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| NFDI4Health Metadata Schema (MDS) | ResearchStudy | Questionnaire | DocumentReference | ||||||||||||||||||||||
| NFDI.Entity | NFDI.Entity.Item | Obligation: Mandatory / Recommended | Field type | Allowed Values | Data item description | General NFDI.Items (applicable for each type of NFDI resources) | NFDI.Items related to Studies only | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Sets / Terminologies | Binding strength | Studies_ Mapping_high_level | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Sets / Terminologies | Binding strength | Questionnaires_ Mapping_high_level | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Sets / Terminologies | Binding strength | Documents _Mapping_high_level |
| Resource | resource_type | Mandatory | Drop-down | Study, Substudy, Dataset, StudyProtocol, ProtocolAmendment, DataDictionary, InformedConsentForm, PatientInformationSheet, Manual of Operations (SOPs), StatisticalAnalysisPlan, DataManagementPlan, CaseReportForm, CodeBook, Questionnaire, InterviewSchemeAndThemes, ObservationGuide, DiscussionGuide, ParticipantTasks, OtherDataCollectionInstrument, OtherStudyDocument, Other | A short description of the resource. Select one value from the drop-down list. | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
| Resource | resource_type_general | Mandatory | Drop-down | Audiovisual, Collection, DataPaper, Dataset, Event, Image, InteractiveResource, Model, PhysicalObject, Service, Software, Sound, Text, Workflow, Other | A more general description of the resource. It is used to enable DOI-assignment. The categories are predefined by DataCite. For category definitions and examples, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/ Example: If a resource (i.e., resource_type) is a “Study”, use “Other.” If a resource(i.e., resource_type) is a “OtherStudyDocument”, use here “Text.” | 1 | 0 | ResearchStudy.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 |
| Resource | resource_language | Recommended | Drop-down | EN, DE, FR, ES | The primary language of the resource. | 1 | 0 | ResearchStudy.language | 0..1 | Code | Common Languages | Preferred | 0 | Questionnaire.language | 0..1 | Code | Common Languages | Preferred | 0 | DocumentReference.language | 0..1 | Code | Common Languages | Preferred | 0 |
| Resource | resource_use_rights | Mandatory | Text | CC BY 4.0 CC BY-ND 4.0 N/A Other | License defining the rights to re-use the resource. In lines with the FAIR Guiding Principles, an open license is preferred. “N/A” can be selected if a license is not applicable (e.g., for metadata of a resource). “Other” can be selected in case if another license type is assigned or if it is unknown. | 1 | 0 | ResearchStudy.extension[Use_rights].valueString | 0..1 | String | -9 | -9 | 1 | Questionnaire.copyright | 0..1 | markdown | -9 | -9 | 0 | DocumentReference.extension[Use_rights].valueString | 0..1 | String | -9 | -9 | 1 |
| Resource | resource_web_page | Recommended | Text | If existing, web page directly relevant to the resource | 1 | 0 | ResearchStudy.RelatedArtifact.type + ResearchStudy.RelatedArtifact.url + ResearchStudy.RelatedArtifact.label | 1..1 / 0..1 / 0..1 | code / url / String | RelatedArtifactType: documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of / -9 / -9 | Required / -9 / -9 | 0 | Questionnaire.extension[Webpage].valueUrl | 0..1 | url | url | Required | 1 | DocumentReference.Content.attachment | 1..1 | Attachment | Document or URL | Required | 0 | |
| ResourceDescription | description_text | Mandatory | Text | A short plain text summary describing the resource in English language. The provided information should be understandable by a scientific audience. Description text can be additionally provided in German. | 1 | 0 | ResearchStudy.description | 0..1 | markdown | -9 | -9 | 0 | Questionnaire.description | 0..1 | markdown | -9 | -9 | 0 | DocumentReference.Description | 0..1 | string | -9 | -9 | 0 | |
| ResourceDescription | description_language | Mandatory | Drop-down | EN, DE | Language of the description | 1 | 0 | ResearchStudy.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | Questionnaire.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | DocumentReference.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 |
| ResourceTitle | title | Mandatory | Text | - | Scientific unabbreviated title of the resource. The title must be provided in English language. If original title of the resource is non-English, please provide both titles: an original title and its English translation. | 1 | 0 | ResearchStudy.title | 0..1 | string | -9 | -9 | 0 | Questionnaire.title | 0..1 | string | -9 | -9 | 0 | Extension[document_title].valueString | 0..1 | string | -9 | -9 | 1 |
