interchange vs interoperability main entry: in·ter·op·er·a·bil·i·ty : ability of a system......

Interchange vs Interoperability

• Main Entry: in·ter·op·er·a·bil·i·ty: ability of a system ... to use the parts or equipment of another system

Source: Merriam-Webster web site

• interoperability : ability of two or more systems or components toexchange information and to predictably use the information that has been exchanged.

» Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE,

1990]

Semanticinteroperability

Syntacticinteroperability

(interchange)

Syntax StructureSemantics Meaning

Source: Charles Mead, MD, HL7

1

2

3 4

5

6

Computerized doesn’t mean syntactic interoperability

Semantic interoperability: “Protocol” and the Semiotic Triangle

Symbol

“Protocol”

“We need to sign off on the protocol by Friday”

Concept 1

Thing 1

Document Study

“Protocol XYZ has enrolled 73 patients”

Thing 2

Concept 2

“Per the protocol, you must be at least 18 to be enrolled”

Concept 3Thing 3

Plan

Source: John Speakman/Charlie Mead

Semantic Interoperability

• To understand the data being received you must know both:

• The definition of each element of data, and its relationship with each of the other elements – you must have a semantic model of the data

and– The terminology to be used to represent coded

elements, including the definitions, and relationships within the terminology

Source: HL7

BRIDGAdvisory Board

NCI

caBIG

PhRMA

CDISC

Current Organization of the BRIDG project

• BRIDG Advisory Board– Representation from the current

stakeholders– Help to allocate priorities and identify

resources– Assist with vetting the model in the

various constituents• Technical Harmonization Group

– Responsible for ongoing model maintenance

– Developing shared harmonization processes

• Multiple subdomain projects– Representation from pharmaceutical

companies, technology companies, government agencies, and cancer centers BRIDG

Technical Harmonization Group

caBIG HL7CDISC

HL7FDA

BRIDG projects and contributors

BRIDG model

Protocol Authoring &Trial Design

FDA(M. Walker)

HL7(M Walker)

SDTM(CDISC)

caAERS(caBIG)

PDQClinicalTrials.gov

EudraCT

CONSORT(cancerGRID)

WHO

ODM(CDISC)

HL7(M Walker)

CTOM(caBIG)

CDISCODM

Oracle

caBIGNCI

Study calendar(caBIG)

JANUS(IBM)

Lab SIG(caBIG)

CTLab std(CDISC)

JANUS(IBM)

FastTrack

SDTM(CDISC)

SDTM(CDISC)

Protocol Registration

Clinical Trials Operations

AdverseEvents

LabSpecification

eDCI

SDTM(CDISC)

Model organization

• Dynamic View– Captures the business

process decomposition of the lifecycle of clinical trials research

Behavioral Aspects of BRIDGad Conduct Clinical Trial

Scientific Team Operational Team Clinical Management Team

Set-up Study

Execute Study

Analysis and Report

Plan Study

The study is planned by a principal investigator at a cancer center.

The proposal is submitted by the cooperative group on behalf of the PI to NCI/CTEP, and once approved, the principal investigator will set up the operational aspects of conducting the study through the cooperative group that the cancer center is affi l iated with.

Once the operational aspects are completed, the cancer centers responsible for executing the study will begin to enroll patients and execute the study according to the protocol plan.

At periodic intervals, cooperative groups, and PI will report back to the NCI the results of the study.

Note:

This storyboard is specific to the NCI and cancer research. For Pharmaceutical industry, the activities are similar, although there are different actors assigned to these tasks.

Operational Team

The operational team are responsible for turning the study plan into tasks and systems that can be executed by other investigators. This is the technical, legal, and other infrastructure that is necessary to have before a clinical trial can be executed.

Organizations which may play this roleinclude:

Clinical Research OrganizationSponsoring OrganizationCooperative Group

Scientific Team

This is the group that is responsible for authoring the study.

For example, at a cancer center, this team might be lead by the Principal Investigator, and consist of co-investigators.

In a pharmaceutical company, this team might consist of a medical writer, scientific leaders, statisticians and other administrative staff and be lead by an individual who takes responsibil ity for leading the team who will write the study and guiding it through the steps of approval.

This group identifies the research question to be answered, and then after the study is completed, analyzes the data, to see how the question was answered.

