{
"description": "NFDI4Health LogicalModel General Metadataschema",
"_filename": "StructureDefinition-nfdi4health-lm-metadataschema-general-v3.json",
"package_name": "de.nfdi4health.mds",
"date": null,
"derivation": "specialization",
"publisher": "NFDI4Health",
"fhirVersion": "4.0.1",
"name": "NFDI4Health_LM_Metadataschema_General_V3",
"mapping": [ {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
}, {
"name": "NFDI4Health General Metadataschema Version 3 Mapping to internal numbering of Metadataschema V3.0",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"name": "NFDI4Health General Metadataschema Version 3 Mapping to internal numbering of Metadataschema Version 2.1",
"identity": "NFDI4Health-V2.1"
} ],
"abstract": false,
"type": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "NFDI4Health LM General Metadataschema V3",
"package_version": "1.0.0",
"status": "draft",
"id": "a4b1b97d-275d-4929-a99d-5cc59728f6f5",
"kind": "logical",
"url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"version": null,
"differential": {
"element": [ {
"id": "nfdi4health-lm-metadataschema-general-v3",
"path": "nfdi4health-lm-metadataschema-general-v3",
"short": "NFDI4Health LM General Metadataschema V3",
"definition": "NFDI4Health LogicalModel General Metadataschema"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource",
"min": 1,
"definition": "Group of items providing Information about a resource. Resources can be, for example, files or parts of them (e.g. datasets or study documents such as study protocols or questionnaires) or also abstractions (e.g. studies or substudies/data collection events).",
"short": "Resource",
"mapping": [ {
"map": "1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.identifier",
"min": 1,
"definition": "Unique identifier of the resource used for identification within the NFDI4Health.",
"short": "ID of the [Resource]",
"mapping": [ {
"map": "1.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.identifier",
"comment": "Additional Information: The identifier is assigned automatically. / Display information? (Data capturing): no / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.classification",
"min": 1,
"definition": "Group of items providing Information about classification of the resource within the predefined categories.",
"short": "Classification of the resource within the predefined categories",
"mapping": [ {
"map": "1.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.classification",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"constraint": [ {
"key": "eocd1",
"human": "Cardinality: 1..*, if Resource.chronicDiseases == 'Yes' AND Resource.classification.resourceType == ('Study protocol' OR 'Protocol amendment' OR 'Informed consent form' OR 'Patient information sheet' OR 'Manual of operations (SOPs)' OR 'Statistical analysis plan' OR 'Data management plan' OR 'Case report form' OR 'Interview scheme and themes' OR 'Observation guide' OR 'Discussion guide' OR 'Participant tasks' OR 'Other study document' OR 'Other'); otherwise 0.. 0",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"severity": "error",
"expression": "Resource.chronicDiseases = false OR Resource.classification.resourceType.exists(Study) OR Resource.classification.resourceType.exists(Substudy/Data collection event) OR Resource.classification.resourceType.exists(Dataset) OR Resource.classification.resourceType.exists(Data dictionary) OR Resource.classification.resourceType.exists(Code book) OR Resource.classification.resourceType.exists(Questionnaire) OR Resource.classification.resourceType.exists(Other data collection instrument) implies ChronicDiseasesEpidemiology.exists().not()"
} ],
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.classification.resourceType",
"min": 1,
"definition": "A term describing the resource.",
"short": "Type of the resource",
"mapping": [ {
"map": "1.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-resource-type-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.classification.resourceType",
"comment": "Additional Information: The selected value determines which type of information needs to be provided. / Short Input Help: You can register a study, a study protocoll, a questionnaire, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.classification.resourceTypeGeneral",
"min": 1,
"definition": "A more general term describing the resource which forms a pair with the property 'Type of the resource' (e.g. 'Questionnaire'/'Text').",
"short": "A more general type of the resource",
"mapping": [ {
"map": "1.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.2.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-resource-type-general-nci-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.classification.resourceTypeGeneral",
"comment": "Cardinality: 1..1, if Resource.classification.resourceType != ('Study' OR 'Substudy/Data collection event' OR 'Dataset') / Short Input Help: You can select 'Text' for most of the study documents, e.g. for questionnaires, informed consent forms, case report forms, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.titles",
"min": 1,
"definition": "Group of items providing Information about title(s)/name(s) of the resource.",
"short": "Title(s)/name(s) of the [RESOURCE]",
"mapping": [ {
"map": "1.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.titles",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.titles.text",
"min": 1,
"definition": "Scientific unabbreviated title or name of the resource.",
"short": "Title/name",
"mapping": [ {
"map": "1.3.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.3.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.titles.text",
"comment": "Additional Information: If no official title/name has been defined yet, please provide a title/name that is suitable for public display. / Short Input Help: Please provide at least one title/name of the resource. If the original title is not in English, please also provide an English translation of the original title. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.titles.language",
"min": 1,
"definition": "Language of the title/name.",
"short": "Language of the title/name",
"mapping": [ {
"map": "1.3.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.3.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-language-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.titles.language",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms",
"min": 0,
"definition": "Group of items providing Information about acronym(s) of the resource.",
"short": "Acronym(s) of the [RESOURCE]",
"mapping": [ {
"map": "1.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms.text",
"min": 1,
"definition": "If existing, acronym(s) of the resource.",
"short": "Acronym",
"mapping": [ {
"map": "1.4.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.4.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms.text",
"comment": "Short Input Help: The property refers primarily to studies which often have an acronym. For other types of resources, a short title (preferably up to 5 words) can be provided, e.g. 'NAKO-COVID Questionnaire'. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]",
"example": [ {
"label": "General",
"valueString": "NAKO"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms.language",
"min": 1,
"definition": "Language of the acronym.",
"short": "Language of the acronym",
"mapping": [ {
"map": "1.4.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.4.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-language-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.acronyms.language",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish",
"min": 1,
"definition": "Group of items with an English description of the resource.",
"short": "English description of the [RESOURCE]",
"mapping": [ {
"map": "1.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish.text",
"min": 1,
"definition": "A short plain text summary describing the resource in English.",
"short": "English description of the [RESOURCE]",
"mapping": [ {
"map": "1.5.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.5.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish.text",
"comment": "Additional Information: An English description is mandatory to facilitate the search. / Short Input Help: The provided information should be understandable by scientific audience. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish.language",
"fixedCode": "C0376245",
"min": 1,
"definition": "Language of the description text.",
"short": "Language of the description",
"mapping": [ {
"map": "1.5.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.5.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionEnglish.language",
"comment": "Additional Information: English is a default value. / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish",
"min": 0,
"definition": "Group of items with description(s) of the resource written not in English.",
"short": "Additional description(s) of the [RESOURCE]",
"mapping": [ {
"map": "1.6",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.6",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish.text",
"min": 1,
"definition": "Short plain text summary of the resource other than in English.",
"short": "Description",
"mapping": [ {
"map": "1.6.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.6.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish.text",
"comment": "Short Input Help: Additional descriptions of the resource are optional. The provided information should be understandable by scientific audience. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish.language",
"min": 1,
"definition": "Language of the description text.",
"short": "Language of the description",
"mapping": [ {
"map": "1.6.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.6.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-language-nonenglish-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.descriptionNonEnglish.language",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords",
"min": 0,
"definition": "Group of items providing Information about keywords describing the resource.",
"short": "Keyword(s) describing the [RESOURCE]",
"mapping": [ {
"map": "1.7",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.7",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords",
"comment": "Additional Information: The findability of the resource can be significantly increased if proper keywords are stated. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords.label",
"min": 1,
"definition": "Keyword(s) describing the resource.",
"short": "Keyword",
"mapping": [ {
"map": "1.7.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.7.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords.label",
"comment": "Additional Information: The use of terms from established classifications/vocabularies (e.g. MeSH, UMLS, SNOMED CT) is preferred. However, also self-assigned keywords are allowed. / Short Input Help: Preferably, use terms from MeSH (https://meshb.nlm.nih.gov/search) or UMLS (https://uts.nlm.nih.gov/uts/umls/home). / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]",
"example": [ {
"label": "General",
"valueString": "SARS-CoV-2"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords.code",