| ResourceTitle | title_language | Mandatory | Drop-down | EN, DE, FR, ES | The language of the title. Currently, three languages are accepted. | 1 | 0 | ResearchStudy.title.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | Questionnaire.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | DocumentReference.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 |
| ResourceAcronym | acronym | Recommended | Text | - | If existing, the acronym of the resource. Only use an acronym that is officially used for the resource. Otherwise leave empty. | 1 | 0 | ResearchStudy.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 | Questionnaire.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 | DocumentReference.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 |
| ID | ID_type | Recommended | Drop-down | arXiv, bibcode, DOI, EAN13, EISSN, ISBN, ISSN, ISTC, LISSN, LSID, PMID, PURL, URL, URN, w3id, ORCID, ISNI, ROR, GRID, DRKS, ISRCTN, EudraCT, NCT (clinicaltrials.gov), Other | The type of ID. Several ID types can be chosen. Four main groups of ID types are available: (*) IDs usually applied to documents and publications; (**) IDs applied to persons or institutions; (***) IDs applied to clinical trials which were registered in some clinical trials register(s); (****) any other related identifier (e.g., grant number). Controlled List Values: (*) arXiv, bibcode, DOI, EAN13, EISSN, ISBN, ISSN, ISTC, LISSN, LSID, PMID, PURL, URL, URN; (**) ORCID, ISNI, ROR, GRID; (***) DRKS, UTN, ISRCTN, EudraCT, EUDAMED, NCT (clinicaltrials.gov); (****) Other | 1 | 0 | ResearchStudy.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 | Questionnaire.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 | DocumentReference.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 |
| ID | ID | Recommended | Text | - | Any identifiers associated with the resource. This can be an identifier or identifiers of the related resource(s), contributor(s), institution(s) or an alternate identifier of the given resource provided by another registering system. The format is a free text and depends on the ID Type. | 1 | 0 | ResearchStudy.Identifier with related Types, System, Assigner, etc | 0..* | identifier | -9 | -9 | 0 | Questionnaire.Identifier | 0..* | identifier | -9 | -9 | 0 | DocumentReference.Identifier DocumentReference.related | 0..* / 0..* | identifier / Reference | -9 / any | -9 / -9 | 0 |
| ID | ID_date | Recommended | Date | - | If known, the date when an ID has been assigned. Please, enter the date in the following format: DD.MM.YYYY | 1 | 0 | ResearchStudy.identifier.period | 0..1 | Period | dateTime | Required | 0 | Questionnaire.identifier.period | 0..1 | Period | dateTime | Required | 0 | DocumentReference.identifier.period | 0..1 | Period | dateTime | Required | 0 |
| ID | RelationType | Recommended | IsCitedBy, Cites IsSupplementTo, IsSupplementedBy IsContinuedBy, Continues IsDescribedBy, Describes HasMetadata, IsMetadataFor HasVersion, IsVersionOf IsNewVersionOf, IsPreviousVersionOf IsPartOf, HasPart IsReferencedBy, References IsDocumentedBy, Documents IsCompiledBy, Compiles IsVariantFormOf, IsOriginalFormOf IsIdenticalTo IsReviewedBy, Reviews IsDerivedFrom, IsSourceOf IsRequiredBy, Requires IsObsoletedBy, Obsoletes | Description of the relationship of the given resource and the related resource, person, or institution. Alternate identifiers can be also included. For definitions, examples and usage notes, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/. | 1 | 0 | ResearchStudy.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | |
| Roles | role_type | Mandatory | Drop-down | Contributor, ContactPerson, DataCollector, DataCurator, DataManager, Distributor, Editor, HostingInstitution, Producer, ProjectLeader, ProjectManager, ProjectMember, RegistrationAgency, RegistrationAuthority, RelatedPerson, Researcher, ResearchGroup, RightsHolder, Supervisor, WorkPackageLeader, Sponsor, Sponsor-Investigator, Funder, Publisher, Other | The type of contributor of the resource. For each resource there may be multiple but must be at least one role type. For definition, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/. Please note that the following terms have the meanings slightly different from DataCite definitions: “Sponsor” is an organization or person who takes responsibility for and initiates a study. “Sponsor-Investigator” is the person who both initiates and conducts the study. “Funder” is an organization or person providing financial support for a study. “ProjectLeader” is equivalent to the Principal Investigator of a study, i.e. the person who both initiates and conducts the study . | 1 | 0 | ResearchStudy.Contact.ContactDetail.extension[Role_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.Contact.ContactDetail.extension[Role_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.author.extension[Role_type].valueCodeableConcept / DocumentReference.authenticator.extension[Role_type] / DocumentReference.custodian.extension[Role_type] or set by default when selecting one of these items | 0..1 | CodeableConcept | -9 | -9 | 1 |
