "1",
"id": "ResearchStudy.sponsor",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.sponsor"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.principalInvestigator",
"min": 0,
"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.",
"isModifier": false,
"short": "Researcher who oversees multiple aspects of the study",
"mapping": [ {
"map": "Principal Investigator",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.actor",
"identity": "w5"
}, {
"map": "StudyInvestigator",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ]
} ],
"max": "1",
"id": "ResearchStudy.principalInvestigator",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.principalInvestigator"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.site",
"min": 0,
"definition": "A facility in which study activities are conducted.",
"isModifier": false,
"short": "Lieux / Countries of Recruitment",
"mapping": [ {
"map": "Facility",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.where[x]",
"identity": "w5"
}, {
"map": "PlannedStudySite; StudySite",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Location" ]
} ],
"mustSupport": true,
"max": "*",
"id": "ResearchStudy.site",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.site"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.reasonStopped",
"min": 0,
"definition": "A description and/or code explaining the premature termination of the study.",
"isModifier": false,
"short": "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
"mapping": [ {
"map": "Why Study Stopped",
"identity": "clinicaltrials-gov"
}, {
"map": "FiveWs.why[x]",
"identity": "w5"
}, {
"map": "StudyOverallStatus.studyStoppedReasonCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-reason-stopped",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyReasonStopped"
} ],
"description": "Codes for why the study ended prematurely."
},
"max": "1",
"id": "ResearchStudy.reasonStopped",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.reasonStopped"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.note",
"min": 0,
"definition": "Comments made about the study by the performer, subject or other participants.",
"isModifier": false,
"short": "Comments made about the study",
"mapping": [ {
"map": "No BRIDG mapping",
"identity": "BRIDG5.1"
}, {
"map": ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]",
"identity": "rim"
} ],
"type": [ {
"code": "Annotation"
} ],
"max": "*",
"id": "ResearchStudy.note",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.note"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.arm",
"min": 0,
"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.",
"isModifier": false,
"short": "Defined path through the study for a subject",
"mapping": [ {
"map": "Arms",
"identity": "clinicaltrials-gov"
}, {
"map": "Arm",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "ResearchStudy.arm",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.arm"
},
"isSummary": false
}, {
"path": "ResearchStudy.arm.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.arm.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.arm.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.arm.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.arm.modifierExtension",
"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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).",
"min": 0,
"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).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ResearchStudy.arm.modifierExtension",
"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.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.arm.name",
"min": 1,
"definition": "Unique, human-readable label for this arm of the study.",
"isModifier": false,
"short": "Label for study arm",
"mapping": [ {
"map": "Arm Label",
"identity": "clinicaltrials-gov"
}, {
"map": "Arm.name",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.arm.name",
"base": {
"max": "1",
"min": 1,
"path": "ResearchStudy.arm.name"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.arm.type",
"min": 0,
"definition": "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
"isModifier": false,
"short": "Categorization of study arm",
"mapping": [ {
"map": "Arm Type",
"identity": "clinicaltrials-gov"
}, {
"map": "Arm.typeCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "ResearchStudy.arm.type",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.arm.type"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.arm.description",
"min": 0,
"definition": "A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
"isModifier": false,
"short": "Short explanation of study path",
"mapping": [ {
"map": "Arm Description",
"identity": "clinicaltrials-gov"
}, {
"map": "Arm.description",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.arm.description",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.arm.description"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.objective",
"min": 0,
"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.",
"isModifier": false,
"short": "A goal for the study",
"mapping": [ {
"map": "StudyObjective",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "ResearchStudy.objective",
"base": {
"max": "*",
"min": 0,
"path": "ResearchStudy.objective"
},
"isSummary": false
}, {
"path": "ResearchStudy.objective.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "ResearchStudy.objective.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.objective.extension",
"min": 0,
"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.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "ResearchStudy.objective.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.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "ResearchStudy.objective.modifierExtension",
"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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).",
"min": 0,
"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).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "ResearchStudy.objective.modifierExtension",
"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.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.objective.name",
"min": 0,
"definition": "Unique, human-readable label for this objective of the study.",
"isModifier": false,
"short": "Label for the objective",
"mapping": [ {
"map": "No BRIDG mapping (BRIDG has a description, but not a name)",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "ResearchStudy.objective.name",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.objective.name"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "ResearchStudy.objective.type",
"min": 0,
"definition": "The kind of study objective.",
"isModifier": false,
"short": "primary | secondary | exploratory",
"mapping": [ {
"map": "StudyObjective.typeCode",
"identity": "BRIDG5.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "preferred",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchStudyObjectiveType"
} ],
"description": "Codes for the kind of study objective."
