NARA's Agency Services Bimonthly Records and Information Discussion Group (BRIDG)
BRIDG Overview
description
Transcript of BRIDG Overview
BRIDG Overview
Clinical Observation InteroperabilityMarch 18, 2008
2
BRIDG Background
Stakeholders: HL7, CDISC, NCI/caBIG, FDA
Goals: shared semantics
Domain of Interest: protocol driven research
Project Organization: BAB, THC
3
BRIDG Content
CDISC SDTM – Submission Data Tabulation Model HL7 CDA – Clinical Document Architecture NCI/HL7/CDISC caXChange/LabHub HL7 RPS – Regulated Product Submission CDISC TDM – Trial Design Model NCI PSC – Patient Study Calendar NCI CTOM – Cancer Trial Object Model NCI/? AE – Adverse Events NCI C3PR – Cancer Central Clinical Participant
Registry
4
BRIDG Components
UML (Unified Modeling Language) Static Model: Class diagram, Object diagram
Dynamic Models: Activity diagrams, State diagrams, Sequence diagrams
Abstract Data Types (HL7) Binding to Terminologies (NCI) Mapping to application models Mapping to HL7 RIM
5
Binding to Terminologies
specifies the shared semantics at a comprehensive level
at attribute level to both local and global terminologies occurs in context of run-time instances must remain implementation independent caBIG™ Cancer Data Standards Repository
(caDSR) Enterprise Vocabulary Service (EVS)
6
Backbone – Part 1
Entity Role Participation
class PersonOrganizationView
BiologicEntity
Person
+ name: PN+ initials: ST+ postalAddress: AD+ telecomAddress: SET<TEL>+ educationLevel: CD+ ethnicGroup: SET<CD>+ householdIncome: CD+ maritalStatus: CD+ race: SET<CD>+ adoptedIndicator: BL+ eyeColor: ST- deathIndicator: BL- primaryOccupation: CD- occupationDateRange: IVL<TS>::BiologicEntity+ identifier: SET<II>+ birthOrder: INT+ birthCountry: CD+ deathDate: TS+ sex: CD+ birthDate: TS
Organization
+ identifier: SET<II>+ name: ON+ description: ST+ department: ST+ postalAddress: ST+ telecomAddress: SET<TEL>+ status: CD+ statusDateRange: IVL<TS>
Document
StudyProtocol
+ disease: SET<CD>+ phase: CD+ intent: CD+ populationDescription: ST+ blindedIndicator: BL+ subjectType: CD+ blindingSchema: CD+ multiInstitutionIndicator: BL+ randomizedIndicator: BL+ confidentiality: CD+ monitor: CD::Document+ identifier: SET<II>+ title: ST+ universalResourceLocator: ST+ bibliographicDesignation: ST+ text: ST+ summaryDescription: ST+ synopsis: ST+ type: CD+ subtype: SET<CD>+ revision: ST+ language: CD+ status: CD+ statusDateRange: IVL<TS>
StudyAuthor
Subject
+ state: ST
StudySubject
+ identifier: SET<II>+ confidentialityIndicator: BL+ paymentMethod: CD+ status: CD+ subgroup: CD+ statusDateRange: IVL<TS>+ actualSubjectIndicator: BL
ApplicationSponsor
AssociatedPerson
+ type: CD
ClinicalResearchCoordinator
ClinicalResearchStaff
DocumentAuthor
DocumentReceiv ingOrganization
DocumentReceiv ingPerson
FundingSource
+ identifier: II
HealthCareFacility
+ identifier: II+ postalAddress: AD
CentralLaboratory
HealthCareProv ider
+ identifier: II+ certificateLicenseText: ST
ManufacturerManufacturingSite
PerformingLaboratory
PerformingParty
+ actualPartyIndicator: BL
RegulatedProduct
+ approvalIdentifier: SET<II>+ authorizationType: CD+ approvalStatus: CD
RegulatoryAuthority
+ jurisdiction: CD
StudyCommittee
+ type: CD
StudyCoordinatingCenter
- responsibility: SET<CD>
StudyInvestigator
+ identifier: II+ role: CD+ dateRange: IVL<TS>+ status: CD+ statusDateRange: IVL<TS>+ signatureText: ST
StudySite
+ identifier: II+ role: CD+ accrualStatus: CD+ targetAccrualNumber: INT+ irbApprovalDate: TS+ dateRange: IVL<TS>+ status: CD+ statusDateRange: IVL<TS>
StudySponsor
+ type: CD
OrganizationalStructure
Place
Laboratory
+ identifier: II
Need to add all examples that have been identified through harmonizations.
