BRIDG Model

BRIDG Model: A Comprehensive Information Model for Biomedical Research

25-April-2006

Douglas B. Fridsma University of Pittsburgh School of Medicine

Julie EvansCDISC

The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

CDISC Mission

Data Sources

• Site CRFs •Laboratories

•Contract Research

Organizations•Development

Partners

OperationalDatabase

•Study Data•Audit Trail•Metadata

OperationalData

Interchange& Archive:ODM, LAB

Submission Data

•CRT/Domain Datasets•Analysis

Datasets•Metadata

SubmissionData

Interchange & Archive:

SDTM,SEND, ADaM

Future of CDISC Models

ODM = Operational Data Model SDS = Submission Domain StandardsLAB = Laboratory Data Model ADaM = Analysis Dataset Models SEND = Std. Exchg. Non-clinical Data

Standard Protocol Representation and Terminology

Future Uniform CDISC Standard

Harmonized with HL7

Prot

ocol

How does BRIDG support these goals?

• CDISC started constructing an analysis model in 2003 to clarify semantic interoperability among CDISC models, and between the CDISC models and HL7

• BRIDG has become a collaborative mechanism with other people interested in developing standards– HL7 is using it as the basis for HL7 messages in RCRIM – NCI is using it to develop interoperable applications to support cancer

research– Technology providers are using it to develop standards-based

applications– CDISC continues to use it to clarify the semantics of the existing CDISC

models

• BRIDG has provided a way for CDISC standards to gain visibility among standards, research, and technology organizations

CDISC Roadmap Timeline

LABODM

define.xml

PROTOCOL

ADaM

A

ODM

LAB, ODM,define.xml& SDTM

B

D

C

LAB &SDTM

LAB, ODM,define.xml

ADaM & SDTM

BRIDG

2005 2007 - 2010

The CDISC Standard

STDM

20062005-2006

Data Sources

• Site CRFs •Laboratories

•Contract Research

Organizations•Development

Partners

OperationalDatabase

•Study Data•Audit Trail•Metadata

OperationalData

Interchange& Archive:ODM, LAB

Submission Data

•CRT/Domain Datasets•Analysis

Datasets•Metadata

SubmissionData

Interchange & Archive:SDS, ADaM

SEND

CDISC Standards Harmonization

ODM = Operational Data Model/Std SDS = Submission Domain StandardsLAB = Laboratory Data Model/Std ADaM = Analysis Data Models

SEND = Standards for the Exchange of Non-Clinical Data

Pro

toco

l

BRIDG: Harmonizing to THE CDISC Standard

Why BRIDG?

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

23 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 1Document 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

The Pillars of (Semantic) InteroperabilityNecessary but not Sufficient

• Common model across all domains-of-interest– The representation of clinical trials in BRIDG

• Model grounded on robust data type specification– Common data elements (ISO 11179) in the cancer Data

Standards Repository (caDSR)• Methodology for binding terms from concept-based

terminologies– Enterprise Vocabulary Server, terminologies

• A formally defined process for defining specific structures to be exchanged between machines, i.e. a “messaging standard”– HL7 and implementation specifications– CDISC standards development process– caBIG unified process/model driven architecture

What is BRIDG?

• A formal model of the shared semantics of regulated clinical trials research

• A communication bridge between– clinical trial domain experts and technical experts– different models of clinical trials information

• An open community of stakeholders interested in developing standards for exchanging information about clinical trials– HL7 Domain analysis model in Regulated Clinical Research

(RCRIM) technical committee– caBIG analysis model for model-driven development– CDISC integrating model for current standards

• The semantic foundation for application and message development in HL7, caBIG, and CDISC

So how did BRIDG get started?

• Two important streams of development that have been brought together into a collaborative framework– CDISC – 2003, started constructing an

analysis model to map ODM standards to HL7– NCI – 2004, started caBIG initiative to

construct a structured protocol representation and interoperability among clinical trials research in cancer

Model History – the CDISC work

• Fall 2003 – CDISC board meeting – recognized that integration of their standards required an comprehensive model of clinical trials

• Jan 2004 – CDISC begins work on integrated domain analysis model

• Mar 2004 – First modeling session in Philadelphia

• Summer 2004 – Multiple modeling sessions to expand the model

• Presentation to HL7 RCRIM, Fall 2004

caBIG and the Development of Structured Protocol Representation

• Spring 2004 – kick-off of the caBIG project• University of Pittsburgh award the contract

to develop a structured protocol representation to support clinical trials

Merging the caBIG and CDISC projects

• Fall 2004 – caBIG identified “best of breed” models in the CDISC standards and HL7 messages

• November 2004 – First joint CDISC/HL7/caBIG modeling session

• Between November 2004 and March 2005 – multiple modeling sessions to develop the “scaffolding” of the domain analysis model (SPR). Renamed BRIDG to reflect the shared interests of all stakeholders

• March 2005 to now – Development of the dynamic aspects of the model– Develop scalable processes to support collaboration and

expansion of the model, based on software best practices– Initiation of 8 subdomain projects within BRIDG

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)

Principles for model organization

• Make the work process explicit– Recognizes that concepts and models are in different

stages of development and harmonization• Provide a mechanism to scale the development

work– Parallelize the development– Prevent collaborators from “colliding” with each other

• Allows us to modeling in the open

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 affiliated 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 cl inical 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, reconcil ing 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 wi ll authorize aparty to transmit information about a trial to an external registry such as cl inicaltrials.gov.

For example, in an academic insti tution the principal investigatorwil l transmit information about a trial to an external registry.

The enti ty (person, org or system) that receives, processes and publ ishes registry information .

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

Storyboard: A pharmaceutical companyhasjust completed authoring a cl inical trial protocol document, they are ready to register the cl inical 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?Receive error message

Modify Information

Receiv eacknowledgement

ActivityFinal

Release information

Send error message

Send acknowledgement

Yes

No

ad RegisterClinicalTrial



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.

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

Behavioral Aspects of BRIDGad RegisterClinicalTrial



For example, a pharmaceutical organization/agent wi ll authorize aparty to transmit information about a trial to an external registry such as cl inicaltrials.gov.

For example, in an academic insti tution the principal investigatorwil l transmit information about a trial to an external registry.

The enti ty (person, org or system) that receives, processes and publ ishes registry information .

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

Storyboard: A pharmaceutical companyhasjust completed authoring a cl inical trial protocol document, they are ready to register the cl inical 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).