| Roles | role_name | Mandatory | Text | - | The name of the role in plain text. This may be a personal or an institutional name. Note: For the personal name, format should be: family name, given name. | 1 | 0 | ResearchStudy.Contact.ContactDetail.name | 0..1 | string | -9 | -9 | 0 | Questionnaire.Contact.ContactDetail.name | 0..1 | string | -9 | -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with name in related Reference (Practioner, PractitionerRole, Organization) | 0..1 | string | -9 | -9 | 0 |
| Roles | role_email | Recommended | Text | - | If applicable, the email address associated with a role. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_phone | Recommended | Text | - | If applicable, the phone number associated with a role. Please, use the International ITU-T E.164-number structure for geographic areas. Example: +49 (0)153 1112233 | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_web_page | Recommended | Text | - | If applicable, the web-page associated with a role. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_address | Recommended | Text | - | If applicable, the address associated with a role. The address includes the elements of a postal address, i.e. street, house number, city, postal code, state/province (if applicable), country. If a personal name was entered for the property “role_name”, please additionally indicate the name of the institution associated with the role. Example: ZB MED – Information Centre for Life Sciences Gleueler Str. 60 50931 Cologne, Germany | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_specific_type | Recommended | Drop-down | Sponsor: primary, secondary Funder: public/private | The classification of some role into a predefined list of specific role types. Select one value. For role type “Sponsor”: Primary, Secondary For role type “Funder” : Public, Private | 1 | 0 | ResearchStudy.Contact.ContactDetail.extension[Role_specific_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.Contact.ContactDetail.extension[Role_specific_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.author.extension[Role_specific_type].valueCodeableConcept or DocumentReference.authenticator.extension[Role_specific_type] or DocumentReference.custodian.extension[Role_specific_type] | 0..1 | CodeableConcept | -9 | -9 | 1 |
| StudyDesign | study_primary_design | Mandatory | Drop-down | non-interventional, interventional | The primary design of a study. Select between non-interventionl and interventional study design. non-interventional study: Refers to studies that do not aim to alter study outcomes of interest. Interventional study: Refers to studies that aim to alter study outcomes of interest. | 0 | 1 | ResearchStudy.category | 0..* | CodeableConcept | ResearchStudyFocus | -8 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_type | Mandatory | Drop-down | Interventional study models: Single Group, Parallel, Crossover, Factorial, Sequential, Other Non-interventionl - Observational study models: Cohort, Case-Control, Case-Only, Case-Crossover, Cross-Sectional, Ecologic or Community Studies, Family-Based, Other | In case of an interventional study, the strategy for assigning interventions to participants. In case of a non-interventional (observational) study, the primary strategy for participant identification and follow-up. | 0 | 1 | ResearchStudy.category | 0..