Device Operator,Technician
Need to add OCL to state thatassociations to PerformingParty are "or".
ResearchOrganization
Distributor
Serv iceDeliveryLocation
+ locationTypeCode: CD
Member
TreatingSite
CooperativeGroup
AdministrativeMemberPI
Class needs to be defined.
AdministrativeMemberCRA
Contact
- postalAddress: AD- telecomAddress: SET<TEL>- primaryIndicator: BL
0..1
scopes / is scoped by
1
0..1
functions as/ isrepresented by
1..*
0..1
functions as/ isrepresented by
0..*
0..1
functions as/ isrepresented by
0..*
0..1
functions as/ isrepresented by
0..*
1plays / is playedby 0..1 0..1
functions as/ isrepresented by
1..*
1
plays / is playedby
0..1
0..*
functions as/ isrepresented by
1
1
functions as / isrepresented by
1..*
1
plays / is playedby
0..1
1
plays / is playedby
0..*
1
plays / is playedby
0..1
1
plays / is playedby «player» 0..*
1
plays / is playedby
0..1
0..*
executes/ isexecuted at
1
1
plays / is playedby
0..1
1
plays/ is playedby
0..1
1
plays / is playedby
0..1
1
plays / is playedby
0..*
0..*
develops / isauthored by
1
1
plays / is playedby
0..1
1
plays / is playedby
0..1
0..*
functions as/ is represented by
1
1
functions as / isrepresented by
0..*
1..*
is sponsored by /sponsors
1
0..*
is the treatmentlocation for / isassigned to
1
1
functions as/ isrepresented by
0..* 1..*
is conducted by /participates in
1
0..*
functions as / isrepresented by
1
1
manufactures at /manufactures for
0..*
1
scopes / is scoped by
0..*
1plays / is playedby
0..1
1
plays / is playedby
0..*
1
plays / is playedby
0..*
1
scopes / is scoped by
1..*
1
contains / contained in0..*
1
scopes / is scoped by
0..*
1
contains / contained in
0..*
1
plays / is playedby
0..*
1
scopes / is scoped by
1
1
scopes / is scoped by
1
1
plays / is playedby
0..*
1plays / is playedby
0..*
1
plays / is playedby
0..1
1
plays / is playedby
0..1
1
scopes / isscoped by
0..*
1
plays / isplayed by
0..*
1
plays / is playedby
0..*
1
operates as /represented by
1..*
1..*
scopes / is scoped by
1
0..*
1..*
0..1
scopes / is scoped by
1
0..*
scopes / is scoped by
1
1
plays / is playedby
0..1
1
scopes / is scoped by
0..*
1
scopes / is scoped by
0..*
1
scopes / is scoped by
1..*
7
class View 8 - Backbone - Part 2
Document
StudyProtocol
Classes to be deleted?::PlannedStudy
Activity ObservationResult
PerformedActiv ity
ScheduledActiv ity
«StudyRelationship»Activ ityRelationship
«StudyRelationship»ObservationResultRelationship
PlannedActiv ity
PerformedObservationResult
«StudyRelationship»DocumentRelationship
PerformedObservation
0..*
associates from /may be thesource for
1
0..1
is used to createa / subject-specificdescription of
0..*
0..1
isoperationalizedby/ is describedby
0..1
1..1
0..*
associates to /may be thetarget for
1
1
associates to /may be thetarget for
0..*0..*
associates from /may be thesource for1
0..*
associates from / maybe the source for
1
0..*
associates to /may be the targetfor
1
0..*
is fulfi l led by / is theinstantiation of
0..1
+disease 1..*
0..1
Name:Package:Version:Author:
View 8 - Backbone - Part 2BRIDG Release 2.0 -- Static Classes1.1BRIDG THC
Backbone – Part 2
Document Activity Result
8
class View 10 - Complete 2 - Classes with Local Attributes
Material