Is information acceptable?Is information acceptable?Receive error message

Modify Information

Receiv eacknowledgement

ActivityFinal

Release information

Send error message

Send acknowledgement

Yes

No

ad RegisterClinicalTrial






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

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 Elementscd Comprehensive Class-only diagram

MaterialRole

MaterialRole

FundingSponsor

HealthCareSite

Investigator

Organization RoleOrganizationRole

Participant

Person RolePersonRole

TherapeuticAgent

Activi tyPerformedActiv ity

PerformedStudy

ActivityPlannedActiv ity

PlannedStudy

ParticipationStudyAgent

ParticipationStudyInv estigator

ParticipationStudySite

ParticipationSubjectAssignment

DocumentStudyDocument

Dev iceDrug

Study

ParticipationStudyAuthor

+is described by1..1

+is operational ized by

0..1

+is fulfi led bythe role

1

+participate as

0..*

+areattributedto

+have

+areattributedto

+have

1 0..*+areattributedto

+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+ expi rationDate: DATETIME+ name: Text+ status: BRIDGStatus

Clinical Research Entities and Roles::

MaterialRole


FundingSponsor


HealthCareSite

Clinical Research Entities and Roles::Inv estigator

+ certif icateLicenseText: Text

Clinical Research Entities and Roles::Organization

+ description: Text+ geographi cAddr: BRIDGContactAddr+ name: Text+ status: BRIDGStatus+ tel ecomAddr: BRIDGTelecomAddress

Clinical Research Entities and Roles::OrganizationRole

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

Clinical Research Entities and Roles::Participant

+ confi denti alityIndicator: boolean+ paymentMethod: ENUM

Clinical Research Entities and Roles::Person

+ address: BRIDGContactAddr+ admini strativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ dateOfDeath: DATETIME+ educationLevelCode: BRIDGCodedConcept+ electronicCommAddr: BRIDGTelecomAddress+ ethnicGroupCode: BRIDGCodedConcept+ householdIncomeCategory: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ name: Text+ raceCode: BRIDGCodedConcept+ tel ecomAddress: BRIDGTelecomAddress

Clinical Research Entities and Roles::PersonRole

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

Clinical Research Entities and Roles::TherapeuticAgent

Clinical Trials Activ ities::PerformedActivity

+ plannnedUnplannedInd: boolean::Activity+ codedDescripti on: BRIDGCodedConcept+ confidential ityCode: BRIDGCodedConcept+ description: BRIDGDescri ption+ endDate: DATETIME+ pri orityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Cl inical Trials Activiti es::PerformedStudy

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

Clinical Trials Activities::PlannedActivity

+ repeatNumber: rangeOfIntegers::Activity+ codedDescription: BRIDGCodedConcept+ confi dentiali tyCode: BRIDGCodedConcept+ descripti on: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Clinical Trials Activ ities::PlannedStudy

+ targetAccrualNumber: int::Study+ blindedInd: boolean+ descripti on: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ mul tiInstitutionInd: 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 Activities::StudyInv estigator

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

Clinical Trials Activ ities::StudySite

+ targetAccrualNumber: int::Parti cipation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activ ities::Subj ectAssignment

+ ageAtEnrollment: i nt+ arm: string+ eligibil ityWaiverReason: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ studySubjectIdentif ier: int+ subgroupCode: stri ng::Parti cipation+ 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::ActivityActivityRelationship

+ checkpointCode: + conjunctionCode: + joi nCode: + negati onIndicator: BOOLEAN- negati onRule: AbstractRule+ pri orityNumber: 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+ electroni cCommAddr: 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- ori ginalText: TEXT- translation: SET{PSMCodedConcept}

BRIDG Shared Classes::BRIDGContactAddr

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

BRIDG Shared Classes::BRIDGDescription

+ detailedDescri ption: EncapsulatedData+ summaryDescription: EncapsulatedData+ synopsis: EncapsulatedData

BRIDG Shared Classes::BRIDGID

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

BRIDG Shared Classes::BRIDGInterv al

+ endTime: timestamp- startTime: timestamp

BRIDG Shared Classes::BRIDGStatus

+ effectiveEndDate: + effectiveStartDate: + statusValue:

Specimen may have to re-located

Needs additi onal work and cleanup

Clinical Trials Activ ities::StudyDocument

+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ mul tiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept::Document+ confi dentiali tyCode: 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 thi nking is that this will be used for caAERS. Ifnot, then it should be deleted.

This maybe an Acti vity?

Review the data types -- inconsistency in definit ion and what is used i n the model

BRIDG Shared Classes::BRIDGTelecomAddress

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

BRIDG Shared Classes::Dev ice

::Material+ descripti on: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus

BRIDG Shared Classes::Drug

+ formCode: BRIDGCodedConcept+ lotNumber: i nt+ stabili tyTime: DATETIME::Material+ description: Text+ expi rationDate: DATETIME+ name: Text+ status: BRIDGStatus

Clinical Trials Activities::Study

+ blindedInd: boolean+ descripti on: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activ ities::StudyAuthor

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

BRIDG Shared Classes::Document

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

We wi ll need to MANUALLY keep these two classes in synch with thei r attributes.

CTOM Elements::PerformedObserv ation

+ confi denti alityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

CTOM Elements::Observ ationRelationship

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

PlannedObserv ation

We may or may not need thi s cl ass -- it depends on the number of shared cl asses between thetwo performed/planned activiti es

CTOM Elements::Histopathology

+ grossExamResultCode: string+ invol vedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string

CTOM Elements::ClinicalResult

+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositi onCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVi talStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string

CTOM Elements::LesionDescription

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

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

+ evaluati onInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

SDTM::Quantitativ eMeasurement

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

SDTM::Examination

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

TestInterpretationSDTM::InterpretedResults

::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resul tCategory: i nt::Quanti tativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ resul t: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

TestInterpretation

SDTM::VitalSign

+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPositi on: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndi cator: enum- resultCategory: int::Quanti tativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

+is fulf iled by the role

1

+participate as

0..*

+are attributed to +have

0..*

1


1 0..*

+are written by

+write

0..*

1


+is operati onalized by

0..1

+is descri bed by

1..1

+is descri bed by 1

+describes 1

+source activity

*

*

+target activi ty

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

BRIDG Sub-Projects• Trial Design Model

• Based on CDISC and FDA/Janus standard

• Developing common concepts and understanding for arms, treatment groups, visits, cycles, courses, etc.

