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BRIDG Overview Clinical Observation Interoperability March 18, 2008

BRIDG Overview Clinical Observation Interoperability March 18, 2008

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Page 1: BRIDG Overview Clinical Observation Interoperability March 18, 2008

BRIDG Overview

Clinical Observation InteroperabilityMarch 18, 2008

Page 2: BRIDG Overview Clinical Observation Interoperability March 18, 2008

2

BRIDG Background

Stakeholders: HL7, CDISC, NCI/caBIG, FDA

Goals: shared semantics

Domain of Interest: protocol driven research

Project Organization: BAB, THC

Page 3: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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

Page 4: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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

Page 5: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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)

Page 6: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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..*

Page 7: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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

Page 8: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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

Page 9: BRIDG Overview Clinical Observation Interoperability March 18, 2008

9

SDTM Implementation Guide

Page 10: BRIDG Overview Clinical Observation Interoperability March 18, 2008

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SDTM Mapping

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HL7 RIM

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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

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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

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Questions

http://bridgmodel.org