+ identifier: II+ name: ST+ description: ST+ form: CD+ status: CD+ statusDateRange: IVL<TS>
Organization
+ identifier: II+ name: ST+ description: ST+ postalAddress: ST+ telecomAddress: SET<TEL>+ status: CD+ statusDateRange: IVL<TS>
Person
+ name: ST+ initials: ST+ postalAddress: AD+ telecomAddress: SET<TEL>+ birthDate: PQ+ deathDate: PQ+ educationLevel: CD+ ethnicGroup: SET<CD>+ gender: CD+ householdIncome: CD+ maritalStatus: CD+ race: SET<CD>+ adoptedIndicator: BL+ birthOrder: INT+ birthCountry: CD+ eyeColor: ST
CentralLaboratory
PerformingLaboratory
Activity
+ category: CD+ subcategory: CD+ codedDescription: CD+ textDescription: ST+ reason: SET<CD>+ status: CD+ statusDateRange: IVL<TS>+ comment: ST
Document
+ identifier: SET<II>+ title: ST+ detailedDescription: ST+ summaryDescription: ST+ synopsis: ST+ type: CD+ subtype: SET<CD>+ revision: ST+ language: CD+ status: CD+ statusDateRange: IVL<TS>
Participant
+ identifier: SET<II>+ confidentialityIndicator: BL+ paymentMethod: CD
Assessment
+ evaluationDate: TS+ codedInterpretation: CD+ textInterpretation: ST+ baselineIndicator: BL+ comment: ST
ObservationResult
+ reportedDate: TS+ codedResult: CD+ numericResult: PQ+ textResult: ST+ targetSite: CD+ confidentiality: CD+ uncertainty: CD+ baselineIndicator: BL+ comment: ST
PerformedActivity
+ actualDateRange: IVL<TS>+ actualDuration: PQ+ effectiveDateRange: IVL<TS>+ effectiveDuration: PQ+ missedIndicator: BL+ missedReason: ST
ScheduledActivity
+ scheduledDateRange: IVL<TS>+ scheduledDuration: PQ+ scheduledRangeOfRepetitions: ST
SubmissionUnitRelationship
SubmissionUnit
+ receiptDate: TS+ type: CD+ status: CD+ statusDateRange: IVL<TS>
Submission
+ receiptDate: TS+ type: CD+ regulatoryAssessment: CD+ assessmentDateRange: IVL<TS>
Application
+ identifier: II+ type: CD
ReviewableUnit
ApplicationSponsor
RegulatedIndustry
+ registrationNumber: II
PerformedAdministrativeActivity
+ name: CD+ varianceReason: ST
DocumentRelationship
AdverseEventData
HealthCareSite
+ identifier: II+ postalAddress: AD
Specimen
+ identifier: II+ accessionNumber: ST+ type: CD+ condition: ST
PerformedSpecimenCollection
+ method: CD+ fastingStatusIndicator: BL
AssessmentRelationship
ObservationResultRelationship
PerformedProcedure
+ method: CD+ targetSite: CD+ name: CD
StudySite
+ identifier: II+ role: CD+ accrualStatus: CD+ targetAccrualNumber: INT+ irbApprovalDate: TS+ dateRange: IVL<TS>+ status: CD+ statusDateRange: IVL<TS>
HealthCareProvider
+ identifier: II+ certificateLicenseText: ST
StudySubject
+ identifier: SET<II>+ subgroup: CD+ status: CD+ statusDateRange: IVL<TS>+ state: ST+ actualSubjectIndicator: BL
PerformedSubstanceAdministration
+ dose: PQ+ doseFrequency: CD+ doseRegimen: ST+ doseDescription: ST+ doseForm: CD+ doseTotal: PQ+ doseModificationType: ST+ doseChangeType: CD+ doseChangeReason: ST+ routeOfAdministration: CD+ locationOfDoseAdministration: CD+ treatment: CD+ treatmentVehicle: CD+ treatmentVehicleVolume: PQ+ treatmentModifiedText: ST+ substanceUseStartRelativeToReference: CD+ substanceUseEndRelativeToReference: CD
PerformedClinicalResult
+ name: CD+ numericPrecision: INT+ referenceTextList: CD+ referenceRangeLow: REAL+ referenceRangeHigh: REAL+ referenceRangeComment: ST+ reportedResultStatus: CD+ asCollectedIndicator: BL+ normalRangeComparison: CD