• At present, input from Pharmaceutical companies thru CDISC and FDA

• Current Status – – Recently worked with CDISC

SDTM team to model SDTM requirements

– Plans to harmonize with BRIDG

Follow-upTreatmentRun-InScreen

Screen Run-In

Trt Phase 1

Standard Care

Trt Phase 2 Follow-up

Follow-up

Example: Dissimilar Arms

Source: Diane Wold - GSK

Arm segmentArm

Epoch

BRIDG Sub-Projects (cont’d)

• Clinical Trial Registry • Objective: To define requirements for

registering a clinical trial in a clinical trial repository

• Working with NCI, CDISC, PDQ, clinicaltrials.gov and European EUDRACT

• Have recently established collaboration with the WHO activity of clinical trials registry

– Becky Kush (CDISC president) on the advisory board

– Working with cancerGRID to incorporate and make explicit the CONSORT model

• Current Status –• Group has defined a list of 70 elements• Modeled in BRIDG April 2006• Planning on developing a HL7 v3 message• POC – Lakshmi Grama, NCI

cd External Registry


+ blindedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ populationDescription: BRIDGDescription+ randomizedInd: boolean+ shortTitl e: string+ sponsorCode: CodedConceptDataT ype+ status: BRIDGStatus+ SubjectType: BRIDGCodedConcept+ targetConditi onCode: BRIDGCodedConcept+ type: BRIDGCodedConcept

DocumentClinical Trials Activ ities::

StudyDocument

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

Clini cal Trials Activities::PerformedStudy

+ ActualAccrualNumber: int+ enrollmentEndDate: Date+ enrollmentstartDate: Date::Study+ bli ndedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTi tl e: stri ng+ monitorCode: ENUM+ multiInstituti onInd: boolean+ phaseCode: ENUM+ populationDescription: BRIDGDescription+ randomizedInd: boolean+ shortT itle: string+ sponsorCode: CodedConceptDataType+ status: BRIDGStatus+ SubjectType: BRIDGCodedConcept+ targetConditionCode: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activities::PlannedStudy

+ plannedSubjectInterventionDuration: DATET IME+ plannedSubjectParticipationDuration: DATETIME+ targetAccrualNumber: int::Study+ blindedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ populationDescription: BRIDGDescription+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ status: BRIDGStatus+ SubjectType: BRIDGCodedConcept+ targetConditionCode: BRIDGCodedConcept+ type: BRIDGCodedConcept

OrganizationRole

Clinical Research Entities and Roles::Registry

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

StudyRegistration

+ isPrimary: boolean::Participation+ endDate: DATETIME+ startDate: DAT ETIME = + status: CodedConcept+ statusDate: DATET IME+ type: CodedConcept


+ endDate: DATETIME+ startDate: DAT ETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

RegulatoryInv estigationalProductId

We need to address regulatory information such as route of administration, substance, indication. Check with SDTM

StudySponsor

::Parti cipation+ endDate: DAT ETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DAT ETIME+ type: CodedConcept

sponsorCode is a CTOM specific attributeand needs to be harmonized with the new StudySponsor class.

External Registry: Need an attribute plannedEnrollmentStartDate and plannedEnrollmentEndDate


+ accrualStatus: BRIDGStatus+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ targetAccrualNumber: int+ telecomAddr: BRIDGTelecomAddress::Participation+ endDate: DATETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

status should be BRIDG status

SDTM::SDTMInterv ention

+ description: SDTMInterventionDescriptionDataType+ endTime: DATETIME+ evaluationInterval: tim ing specification+ indication: text+ missingValueCode: CodedConceptDataType+ startT ime: DAT ET IME

SDTM::StudyDrug

+ dose: numeric+ doseDescription: text+ doseForm: CodedConceptDataType+ doseFrequency: CodedConceptDataType+ doseTotal: numeric+ doseUnits: CodedConceptDataType+ locationOfDoseAdministration: CodedConceptDataType+ reasonForDoseAdjustment: text+ routeOfAdministration: text+ treatment: text+ treatmentVehicle: CodedConceptDataType+ treatmentVehicleVolume: num+ treatmentVehicleVolumeUnits: text::SDTMIntervention+ description: SDTMInterventionDescripti onDataType+ endTime: DATETIME+ evaluationInterval: timing specifi cation+ indication: text+ missingValueCode: CodedConceptDataType+ startTime: DATETIME::Participation+ endDate: DATETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activities::StudyAgent

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

SDTM::DoseRegimen

CTOM Elements::Procedure

+ targetSiteCode: stri ng

CTOM Elements::Radiation

+ dose: string+ doseUnitOfMeasure: string+ therapyType: string

CTOM Elements::SubstanceAdministration

+ doseChangeType: int+ doseFrequency: string+ doseModificationType: string+ doseQuantity: int+ doseUnitOfMeasure: string+ route: string

CTOM Elements::

Surgery

ActivityClinical Trials Activ ities::PerformedActiv ity

+ plannnedUnplannedInd: boolean::Activity+ codedDescription: BRIDGCodedConcept+ confidentiali tyCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATET IME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Review SDTM and CTOM models

Arm

+ plannedSubjectNumber: int+ type: text

StudyBackground(why)

+ description: PSMDescription+ justificationOfApproach: PSMDescription+ justificationOfObjectives: PSMDescription+ populationDescripti on: PSMDescription+ rationaleForAnalysisApproach: PSMDescription+ rationaleForControl : PSMDescription+ rationaleForDesign: PSMDescription+ rationaleForEndpoints: PSMDescription+ rationaleForMasking: PSMDescription+ studyPurposeSummary: Text+ summaryOfPreviousFindings: PSMDescription+ summaryOfRisksAndBenefi ts: PSMDescription

SerializableeligibilityCriteria::EligibilityCriterion

+ codedName: BRIDGCodedConcept+ comparisonOperator: Text+ description: T ext+ eligibil ityType: String+ uni t: Text+ value: Text

StudyObjectiv e(what)

+ description: BRIDGDescription+ objectiveCode: SET ENUMERATED+ objectiveType: ENUM{Primary,Secondary,Ancillary}

Outcome

- analyticMethods: Set- asMeasuredBy: Set- associatedObjective: Set+ description: BRIDGDescription+ outcomeType: ENUM{Primary,Secondary,Ancillary}- outcomeVariable: - threshold:

If the objecti ve is of type 'Primary' then there outcome should be of type primary.

+is operationalized by

0..1

+is described by

1..1

+is described by 1

+describes 1

1..*

1..*

+defines study population

1

+study population is defined by

1..*

+is registered through

+registers

+has 1

+defines the purpose of 1..*

+performs +is performed by

0..*

1

0..*

1

+is administered according to 1..*

+describes administration of 0..1

+are performed at+participate in

+is contained in

+contains

CT Registration message

BRIDG Sub-Projects (cont’d)

• eDCI message (electronic Data Capture Instrument)

– A DCI is a set of related questions for which values are to be collected during a clinical trial visit.