Clinical Management Team

The clinical management team is responsible for managing the clinical trial subjects, data aboutthe subjects, and information and processes related to the execution of the study.

For example, a data manager would be a participant in this team, managing data related to a clinical trial subject.

In addition, the data manager would be responsible for closing out the data base, reconciling the database, etc.

Name:Package:Version:Author:

Conduct Clinical TrialConduct Clinical Trial1.0Fridsma

Behavioral Aspects of BRIDGad RegisterClinicalTrial

RegistrySteward Registry RegistryClearinghouse

The entity that is sending/transmitting a registry message.

For example, a pharmaceutical organization/agent will authorize aparty to transmit information about a trial to an external registry such as clinicaltrials.gov.

For example, in an academic institution the principal investigatorwill transmit information about a trial to an external registry.

The entity (person, org or system) that receives, processes and publishes registry information .

For example, clinicaltrials.gov PDQ, or EudraCT are considered registries.

Storyboard: A pharmaceutical companyhasjust completed authoring a clinical trial protocol document, they are ready to register the clinical trial. A pharmaceutical company extracts information from the protocol and associated sources. This original or derived information may be entered directly from the protocol or entered from other sources. This information may require formatting or modification according to the registry institution. The information is transmitted to the registry. There is an acknowledgement of the transmission.

For example, WHO or IFPMA (International Federation of Pharmaceutical Manufacturers and Associations).

Compile RegistryInformation

Transmit Information

Receiv e Information

Validate Information

Is information acceptable?Is information acceptable?Receiv e error message

Modify Information

Receiv eacknowledgement

ActivityFinal

Release information

Send error message

Send acknowledgement

Yes

No

ad RegisterClinicalTrial





Roles are defined in the swim lanes with examples drawn from discussions with the domain experts

Behavioral Aspects of BRIDGad RegisterClinicalTrial





The entity (person, org or system) that receives, processes and publishes registry information .

For example, clinicaltrials.gov PDQ, or EudraCT are considered registries.

Storyboard: A pharmaceutical companyhasjust completed authoring a clinical trial protocol document, they are ready to register the clinical trial. A pharmaceutical company extracts information from the protocol and associated sources. This original or derived information may be entered directly from the protocol or entered from other sources. This information may require formatting or modification according to the registry institution. The information is transmitted to the registry. There is an acknowledgement of the transmission.

For example, WHO or IFPMA (International Federation of Pharmaceutical Manufacturers and Associations).






Modify Information

Receiv eacknowledgement

ActivityFinal

Release information

Send error message

Send acknowledgement

Yes

No

ad RegisterClinicalTrial







Modify Information

Send error messageNo

The activities are described in activity diagrams that can be drilled down to provide additional detail. These are linked to the static (logical) portions of the model

Model organization

• Logical View– Contains three core packages

• Harmonized elements

• Staging Area

• Manual review area

– Addition resources• HL7 V3 RIM

– Contains the semantics for the static objects (data) that is used in clinical trials research

– Currently have 9 subdomain models in the process of harmonization

Current Classes in Core Elements

MaterialRole

MaterialRole

FundingSponsor

HealthCareSite

Investigator

Organization Role

OrganizationRole

Participant

Person Role

PersonRole

TherapeuticAgent

Activity

PerformedActivity

PerformedStudy

Activity

PlannedActivity

PlannedStudy

Participation

StudyAgent

Participation

StudyInvestigator

Participation

StudySite

Participation

SubjectAssignment

Document

StudyDocument

DeviceDrug

Study

Participation

StudyAuthor

+is described by1..1

+is operationalized by

0..1

+is fulfiled bythe role

1

+participate as

0..*

+areattributed

to

+have

+are

attributed

to

+have

1 0..*

+are

attributedto

+have

+are written by

+write

0..* 1

+are performed by

+participate in

0..*

1

+are performed at

+participate in

+assign0..*

+are assigned by1

0..1

1

+is described by1

+describes

1

+is operationalized by0..1

+is described by1..1

Harmonized BRIDG elements

cd Comprehensive Class and attribute diagram

SDTM CTOM harmonization in process

Clinical Research Entities and Roles::Material

+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus

Clinical Research Entities and Roles::