StudyInvestigator
+ identifier: II+ role: CD+ dateRange: IVL<TS>+ status: CD+ statusDateRange: IVL<TS>+ signatureText: ST
PlannedStudy
+ targetAccrual: INT+ plannedSubjectParticipationDuration: ST+ plannedSubjectInterventionDuration: ST PerformedStudy
+ actualAccrualNumber: INT+ referenceDateRange: IVL<TS>
StudyProtocol
+ disease: CD+ phase: CD+ intent: CD+ populationDescription: ST+ blindedIndicator: BL+ subjectType: CD+ blindingSchema: CD+ multiInstitutionIndicator: BL+ randomizedIndicator: BL+ confidentiality: CD+ monitor: CD
ManufacturedMaterial
+ lotNumberText: ST+ stabilityDate: TS+ expirationDate: TS
StudyAgent
+ leadAgentIndicator: BL
«StudyRelationship»ActivityRelationship
TherapeuticAgent
+ identifier: II+ indIndicator: BL
PlannedArmSoA
+ referenceTimePoint: ST
ScheduledStudySoA
PlannedSoACell
+ plannedTiming: BRIDGRelative<TS>
PlannedStudySegmentStudyCellRule
ScheduledSoACell
+ scheduledTiming: IVL<TS>+ note: ST
PlannedEpochRule
ConcomitantAgent
PlannedObservationResult
StudyAuthor
BiologicMaterial
PlannedArm
+ name: ST+ description: ST+ targetAccrual: INT+ randomizationWeight: ST
PlannedEpoch
+ name: ST+ description: ST+ type: CD+ firstEpochIndicator: BL
PlannedStudySegment
+ name: ST+ description: ST+ firstStudySegmentIndicator: BL+ plannedDuration: PQ
PlannedActivityStudySegmentRule
PlannedStudyCell
+ name: ST+ blindedDescription: ST
StudySponsor
+ type: CDFundingSource
+ identifier: II
ask RPS team if identifier and type are needed for application sponsor -- review mapping document
AdministrativeActivity.nameEnrollmentRegistrationOff StudyInformed Consent
ObservationResultAssessmentRelationship
AECausalAssessment
AEIdentification
PerformedObservationResult
AssessmentPerformedActivityRelationship
These AE classes are work-in-progress and may change in R 2.0
Laboratory
+ identifier: II
PlannedActivity
+ plannedDuration: BRIDGRelative<TS>+ additionalDurationDescription: ST+ plannedRangeOfRepetitions: ST+ contingentIndicator: BL+ actualIndicator: BL+ inStudySegmentPlannedActivityType: CD
AdverseEvent
+ seriousness: CD+ grade/severity: CD+ expected/unexpected: CD+ hospitalizationRequired: BL
Analysis
Work in progressAssessor
+ type: CD
AssociatedPerson
+ type: CD
ClinicalResearchCoordinator
Container
+ type: CD
ClinicalInterpretation
+ toxicityTerm: CD+ abnormalIndicator: BL+ toxicityGrade: CD+ clinicallySignificantIndicator: BL+ severity: CD
PerformedMedicalHistoryResult
+ name: CD+ nameModifiedText: ST+ description: ST+ occurrenceDateRange: IVL<TS>+ endRelativeToReference: CD+ startRelativeToReference: CD
PerformingParty
+ actualPartyIndicator: BL
PlannedSubstanceAdministration
+ dose: PQ+ doseFrequency: CD+ doseRegimen: ST+ doseDescription: ST+ doseForm: CD+ doseTotal: PQ+ routeOfAdministration: CD+ locationOfDoseAdministration: CD+ treatment: CD+ treatmentVehicle: CD+ treatmentVehicleAmount: PQ
ProtocolDeviation
+ name: CD+ description: ST+ category: CD+ dateRange: IVL<TS>
PerformedStudyAgentTransfer
+ quantity: PQ+ originalQuantity: PQ
StudyCommittee
+ type: CD
StudyObective
+ description: ST+ primaryIndicator: BL
Needs defined.
