NFDI4Health Task Force COVID-19 Metadata Schema Mapping

Selected Cell

Cell:

Value:

NFDI4HealthTF.Entity	NFDI4HealthTF.Entity.Item	HL7 FHIR	CDISC ODM, SDM, CTR-XML	WHO ICTRP	DRKS	DataCite
ResourceHierarchy	parent_id	ResearchStudy.partOf
Resource	resource_id	ResearchStudy.id
Resource	resource_type	ResearchStudy	odm:Study			ResourceType
Resource	resource_type_general	DomainResource				ResourceType.resourceTypeGeneral
Resource	resource_language	ResearchStudy.language	xml:lang			Language
Resource	resource_web_page	ResearchStudy.contact.telecom.value when ResearchStudy.contact.telecom.system=url		web address	url
Resource	resource_use_rights					Rights
ResourceDescription	description_text	ResearchStudy.description	odm:StudyDescription sdm:Summary ctr:StudyDetailedDescription		scientificSynopsis, publicSummary	Description (when Description.descriptionType=="Abstract")
ResourceDescription	description_language	ResearchStudy.description (Translation extension)	xml:lang
ResourceTitle	title	ResearchStudy.title	odm:StudyName bzw. ctr:PublicTitle		title	Title
ResourceTitle	title_type			Scientific title
ResourceTitle	title_language	ResearchStudy.title (Translation extension)	xml:lang
ResourceAcronym	acronym			Acronym	acronym
ID	ID_type	ResearchStudy.identifier.assigner	ctr:Registration.Type="Primary" && ctr:Registration.RegistrationAuthority		Creator.nameIdentifier	ID_type=="DOI"; Creator.nameIdentifier.nameIdentifierScheme; Creator.affiliation.affiliationIdentifier.b affiliationIdentifierSche me Contributor.nameIdentifier.nameIdentifierScheme; Contributor.affiliation.affiliationIdentifier.affiliationIdentifierScheme; alternateIdentifierType.alternateIdentifierType; RelatedIdentifier.relatedIdentifierType; FundingReference.funderIdentifier.funderIdentifierType
ID	ID	ResearchStudy.identifier.value	ctr:Registration.Type="Primary" && ctr:Registration.RegistrationID bzw. ctr:Registration.Type="Secondary" && ctr:Registration RegistrationID	TrialID	drksId; secId.id0	Identifier; Creator.nameIdentifier.nameIdentifierScheme; Creator.affiliation.affiliationIdentifier Contributor.nameIdentifier.nameIdentifierScheme; Contributor.affiliation.affiliationIdentifier; alternateIdentifier; RelatedIdentifier; FundingReference.funderIdentifier
ID	ID_date	ResearchStudy.identifier.period	ctr:Registration.Type="Primary" && ctr:Registration.RegistrationDate	Date registration	firstDrksPublishDate	PublicationYear
ID	RelationType					RelatedIdentifier.relationType
Roles	role_type	ResearchStudy.sponsor resp. ResearchStudy.principalInvestigator	ctr:Contact UserOID ContactRole="CONTACT FOR PUBLIC QUERIES" ContactRoleCodeListOID="CL.CONTACTROLES"		address.type0; materialSupport.type0	Contributor.contributorType
Roles	role_name	ResearchStudy.sponsor.name resp. ResearchStudy.principalInvestigator.name	ctr:Contact UserOID ContactRole="CONTACT FOR SCIENTIFIC QUERIES" ContactRoleCodeListOID="CL.CONTACTROLES" bzw. ctr:Contact UserOID	Contact Lastname, Contact Firstname; Primary sponsor (when role_type = "Sponsor" && role_specific_type = "Primary")	address.lastname0, address.firstname0; materialSupport.affiliation0	Creator.creatorName, Creator.familyName, Creator.givenName; Publisher; Contributor.contributorName; FundingReference.funderName
Roles	role_email	ResearchStudy.sponsor.telecom.value when ResearchStudy.sponsor.telecom.system=email resp. ResearchStudy.principalInvestigator.telecom.value when ResearchStudy.principalInvestigator.telecom.system=email	ctr:Organization.Email	Contact Email	address.email0; materialSupport.email0
Roles	role_phone	ResearchStudy.sponsor.telecom.value when ResearchStudy.sponsor.telecom.system=phone resp. ResearchStudy.principalInvestigator.telecom.value when ResearchStudy.principalInvestigator.telecom.system=phone	ctr:Organization.Fax	Contact Tel	address.telephone0; materialSupport.telephone0