MaterialRole


FundingSponsor


HealthCareSite

Clinical Research Entities and Roles::Investigator

+ certificateLicenseText: Text

Clinical Research Entities and Roles::Organization

+ description: Text+ geographicAddr: BRIDGContactAddr+ name: Text+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress

Clinical Research Entities and Roles::OrganizationRole

::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress

Clinical Research Entities and Roles::Participant

+ confidentialityIndicator: boolean+ paymentMethod: ENUM

Clinical Research Entities and Roles::Person

+ address: BRIDGContactAddr+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ dateOfDeath: DATETIME+ educationLevelCode: BRIDGCodedConcept+ electronicCommAddr: BRIDGTelecomAddress+ ethnicGroupCode: BRIDGCodedConcept+ householdIncomeCategory: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ name: Text+ raceCode: BRIDGCodedConcept+ telecomAddress: BRIDGTelecomAddress

Clinical Research Entities and Roles::PersonRole

::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress

Clinical Research Entities and Roles::TherapeuticAgent

Clinical Trials Activ ities::PerformedActiv ity

+ plannnedUnplannedInd: boolean::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Clinical Trials Activities::PerformedStudy

+ ActualAccrualNumber: int+ enrollmentEndDate: Date+ enrollmentstartDate: Date::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activ ities::PlannedActiv ity

+ repeatNumber: rangeOfIntegers::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Clinical Trials Activ ities::PlannedStudy

+ targetAccrualNumber: int::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activ ities::StudyAgent

::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activ ities::StudyInvestigator

+ signatureCode: int+ signatureText: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activ ities::StudySite

+ targetAccrualNumber: int::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activ ities::SubjectAssignment

+ ageAtEnrollment: int+ arm: string+ eligibilityWaiverReason: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ studySubjectIdentifier: int+ subgroupCode: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

BRIDG Shared Classes::Activity

+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

BRIDG Shared Classes::Activ ityActiv ityRelationship

+ checkpointCode: + conjunctionCode: + joinCode: + negationIndicator: BOOLEAN- negationRule: AbstractRule+ priorityNumber: NUMBER+ relationshipCode: BRIDGCodedConcept+ sequenceNumber: NUMBER+ splitCode:

BRIDG Shared Classes::Participation

+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

BRIDG Shared Classes::Role

+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress

BRIDG Shared Classes::RoleRoleRelationship

+ source: + target: + type: CodedConcept

BRIDG Shared Classes::BRIDGAnalysisVariable

+ businessProcessMode: PSMBusinessProcessMode+ controlledName: PSMCodedConcept+ name: TEXT+ value:

BRIDG Shared Classes::BRIDGCodedConcept

- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}

BRIDG Shared Classes::BRIDGContactAddr

+ effectiveTime: BRIDGInterval+ type: BRIDGCodedConcept+ usage: BRIDGCodedConcept

BRIDG Shared Classes::BRIDGDescription

+ detailedDescription: EncapsulatedData+ summaryDescription: EncapsulatedData+ synopsis: EncapsulatedData

BRIDG Shared Classes::BRIDGID

+ source: Text+ value: Text+ version: Text

BRIDG Shared Classes::BRIDGInterval

+ endTime: timestamp- startTime: timestamp

BRIDG Shared Classes::BRIDGStatus

+ effectiveEndDate: + effectiveStartDate: + statusValue:

Specimen may have to re-located

Needs additional work and cleanup

Clinical Trials Activ ities::StudyDocument

+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept::Document+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string

Potential hook for the eDCI model

Attributes needs to be reviewed -- need to be domain oriented -- too RIM like

Do we need this -- what is the use case? The thinking is that this will be used for caAERS. Ifnot, then it should be deleted.

This maybe an Activity?

Review the data types -- inconsistency in definition and what is used in the model

BRIDG Shared Classes::BRIDGTelecomAddress

- addressType: ENUM- usageType: ENUM- value: Text

BRIDG Shared Classes::Dev ice

::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus

BRIDG Shared Classes::Drug

+ formCode: BRIDGCodedConcept+ lotNumber: int+ stabilityTime: DATETIME::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus

Clinical Trials Activities::Study

+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activ ities::StudyAuthor

::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

BRIDG Shared Classes::Document

+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string

We will need to MANUALLY keep these two classes in synch with their attributes.