– This model will be used as an HL7 message definition (or a set of definitions) that can be used to transmit a DCI Definition between databases managed by clinical data management systems (CDMS).

– Participation from NCI, CDISC, Oracle– UML model on bridgproject site --

https://www.bridgproject.org/edci/

– Current Status –• Requirements have been defined for 1st iteration• UML class diagram is completed• Working on building the message specification

(RMIM)• POC – Don Kacher, Oracle

cd DCI Definition, v1.5.2

«structure»DciDefinition

+ MetadataRegistryDCIId: + MetadataRegistryDCIVersion: + MetadataRegistryLayoutId: + MetadataRegistryRAI: + Name: + IsTemplateDciFlag: + CreationTimestamp: + eDciStandardVersion: + ClinicalArea: [0..1]+ ClinicalStudy: [0..1]+ HelpText: [0..1]+ DciDescription: [0..1]+ LayoutDescription: [0..1]

«logical behavior»TriggeredAction

+ Action: + TargetId: + CriterionValue: + TriggerRelationship: + ForcedValue: [0..1]+ EnumeratedValueDomainSubsetId: [0..1]

«logical behavior»CheckValue

+ CheckValue:

«rendering»DciPresentation

+ IntendedFormHeight: + IntendedFormWidth:

«semantic content»ItemRef

+ Id: + ContainerType: [0..1]+ ContainerId: + HelpText: [0..1]+ NavigationSequenceNumber: + IsContextItemFlag: + PromptText: + EnumeratedValueDomainSubsetId: [0..1]+ IsMandatoryFlag: [0..1]+ ROASId: [0..1]

«structure»SectionRef

+ Id: + Name: + NavigationSequenceNumber: + EncloseSectionRefInBoxFlag: [0..1]+ DifferentiatorQuestionValue: [0..1]+ HelpText: [0..1]+ DifferentiatorQuestion: [0..1]

«structure»GroupRef

+ Id: + SectionRefId: + SequenceNumber: + Name: [0..1]+ NavigateByItemInRepeatFlag: [0..1]+ MaximumItemRefRepeats: [0..1]+ HelpT ext: [0..1]+ EncloseGroupRefInBoxFlag: [0..1]

«semantic content»ContextItem

+ DataElementConceptId:

«semantic content»EVDSubsetElementRecord

+ Value: + SequenceNumber: + ValueMeaning: [0..1]+ ValueMeaningDescription: [0..1]+ RadioButtonLabel: [0..1]+ HelpText: [0..1]

«rendering»RadioButtonPresentation

+ EVDSubsetElementRecordSN: + ButtonPage: + LabelULX: + LabelULY: + ButtonULX: + ButtonULY: + ButtonLRX: + ButtonLRY:

«semantic content»DataElementConcept

+ Id: + Definition: + Name: + ObjectClassDefinition: + PropertyDefinition: [0..1]+ SASDesignatedName: [0..1]+ ROASId: [0..1]

Name: DCI Definition, v1.5.2Author: Don KacherVersion: 1.0Created: 6/7/2005 12:05:46 PMUpdated: 11/2/2005 5:47:04 PM

«semantic content»ItemDef

+ Id: + Name: + DataElementConceptId: + ValueDomainId: + ROASId: [0..1]+ Definition: [0..1]+ Comment: [0..1]+ IsMandatoryFlag: [0..1]

«semantic content»GroupDef

+ Id: + Name: + RepeatingGroupFlag: + ROASId: [0..1]+ DataPersistenceEntityName: [0..1]

«semantic content»ExplicitItemRefRepetition

+ RepeatSequenceNumber: + RepeatSpecificDefaultValue: [0..1]

«rendering»ItemAppearance

+ PromptOrientation: + PromptTypeFace: + PromptTypeSize: + PromptTypeStyle:

«rendering»ValueEditField

+ FieldPage: + FieldULX: + FieldULY: + FieldHeight: + FieldWidth:

«rendering»PromptRenderingLocation

+ Page: + PromptULX: + PromptULY:

«rendering»ValueEditWidget

«semantic content»EnumeratedValueDomain

+ VocabularyName: + VocabularyOID: [0..1]+ VocabularyVersion: [0..1]+ VocabularyCodeset: [0..1]

«semantic content»EnumeratedValueDomainSubset

+ SubsetNumber: + IsBaseSubsetFlag:

«rendering»Instruction

+ InstructionText: + TypeFace: [0..1]+ TypeSize: [0..1]+ TypeStyle: [0..1]

«rendering»PersistentInformation

+ AssociatedElement: + Page: [0..1]+ ULX: [0..1]+ ULY: [0..1]+ LRY: [0..1]+ LRX: [0..1]

«rendering»GraphicImage

+ Source:

«rendering»RadioButtonAppearance

+ ButtonLabelTypeFace: + ButtonLabelTypeSize: + ButtonLabelTypeStyle: + ButtonEnclosureStyle: + SymbolWhenSet:

«rendering»FieldAppearance

+ FieldTypeFace: + FieldTypesize: + FieldTypeStyle: + FieldEnclosure:

«rendering»RadioButtonSet

Global Metadata for the eDCI

Guidance on rendering the DCI as a form. This information is of three sorts: 1. Logical behavior: TriggerAction conveys business rules for interactions among fields2. Appearance of elements on the form3. Postion of elements on the form.All three are optional. However, if position is sent, appearance should be sent as well.

«semantic content»SectionDef

+ Id: + Name: + ROASId: [0..1]

«logical behavior»RangeCheck

+ Id: + Comparator: + SoftHard: + ErrorMessage: [0..1]+ UnitOfMeasure: [0..1]

Definitions of DCI component base objects.