"min": 0,
"definition": "If known, the code of the keyword in a classification/vocabulary.",
"short": "Code of the keyword",
"mapping": [ {
"map": "1.7.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.7.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.keywords.code",
"comment": "Short Input Help: If found, the code from the classification/vocabulary used. / Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]",
"example": [ {
"label": "General",
"valueUri": "http://id.nlm.nih.gov/mesh/D000086402"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.languages",
"min": 0,
"definition": "Language(s) in which a study/substudy is conducted, or a language in which a study document is composed.",
"short": "Language(s) of the [RESOURCE]",
"mapping": [ {
"map": "1.8",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.8",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "code"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-execution-language-iso"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.languages",
"comment": "Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.webpage",
"min": 0,
"definition": "If existing, a link to the web page directly relevant to the resource.",
"short": "Web page of the [RESOURCE]",
"mapping": [ {
"map": "1.9",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.9",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "url"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.webpage",
"comment": "Additional Information: Other web pages related to the resource can additionally be entered in the section 'Related resources'. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails",
"min": 1,
"definition": "Group of items applicable only to the resources which are not a study/substudy.",
"short": "Detailed information about the [RESOURCE]",
"mapping": [ {
"map": "1.10",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails",
"comment": "Cardinality: 1..1, if Resource.classification.resourceType != ('Study' OR 'Substudy/Data collection event'); otherwise 0..0 / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.version",
"min": 0,
"definition": "If existing, the version number of the resource.",
"short": "Version of the [RESOURCE]",
"mapping": [ {
"map": "1.10.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.version",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.format",
"min": 0,
"definition": "Technical format of the resource.",
"short": "Format of the [RESOURCE]",
"mapping": [ {
"map": "1.10.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.format",
"comment": "Short Input Help: E.g., XML, PDF, XLSX, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights",
"min": 0,
"definition": "Group of items providing Information about the rights to (re-)use the resource.",
"short": "Information about the rights to (re-)use the [RESOURCE]",
"mapping": [ {
"map": "1.10.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.label",
"min": 1,
"definition": "License defining the rights to (re-)use the resource.",
"short": "License",
"mapping": [ {
"map": "1.10.3.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-use-rights-label-spdx-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.label",
"comment": "Short Input Help: Select one value from the list. If 'Other' is selected, an explanation of the (re-)use terms and conditions can be provided in the property 'Additional information about use rights'. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations",
"min": 1,
"definition": "Group of items applicable if a Creative Commons liesense is selected.",
"short": "Important nformation about licensing, if a Creative Commons liesense is selected.",
"mapping": [ {
"map": "1.10.3.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations",
"comment": "Cardinality: 1..1, if Resource.nonStudyDetails.useRights.label != ('CC0 1.0 (Creative Commons Zero v1.0 Universal)' OR 'All rights reserved' OR 'Other' OR 'Not applicable'); otherwise 0..0 / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.authority",
"min": 1,
"definition": "Confirmation that the authors have authority to license the resource.",
"short": "Do you confirm that the authors have authority to license the [RESOURCE]?",
"mapping": [ {
"map": "1.10.3.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.authority",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.terms",
"min": 1,
"definition": "Confirmation that the authors have read and understand the terms of the chosen license.",
"short": "Do you confirm that the authors have read and understood the terms of the chosen license?",
"mapping": [ {
"map": "1.10.3.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.terms",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.irrevocability",
"min": 1,
"definition": "Confirmation that the authors understand that Creative Commons (CC) licensing is not revocable.",
"short": "Do you confirm that the authors understand that Creative Commons (CC) licensing is irrevocable?",
"mapping": [ {
"map": "1.10.3.2.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1.1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.irrevocability",
"comment": "Additional Information: The resource can be licensed using a CC-license only if it is free of the third-party rights. / Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.supportByLicencing",
"min": 1,
"definition": "Confirmation that NFDI4Health is allowed to licence the document, i.e. to mark the resource with the licence information.",
"short": "Do you confirm that the authors allow NFDI4Health to license the document?",
"mapping": [ {
"map": "1.10.3.2.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.1.1.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.confirmations.supportByLicencing",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.description",
"min": 0,
"definition": "Any additional descriptive information explaining terms and conditions to (re-)use the resource.",
"short": "Additional information about use rights",
"mapping": [ {
"map": "1.10.3.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.10.3.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nonStudyDetails.useRights.description",
"comment": "Short Input Help: If 'Other' is selected in the property 'License', the preferred license or terms and conditions for (re-)use can be specified here. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles",
"min": 1,
"definition": "Group of items providing information about person(s), group(s) of persons or institution(s)/organisation(s) contributing to the resource.",
"short": "Roles",
"mapping": [ {
"map": "1.11",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles",
"comment": "Additional Information: For each resource, there may be multiple roles, but at least one person, group of persons or institution/organisation must be specified. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.nameType",
"min": 1,
"definition": "Personal or organisational/group type of the name.",
"short": "Type of the name",
"mapping": [ {
"map": "1.11.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-role-name-type-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.nameType",
"comment": "Short Input Help: Personal or organisational/group name? / Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational",
"min": 1,
"definition": "Group of items providing information about group(s) of persons, institution(s) or organisation(s) contributing to the resource.",
"short": "Details about the organisation/institution/group/etc.",
"mapping": [ {
"map": "1.11.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational",
"comment": "Cardinality: 1..1, if role_name_type=='Organisational'; otherwise 0..0 / Additional Information: Group of items applicable to organisational/group names. / Short Input Help: Organisational name can be used to denote a research group or an institution. / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.type",
"min": 1,
"definition": "Type of the role an organisation, institution or group fulllfils. For example, this can be a sponsor of the study or a group of authors of the document.",
"short": "Type of the role",
"mapping": [ {
"map": "1.11.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-organisational-roles-nci-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.type",
"comment": "Short Input Help: Which role does the organisation/institution/group/etc. fulllfil? Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.fundingId",
"min": 0,
"definition": "Identifier assigned by a funder to the resource.",
"short": "Funding identifier",
"mapping": [ {
"map": "1.11.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.1.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.fundingId",
"comment": "Cardinality: 0..*, if Resource.roles.organisational.type == ('Funder (public)' OR 'Funder (private)'); otherwise 0..0 / Short Input Help: If available, you can enter a funding identifier / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.name",
"min": 1,
"definition": "Name of the organisation, institution or group.",
"short": "Name of the organisation/institution/group",
"mapping": [ {
"map": "1.11.2.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.organisational.name",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal",
"min": 1,
"definition": "Group of items providing information about person(s) contributing to the resource.",
"short": "Details about the person",
"mapping": [ {
"map": "1.11.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal",
"comment": "Cardinality: 1..1, if role_name_type=='Personal'; otherwise 0..0 / Additional Information: Group of items applicable to personal names. / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.type",
"min": 1,
"definition": "Type of the role a person fulllfils. For example, this can be a principal investigator of a study or an author of a document.",
"short": "Type of the role",
"mapping": [ {
"map": "1.11.3.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-personal-roles-nci-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.type",
"comment": "Short Input Help: Which role does the person fulllfil? Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.givenName",
"min": 1,
"definition": "Given name of the person",
"short": "Given name of the person",
"mapping": [ {
"map": "1.11.3.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.givenName",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.familyName",
"min": 1,
"definition": "Family name of the person",
"short": "Family name of the person",
"mapping": [ {
"map": "1.11.3.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.familyName",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.title",
"min": 1,
"definition": "Title of the person",
"short": "Title of the person",
"mapping": [ {
"map": "1.11.3.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-role-name-personal-title-nci"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.title",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers",
"min": 0,
"definition": "Group of items providing information about digital identifiers of the person.",
"short": "Digital identifier(s) of the person",
"mapping": [ {
"map": "1.11.3.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers.identifier",