},
"max": "1",
"id": "ResearchStudy.objective.type",
"base": {
"max": "1",
"min": 0,
"path": "ResearchStudy.objective.type"
},
"isSummary": false
} ]
},
"status": "draft",
"id": "5ef5964f-25fe-46f7-8eab-b0ca0cd1ced0",
"kind": "resource",
"url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy",
"version": "0.2.0",
"differential": {
"element": [ {
"id": "ResearchStudy",
"path": "ResearchStudy"
}, {
"id": "ResearchStudy.extension",
"path": "ResearchStudy.extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "ResearchStudy.extension:eclaire-review-date",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date" ]
} ],
"short": "Date de dernière modification substancielle",
"sliceName": "eclaire-review-date",
"mustSupport": true
}, {
"id": "ResearchStudy.extension:eclaire-therapeutic-area",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area" ]
} ],
"short": "Domaine thérapeutique concerné",
"sliceName": "eclaire-therapeutic-area",
"mustSupport": true
}, {
"id": "ResearchStudy.extension:eclaire-recruitment-period",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period" ]
} ],
"short": "Période prévisionnelle de recrutement",
"sliceName": "eclaire-recruitment-period",
"mustSupport": true
}, {
"id": "ResearchStudy.extension:eclaire-secondary-sponsor",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor" ]
} ],
"short": "Promoteur(s) secondaire(s) / Secondary Sponsor(s)",
"sliceName": "eclaire-secondary-sponsor",
"mustSupport": true
}, {
"id": "ResearchStudy.extension:eclaire-label",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-label" ]
} ],
"short": "autres titres et acronyme / Additional names for the study",
"sliceName": "eclaire-label",
"mustSupport": true
}, {
"id": "ResearchStudy.identifier",
"path": "ResearchStudy.identifier",
"slicing": {
"rules": "open",
"description": "Slicing pour les différents identifiants de l'essai clinique",
"discriminator": [ {
"path": "use",
"type": "value"
} ]
}
}, {
"id": "ResearchStudy.identifier:idPrimary",
"max": "1",
"min": 0,
"path": "ResearchStudy.identifier",
"short": "Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number",
"sliceName": "idPrimary",
"mustSupport": true
}, {
"id": "ResearchStudy.identifier:idPrimary.use",
"min": 1,
"path": "ResearchStudy.identifier.use",
"patternCode": "official"
}, {
"id": "ResearchStudy.identifier:idSecondary",
"max": "*",
"min": 0,
"path": "ResearchStudy.identifier",
"short": "identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.",
"sliceName": "idSecondary",
"mustSupport": true
}, {
"id": "ResearchStudy.identifier:idSecondary.use",
"min": 1,
"path": "ResearchStudy.identifier.use",
"patternCode": "secondary"
}, {
"id": "ResearchStudy.title",
"path": "ResearchStudy.title",
"short": "Nom scientifique de l'étude / Scientific Title",
"mustSupport": true
}, {
"id": "ResearchStudy.status",
"path": "ResearchStudy.status",
"short": "Statut de l'essai / Study Status",
"mustSupport": true
}, {
"id": "ResearchStudy.phase",
"path": "ResearchStudy.phase",
"short": "Phase de l'essai / Study type : phase",
"binding": {
"strength": "extensible",
"valueSet": "https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs"
},
"mustSupport": true
}, {
"id": "ResearchStudy.category",
"path": "ResearchStudy.category",
"short": "Type d'essai / Study type : type of study",
"binding": {
"strength": "extensible",
"valueSet": "https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs"
},
"mustSupport": true
}, {
"id": "ResearchStudy.condition",
"path": "ResearchStudy.condition",
"short": "Sujet concerné / Problem(s) Studied exemple code MedDRA",