* | CodeableConcept | ResearchStudyFocus | -8 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_hypothesis | Recommended | Text | A statement of the hypotheses underlying the study. | 0 | 1 | ResearchStudy.objective.name, ResearchStudy.objective.type | 0..1 / 0..1 | string / CodeableConcept | -9 / ResearchStudyObjectiveType | -9 / Preferred | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_analysis_unit | Recommended | Drop-down | Individual, Organization, Family, Household, Event/Process, Geographic Unit, Time Unit, Text Unit, Group, Object, Pathogens, Twins, Other | The primary units of analysis. For definitions, see the DDI Controlled Vocabulary: https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.0.html | 0 | 1 | ResearchStudy.enrollment: Reference(Group) -> Group.type (Code) | 1..1 | Code | GroupType: person | animal | practitioner | device | medication | substance | Required | 2 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_status | Mandatory | Drop-down | Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn | The process status of a study. | 0 | 1 | ResearchStudy.status | 1..1 | code | ResearchStudyStatus: active, administratively-completed, approved, closed-to-accrual, closed-to-accrual-and-intervention, completed, disapproved, in-review, temporarily-closed-to-accrual, temporarily-closed-to-accrual-and-intervention, withdrawn | Required | 2 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_eligibility | Mandatory | Text | - | Eligibility criteria for the study, if possible organized by inclusion and exclusion criteria. | 0 | 1 | ResearchStudy.enrollment.extension[Study_eligibility].valueString | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_sampling | Recommended | Drop-down | TotalUniverseCompleteEnumeration, Probability, Probability.SimpleRandom, Probability.SystematicRandom, Probability.Stratified, Probability.Stratified.Proportional, Probability.Stratified.Disproportional, Probability.Cluster, Probability.Cluster.SimpleRandom, Probability.Cluster.StratifiedRandom, Probability.Multistage, Nonprobability, Nonprobability.Availability, Nonprobability.Purposive, Nonprobability.Quota, Nonprobability.RespondentAssisted, MixedProbabilityNonprobability, Other | A description of the applied sampling methods. For definitions, see DDI Controlled Vocabulary: https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html | 0 | 1 | ResearchStudy.extension[Study_sampling].valueCodeableConcept or ResearchStudy.enrollment.extension[Study_sampling].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_country | Mandatory | Multiselect | ISO 3166-1 | The countries in which a study takes place. | 0 | 1 | ResearchStudy.location | 0..* | CodeableConcept | Jurisdiction | Extensible | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_region | Recommended | Text | If applicable, region(s) and/or cities within a country, in which a study takes place. | 0 | 1 | ResearchStudy.location | 0..* | CodeableConcept | Jurisdiction | Extensible | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_conditions | Recommended | Text | A description of the health conditions or problems which a study wants to describe. IF available enter ICD-10 or other controlled terminology. | 0 | 1 | ResearchStudy.condition | 0..* | CodeableConcept | Condition/Problem/Diagnosis Codes | Example | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_population | Mandatory | Text | A more detailed description of the study population. | 0 | 1 | ResearchStudy.extension[General_description_study_population].valueString or ResearchStudy.enrollment.extension[General_description_study_population].valueString | 0..1 | String | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_target_sample_size | Recommended | Integer | The intended number of observational units (e.g. study participants). | 0 | 1 | ResearchStudy.enrollment: Reference(Group) -> Group.quantity (unsignedInt) + Group.actual (boolean) | 0..* | unsignedInt / boolean | Any non-negative integer in the range 0..2,147,483,647 / boolean (actual or descriptive) | Required / required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_obtained_sample_size | Recommended | Integer | The obtained sample size of a study. (Is only available after recruitment ends.) | 0 | 1 | ResearchStudy.enrollment: Reference(Group) -> Group.quantity (unsignedInt) + Group.actual (boolean) | 0..* | unsignedInt / boolean | Any non-negative integer in the range 0..2,147,483,647 / boolean (actual or descriptive) | Required / required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_age_min | Recommended | Float | The minimum age of participants for inclusion. Enter “-1”, if no limit is applicable. | 0 | 1 | ResearchStudy.enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Quantity (Quantity) + Group.characteristic.value.Exclude (boolean) + Group.actual (boolean) or ResearchStudy.enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Range (Range) + Group.characteristic.value.Exclude (boolean) + Group.actual (boolean) | 0..