"min": 1,
"definition": "Digital identifier of the person according to a definite scheme.",
"short": "Identifier",
"mapping": [ {
"map": "1.11.3.5.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.6",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers.identifier",
"comment": "Short Input Help: Preferably, provide an ORCID (https://orcid.org/). / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueString": "0000-0003-1379-7023"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers.scheme",
"min": 1,
"definition": "Type of the identifier scheme.",
"short": "Which type of identifer is reported?",
"mapping": [ {
"map": "1.11.3.5.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.2.6.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-role-name-identifier-scheme-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.personal.identifiers.scheme",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "ORCID"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.email",
"min": 0,
"definition": "Email address of the person, group of persons or institution/organisation.",
"short": "Email address",
"mapping": [ {
"map": "1.11.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.email",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.phone",
"min": 0,
"definition": "Phone number of the person, group of persons or institution/organisation.",
"short": "Phone number",
"mapping": [ {
"map": "1.11.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.phone",
"comment": "Short Input Help: Please, use the International ITU-T E.164-number structure for geographic areas, e.g. +49 (0)153 1112233. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]",
"example": [ {
"label": "General",
"valueString": "+49 (0)153 1112233"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation",
"min": 0,
"definition": "Group of items providing further information about the organisation(s) associated with the role.",
"short": "Further information about organisation(s) associated with the role",
"mapping": [ {
"map": "1.11.6",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.name",
"min": 1,
"definition": "Name of the organisation associated with the role.",
"short": "Name of the organisation",
"mapping": [ {
"map": "1.11.6.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.name",
"comment": "Short Input Help: If you are have already entered the name of the organistion in the property 'Name of the organisation/institution/group', please repeat it here. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.address",
"min": 0,
"definition": "Address of the organisation associated with the role.",
"short": "Address of the organisation",
"mapping": [ {
"map": "1.11.6.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.address",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.webpage",
"min": 0,
"definition": "Web page of the organisation associated with the role.",
"short": "Web page of the organisation",
"mapping": [ {
"map": "1.11.6.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "url"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.webpage",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers",
"min": 0,
"definition": "Group of items providing information about identifiers of the organisation.",
"short": "Digital identifier(s) of the organisation",
"mapping": [ {
"map": "1.11.6.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers.identifier",
"min": 1,
"definition": "Digital identifier of the organisation according to a definite scheme.",
"short": "Identifier",
"mapping": [ {
"map": "1.11.6.4.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.4.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers.identifier",
"comment": "Short Input Help: Preferably, provide an identifier from ROR (https://ror.org/search). / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueString": "0259fwx54"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers.scheme",
"min": 1,
"definition": "Type of the identifier scheme.",
"short": "Identifier scheme",
"mapping": [ {
"map": "1.11.6.4.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.11.1.5.4.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-role-affiliation-identifier-scheme-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.roles.affiliation.identifiers.scheme",
"comment": "Short Input Help: Which type of identifer is reported? / Display information? (Data capturing): yes / Display information? (Data visualization): no / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "ROR"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative",
"min": 0,
"definition": "Group of items providing information about identifiers (IDs) assigned to the given resource by another registering systems, e.g. a register of clinical trials or a data repository.",
"short": "Alternative identifiers",
"mapping": [ {
"map": "1.12",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.12",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative",
"comment": "Short Input Help: If the [RESOURCE] is registered in other systems (e.g. a register of clinical trials or a data repository), you can provide corresponding identifier(s) here. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative.scheme",
"min": 1,
"definition": "Type/name of the system where the given resource is already registered.",
"short": "Type of the register",
"mapping": [ {
"map": "1.12.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.12.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative.scheme",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "DRKS"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative.identifier",
"min": 1,
"definition": "Identifier (ID) assigned to the given resource by another registering system, e.g. by a register of clinical trials or a data repository.",
"short": "Identifier",
"mapping": [ {
"map": "1.12.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.12.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsAlternative.identifier",
"comment": "Short Input Help: E. g., DRKS00021273, NCT04327505, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DataCite [1]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids",
"min": 0,
"definition": "Group of items providing information about identifiers (IDs) of the resources related to the given resource, e.g. DOIs of publications, datasets, study documents or links to web pages.",
"short": "Related publications, datasets, study documents, web pages, etc.",
"mapping": [ {
"map": "1.13",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids",
"comment": "Short Input Help: If existing, you can specify identifier(s) of any related resources, e.g. DOIs of publications, datasets, study documents, links to web pages, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.identifier",
"min": 1,
"definition": "Identifier (ID) related to, or associated with, the resource being registered. These can be IDs of related publications, datasets, study documents, web pages, etc.",
"short": "Identifier of the related resource",
"mapping": [ {
"map": "1.13.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.identifier",
"comment": "Short Input Help: a) Publications like journal articles usually have a DOI, e.g. 10.3238/arztebl.2020.0861. b) A link (URL) starting with 'http(s)://' to a web page with any additional information can also be provided here. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueString": "10.4126/FRL01-006431467"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.scheme",
"min": 1,
"definition": "Type of the identifier of the related resource.",
"short": "Type of the identifier",
"mapping": [ {
"map": "1.13.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.scheme",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "DOI"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.date",
"min": 0,
"definition": "Date when the identifier of the related resource was assigned.",
"short": "Date of ID assignment",
"mapping": [ {
"map": "1.13.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.date",
"comment": "Additional Information: Preferred date format: DD.MM.YYYY / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.relationType",
"min": 1,
"definition": "Relationship between the resource being registered (A) and the related resource (B).",
"short": "Relationship between this [RESOURCE] (A) and the related resource (B)?",
"mapping": [ {
"map": "1.13.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-relation-type-ids-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.relationType",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "A is part of B"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.resourceTypeGeneral",
"min": 0,
"definition": "Type of the related resource, e.g. journal article, dataset, text, etc.",
"short": "Type of the related resource",
"mapping": [ {
"map": "1.13.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.13.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-resource-type-general-nci-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.ids.resourceTypeGeneral",
"comment": "Short Input Help: Select one value from the list. For example,. a journal article, dataset, text, etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "Text"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health",
"min": 0,
"definition": "Group of items providing information about related resources registered on this portal.",
"short": "Related (sub-)studies, study documents, etc. registered on this portal",
"mapping": [ {
"map": "1.14",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.14",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health",
"comment": "Short Input Help: Does the [RESOURCE] have any related resources registered on this portal? / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health.identifier",
"min": 1,
"definition": "Identifier (ID) of the related resource assigned on this portal.",
"short": "Identifier of the related resource",
"mapping": [ {
"map": "1.14.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.14.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health.identifier",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health",
"example": [ {
"label": "General",
"valueString": "39"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health.relationType",
"min": 0,
"definition": "Relationship between the resource being registered (A) and the related resource (B).",
"short": "Relationship between this [RESOURCE] (A) and the related resource (B)?",
"mapping": [ {
"map": "1.14.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.14.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-relation-type-ids-nfdi-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.idsNfdi4health.relationType",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]"
}, {
"constraint": [ {
"key": "ne1",
"human": "Cardinality: 1..*, if Resource.nutritionalData == 'Yes'; otherwise 0.. 0 / Additional Information: Filtering condition to decide if all following questions will be asked.",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"severity": "error",
"expression": "Resource.nutritionalData = false implies DietAssessment.exists().not()"
} ],
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.nutritionalData",