Needs defined.
Class and attributes need defined.
Needs defined.
Class and attribute needs defined.
Needs definition.
Needs defined.
NonTherapeuticAgent
DocumentFrameDocumentStructure
DocumentStructureRelationship
DocumentContent
PlannedStudySoA
PlannedSubjectStudyEncounter
+ name: ST+ type: CD+ plannedTiming: BRIDGRelative<TS>
PlannedSubjectStudyEncounterRule
ScheduledSubjectStudyEncounterRule
ScheduledSubjectStudyEncounter
+ name: ST+ type: CD+ scheduledTiming: IVL<TS>
ScheduledArmSoA
+ referenceTimePoint: ST
ScheduledArm
+ name: ST+ description: ST+ randomizationWeight: ST
PerformedStudySoA
PerformedArmSoA
+ referenceTimePoint: ST
PerformedArm
+ name: ST+ description: ST+ randomizationWeight: ST
PerformedSubjectStudyEncounter
+ name: ST+ type: CD+ performedTiming: IVL<TS>
PerformedSubjectStudyEncounterRule
PerformedSoACell
+ performedTiming: IVL<TS>
DefinedStudySegment
DefinedActivityStudySegmentRule
PerformedActivityStudySegmentRule
ScheduledStudyCell
+ name: ST+ blindedDescription: ST
ScheduledEpoch
+ name: ST+ description: ST+ type: CD+ firstEpochIndicator: BL+ scheduledStartDate: TS
ScheduledEpochRule
ScheduledStudySegmentStudyCellRule
ScheduledStudySegment
+ name: ST+ description: ST+ firstStudySegmentIndicator: BL
ScheduledActivityStudySegmentRule
PerformedStudyCell
+ name: ST+ blindedDescription: ST
PerformedEpoch
+ name: ST+ description: ST+ type: CD+ firstEpochIndicator: BL
PerformedEpochRule
PerformedStudySegment
+ name: ST+ description: ST+ firstStudySegmentIndicator: BL
PerformedStudySegmentStudyCellRule
DefinedActivity
DefinedSubstanceAdministration
DefinedProcedure
DefinedSpecimenCollection
DefinedObservation DefinedAdministrativeActivity
DefinedStudyAgentTransfer
PlannedSpecimenCollection
+ method: CD+ fastingStatusIndicator: BL
PlannedProcedure
+ name: CD+ method: CD+ targetSite: CD
PlannedObservation
+ name: CD+ method: CD+ targetSite: CD
PlannedAdministrativeActivity
+ name: CD
PlannedStudyAgentTransfer
+ quantity: PQ+ originalQuantity: PQ
ScheduledObservation
+ name: CD+ method: CD+ targetSite: CD
ScheduledProcedure
+ name: CD+ targetSite: CD+ method: CD
ScheduledSpecimenCollection
+ method: CD+ fastingStatusIndicator: BL
ScheduledStudyAgentTransfer
+ quantity: PQ+ originalQuantity: PQ
ScheduledAdministrativeActivity
+ name: CD
ScheduledSubstanceAdministration
+ dose: PQ+ doseFrequency: CD+ doseRegimen: ST+ doseDescription: ST+ doseForm: CD+ doseTotal: PQ+ routeOfAdministration: CD+ locationOfDoseAdministration: CD+ treatment: CD+ treatmentVehicle: CD+ treatmentVehicleAmount: PQ
StudyRelationship
+ description: ST+ type: CD+ inversionIndicator: BL+ contextControl: CD+ contextConductionIndicator: BL+ sequenceNumber: INT+ priorityNumber: INT+ split: CD+ pauseQuantity: PQ+ checkpoint: CD+ join: CD+ negationIndicator: BL+ conjunction: CD+ separableIndicator: BL+ subset: CS+ evaluableExpression: CD+ comment: ST
ClinicalResearchStaff DocumentAuthor
HL7 RIM Entity
HL7 RIM Role
HL7 RIM Participation
HL7 RIM Act
HL7 RIM ActRelationship
Placeholder
Draft
Data Type
DefinedEpoch
PerformedObservation