DCI fields, in grouping structures

«semantic content»ValueDomain

+ Id: + Name: + Datatype: + Description: [0..1]+ DecimalPlaces: [0..1]+ MaximumLength: [0..1]+ ROASId: [0..1]+ SasFormatName: [0..1]

«semantic content»NonEnumeratedValueDomain

«rendering»ItemInstantiationOnAForm

+ ValueEditWidgetType:

«semantic content»RegistryObjectAttributeSet

+ Id: + RegistryAuthorityId: [0..1]+ ObjectId: [0..1]+ ObjectVersion: [0..1]

0..*

0..2

DCI-wide default appearance setting

1..*

1..*

1..*

reference

1..*

1..*

0..*

for a ref and any repetitions

0..1

0..1

Item-specific appearance setting

1..*

0..*

0..*

ItemDef-wide specification

0..*

1..*

1..*

reference

0..1

1..*1..*

1..*0..*

ItemRef-specific specification

0..1

sizes "page"

0..1

0..*

0..1

0..*

for a specific explicit rep

1..*

reference

1..*

DCIDefinition (aka CRF)

SDTM

• SDTM model– Being harmonized with

adverse event reporting, CTOM (NCI clinical trial object model) and HL7

cd SDTM Analysis Model

StudySubject

+ subjectID: CodedConceptDataType+ studyRefStartTime: DATETIME+ studyRefStopTime: DATETIME::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME

Clinical Trials Activ ities::StudyInvestigator

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


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


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

Activi tyClinical Trials Activi ties::PerformedStudy

+ id: BRIDGID+ longTitle: string+ shortTi tle: string+ phaseCode: ENUM+ intentCode: ENUM+ monitorCode: ENUM+ blindedInd: boolean+ randomizedInd: boolean+ diseaseCode: CodedConceptDataType+ sponsorCode: CodedConceptDataType+ multiInsti tutionInd: boolean+ targetAccrualNumber: int::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ avai labi l ityTime: T imingSpecification+ priorityCode: PSMCodedConcept+ confidential ityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME

Each StudySubject is associated with only 1 si te. A StudySite is associated with 1 or more StudySubject.

Date and Time of Col lection are probably going to be attributes of the CRF.

ARMCD and ARM are going to be associated with Trial Design.

SDTMInterv ention

+ description: SDTMInterventionDescriptionDataType+ missingValueCode: CodedConceptDataType+ indication: text+ startT ime: DATETIME+ endTime: DATETIME+ evaluationInterval: timing specification

SDTMInterventionDescriptionDataType

+ verbatim: text+ decode: CodedConceptDataType+ modified: text+ class: CodedConceptDataType


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

StudyDrug

+ dose: numeric+ doseDescription: text+ doseUnits: CodedConceptDataType+ doseForm: CodedConceptDataType+ doseFrequency: CodedConceptDataType+ doseTotal : numeric+ locationOfDoseAdministration: CodedConceptDataType+ routeOfAdministration: text+ reasonForDoseAdjustment: text+ treatmentVehicle: CodedConceptDataType+ treatmentVehicleVolume: num+ treatment: text+ treatmentVehicleVolumeUnits: text::SDTMIntervention+ description: SDTMInterventionDescriptionDataType+ missingValueCode: CodedConceptDataType+ indication: text+ startT ime: DATETIME+ endTime: DATETIME+ evaluationInterval: timing specification::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME

Action: Check with CTOM team about what StudyAgent means.

Action: Check with RXNORM and Structured Product Label for the standards to describe drug dosing.

DoseRegimen

Action: Revisi t --ADJ(Reason for Dose Adjustment) since we haven't includedit yet.

ConMeds and Substance Use are also subclasses of Interventions. There likely needs to be intermediate levels of Intervention subclasses, for example, drug and non-drug interventions. Also, evaluationInterval isan attribute of these2 subclasses, but not StudyDrug.

SDTMEvent

+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startT ime: DATETIME

Adv erseEv ent

+ isSerious: boolean+ location: CodedConceptDataType+ severi ty: enum+ actionTakenWithStudyTreatment: enum+ otherActionTaken: text+ relationshipToStudyTreatment: CodedConceptDataType+ actionTakenWithConcomitantTreatment: text+ toxicityGrade: CodedConceptDataType+ seriousnessCriteria: enum+ outcome: CodedConceptDataType::SDTMEvent+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startT ime: DATETIME

SDTMEventDescriptionDataType

+ decode: CodedConceptDataType+ verbatim: text+ bodySystem: CodedConceptDataType+ modified: text

Action: Determinehow to handle PATTERN since i tisn't included yet.

Disposition

::SDTMEvent+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startTime: DATETIME

MedicalHistory

+ missingValueCode: CodedConceptDataType+ negationIndicator: boolean+ evaluationInterval: timing specification::SDTMEvent+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startTime: DATETIME

Medical History wi ll probably not harmonize into the BRIDG in this way but wil l probably be associated with Subject.

Could have NonAdverseEvent abstract class above MedicalHistory

Represent Concomicant Medications and Substance Use

SDTMFinding

+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType

QuantitativeMeasurement

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

Examination

- resultDescription: SDTMFindingDescriptionDataType+ measurementT ime: int::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType

OtherFindings

+ measurementT ime: DATETIME+ evaluationInterval: timing specification::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType

Action: Determine how HL7 handles units.--PQ data type

Note: There are regulatoryrequirements to report original and standard results, units, and normal ranges. The primary concept is denoted in tthe QuantitativeMeasurement class, and not al l the variations.

SDTMFindingDescriptionDataType

+ verbatim: text+ modified: text

LaboratoryTest

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

Specimen

::Sample+ type: enum+ condition: text+ col lectionTime: DATETIME+ col lectionMethod: enum+ id: CodedConceptDataType

PerformingLaboratory

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

InterpretedLaboratoryTest

+ toxicityGrade: enum::LaboratoryTest+ method: enum+ fastingStatus: boolean::TestInterpretation+ normalRangeIndicator: enum- resultCategory: int+ interpretedBy: enum::Quanti tativeMeasurement+ result: text+ units: text+ normalRangeLow: text+ normalRangeHigh: text::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType

Action:; Need to determine how to handle basel ine. The baseline is an interpretation based on many ofthe test results.

Action: Determine how tohandle derived tests or findings.

TestTestRelationship

+ description: text

VitalSign

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

InterpretedResults

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

TestInterpretation

+ normalRangeIndicator: enum- resultCategory: int+ interpretedBy: enum

Image

+ id: URL::Sample+ type: enum+ condition: text+ collectionT ime: DATETIME+ collectionMethod: enum

Sample

+ type: enum+ condition: text+ collectionTime: DATETIME+ collectionMethod: enum+ id: CodedConceptDataType

Note: The variable PEBODSYS may apply to either the test description or the result description.

these are complex data types used to support the classes in the model.

There are complex date times that wi ll require collection intervals -- for example, a 24 hour cortisone, a 24 hoururine col lection, etc. We wi l l need to take a look at the HL7 date/time data types to provide more information abouthow best to represent the dates and times.

subjectVisit

+ visi tNum: sequentiall ist+ plannedunplannedind: boolean+ descriptionOfUnplannedVisit: text::SDTMEvent+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startTime: DATETIME Action: Need to address start

and end relative to a fixed timepoint for both Events and Findings (--ENRF and --STRF). HL7 timing specs may have ways to deal with this problem. Also applies to Substance Use and Concomitant Medications.