"min": 1,
"definition": "Indication whether nutritional data was collected by the resource.",
"short": "Nutritional data collected?",
"mapping": [ {
"map": "1.15",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "NA",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.nutritionalData",
"comment": "Cardinality: 1..1, if Resource.classification.resourceType == ('Study' OR 'Substudy/Data collection') AND Resource.provenance.dataSource != 'Manually collected'; otherwise 0..0 / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"constraint": [ {
"key": "eocd1",
"human": "Cardinality: 1..*, if Resource.chronicDiseases == 'Yes' AND Resource.classification.resourceType == ('Study protocol' OR 'Protocol amendment' OR 'Informed consent form' OR 'Patient information sheet' OR 'Manual of operations (SOPs)' OR 'Statistical analysis plan' OR 'Data management plan' OR 'Case report form' OR 'Interview scheme and themes' OR 'Observation guide' OR 'Discussion guide' OR 'Participant tasks' OR 'Other study document' OR 'Other'); otherwise 0.. 0",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"severity": "error",
"expression": "Resource.chronicDiseases = false OR Resource.classification.resourceType.exists(Study) OR Resource.classification.resourceType.exists(Substudy/Data collection event) OR Resource.classification.resourceType.exists(Dataset) OR Resource.classification.resourceType.exists(Data dictionary) OR Resource.classification.resourceType.exists(Code book) OR Resource.classification.resourceType.exists(Questionnaire) OR Resource.classification.resourceType.exists(Other data collection instrument) implies ChronicDiseasesEpidemiology.exists().not()"
} ],
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.chronicDiseases",
"min": 1,
"definition": "Indication whether chronic diseases were addressed by the resource.",
"short": "Chronic diseases included?",
"mapping": [ {
"map": "1.16",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "NA",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.chronicDiseases",
"comment": "Cardinality: 1..1, if provenance.data_source != 'Manually collected'; otherwise 0..0 / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign",
"min": 1,
"definition": "Group of items providing information about the characteristics of a study or a substudy.",
"short": "Characteristics of the [RESOURCE]",
"mapping": [ {
"map": "1.17",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign",
"comment": "Cardinality: 1..1, if resource_type == ('Study' OR 'Substudy/Data collection'); otherwise 0..0 / Additional Information: Group of items applicable only to studies and substudies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.primaryDesign",
"min": 1,
"definition": "Non-interventional study design refers to a study that does not aim to alter study outcomes of interest. Interventional study design refers to a study that aims to alter study outcomes of interest.",
"short": "Is it an interventional or non-interventional study?",
"mapping": [ {
"map": "1.17.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-design-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.primaryDesign",
"comment": "Select between non-interventional and interventional study design. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType",
"min": 1,
"definition": "Group of items providing information about the study type.",
"short": "Specification of study type",
"mapping": [ {
"map": "1.17.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2], DRKS [3], DDI [9], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType.interventional",
"min": 1,
"definition": "The strategy for assigning interventions to participants.",
"short": "Specification of study type",
"mapping": [ {
"map": "1.17.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-type-interventional-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType.interventional",
"comment": "Cardinality: 1..*, if Resource.studyDesign.primaryDesign == 'Interventional'; otherwise 0..0 / Short Input Help: Select all that apply. If 'Other' is selected, you can specify the study type in the field 'Additional information about the study'. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType.nonInterventional",
"min": 1,
"definition": "The primary strategy for participant identification and follow-up.",
"short": "Specification of study type",
"mapping": [ {
"map": "1.17.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.2.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-type-non-interventional-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyType.nonInterventional",
"comment": "Cardinality: 1..*, if Resource.studyDesign.primaryDesign == 'Non-interventional'; otherwise 0..0 / Short Input Help: Select all that apply. If 'Other' is selected, you can specify the study type in the field 'Additional information about the study'. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3], DDI [9], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions",
"min": 0,
"definition": "Group of items providing information about primary health condition(s) or disease(s) considered in the study, or the focus of the study (e.g. medication, food, therapy, device, etc.).",
"short": "Primary health condition(s), disease(s) or focus of the study",
"mapping": [ {
"map": "1.17.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.label",
"min": 1,
"definition": "Name of primary health condition or disease considered in the study, or the focus of the study (e.g. medication, food, therapy, device, etc.).",
"short": "Name of the primary health condition, disease or focus of the study",
"mapping": [ {
"map": "1.17.3.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.3.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.label",
"comment": "Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. / Short Input Help: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]",
"example": [ {
"label": "General",
"valueString": "SARS-CoV-2"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.classification",
"min": 1,
"definition": "Terminology/classification used for the health condition, diesease or focus.",
"short": "Terminology/classification",
"mapping": [ {
"map": "1.17.3.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.3.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-conditions-classification-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.classification",
"comment": "Short Input Help: If used, name of the terminology/classification. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DRKS [3], DataCite [1]",
"example": [ {
"label": "General",
"valueCodeableConcept": {
"text": "SNOMED CT"
}
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.code",
"min": 0,
"definition": "Code of the health condition, disease, focus in the terminology/classification used.",
"short": "Code ---- If known, code of the health condition, disease or focus in the terminology/classification used",
"mapping": [ {
"map": "1.17.3.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.3.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyConditions.code",
"comment": "Short Input Help: If found, the code from the terminology/classification used. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DataCite [1]",
"example": [ {
"label": "General",
"valueUri": "http://snomed.info/id/840533007"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases",
"min": 1,
"definition": "Group of items providing information about groups of diseases or conditions on which the data were collected in the study.",
"short": "Which groups of diseases or conditions were the data collected on?",
"mapping": [ {
"map": "1.17.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases.generally",
"min": 1,
"definition": "Groups of diseases or conditions on which the data were collected in the study.",
"short": "Which groups of diseases or conditions were the data collected on?",
"mapping": [ {
"map": "1.17.4.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.4.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-diseases-generally-icd10-umls-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases.generally",
"comment": "Additional Information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 11th Revision (ICD-11)./ Short Input Help: Select all that apply. For more information about the groups of diseases/conditions, visit the WHO's ICD-11 homepage: https://icd.who.int/en. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: ICD-11 [20]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases.conditions",
"min": 0,
"definition": "Other diseases or conditions on which the data were collected in the study.",
"short": "On which other diseases or conditions were the data collected?",
"mapping": [ {
"map": "1.17.4.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "NA",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyGroupsOfDiseases.conditions",
"comment": "Additional Information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 11th Revision (ICD-11). / Short Input Help: For more information about the groups of diseases/conditions, visit the WHO's ICD-11 homepage: https://icd.who.int/en. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: ICD-11 [20] (NFDI4Health UC 5.2 requirement)",
"example": [ {
"label": "General",
"valueString": "Values are based on lower level ICD-11"
} ]
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.mortalityData",
"min": 0,
"definition": "Mortality data.",
"short": "Were mortality data collected?",
"mapping": [ {
"map": "1.17.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "NA",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-mortality-data-nci"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.mortalityData",
"comment": "Cardinality: 0..1, if Resource.studyDesign.studyType.nonInterventional == ('Longitudinal' OR 'Cohort' OR 'Case-cohort' OR 'Birth cohort' OR 'Trend' OR 'Panel'); otherwise 0..0 / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health UC 5.2 requirements"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ethicsCommiteeApproval",
"min": 0,
"definition": "Status of the study approval from the (leading) ethics committee.",
"short": "Status of the ethics committee approval",
"mapping": [ {
"map": "1.17.6",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-ethics-committee-approval-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ethicsCommiteeApproval",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.status",
"min": 1,
"definition": "Overall study status",
"short": "Overall study status",
"mapping": [ {
"map": "1.17.7",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.6",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-overall-status-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.status",
"comment": "Additional Information: If at least one study site in a multicenter study has the status 'Ongoing' then the overall status for the study must be 'Ongoing'. / Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.statusWhenIntervention",
"min": 0,
"definition": "Specification whether study participants receive intervention or have completed it but are still being followed according to the primary objective of the study.",
"short": "Do participants receive an intervention?",