+ name: CD+ nameModifiedText: ST+ targetSite: CD+ method: CD+ bodyPosition: CD
PerformedSubjectMilestone
+ informedConsentSignatureText: ST+ informedConsentDate: TS+ registrationDate: TS+ offStudyDate: TS+ offStudyReason: CD+ studyReferenceDateRange: IVL<TS>
0..*
executes/ isexecuted at
1
0..*is the treatmentlocation for / isassigned to 1
1..*
1
0..*
associates to /may be thetarget for
1
0..*
associates from /may be thesource for
1
1..*
performs at /facility for
0..*
1..*
is sponsoredby / sponsors
1
1functions as /is representedby
0..*
0..*
associates from /may be thesource for
11
associates to /may be thetarget for
0..*
1
plays / isplayed by
0..1
0..*associates from /may be thesource for 1
0..*
performs / isperformed at
1
1
functions as /representedby
1..*
1..*
1
1..*
1
1
is used as / isfulfilled by
0..*
0..*
isadministeredduring / uses
0..1
1..*
facility for /performs at 0..*
1..*
1
0..*
includes / isincluded in
1..*
0..*associates to /may be thetarget for
1
1
associates from /may becontained by
0..*
0..*
functions as/ isrepresented by
1
0..*
functions as/ isrepresented by
1
0..*
participatesas / isfulfilled by
1
0..1
performs / isperformed at
1..*
0..*
may be thecontainer of /associates to
1
0..*
isoperationalizedby / is describedby
1
1 may report /is reportedby
0..*
1
associates a submissionunit to / is associated to asubmission unit via
1..*
0..*
is fulfilled by /is theinstantiation of
0..1
0..*
1
0..*
functions as / isrepresented by
1
0..*
identifiesevents for /has
1
0..*
identifiesevents for /has
1
1..*
is conductedby /participatesin
1
1
functions as/ isrepresented by 0..*
1..*
1
1
performs / isperformed at
0..*
1
submits / issubmittedby
1
0..*
is associated to asubmission via /associates asubmission to
1
1..*
1
0..*
associates to /may be thetarget for
1
1..*
is collected during/ results in
0..1
1
plays / isplayed by
0..1
1
plays / isplayed by
0..1
1
may be the source for/ associates from
0..*
1..*
associates to / is acomponent of
1
1
plays / isplayed by
0..*
1
is fulfilled by / isthe fulfillment of
0..1
1
is used to create a/ subject-specificdescription of
0..*
1 0..*
1 0..*
0..*
1
1
associates to /may be thetarget for
0..*
1
plays / isplayed by
0..1
1
plays/ isplayedby 0..1
1
plays / isplayed by
0..1
1..*
1
1 0..1
1..*
1
1..*
contains / iscontained in
1
1..* 1
1
1
0..1isadministeredduring / uses
1..*
1
is used as / isfulfilled by
0..*
1
plays / isplayed by
0..1
0..*
is evaluating / isa research topicin
1
0..*
develops / isauthored by
1
1..*
1
0..*
associates from /may be thesource for
11..*
0..*
1
results in / is theresult of
0..*
1 0..*
1..*
is comprised of /associates from
1
0..*
may be the target for /associates to
1
0..1
is operationalized by/is described by
0..1
0..1
is used to create a/ subject-specificdescription of
0..*
0..* 1
1 0..*
1
associates from /may be thesource for
0..*
0..*
may be thetarget for /associatesto
1
1..*
0..1
0..*
may be thecontainer of /associates to
1
1..*
associates to / is acomponent of
1
1..*
is comprised of /associates from
1
1..*
is comprised of /is a componentof
0..1