CTOM Elements::PerformedObservation

+ confidentialityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

CTOM Elements::ObservationRelationship

+ comments: string+ id: int- type: string

PlannedObservation

We may or may not need this class -- it depends on the number of shared classes between thetwo performed/planned activities

CTOM Elements::Histopathology

+ grossExamResultCode: string+ involvedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string

CTOM Elements::ClinicalResult

+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string

CTOM Elements::LesionDescription

+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ appearanceTypeCode: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ dimensionProduct: int+ evaluationNumber: int+ lesionNumber: string+ measurableIndicator: boolean+ methodCode: string+ previouslyIrradiatedSiteIndicator: boolean+ targetNonTargetCode: string+ xDimension: int+ yDimension: int+ zDimension: int

SDTM::LaboratoryTest

+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

SDTM::SDTMFinding

+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

SDTM::OtherFindings

+ evaluationInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

SDTM::QuantitativeMeasurement

+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

SDTM::Examination

+ measurementTime: int- resultDescription: SDTMFindingDescriptionDataType::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

TestInterpretation

SDTM::InterpretedResults

::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

TestInterpretation

SDTM::VitalSign

+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPosition: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

+is fulfi led by the role

1

+participate as

0..*

+are attributed to +have

0..*

1


1 0..*

+are written by

+write

0..*

1


+is operationalized by

0..1

+is described by

1..1

+is described by 1

+describes 1

+source activity

*

*

+target activity

1

has a 1..*1..*has a

1

+assign 0..*+are assigned by 1

«abstraction»

0..* 1

1 0..*

+is described by

1..1

+is operationalized by 0..1

0..11

+are performed by+participate in

0..*

1

+are performed at

+participate in

Models in the staging areapd Staging Area

CDISC content

+ External Registry

+ ODM

+ StudyDocument(ICH)

+ SDTM

caBIG/NCI

+ caAERS 23-Jan-2006

+ CT lab SIG

+ DCI Definition, v1.5.2

+ CTOM (imported package)

cancerGRID

+ CONSORT

+ Protocol

+ thoughts

+ XSDDatatypes


Staging AreaStaging Area1.0Fridsma

Harmonizing attributes

cd CTOM observ ations and SDTM




CTOM observations and SDTMCTOM (imported package)1.0Fridsma






Adding tags to provide semantic traceability (and notes)











Simple semantic can be tracked in tagged values







SDTM::Quantitativ eMeasurement




This linking can be extended down to the CDE level











More complex relationships







TestInterpretation

SDTM::InterpretedResults

::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType








cd Comprehensiv e Model

Clinical Research Entities and

Roles::Agent

+ id: CodedConcept+ name: string

+ description: string

+ status: CodedConcept

+ formCode: CodedConcept+ lotNumber: int

+ expirationDate: DATETIME

+ stabi l i tyT ime: DATETIME

Clinical Research

Entities and Roles::

AgentRole


FundingSponsor

Clinical Research


HealthCareSite


Inv estigator

+ certi ficateLicenseText:

Clinical Research Entities

and Roles::Organization

+ id: CodedConcept

+ name: string+ description: string


+ statusDate: DATETIME

+ geographicAddr: addrType+ telecomAddr: TEL


Roles::OrganizationRole


Roles::Participant

+ paymentMethod: CodedConcept

+ confidential i tyCode: string

Clinical Research Entities and Roles::Person

+ id: CodedConcept

+ administrativeGenderCode: BRIDGCodedConcept

+ dateOfBirth: DATETIME+ raceCode: BRIDGCodedConcept

+ ethnicGroupCode: BRIDGCodedConcept

+ maritalStatusCode: BRIDGCodedConcept

+ electronicCommAddr: + householdIncomeCategory: BRIDGCodedConcept

+ educationLevelCode: BRIDGCodedConcept

+ telecomAddress: TEL

+ name: enti tyName+ dateOfDeath: DATETIME

+ address: addrType


PersonRole

::Role

+ id: CodedConcept

+ code: CodedConcept+ status:

+ electronicCommAddr:

+ geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME

+ effectiveEndDate: DATETIME

Clinical Research


TherapeuticAgent

Clinical Trials Activ ities::Adv erseEv ent

+ onsetDate: date+ resolvedDate: date

+ ctcCategoryCode: string

+ ctcCategoryCodeSystem: string

+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string

+ ctcAttributionCode: string

+ ctcAttributionCodeSystem: string

+ ctcGradeCode: string+ ctcGradeCodeSystem: string

+ seriousReasonCode: string

+ outcomeCode: string

+ actionTakenCode: string

+ conditionPatternCode: string+ doseLimitingToxici tyIndicator: boolean

+ doseLimitingToxici tyDescriptionText: string

+ descriptionText: string

Clinical Trials Activ ities::

Adv erseEv entReport

+ id: int

+ submissionDate: date

+ fi ledIndicator: boolean


Adv erseEv entTherapy

+ id: int

+ treatmentDate: date

+ delayDuration: int

+ delayDurationUnitOfMeasureCode: string+ intensityCode: string

Clinical Trials Activities::Assessment

+ id: int

+ evaluationDate: date

Clinical Trials

Activ ities::AssessmentRelationship

+ id: int

+ typeCode: string

+ commentText: string


CancerStage

+ id: int

+ tnmStage: string+ tnmStageCodeSystem: string

+ stageCode: string

+ stageCodeSystem: string


ClinicalResult

+ panelName: string

+ value: string

+ valueUnitOfMeasureCode: string+ assayMethodCode: string

+ bodyPositionCode: string

+ labReferenceRangeCode: string

+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string

+ abnormalIndicator: boolean

+ biomarkerInd: boolean

+ significanceInd: boolean


DeathSummary

+ deathDate: date

+ deathCauseCode: char+ deathCauseText: string

+ autopsiedIndicator: boolean

Clinical Trials Activ ities::Diagnosis

+ name: string+ diseaseDiagnosisCode: string

+ diseaseDiagnosisCodeSystem: string

+ ageAtDiagnosis: int

+ confirmationDate: date+ primaryAnatomicSiteCode: string

+ primaryAnatomicSiteCodeSystem: string

+ primaryAnatomicSiteLateral i tyCode: string

+ recurrenceIndicator: boolean+ diseaseStatusCode: string

+ sourceCode: string

+ sourceOther: string

+ diseaseExtentText: string

Clinical Trials Activ ities::DiseaseResponse

+ responseCode: char+ responseCodeSystem: string

+ bestResponseCode: char

+ bestResponseDate: date

+ progressionDate: date+ progressionPeriod: int

+ progressionPeriodUnitOfMeasureCode: string

+ doseChangeIndicatorCode: int

+ courseDispositionCode: string+ commentText: string

Clinical Trials Activ ities::Histopathology

+ grossExamResultCode: string

+ reportDescriptiveText: string

+ involvedSurgicalMarginIndicator: boolean


HistopathologyGrade

+ id: int

+ gradingSystemName: string

+ grade: string+ comments: string

Clinical Trials Activ ities::Imaging

+ identi fier: string

+ contrastAgentEnhancement: string

+ descriptiveText: string

+ rateOfEnhancementValue: int


LesionDescription

+ lesionNumber: string

+ evaluationNumber: int

+ appearanceTypeCode: string+ targetNonTargetCode: string

+ measurableIndicator: boolean

+ methodCode: string

+ xDimension: int+ yDimension: int

+ zDimension: int

+ dimensionProduct: int

+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string

+ contactAnatomicSiteCode: string

+ contactAnatomicSiteCodeSytem: string

+ previouslyIrradiatedSiteIndicator: boolean Clinical Trials

Activ ities::