"slicing": {
"rules": "open",
"description": "Slicing pour apporter des précisions sur le sujet / Health Condition(s) or Problem(s) Studied. Dans le CTIS, il y a un champ texte ouvert (obligatoire) pour indiquer la pathologie et éventuellement des précisons. Un code MedDRA peut-être ajouté mais il est optionnel.\nAinsi la slice medDRACondition contient un code meddra, la slice diseaseCondition contient un texte libre. "
},
"mustSupport": true
}, {
"id": "ResearchStudy.condition:medDRACondition",
"max": "*",
"min": 0,
"path": "ResearchStudy.condition",
"short": "code MedDRA / MedDRA condition",
"sliceName": "medDRACondition",
"mustSupport": true
}, {
"id": "ResearchStudy.condition:medDRACondition.id",
"path": "ResearchStudy.condition.id",
"patternString": "meddra-condition"
}, {
"id": "ResearchStudy.condition:medDRACondition.coding.system",
"path": "ResearchStudy.condition.coding.system",
"patternUri": "http://terminology.hl7.org/CodeSystem/mdr"
}, {
"id": "ResearchStudy.condition:diseaseCondition",
"max": "*",
"min": 0,
"path": "ResearchStudy.condition",
"short": "condition de la pathologie / Disease Condition",
"sliceName": "diseaseCondition",
"mustSupport": true
}, {
"id": "ResearchStudy.condition:diseaseCondition.id",
"path": "ResearchStudy.condition.id",
"patternString": "disease-condition"
}, {
"id": "ResearchStudy.condition:diseaseCondition.text",
"min": 1,
"path": "ResearchStudy.condition.text"
}, {
"id": "ResearchStudy.contact",
"path": "ResearchStudy.contact",
"short": "Contact (Contact for public / scientific queries)",
"mustSupport": true
}, {
"id": "ResearchStudy.contact.extension:eclaire-contact-type",
"max": "1",
"min": 0,
"path": "ResearchStudy.contact.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type" ]
} ],
"short": "Type de contact : Public ou Scientific",
"sliceName": "eclaire-contact-type",
"mustSupport": true
}, {
"id": "ResearchStudy.contact.extension:eclaire-contact-address",
"max": "1",
"min": 0,
"path": "ResearchStudy.contact.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address" ]
} ],
"short": "Adresse du contact",
"sliceName": "eclaire-contact-address",
"mustSupport": true
}, {
"id": "ResearchStudy.contact.extension:eclaire-contact-affiliation",
"max": "1",
"min": 0,
"path": "ResearchStudy.contact.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation" ]
} ],
"short": "Affiliation du contact",
"sliceName": "eclaire-contact-affiliation",
"mustSupport": true
}, {
"id": "ResearchStudy.contact.extension:eclaire-contact-name",
"max": "1",
"min": 0,
"path": "ResearchStudy.contact.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name" ]
} ],
"short": "Nom du contact",
"sliceName": "eclaire-contact-name"
}, {
"id": "ResearchStudy.location",
"path": "ResearchStudy.location",
"short": "Pays de recrutement / Countries of Recruitment",
"mustSupport": true
}, {
"id": "ResearchStudy.description",
"path": "ResearchStudy.description",
"short": "Résumé de l'essai / Summary Results",
"mustSupport": true
}, {
"id": "ResearchStudy.enrollment",
"path": "ResearchStudy.enrollment",
"short": "Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria",
"mustSupport": true
}, {
"id": "ResearchStudy.sponsor",
"path": "ResearchStudy.sponsor",
"short": "Promoteur / primary Sponsor",
"mustSupport": true
}, {
"id": "ResearchStudy.site",
"path": "ResearchStudy.site",
"short": "Lieux / Countries of Recruitment",
"mustSupport": true
} ]
},
"contact": [ {
"name": "ANS",
"telecom": [ {
"value": "https://esante.gouv.fr",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
}