ArmAssignment

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

SupplementalQualifiers

+ Evaluator: ENUM+ Value: string+ variableName: string+ Reference: string

In SDTM the RelRec table associates observations to one another. This would berepresented as a ActAct Relationship within BRIDG. The RelRec table does not give the kind of relationship, just the existence of the relationship.

SDTMActActRelationship

+ relationshipType: ENUM

Harmonization notes (HN)-- simi lar to Observation--SH

Harmonization notes -- simi lar to clinicalResults--SH

Harmonization Notes -- simi lar toActivi ty >SubstanceAdministration--SH

Harmonization Notes - similar to AEclasses --SH

Harmonization Notes -similar to Proceudre, SpecimenCol lection, Sample --SH

Harmonization Notes: Move to Activi ties and Particiaptions package

Harmonization Notes: This maybe a Performed Activty --SH

Harmonization Notes (HN): PerformedSutdy .....review --duplicate of plannedUnplannedInd--SH

HN: harmonize with SubjectAssignment --SH

HN: Add as a Role to Entities and Roles package--SH

HN: Good concept defintion; similar to Imaging class; review theassociai tons -SH

Preliminary Techincial Harrmonization notes

1

+must have

1..*

+is experiencedby

0..*

+is taken from

1+is the source of

1+performs

1..*+is performed by

1..*+is performed on

1+is analyzed by

1..

+may experience

0..*

+may happen to

1

+may have a

0..*

+belongs to

1..*

+is screened for orenrolled in

1

+screens or enrol ls

0..*+is assigned to

1

+is responsible for

0..*

1

0..* 1

0..* 1

1..*

+is administered accordingto

0..1

+describes administration of

1

+receives Interventions

0..*+are performed on

0..*+has test performed

1

+Is performed on

0..*+is assigned to

1

+is thelocation forparticipationfor

1

+has

1

+receives

0..1+col lects

0..*+are col lected at

0..*+is col lected at

0..1+col lects

0..*

+is col lecte at

0..1

+collects

1+interprets

1..*+is interpreted by

SDTM Class Diagram

Subprojects

• caAERS– Project lead: Joyce Niland– Developing an HL7 message and application(s) to

support adverse event reporting– Other AE models –

• CDC – incidence reporting• HL7 – patient safety and public health reporting• caBIG (caAERS)• FDA and SDTM (CDISC)

– Harmonization meeting in May with all stakeholders to identify commonalities and differences between these models, and harmonize them into BRIDG

caAERScd Logical Model

StudySubject

+ birthDate: date+ ethnicGroup: string+ sex: string+ race: string::Person+ namePrefix: string+ fi rstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long

Activ ity

+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

Organization

+ name: string::ParticipatingEnti ty+ id: long

ParticipatingEntity

+ id: long

Activ ityParticipation

+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ id: long+ participantSignature: string+ participantSignatureDate: dateTime+ type: string

Product

+ name: string+ status: string::ParticipatingEntity+ id: long

Observation

+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean+ resultValue: string::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

PharmacuticalTreatment

+ administrationDose: int+ administrationFrequency: string+ administrationRoute: string+ doseUnit: string+ totalDoseAdministered: int+ dateAgentProvided: date+ lastDateAgentAdministered: date::Treatment+ courseNumber: string+ cycleNumber: string+ negationIndicator: boolean+ isContinuingIndicator: boolean+ treatmentAssignmentCode: string+ schedule: string+ totalCourseNumber: int::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

AdverseEvent

+ outcomeCode: string+ severi ty: string+ adverseEventVerbatimTerm: string+ attributableEventOrEntityType: string+ attributableEventName: string+ isContinuingIndicator: boolean+ comment: string+ evaluationMethodCode: string+ evaluationConclusionCode: string+ evaluationResultCode: string+ otherTypeOfReportableEvent: string+ reportableEventType: string+ otherReasonBeingSerious: string+ reasonBeingSerious: string+ ctcAdverseEventCategory: string+ ctcAdverseEventGrade: int+ ctcAdverseEventTerm: string+ medDRAcode: string+ abatedAfterRemedialActionIndicator: boolean+ locationOccurred: string+ otherContributingCause: string+ reappearedAfterAgentReintroductionIndicator: boolean+ seriousAdverseEventIndicator: boolean+ otherCTCAdverseEventTerm: string+ seriousAdverseEventTreatmentDateApplicableIndicator: boolean+ ageAtTimeOfEvent: int+ removedFromStudyAfterAdverseEventIndicator: boolean+ dateRemovedFromStudy: date+ remedialActionTaken: string::Observation+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean+ resultValue: string::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string = New

AdverseEventActiv ityRelationship

+ expectedness: boolean+ attributionCode: int+ studyDesignBroken: boolean+ administrationDelayed: boolean+ durationDelayedTimeUnitCode: string+ delayedDurationTimeAmount: int::Activi tyRelationship+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivi tyRole: string+ sequence: int

ProcedureTreatment

::Treatment+ courseNumber: string+ cycleNumber: string+ negationIndicator: boolean+ isContinuingIndicator: boolean+ treatmentAssignmentCode: string+ schedule: string+ totalCourseNumber: int::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

ClincalStudy

+ type: string+ researchComment: string::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

AdverseEventDetail

+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string

MaterialKind

+ name: string::ParticipatingEnti ty+ id: long

AdverseEventDetailKind

+ id: string+ adverseEventDetai lCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string

ParticipatingEntityIdentifier

+ id: long+ identi fierValue: string+ identi fierType: string

AdverseEventReport

+ sequenceIdentifier: int+ subjectDiscloserAllowed: boolean+ hasAmendedDataIndicator: boolean+ sentToFDAIndicator: boolean+ sentToManufacturerIndicator: boolean+ followUpNumber: int+ followUpType: string+ additionalInformationAttachedType: string+ reasonNoRelevantHistoryProvided: string+ containsCorrectedDataIndicator: boolean+ type: string+ sponsorNoti fiedBeforeReportFil ingIndicator: boolean+ sponsorNoti ficationDate: dateTime+ sponsorNoti ficationMethod: string+ otherAdditionalInformationAttached: string+ is24hourReportIndicator: boolean::Activity+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

Treatment

+ courseNumber: string+ cycleNumber: string+ negationIndicator: boolean+ isContinuingIndicator: boolean+ treatmentAssignmentCode: string+ schedule: string+ totalCourseNumber: int::Activi ty+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

Person

+ namePrefix: string+ fi rstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEnti ty+ id: long

+ isHealthProfessional() : boolean

Activ ityIdentifier

+ id: long+ identi fierValue: string+ identi fierType: string+ versionIdenti fier: string+ versionEffectiveDate: dateTime