"mapping": [ {
"map": "1.17.8",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.6.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-when-intervention-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.statusWhenIntervention",
"comment": "Cardinality: '0..1, if Resource.studyDesign.primaryDesign == 'Interventional' AND Resource.studyDesign.status == ('At the planning stage' OR 'Ongoing (I): Recruitment ongoing, but data collection not yet started' OR 'Ongoing (II): Recruitment and data collection ongoing' OR 'Ongoing (III): Recruitment completed, but data collection ongoing' OR 'Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing'); otherwise 0..0 / Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.stageStopped",
"min": 0,
"definition": "If the study was stopped prematurely, specification of the stage at what it was halted.",
"short": "At what stage was the study stopped?",
"mapping": [ {
"map": "1.17.9",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.6.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-halted-stage-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.stageStopped",
"comment": "Cardinality: 0..1, if Resource.studyDesign.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.reasonStopped",
"min": 0,
"definition": "If the study was stopped prematurely, specification of the reason(s) why it was halted.",
"short": "Reason why the study was stopped",
"mapping": [ {
"map": "1.17.10",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.6.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.reasonStopped",
"comment": "Cardinality: 0..1, if Resource.studyDesign.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: E.g., accrual goal met / closed due to toxicity / closed due to lack of study progress / temporarily-closed per study design /etc. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.statusEnrollingByInvitation",
"min": 0,
"definition": "Specification whether study participants have been selected from a predetermined population or enrolled by invitation.",
"short": "Are participants enrolled by invitation?",
"mapping": [ {
"map": "1.17.11",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.6.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-not-applicable-snomedct"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.statusEnrollingByInvitation",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.recruitmentStatusRegister",
"min": 0,
"definition": "Overall recruitment status of the study as indicated in the corresponding register of clinical trials.",
"short": "Overall recruitment status of the study from the register of clinical trials",
"mapping": [ {
"map": "1.17.12",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.7",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-recruitment-status-register-umls-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.recruitmentStatusRegister",
"comment": "Additional Information: The item applies only to studies automatically uploaded from the registers of clinical trials. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyStartDate",
"min": 0,
"definition": "Start date of data collection for the study.",
"short": "Start date of data collection for the study",
"mapping": [ {
"map": "1.17.13",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.8",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyStartDate",
"comment": "Additional Information: Preferred date format: DD.MM.YYYY. / Short Input Information: In case of a planned study, it is the intended start date; in case of an ongoing study — the actual start date. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyEndDate",
"min": 0,
"definition": "In case of studies with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant's last visit.",
"short": "End date of data collection for the study",
"mapping": [ {
"map": "1.17.14",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.9",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyEndDate",
"comment": "Additional Information: Preferred date format: DD.MM.YYYY. / Short Input Information: In case of a planned or ongoing study, it is the intended end date; in case of a completed study — the actual end date. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.countries",
"min": 1,
"definition": "Country or countries where the study takes place.",
"short": "Country(ies) where the study takes place",
"mapping": [ {
"map": "1.17.15",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.10",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-countries-iso"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.countries",
"comment": "Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.region",
"min": 0,
"definition": "If applicable, region(s) and/or city(ies) within a country where the study takes place.",
"short": "Regions and/or cities within a country where the study takes place",
"mapping": [ {
"map": "1.17.16",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.11",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.region",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.centers",
"min": 0,
"definition": "Specification whether a study is conducted at one study center or at more than one study center.",
"short": "Is it a mono- or multicentric study?",
"mapping": [ {
"map": "1.17.17",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.12",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-centers-snomedct-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.centers",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.centersNumber",
"min": 0,
"definition": "Number of centers involved in the study.",
"short": "Number of study centers",
"mapping": [ {
"map": "1.17.18",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.12.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.centersNumber",
"comment": "Cardinality: 0..1, if Resource.studyDesign.centers == 'Multicentric'; otherwise 0..0 / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.subject",
"min": 1,
"definition": "Primary study subject, i.e. a person, an animal or some other type of the subject.",
"short": "Primary study subject",
"mapping": [ {
"map": "1.17.19",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.13",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-subject-snomedct"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.subject",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DDI [5]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling",
"min": 0,
"definition": "Group of items providing information about the applied sampling method.",
"short": "Sampling method",
"mapping": [ {
"map": "1.17.20",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.14",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.method",
"min": 1,
"definition": "Type of the sampling method applied for the selection of study participants.",
"short": "Applied sampling method",
"mapping": [ {
"map": "1.17.20.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.14.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-sampling-method-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.method",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DDI [15]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.probabilityMethod",
"min": 0,
"definition": "Specific type of the probability sampling method applied for the selection of study participants.",
"short": "Specific type of probability sampling",
"mapping": [ {
"map": "1.17.20.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
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"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-sampling-prob-method-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.probabilityMethod",
"comment": "Cardinality: 0..1, if study_sampling_method == 'Probability'; otherwise 0..0 / Short Input Help: If known, select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DDI [15]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.nonProbabilityMethod",
"min": 0,
"definition": "Specific type of the probability sampling method applied for the selection of study participants.",
"short": "Specific type of non-probability sampling",
"mapping": [ {
"map": "1.17.20.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.14.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-sampling-method-non-prob-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.sampling.nonProbabilityMethod",
"comment": "Cardinality: 0..1, if study_sampling_method == 'Non-probability'; otherwise 0..0 / Short Input Help: If known, select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, DDI [15]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource",
"min": 0,
"definition": "Group of items providing information about data sources from which study data are generated or extracted.",
"short": "Data sources from which study data are generated or extracted.",
"mapping": [ {
"map": "1.17.21",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.15",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.general",
"min": 0,
"definition": "Different types of data sources from which study data are generated or extracted.",
"short": "Data sources for the study (e.g. biosamples, registries, questionnaires, etc.)",
"mapping": [ {
"map": "1.17.21.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.16",
"identity": "NFDI4Health-V2.1"
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"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sources-general-umls-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.general",
"comment": "Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, Maelstrom [10], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.biosamples",
"min": 0,
"definition": "Specification of biosamples collected in the study.",
"short": "Biosamples collected in the study",
"mapping": [ {
"map": "1.17.21.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.16.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-ds-biosamples-snomedct-nci-umls"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.biosamples",
"comment": "Cardinality: 0..*, if Resource.studyDesign.dataSource.general == 'Biological samples'; otherwise 0..0 / / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, Maelstrom [10], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.imaging",
"min": 0,
"definition": "Specification of imaging data collected in the study.",
"short": "Imaging data collected in the study",
"mapping": [ {
"map": "1.17.21.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.16.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sources-imaging-nci"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.imaging",
"comment": "Cardinality: 0..*, if Resource.studyDesign.dataSource.general == 'Imaging data'; otherwise 0..0 / / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, Maelstrom [10], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.omics",
"min": 0,
"definition": "Specification of omics technology applied in the study.",
"short": "Omics technology used in the study",
"mapping": [ {
"map": "1.17.21.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.16.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sources-omics-nci-umls"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.omics",