LesionEv aluation

+ evaluationCode: char


MetastasisSite

+ id: int

+ anatomicSiteCode: string

+ anatomicSiteCodeName: string

Clinical Trials

Activ ities::Neoplasm

+ id: int

+ cel lType: string

Clinical Trials Activ ities::Observ ation

+ id: int

+ reportingDate: date

+ confidential i tyCode: string+ uncertaintyCode: string

+ statusCode: string


Observ ationRelationship

+ id: int

- type: string

+ comments: string

Clinical Trials Activ ities::PerformedActiv ity

+ plannnedUnplannedInd: boolean

::Activi ty

+ code: PSMCodedConcept+ derivationExpression: TEXT

+ description: PSMDescription

+ startDate: DATETIME

+ status: PSMCodedConcept+ avai labi l i tyT ime: T imingSpecification

+ priori tyCode: PSMCodedConcept

+ confidential i tyCode: PSMCodedConcept

+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN

+ uncertaintyCode: CodedConcept

+ reasonCode: PSMCodedConcept

+ endDate: DATETIME

Clinical Trials Activ ities::PerformedStudy

+ id: BRIDGID+ longT itle: string

+ shortT i tle: string+ phaseCode: ENUM

+ intentCode: ENUM+ monitorCode: ENUM

+ bl indedInd: boolean

+ randomizedInd: boolean+ diseaseCode: CodedConceptDataType

+ sponsorCode: CodedConceptDataType

+ multi Insti tutionInd: boolean

+ targetAccrualNumber: int

Clinical Trials Activ ities::PlannedActiv ity

::Activi ty

+ code: PSMCodedConcept

+ derivationExpression: TEXT+ description: PSMDescription

+ startDate: DATETIME

+ status: PSMCodedConcept

+ avai labi l i tyT ime: T imingSpecification+ priori tyCode: PSMCodedConcept

+ confidential i tyCode: PSMCodedConcept

+ repeatNumber: rangeOfIntegers

+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept

+ reasonCode: PSMCodedConcept

+ endDate: DATETIME

Clinical Trials Activ ities::PlannedStudy

::Activi ty

+ code: PSMCodedConcept

+ derivationExpression: TEXT

+ description: PSMDescription+ startDate: DATETIME

+ status: PSMCodedConcept

+ avai labi l i tyT ime: T imingSpecification

+ priori tyCode: PSMCodedConcept

+ confidential i tyCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers

+ interruptibleIndicator: BOOLEAN

+ uncertaintyCode: CodedConcept

+ reasonCode: PSMCodedConcept+ endDate: DATETIME

Clinical Trials Activ ities::Procedure

+ targetSiteCode: string


Qualitativ eEv aluation

+ survivalStatusCode: int

+ survivalStatusDescriptionText: string+ performanceStatusCode: int

- performanceStatusCodeSystem: string

+ painIndexCode: int

+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int

+ menstrualPatternTypeCode: string

+ menstrualIndicator: boolean


Radiation

+ therapyType: string

+ doseUnitOfMeasure: string

+ dose: string

Clinical Trials Activ ities:

:Specimen

+ id: int

+ idNumber: int

+ samplingType: string

Clinical Trials

Activ ities::

SpecimenCollection

+ siteCondition: string

+ method: string

Clinical Trials Activ ities::StudyAgent

::Participation

+ type: CodedConcept


+ statusDate: DATETIME+ startDate: DATETIME

+ endDate: DATETIME


StudyInv estigator

+ signatureCode: int

+ signatureText: string

::Participation+ type: CodedConcept

+ status: CodedConcept+ statusDate: DATETIME

+ startDate: DATETIME+ endDate: DATETIME


StudySite

+ targetAccrualNumber: int

::Participation+ type: CodedConcept


+ statusDate: DATETIME

+ startDate: DATETIME+ endDate: DATETIME

Clinical Trials Activ ities::Subj ectAssignment

+ studySubjectIdenti fier: int

+ arm: string

+ subgroupCode: string

+ informedConsentFormSignedDate: date+ offStudyDate: date

+ studyAgentDoseLevel: string+ el igibi l i tyWaiverReason: string

+ ageAtEnrol lment: int::Participation

+ type: CodedConcept+ status: CodedConcept


+ endDate: DATETIME


SubstanceAdministration

+ doseQuanti ty: int

+ doseUnitOfMeasure: string

+ route: string+ doseFrequency: string

+ doseModificationType: string+ doseChangeType: int

Clinical Trials

Activ ities::

Surgery

BRIDG Shared Classes::Activity

+ code: PSMCodedConcept+ derivationExpress ion: TEXT+ description: PSMDescription+ s tartDate: DATETIME+ s tatus: PSMCodedConcept+ availabilityTime: Tim ingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME

BRIDG Shared Classes::