Activ ityRelationship

+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivi tyRole: string+ sequence: int

ParticipatingEntityRelationship

+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ id: long+ relationshipStatus: string+ relationshipType: string

Protocol

+ phase: string+ ti tle: string+ CTCVersion: string+ INDusedIndicator: boolean::Activity+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string

Device

+ implantedDate: dateTime+ explantedDate: dateTime+ reprocessedIndicator: boolean+ avai lableForEvaluationIndicator: boolean+ labeledForSingleUseIndicator: boolean+ usage: string::Product+ name: string+ status: string::ParticipatingEnti ty+ id: long

Location

+ name: string+ description: string+ streetAddress: string+ ci ty: string+ state: string+ postalCode: string::ParticipatingEnti ty+ id: long

DrugProduct

+ lotNumber: string+ expirationDate: date+ brandName: string::Product+ name: string+ status: string::ParticipatingEnti ty+ id: long

DrugProductIngredient

+ id: long+ quanti ty: float+ activeIngredientIndicator: boolean+ materialForm: string

Activ ityKind

+ id: long+ activi tyCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string

Name: Logical ModelAuthor: AbdulMal ik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 1/24/2006 10:38:06 AM

Name: Logical ModelAuthor: AbdulMal ik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 1/24/2006 10:38:06 AM

caAERS Conceptual Data Model v20060123.0

PersonTelephone

+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string

OrganizationTelephone


AdverseEventReportDetail

+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string

ParticipatingEntityKind

+ id: long+ entityType: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string

AdverseEventReportDetailKind

+ id: + adverseEventReportDetai lCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string

ObservationKind

+ id: long+ observationValueCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string

ParticipatingEntityRole

+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ id: long+ roleType: string+ status: string+ ti tle: string

ObservationValue

+ id: long

DiseaseHistory

+ category: string+ primaryDiseaseName: string+ primaryDiseaseSite: string+ dateOfIni tialDiagnosis: date+ dateOfIni tialPathologicDiagnosis: date+ otherPrimarySite: string+ nameNotListed: string+ metastaticDiseaseSite: string+ otherMetastaticDiseaseSite: string+ otherPreExistingCondition: string+ preExistingCondition: string+ dateInitialDiagnosisKnownIndicator: boolean::ObservationValue+ id: long

Weight

+ value: real+ unitOfMeasure: string+ obtainedIndicator: boolean::ObservationValue+ id: long

StudySubjectObservation

+ id: long+ baselinePerformanceStatus: int+ medicalHistoryDescription: string

DiagnosticTest

+ name: string+ datePerformed: dateTime+ type: string+ category: string+ value: string+ unitOfMeasure: string::ObservationValue+ id: long

Infection

+ causalAgentName: string+ si te: string+ type: string+ date: date::ObservationValue+ id: long

Death

+ cause: string+ deceasedDate: date+ causeUnrelatedToAdverseEvent: string+ otherCause: string+ causalPrimaryOrganSystemFailure: string+ autopsyPerformedIndicator: boolean+ causeKnownIndicator: boolean+ autopsyDate: date::ObservationValue+ id: long

Height

+ value: real+ obtainedIndicator: boolean+ unitOfMeasure: string::ObservationValue+ id: long

0..*+identi fierCollection

1

+entity

1+organization

0..*+telephoneCollection

0..*

+identifierCollection

1+assigningAuthori ty

0..*+identifierCollection

1

+assigningAuthority

1

+entity

0..*

+participationCollection

0..*+relationshipCollection

1+targetEnti ty

1..*+ingredientCollection

1+product

1

+activityKind

0..*+activityCol lection

1+person

0..*+telephoneCollection

0..*+adverseEventReportDetai lCollection

1+adverseEventReportDetai lKind

0..*+adverseEventReportDetai lCollection

1

+adverseEventReport

0..*

+ingredientCollection

1 +material

0..* +relationshipCollection

1+sourceEntity

0..*

+eventDetailCol lection

1

+adverseEvent

1+studySubject

0..1+studySubjectObervationCollection

1

+observation0..*

+observationValueCollection

0..1+role

0..*+participationCollection

0..*+roleCollection

0..1

+entityRelationship

0..*

+roleCollection

1

+entity

0..*

+relationshipCollection

1

+sourceActivity

1+participatingEntityKind

0..*+entityCollection

1

+eventDetailKind

0..*+eventDetailCollection

0..*+AdverseEventReportCol lection

1

+adverseEvent

0..*

+activityRelationshipCol lections

1+adverseEvent

1

+act

0..*

+participationCollection

1

+activity

+identifierCollection

0..*

+relationshipCollection1

+targetActivi ty

0..*

+observationCollection1

+observationValueKind

Harmonization

Project plan

• Registration of the project – Allows the BRIDG team to provide information

and updates• Regular releases• Monthly modeling session• Priorities and resources determined by the

BRIDG advisory board (and stakeholders)

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

What does it mean to “adopt BRIDG” or “harmonize with BRIDG?”

• Adopting and harmonizing with BRIDG is a two-way street– The model is not complete, and harmonization and adoption

requires participation and contribution to BRIDG from others– The model is new and is changing, so harmonization and

adoption requires flexibility and change• Early adopters will have a more significant impact on the

direction and development of BRIDG• Adopting and harmonization with BRIDG is less about a

commitment to a specific model, but the realization that– A common standard is a shared good that all can benefit from– It will require contribution and collaboration as we collectively

determine the best approaches– It will require compromise and collective action

BRIDG - Implementation Independent Domain Analysis Model

cd Logic al Model

StudySubject

+ bi rthDate: date+ gend er: string+ ra ce: st ring+ ethnicGro up: string+ deceaseDate: date::Person+ namePref ix: string+ firstName: string+ midd leNa me: string+ la stName: string+ nameSuff ix: string+ occupat io n: string+ emailAdd ress: string::Participating Enti ty+ id : l ong

Activ ity

+ id: long+ sta rtTime: dateTi me+ endTi me: da teTi me+ method: strin g+ reason: st ring+ descri pti on: string+ sta tu s: stri ng

Organization

+ name: stri ng::Participat in gEntity+ id: l ong

+ isFDA() : boolean

ParticipatingEntity

+ id: l ong

Activ ityParticipa tion

+ id: long+ type: st ring+ effecti veFromTime: dateTime+ effecti veThruTi me: da teTi me+ partici pantRole: string+ partici pantSig nature: string+ partici pantSig natureDa te: dateTime