"comment": "Cardinality: 0..*, if Resource.studyDesign.dataSource.general == 'Omics technology'; otherwise 0..0 / / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, Maelstrom [10], MIABIS [8]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.description",
"min": 0,
"definition": "If needed, additional descriptive information about study data sources, e.g. indication of the data source(s) not listed in the property 'Data sources for the study' or more detailed description of the selected data sources.",
"short": "Additional information about data sources",
"mapping": [ {
"map": "1.17.21.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.16.1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSource.description",
"comment": "Short Input Help: E.g., indication of the data source(s) not listed in the field 'Data sources for the study' or more detailed description of the selected data sources. / / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.primaryPurpose",
"min": 0,
"definition": "Specification of the main purpose of the study.",
"short": "Primary purpose of the study",
"mapping": [ {
"map": "1.17.22",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.17",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-purpose-umls-nci"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.primaryPurpose",
"comment": "Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may be not appplicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. / Short Input Help: Foremost for interventional studies, please specify the primary purpose why the study was conducted. For non-interventional studies, this field may be 'Not appplicable' as multiple purposes may be defined as primary ones. / / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria",
"min": 0,
"definition": "Group of items providing information about eligibility criteria for study participants.",
"short": "Eligibility criteria for study participants",
"mapping": [ {
"map": "1.17.23",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin",
"min": 0,
"definition": "Group of items providing information about the minimum eligible age of study participants.",
"short": "Eligibility criteria: Minimum age",
"mapping": [ {
"map": "1.17.23.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin.number",
"min": 1,
"definition": "Numerical value of the minimum age of potential participants eligible to participate in the study.",
"short": "Minimum eligible age",
"mapping": [ {
"map": "1.17.23.1.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin.number",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin.timeUnit",
"min": 1,
"definition": "Unit of time.",
"short": "Unit of time.",
"mapping": [ {
"map": "1.17.23.1.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMin.timeUnit",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax",
"min": 0,
"definition": "Group of items providing information about the maximum eligible age of study participants.",
"short": "Eligibility criteria: Maximum age",
"mapping": [ {
"map": "1.17.23.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax.number",
"min": 1,
"definition": "Numerical value of the maximum age of potential participants eligible to participate in the study.",
"short": "Maximum eligible age",
"mapping": [ {
"map": "1.17.23.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax.number",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax.timeUnit",
"min": 1,
"definition": "Unit of time.",
"short": "Unit of time.",
"mapping": [ {
"map": "1.17.23.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.2.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.ageMax.timeUnit",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.genders",
"min": 0,
"definition": "Gender of potential participants eligible to participate in the study.",
"short": "Eligible gender",
"mapping": [ {
"map": "1.17.23.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-eligibility-gender-snomedct-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.genders",
"comment": "Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.inclusionCriteria",
"min": 0,
"definition": "Inclusion criteria for participation in the study.",
"short": "Inclusion criteria",
"mapping": [ {
"map": "1.17.23.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.inclusionCriteria",
"comment": "Short Input Help: If possible, use an enumerated or bulleted list for each criterion. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.exclusionCriteria",
"min": 0,
"definition": "Exclusion criteria for participation in the study.",
"short": "Exclusion criteria",
"mapping": [ {
"map": "1.17.23.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.18.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.eligibilityCriteria.exclusionCriteria",
"comment": "Short Input Help: If possible, use an enumerated or bulleted list for each criterion. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.population",
"min": 0,
"definition": "Additional descriptive information providing more details about study population.",
"short": "Description of study population",
"mapping": [ {
"map": "1.17.24",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.19",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.population",
"comment": "Short Input Help: Any information important for the given study population can be specified here. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], Maelstrom [10]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.targetSampleSize",
"min": 0,
"definition": "Intended number of observational units for the whole study (e.g. intended number of study participants at all study sites).",
"short": "Target sample size",
"mapping": [ {
"map": "1.17.25",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.20",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.targetSampleSize",
"comment": "Short Input Help: Enter '-1' if target sample size was not set or is unknown. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.obtainedSampleSize",
"min": 0,
"definition": "Obtained number of observational units for the whole study (e.g. obtained number of study participants at all study sites). The value is only available after the end of recruitment.",
"short": "Obtained sample size",
"mapping": [ {
"map": "1.17.26",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.21",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.obtainedSampleSize",
"comment": "Short Input Help: Enter '-1' if obtained sample size was not set or is unknown. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined",
"min": 0,
"definition": "Group of items providing information about the actual minimum age of study participants at the time of examination.",
"short": "Actual minimum age of participants",
"mapping": [ {
"map": "1.17.27",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.22",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined.number",
"min": 1,
"definition": "Numerical value of the minimum age of study participants at the time of examination.",
"short": "Actual minimum age of participants",
"mapping": [ {
"map": "1.17.27.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.22.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined.number",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined.timeUnit",
"min": 1,
"definition": "Unit of time",
"short": "Unit of time",
"mapping": [ {
"map": "1.17.27.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.22.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMinExamined.timeUnit",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined",
"min": 0,
"definition": "Group of items providing information about the actual maximum age of study participants at the time of examination.",
"short": "Actual maximum age of participants",
"mapping": [ {
"map": "1.17.28",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.23",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined.number",
"min": 1,
"definition": "Numerical value of the maximum age of study participants at the time of examination.",
"short": "Actual maximum age of participants",
"mapping": [ {
"map": "1.17.28.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.23.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "integer"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined.number",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined.timeUnit",
"min": 1,
"definition": "Unit of time",
"short": "Unit of time",
"mapping": [ {
"map": "1.17.28.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.23.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.ageMaxExamined.timeUnit",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.hypothesis",
"min": 0,
"definition": "Statement of the research questions and/or hypotheses underlying the study.",
"short": "Research questions and/or hypothesis underlying the study",
"mapping": [ {
"map": "1.17.29",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.24",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.hypothesis",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, ISRCTN [21]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups",
"min": 0,
"definition": "Group of items providing information about arms or groups/cohorts of the study.",
"short": "Arms or groups/cohorts of the study",
"mapping": [ {
"map": "1.17.30",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.25",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.label",
"min": 1,
"definition": "Short name used to identify the arm/group.",
"short": "Name of the arm/group",
"mapping": [ {
"map": "1.17.30.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.25.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.label",
"comment": "Additional Information: For interventional studies: 'Arm' means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. For non-interventional studies: 'Group' means a predefined group (cohort) of participants to be studied. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.type",
"min": 1,
"definition": "Role of the given arm in the study.",
"short": "Role of the arm",
"mapping": [ {
"map": "1.17.30.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.25.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-arm-group-type-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.type",
"comment": "Cardinality: 1..1, if Resource.studyDesign.primaryDesign =='Interventional'; otherwise 0..0 / Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.description",
"min": 0,
"definition": "Additional descriptive information about the given arm/group.",
"short": "Additional information about the arm/group",
"mapping": [ {
"map": "1.17.30.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.25.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.armsGroups.description",
"comment": "Additional Information: For interventional studies: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. For non-interventional studies: Explanation of the nature of the study group (for example, those with a condition and those without a condition; those with an exposure and those without an exposure). / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions",
"min": 0,
"definition": "Group of items providing information about study interventions or exposures.",