Activ ityActiv ityRelationship

+ relationshipCode: PSMCodedConcept

- Obsolete_relationQuali fier: BRIDGCodedConcept+ sequenceNumber: NUMBER

+ pauseCri terion:

+ checkpointCode:

+ priori tyNumber: NUMBER

+ spl i tCode: - negationRule: AbstractRule

+ joinCode:

+ negationIndicator: BOOLEAN

+ conjunctionCode:

BRIDG Shared Classes::Participation

+ type: CodedConcept



+ endDate: DATETIME

BRIDG Shared Classes::Role

+ id: CodedConcept

+ code: CodedConcept

+ status: + electronicCommAddr:

+ geographicAddr:

+ telecomAddr:

+ effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME


RoleRoleRelationship

+ source: + type: CodedConcept

+ target:

BRIDG Shared Classes::BRIDGAnalysisVariable

+ name: TEXT

+ value: + control ledName: PSMCodedConcept

+ businessProcessMode: PSMBusinessProcessMode


BRIDGBusinessProcessMode

+ modeValue: ENUM {Plan, Execute}


BRIDGCodedConcept

- code: TEXT- codeSystem:

- codeSystemName: TEXT

- codeSystemVersion: NUMBER

- displayName: TEXT- originalText: TEXT

- translation: SET{PSMCodedConcept}


BRIDGContactAddr

+ type: BRIDGCodedConcept+ effectiveT ime: BRIDGInterval

+ usage: BRIDGCodedConcept

BRIDG Shared Classes::BRIDGDescription

+ synopsis: EncapsulatedData

+ summaryDescription: EncapsulatedData+ detai ledDescription: EncapsulatedData


BRIDGID

+ source: Text

+ version: Text

+ value: Text

BRIDG Shared Classes:

:BRIDGInterv al

- startT ime: timestamp+ endT ime: timestamp


BRIDGStatus

+ effectiveEndDate: + effectiveStartDate:

+ statusValue:

Protocol Concepts::StudyDocument

+ version: string

+ author: SET+ ID: SET BRIDGID

+ documentID: BRIDGID

+ type: ENUM

+ description: BRIDGDescription+ ti tle: string

+ status: BRIDGStatus

+ confidential i tyCode: CodedConcept

0..1

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«abstraction»

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BRIDG – Domain Analysis Model for Clinical Research

FO

UN

DA

TIO

NM

OD

EL

CDISC

ST

AK

EH

OL

DE

RS

NCI/caBIG HL7 (RCRIM)

Application Development

caCORE Tooling

V3 Message DevelopmentHL7 Tooling

xml data Exchange

CDISC xml

IMP

LE

ME

NT

AT

ION

SO

LU

TIO

NS

Interoperability Interoperability

Achieving interoperability

Cumulative Registered Users

Project Team ActivitiesRegister Project

with BRIDG & submitProject info.

BRIDG THC assignsMentor

Download BRIDG Replica

Items for submission – POC, Project Name, project description, high-level project schedule, projectSponsor, etc.

A BRIDG mentor will be assigned to your project

Begin modelingusing BRIDG replicaand follow BRIDG

guidelinesRefer to best practices for modeling in BRIDG environment

Submit BRIDG Harmonization

Package to THC

Harmonization Package artifacts – the EAP file, package level xmiExport, Modeling analysis & harmonization document)

Submit BRIDG Harmonization

Package to THC

Meet with BRIDG THC to harmonize project model (virtual or F2Fmeeting)

BRIDG THC Activities

Review the Project Registration material.

Assign Mentorto project

Take project to BAB andassign priority and timelinefor harmonization

BRIDG mentor will be available to answer questions

Inform Project POC May require some negotiations based on other efforts

Schedule project Harmonization meeting

Review harmonizationPackage submission

Develop harmonizationResults package for project team

Perform analysis and prepare for harmonization meeting

Further Information

• www.CDISC.org• ncicb.nci.nih.gov• caBIG.nci.nih.gov • www.BRIDGproject.org• [email protected]• [email protected]

interchange vs interoperability main entry: in·ter·op·er·a·bil·i·ty : ability of a system......

Documents

semantic model

terminology source

system source

element of data

static objects data

data andthe terminology

operationalized by0

areattributedto have10