* | CodeableConcept / Quantity / boolean / boolean | -9 / decimal / boolean (includes or excludes) / boolean (actual or descriptive) | -9 / required: decimal / required / required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_age_max | Recommended | Float | The maximum age of participants for inclusion. Enter “-1”, if no limit is applicable. | 0 | 1 | ResearchStudy.enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Quantity (Quantity) + Group.characteristic.value.Exclude (boolean) + Group.actual (boolean) or ResearchStudy.enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Range (Range) + Group.characteristic.value.Exclude (boolean) + Group.actual (boolean) | 0..* | CodeableConcept / Quantity / boolean / boolean | -9 / decimal / boolean (includes or excludes) / boolean (actual or descriptive) | -9 / required: decimal / required / required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_start_date | Recommended | Date | The start date of a data collection for a study. In case of a planned study it is the intended date, incase of a started study the actual date. Please enter the date in the following format: DD.MM.YYYY | 0 | 1 | ResearchStudy.period | 0..1 | Period | dateTime: Starting time with inclusive boundary | Required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_end_date | Recommended | Date | The end date of a data collection for a study. In case of a planned or ongoing study it is the intended date, in case of a completed study the actual date. Please enter the date in the following format: DD.MM.YYYY. | 0 | 1 | ResearchStudy.period | 0..1 | Period | dateTime: End time with inclusive boundary, if not ongoing | Required | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| StudyDesign | study_datasource | Optional | Multipleselect | Questionnaires, Physical measures, Blood, Urine, Saliva, Cord blood, Tissues, Buccal cells, Hair, Nail, Cognitive measures, Imaging, Administrative databases, Other | Sources from which the data are gathered/collected. | 0 | 1 | ResearchStudy.extension[Study_data_source].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_design_comment | Optional | Text | Any information on specific study design aspects that cannot be captured by other fields. | 0 | 1 | ResearchStudy.note | 0..* | Annotation | -9 | -9 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| InterventionalStudyDesign | study_interventions | Mandatory | Text | Specification of the intervention(s) associated with each arm or group; at least one intervention must be specified. If possible, please indicate the type and the name of intervention(s). For intervention types, please refer to the definitions of the clinicaltrials.org at https://prsinfo.clinicaltrials.gov/definitions.html | 0 | 1 | ResearchStudy.arm.name + ResearchStudy.arm.type + ResearchStudy.arm.descriptions | 1..1 / 0..1 / 0..1 | string / CodeableConcept / String | -9 / -9 / -9 | -9 / -9 / -9 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| InterventionalStudyDesign | study_primary_outcomes | Mandatory | Text | A description of each primary outcome measure. If possible, arrange the information as follows: Title, Description, Time Frame. | 0 | 1 | ResearchStudy.extension[Outcome].valueString + ResearchStudy.extension[Primary_outcome] | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| InterventionalStudyDesign | study_secondary_outcomes | Recommended | Text | A description of each secondary outcome measure. If possible, arrange the information as follows: Title, Description, Time Frame. | 0 | 1 | ResearchStudy.extension[Outcome].valueString + ResearchStudy.extension[Secondary_outcome] | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | |
| InterventionalStudyDesign | study_phase | Recommended | Drop Down | n-a | preclinical |early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 | other | For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies. Select only one. | 0 | 1 | ResearchStudy.phase | 0..1 | CodeableConcept | ResearchStudyPhase | Example | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| Processes | DocumentReference.status | 1..1 | code | DocumentReferenceStatus: current, superseded, entered-in-error | Required | x | |||||||||||||||||||
| Processes | Questionnaire.status | 1..1 | code | PublicationStatus: draft, active, retired, unknown | Required | x | |||||||||||||||||||
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| Binary System to classify into general items and study specific items | |||||||||
| Category | Description | ||||||||
| 0 | FALSE | ||||||||
| 1 | TRUE | ||||||||
| Mapping_high_level | |||||||||
| Category | Description | ||||||||
| 0 | Available with FHIR standard resources | ||||||||
| 1 | Available with FHIR extensions | ||||||||
| 2 | Not available in FHIR | ||||||||
| x | To be added to the MDS | ||||||||
| -7 | Item not applicable for this resource type | ||||||||