Roles	role_web_page	ResearchStudy.sponsor.telecom.value when ResearchStudy.sponsor.telecom.system=url resp. ResearchStudy.principalInvestigator.telecom.value when ResearchStudy.principalInvestigator.telecom.system=url			address.url0; materialSupport.url0
Roles	role_address	ResearchStudy.sponsor.address.text	ctr:Organization.Address	Contact Affiliation, Contact Address	address.affiliation0, address.streetAndNo0, address.zip0, address.city0, address.land0; materialSupport.affiliation0, materialSupport.streetAndNo0, materialSupport.zip0, materialSupport.city0, materialSupport.land0
Roles	role_specific_type	PractitionerRole	ctr:Role		materialSupport.type0
StudyDesign	study_primary_design	ResearchStudy.category	sdm:Parameter.Term="Observational Model" / sdm:Parameter.Term="StudyType"	Study type	type
StudyDesign	study_type				assignment
StudyDesign	study_hypothesis	ResearchStudy.description
StudyDesign	study_analysis_unit	ResearchStudy.focus	sdm:Parameter OID="OBSMODEL"
StudyDesign	study_status	ResearchStudy.status	ctr:RecruitmentStatus.CurrentStatus	Recruitment Status	recruitmentStatus
StudyDesign	study_eligibility	ResearchStudy.enrollment	sdm:InclusionExclusionCriteria > sdm:InclusionCriteria > sdm:Criterion	Inclusion Criteria, Exclusion Criteria	inclusion, exclusion
StudyDesign	study_sampling	ResearchStudy.category	sdm:Parameter OID="PAR.AGESPAN"
StudyDesign	study_country	ResearchStudy.location	ctr:RecruitmentCountries	Countries	recruitmentCountries.value0	GeoLocation.geoLocationPlace
StudyDesign	study_region	ResearchStudy.location				GeoLocation.geoLocationPlace
StudyDesign	study_conditions	ResearchStudy.condition	sdm:Parameter ShortName="INDIC" Term="Trial Indication" > sdm:Value	Condition	indication.type0, indication.key0, indication.value0
StudyDesign	study_population		sdm:Parameter OID="OBSTPOPD"
StudyDesign	study_target_sample_size		sdm:Parameter.Term="Planned Number of Subjects	Target size	targetSize
StudyDesign	study_obtained_sample_size
StudyDesign	study_age_min		sdm:Parameter OID="PAR.AGEMIN"	Inclusion agemin	minAge.amount, minAge.unit
StudyDesign	study_age_max		sdm:Parameter OID="PAR.AGEMAX"	Inclusion agemax	maxAge.amount, maxAge.unit
StudyDesign	study_start_date	ResearchStudy.period	ctr:StudyStartDate	Date enrollement	startDate	Date (when Date.dateType== "Collected")
StudyDesign	study_end_date	ResearchStudy.period	ctr:StudyEndDate		studyEnd	Date (when Date.dateType== "Collected")
StudyDesign	study_datasource
StudyDesign	study_design_comment	ResearchStudy.note
InterventionalStudyDesign	study_interventions	ResearchStudy.arm	ctr:Interventions > ctr:Intervention.InterventionType	Intervention	intervention.category0, intervention.value0
InterventionalStudyDesign	study_primary_outcomes	ResearchStudy.objective.name when ResearchStudy.objective.type=primary	ctr:OutcomeMeasures	Primary outcome	primaryEndpoint
InterventionalStudyDesign	study_secondary_outcomes	ResearchStudy.objective.name when ResearchStudy.objective.type=secondary	ctr:OutcomeMeasures		secondaryEndpoints
InterventionalStudyDesign	study_phase	ResearchStudy.phase	sdm:Parameter OID="IT.TPHASE"	Phase	phase


Short dokument description
This document contains elements of the NFDI4Health Task Force COVID-19 Metadata Schema and their mappings to other standards (HL7 FHIR, CDISC ODM, SDM, CTR-XML, DataCite) as well as data formats of some clinical trials registries (ICTRP, DRKS).

Contacts
For questions, please contact contact@nfdi4health.de.

Acknowledgement
This work was done as part of the NFDI4Health Task Force COVID-19 (www.nfdi4health.de). We gratefully acknowledge the financial support of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) – Project Number 451265285.

License
This work is licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) License. To view a copy of the license, visit https://creativecommons.org/licenses/by/4.0/legalcode.