"short": "Interventions/exposures of the study",
"mapping": [ {
"map": "1.17.31",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.26",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions",
"comment": "Additional Information: The items may be not applicable for non-interventional studies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.name",
"min": 1,
"definition": "A short descriptive name of the intervention/exposure.",
"short": "Name of the intervention/exposure",
"mapping": [ {
"map": "1.17.31.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.26.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.name",
"comment": "Additional Information: Please specify the intervention(s)/exposure associated with each arm/group. / Short Input Help: If the same intervention/exposure is associated with more than one arm or group, provide the information once and use the field 'Name of the associated study arm/group' to associate it with more than one arm/group. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.type",
"min": 0,
"definition": "General type of the given intervention/exposure.",
"short": "Type of the intervention/exposure",
"mapping": [ {
"map": "1.17.31.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.26.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-intervention-type-nci-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.type",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.description",
"min": 0,
"definition": "If needed, additional descriptive information about the given intervention/exposure.",
"short": "Additional information about the intervention/exposure",
"mapping": [ {
"map": "1.17.31.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.26.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.description",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.armsGroupsLabel",
"min": 0,
"definition": "Name of the study arm associated with the given intervention. ",
"short": "Name of the arm/group associated with the given intervention",
"mapping": [ {
"map": "1.17.31.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.26.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventions.armsGroupsLabel",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes",
"min": 0,
"definition": "Group of items providing information about outcome measure(s).",
"short": "Outcome measure(s)",
"mapping": [ {
"map": "1.17.32",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.27",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes",
"comment": "Additional Information: The items are optional for non-interventional studies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.type",
"min": 1,
"definition": "Type of the outcome measure.",
"short": "Type of the outcome measure",
"mapping": [ {
"map": "1.17.32.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.27.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-outcome-type-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.type",
"comment": "Cardinality: 1..1, if (Resource.studyDesign.studyOutcomes.title != Null OR Resource.studyDesign.studyOutcomes.description != Null); otherwise 0..0/ Short Input Help: Primary or secondary outcome measure? / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.title",
"min": 0,
"definition": "Name of the outcome measure. For non-interventional studies, this can be the name of specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.",
"short": "Name of the outcome measure",
"mapping": [ {
"map": "1.17.32.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.27.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.title",
"comment": "Short Input Help: For non-interventional studies, this can be specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.description",
"min": 0,
"definition": "Additional descriptive information about the given outcome",
"short": "Description of the outcome measure",
"mapping": [ {
"map": "1.17.32.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.27.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.description",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.timeFrame",
"min": 0,
"definition": "Description of the time point(s) at which the measurement for the outcome is assessed, e.g. the specific duration of time over which each participant is assessed.",
"short": "Time point(s) of assessment",
"mapping": [ {
"map": "1.17.32.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.27.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.studyOutcomes.timeFrame",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.comment",
"min": 0,
"definition": "Any additional information about specific aspects of the study that cannot be captured by other properties.",
"short": "Any additional information about the study",
"mapping": [ {
"map": "1.17.33",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.28",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.comment",
"comment": "Short Input Help: Any additional information about specific aspects of the study that cannot be captured by other properties. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.assessments",
"min": 0,
"definition": "Assessments/measurements included in the study",
"short": "Further assessments/measurements included in the study",
"mapping": [ {
"map": "1.17.34",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "NA",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-assessments-snomedct-umls"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.assessments",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, ENPADASI [22]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan",
"min": 1,
"definition": "Group of items providing information about the data sharing strategy of the study.",
"short": "Information about data sharing",
"mapping": [ {
"map": "1.17.35",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.generally",
"min": 1,
"definition": "Indication whether there is a plan to make data collected in the study available. In case of studies with patients or other individuals, this refers to individual participant data (IPD).",
"short": "Is it planned to share the data?",
"mapping": [ {
"map": "1.17.35.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-undecided-snomedct-nci"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.generally",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.supportingInformation",
"min": 0,
"definition": "Supporting information/documents which will be made available in addition to the study data.",
"short": "Supporting documents available in addition to the data",
"mapping": [ {
"map": "1.17.35.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-sup-inf-umls-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.supportingInformation",
"comment": "Cardinality: 0..*, if Resource.studyDesign.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.timeFrame",
"min": 0,
"definition": "Indication when the data and, if applicable, supporting documents will become available and for how long.",
"short": "When and for how long will the data be available?",
"mapping": [ {
"map": "1.17.35.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.timeFrame",
"comment": "Cardinality: 0..1, if Resource.studyDesign.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.accessCriteria",
"min": 0,
"definition": "Indication by what access criteria data will be shared, including: a) with whom, b) for what types of analyses, and c) by what mechanism.",
"short": "Criteria for the data access",
"mapping": [ {
"map": "1.17.35.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.accessCriteria",
"comment": "Cardinality: 0..1, if Resource.studyDesign.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0 / Short Input Help: E.g., with whom, for what types of analyses and by what mechanism the data will be shared. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.description",
"min": 0,
"definition": "Additional descriptive information providing more details about the data sharing, e.g. indication what data in particular will be shared or why the data will not be shared or why it is not yet decided.",
"short": "Additional information about data sharing",
"mapping": [ {
"map": "1.17.35.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.description",
"comment": "Short Input Help: E.g., indication what data in particular will be shared or why the data will not be shared or why it is not yet decided / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.datashield",
"min": 0,
"definition": "Indication, whether the DataSHIELD/Opal infrastructure is available.",
"short": "Is the DataSHIELD/Opal infrastructure available?",
"mapping": [ {
"map": "1.17.35.6",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-ds-snomedct-umls"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.datashield",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.url",
"min": 0,
"definition": "If existing, a link to the web page where additional information about data sharing can be found.",
"short": "Web page with additional information about data sharing",
"mapping": [ {
"map": "1.17.35.7",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.29.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "url"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.dataSharingPlan.url",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: Taichman DB, et al. [7], CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional",
"min": 0,
"definition": "Group of items providing information about specific aspects of interventional studies or substudies.",
"short": "Information about specific aspects of non-interventional studies/substudies",
"mapping": [ {
"map": "1.17.36",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional",
"comment": "Cardinality: 0..1, if Resource.studyDesign.primaryDesign =='Non-interventional'; otherwise 0..0/ Additional Information: Group of items applicable only to non-interventional studies and substudies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.timePerspectives",
"min": 0,
"definition": "Temporal design of the study, i.e. the relationship of observation period to time of participant enrollment.",
"short": "Temporal design of the study",
"mapping": [ {
"map": "1.17.36.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-time-perspectives-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.timePerspectives",
"comment": "Short Input Help: Is it a retrospective, prospective or cross-sectional study? / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.targetFollowUpDuration",
"min": 0,
"definition": "If applicable, anticipated time period over which each participant is to be followed, provided in years.",
"short": "Target follow-up duration",
"mapping": [ {
"map": "1.17.36.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "decimal"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.targetFollowUpDuration",
"comment": "Short Input Help: The value must be provided in years. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.biospecimenRetention",
"min": 0,
"definition": "Indication whether samples of biomaterial from study participants are retained in a biorepository.",
"short": "Which biosamples are retained in a biorepository?",
"mapping": [ {