1..*
is a component of/ is comprised of
1
0..*
may be thesource for /associatesfrom
1
1 0..1
0..*
may be thetarget for /associatesto
1
1..*
is a division of /is divided into
1
1
contains theactivities for / isdescribed by
1
0..*
associates to /may be thetarget for
1
0..*
may be thesource for /associatesfrom
1
0..*
associates from /may be thesource for
1
1..*
is a component of/ is comprised of
1
1..*
is comprised of /associates from
11..*
associates to / is acomponent of
1
1
may be thecontainer of /associates to
0..*
1
contains theactivities for / isdescribed by
1
1
associates from /may becontained by
0..*
1..*
0..1
0..*
identifiesevents for /has
1
1
contains theactivities for /is describedby
1
1..*
is comprised of /is a componentof
0..1
1
results in / is theresult of 0..*
1..*
is comprised of /is a componentof
0..1
0..*
isadministeredduring / uses
1
1
1..*
1 1..*
1
0..*
1..*1
0..*
1
1..*
1
0..*
associates from /may becontained by 1
0..*
may be thecontainer of /associates to
1
0..*
isadministeredduring / uses
1
1
is collected in /results in
1..*
0..*
associates from /may becontained by
1
0..*
isadministeredduring / uses
1
0..1
is collectedduring / resultsin
1..*
1..*
is a division of /is divided into
1
1..*
1
1..*
1
1..*
1
1..*
0..1
0..1
is collected in /results in
1..*
1..*
is a component of/ is comprised of
1
1
plays / isplayed by
0..*
1
authorizes / isauthorized by
0..*
1
changes handsduring /involves
0..*
0..1
identifies the timeslot for /is planned within
1
1
plays / is playedby
0..1 1
functions as / isrepresented by
1..*
1
is authored by /authors
1..*
0..*
associates from /may be thesource for
1
0..1
functions as/ isrepresented by
1..*1
plays / isplayed by
0..1
0..1
functions as/ isrepresented by
0..*
0..1
functions as/ isrepresented by
0..*
0..1
functions as/ isrepresented by
0..*
0..1
functions as/ isrepresented by
1..*
1
plays / isplayed by
0..1
0..1
is the originator of /is reported by
0..*
1..*
has participation of /participates in
0..1
identifies thetimeslot for / isperformedwithin
1
1
operates as /representedby 1..*
0..1
is the originatorof / is reportedby
0..*
1
is produced by /may produce
0..*
0..1
isadministeredduring / uses
1..*
1
plays / isplayed by
0..1
1 1
1
associates to /may be thetarget for
0..*
0..1
identifies the timeslot for / isscheduled within
10..1
participates in / isperformed for
0..*
1
authorizes / isauthorized by
0..*
1
manages / ismanaged by
0..*
Name:Package:Version:Author:
View 10 - Complete 2 - Classes with Local AttributesBRIDG Release 1.1 -- Static Classes1.1BRIDG THC
BRIDG – Close Up
Labs
Vitals
Meds
9
SDTM Implementation Guide
10
SDTM Mapping
11
HL7 RIM
12
HL7 Mapping
BRIDG attributes may map to Class Attribute Data Type Vocabulary (for structural codes, e.g.,
participation type)
May require several iterations Changes to RIM Changes to BRIDG
13
Eligibility Criteria
ASPIRE – Agreement on Standardized Protocol Inclusion Requirements for Eligibility, Joyce Niland, City of Hope
HL7 CRFQ – Clinical Research Filtered Query, Charlie Mead, BAH
14
Questions
http://bridgmodel.org