"map": "1.17.36.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.1.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-biospecimen-retention-umls"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.biospecimenRetention",
"comment": "Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.biospecimenDescription",
"min": 0,
"definition": "Additional information about biosamples to be retained, i.e. which specific types of biospecimens will be retained (e.g. blood, serum, urine, etc.).",
"short": "Specific types of retained biosamples",
"mapping": [ {
"map": "1.17.36.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.1.3.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.nonInterventional.biospecimenDescription",
"comment": "Cardinality: 0..1, if Resource.studyDesign.nonInterventional.biospecimenRetention != 'None retained'; otherwise 0..0 / Short Input Help: Which specific types of biosamples will be retained (e.g. blood, serum, urine, etc.)? / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional",
"min": 0,
"definition": "Group of items providing information about specific aspects of interventional studies or substudies.",
"short": "Information about specific aspects of interventional studies/substudies",
"mapping": [ {
"map": "1.17.37",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional",
"comment": "Cardinality: 0..1, if Resource.studyDesign.primaryDesign =='Interventional'; otherwise 0..0 / Short Input Help: Group of items applicable only to interventional studies and substudies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.phase",
"min": 0,
"definition": "If applicable, numerical phase of the study.",
"short": "Numerical phase of the study",
"mapping": [ {
"map": "1.17.37.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-phase-nci"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.phase",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking",
"min": 0,
"definition": "Group of items providing information about the masking of intervention(s) assignment.",
"short": "Information about masking of intervention(s) assignment",
"mapping": [ {
"map": "1.17.37.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"constraint": [ {
"key": "smg",
"human": "Cardinality: 0..*, if Resource.studyDesign.interventional.masking.general == true; otherwise 0..0",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/LogicalModel/nfdi4health-lm-metadataschema-general-v3",
"severity": "error",
"expression": "Resource.studyDesign.interventional.masking.general = false implies Resource.studyDesign.interventional.masking.roles.exists().not()"
} ],
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.general",
"min": 0,
"definition": "Indication, whether a masking (or blinding) of intervention(s) assignment is implemented (i.e., whether someone is prevented from having knowledge of the interventions assigned to individual participants).",
"short": "Is masking of intervention(s) assignment implemented?",
"mapping": [ {
"map": "1.17.37.2.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.2.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.general",
"comment": "Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.roles",
"min": 0,
"definition": "If masking is implemented, the party(ies) who are masked.",
"short": "Who is masked?",
"mapping": [ {
"map": "1.17.37.2.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.2.1.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-masking-roles-nci-local"
},
"max": "*",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.roles",
"comment": "Cardinality: 0..*, if Resource.studyDesign.interventional.masking.general == true; otherwise 0..0 / Short Input Help: Select all that apply. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.description",
"min": 0,
"definition": "If needed, additional descriptive information about masking (e.g. information about other parties who may be masked).",
"short": "Additional information about masking",
"mapping": [ {
"map": "1.17.37.2.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.2.1.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.masking.description",
"comment": "Cardinality: 0..1, if Resource.studyDesign.interventional.masking.general == true; otherwise 0..0 / Short Input Help: If needed, additional information about masking, e.g. other parties who may be masked. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.allocation",
"min": 0,
"definition": "Type of allocation/assignment of individual study participants to an arm.",
"short": "Type of allocation of participants to an arm",
"mapping": [ {
"map": "1.17.37.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-allocation-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.allocation",
"comment": "Short Input Help: Select one value from the list. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2], DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.offLabelUse",
"min": 0,
"definition": "Unapproved (off-label) use of a drug product. ",
"short": "Off-label use of a drug product",
"mapping": [ {
"map": "1.17.37.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.15.1.2.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-not-applicable-snomedct"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.studyDesign.interventional.offLabelUse",
"comment": "Short Input Help: Select 'Yes' or 'No' only for drug studies and 'Not applicable' for all other studies. / Display information? (Data capturing): yes / Display information? (Data visualization): yes / Source of the property and/or allowed values: DRKS [3]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance",
"min": 1,
"definition": "Group of items providing information about provenance aspects of the data entry on the portal.",
"short": "Information about provenance aspects of the data entry",
"mapping": [ {
"map": "1.18",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.dataSource",
"min": 1,
"definition": "Source of information about the resource and the way it was uploaded/collected.",
"short": "Source of information about the [RESOURCE]",
"mapping": [ {
"map": "1.18.1",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.1",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "Coding"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-provenance-data-source-local"
},
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.dataSource",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): yes / Source of the property and/or allowed values: NFDI4Health"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.verificationDate",
"min": 0,
"definition": "Date on which the responsible party last verified the information about the resource, even if no additional or updated information is being submitted.",
"short": "Verification date",
"mapping": [ {
"map": "1.18.2",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.2",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.verificationDate",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.verificationUser",
"min": 0,
"definition": "User who last verified the information about the resource.",
"short": "User who last verified the [RESOURCE]",
"mapping": [ {
"map": "1.18.3",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.3",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.verificationUser",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstSubmittedDate",
"min": 0,
"definition": "Date when the resource was first submitted for publication.",
"short": "Date when the [RESOURCE] was first submitted for publication",
"mapping": [ {
"map": "1.18.4",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.4",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstSubmittedDate",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstSubmittedUser",
"min": 0,
"definition": "User who first submitted the [RESOURCE] for publication.",
"short": "User who first submitted the [RESOURCE] for publication",
"mapping": [ {
"map": "1.18.5",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.5",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstSubmittedUser",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstPostedDate",
"min": 0,
"definition": "Date when the resource was first posted/published.",
"short": "Date when the [RESOURCE] was first posted/published",
"mapping": [ {
"map": "1.18.6",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.6",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstPostedDate",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstPostedUser",
"min": 0,
"definition": "User who first posted/published the resource.",
"short": "User who first posted/published the [RESOURCE]",
"mapping": [ {
"map": "1.18.7",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.7",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.firstPostedUser",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdateSubmittedDate",
"min": 0,
"definition": "Date when the last update of the resource was submitted for publication.",
"short": "Date when the last update of the [RESOURCE] was submitted for publication",
"mapping": [ {
"map": "1.18.8",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.8",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdateSubmittedDate",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdateSubmittedUser",
"min": 0,
"definition": "User who submitted the last update of the resource.",
"short": "User who submitted the last update of the [RESOURCE]",
"mapping": [ {
"map": "1.18.9",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.9",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdateSubmittedUser",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdatePostedDate",
"min": 0,
"definition": "Date when the last update of the resource was posted/published.",
"short": "Date when the last update of the [RESOURCE] was posted/published",
"mapping": [ {
"map": "1.18.10",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.10",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "date"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdatePostedDate",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): yes / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdatePostedUser",
"min": 0,
"definition": "User who posted/published the last update.",
"short": "User who posted/published the last update",
"mapping": [ {
"map": "1.18.11",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.11",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.lastUpdatePostedUser",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
}, {
"path": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.resourceVersion",
"min": 0,
"definition": "Version number of the resource within the portal/system.",
"short": "Version number of the resource within the portal/system",
"mapping": [ {
"map": "1.18.12",
"identity": "NFDI4Health-V3-Internal-Numbering"
}, {
"map": "1.16.12",
"identity": "NFDI4Health-V2.1"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "nfdi4health-lm-metadataschema-general-v3.Resource.provenance.resourceVersion",
"comment": "Display information? (Data capturing): no / Display information? (Data visualization): no / Source of the property and/or allowed values: CT.gov [2]"
} ]
},
"contact": [ {
"telecom": [ {
"value": "https://www.nfdi4health.de",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Element"
}