Product

+ name: string+ status: stri ng::Participat ing Entit y+ id: l ong

Obs erv ation

~ resultValue: string+ targetAnatomicalSi te: st ring+ onsetDateTime : dateT ime+ effectiveThuTime: dateTime+ negat ionIndicato r: boolean::Activit y+ id: long+ startTime: da teTime+ endTi me : dateT ime+ metho d: st ring+ reason: string+ descri pt ion: strin g+ status: string


+ administrationRo ute: string+ totalDoseAdmini stere d: int+ administrationDo se: int+ administrationFreque ncy: strin g::Treatment+ courseNu jmber: string+ cycl eNumber: string+ negat io nIn dica to r: boolean::Activity+ id: long+ startTime: dateTime+ endTime : dateT ime+ method : string+ reason: string+ descri pt ion : strin g+ status: st ring

Adv erseEv ent

+ outcome: stri ng+ seri ousness: strin g::Observa tion~ resultValue: string+ targetAnatomicalSi te: st ring+ onsetDateTime : dateT ime+ effectiveThuTime: dateTime+ negat ionIndicato r: boolean::Activit y+ id: long+ startTime: da teTime+ endTi me : dateT ime+ metho d: st ring+ reason: string+ descri pt ion: strin g+ status: string

+ isContinuing() : b oolea n

Adv erseEv entActiv ityRelationship

+ expe ctedness: b ool ean+ att ributi on: int+ studyDesig nBroken: bo olean+ agentAdjustment: string+ administrati onDelaye d: boole an::ActivityRelat ionshi p+ id: l ong+ rel at ion shipType: string+ effecti veFromTime: dateTi me+ effecti veThruTime : dateTi me+ rel at ion shipStatus: st ring+ sourceActi vi tyRole: strin g+ targetActiv it yRole: string+ sequence: i nt

Procedure Treatment

::Treatme nt+ cou rseNujmber: st ring+ cycleNumber: st ring+ neg ationIn di cato r: boolean::Activit y+ id : long+ startTime: dateT ime+ end Time: date Time+ method: st ri ng+ re ason : string+ description : string+ status: st ring

ClincalStudy

::Act iv ity+ id: long+ startTime: da teTime+ endTi me : dateT ime+ metho d: st ring+ reason: string+ descri pt ion: strin g+ status: string

Advers eEventDeta il

+ effectiveFromTime: dateTime+ effectiveThruTi me: dateTi me+ booleanVa lue: boo lea n+ textVa lue: string

MaterialKind

+ name: st ring::Parti ci patingEnt it y+ id: long


+ id: strin g+ adverseEventDetai lCod e: strin g+ name: st ring+ descript ion: strin g+ cod eSystem: stri ng+ cod eSystemVersi on: st ring

ParticipatingEntityIdenti fier

+ id: long+ identifi erValu e: st ring+ identifi erType: string

Adverse EventReport

+ seq uenceIdent ifi er: int+ sub jectDi scloserAll owed: bool ean::Activit y+ id: long+ startTime: da teTime+ endTime: dateT ime+ me thod: st ring+ rea son: string+ description : strin g+ status: st ring

+ hasAmend edData() : boolean+ sen tToFDA() : bo olean+ init ialSentToFDA() : bo olean+ sen tToM anufacturer() : boole an+ treatmentDelayed() : boolean+ del ayDurat ion() : real+ del ayDurat ionUn its() : string

Tre atment

+ courseNuj mber: stri ng+ cycl eNumber: stri ng+ negat ion Ind icator: boolean::Activity+ id: long+ sta rtTime: dateTime+ endTi me: dateTi me+ method: string+ reason: st ring+ descri pti on: string+ sta tus: string

+ isCo ntinui ng() : boo lean+ isAd justm en t() : boolean

Person

+ namePrefix: strin g+ firstName: st ring+ mid dleNa me: st rin g+ lastName: st ring+ nameSuf fix: strin g+ occupatio n: strin g+ emai lAdd ress: st ring::Participat ingEn tity+ id: long

+ isHealthProfessio nal () : bool ean

Activ ityIde ntifier

+ id: long+ iden ti fierValu e: string+ iden ti fierType: string+ versionIdentif ier: st ring+ versionEffecti veDate: dateTime

Activi tyRe lationship

+ i d: long+ rela tionsh ipTyp e: stri ng+ effe cti veFromTime: da teTi me+ effe cti veThruTime: d ateTime+ rela tionsh ipStatus: st ring+ sou rceActivityRole: st ring+ targ etActivityRole: string+ seq uence: i nt

ParticipatingEnti tyRe lationship

+ id: l ong+ rel at ion shipType: string+ effecti veFromTime: dateTime+ effecti veThruTime: dateTi me+ rel at ion shipStatus: st ring+ sourcePartic ipan tRole: st ring+ targetPart ici pantRole : string

Protocol

+ pha se: stri ng+ ti tle : strin g::Activit y+ id : long+ startTime: dateT ime+ end Time: date Time+ method: st ri ng+ re ason : string+ description : string+ status: st ring

Device

+ implantedDate: dateTi me+ expl antedDate: d ate Ti me+ reproce sse dIndica tor: bool ean+ avai lab leForEva lua tionIndicator: boolean::Pro duct+ name: string+ sta tus: string::Particip atingEn ti ty+ id: long

Loc ation

+ name: st ring+ descript io n: stri ng+ st re etAd dre ss: strin g+ ci ty: string+ state: stri ng+ posta lCode : strin g::Parti ci patingEntity+ id: long

DrugProduct

+ l otNumbe r: st ring+ expirationDa te: date::Product+ name: string+ status: string::ParticipatingEn ti ty+ i d: long


+ i d: long+ qua nti ty: float+ activeIngredie ntIndicator: boole an+ m ateri alForm: string

Activ ityKind

+ id: long+ acti vityCod e: stri ng+ name: st ring+ description : strin g+ cod eSystem: stri ng+ cod eSystemVersi on: stri ng

Name: Log ical Mo delAuthor: Abdu lMalik ShakirVersion: 1.0Created : 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM


Pers onTelephone

+ id: long+ usa geType : strin g+ equipmentType: string+ phone Nu mber: string+ extendedPhoneNumber: string


+ id: l ong+ usageType: string+ equi pmentType: st ring+ phone Number: string+ extendedPhoneNumbe r: st ring

Advers eEventReportDetail

+ ef fecti veFromTime: da teTi me+ ef fecti veThruTim e: dateTi me+ bool eanValue: boolea n+ te xtValue: strin g

ParticipatingEnti tyKind

+ id: long+ enti tyType: string+ name: string+ descri ption: strin g+ codeSystem: stri ng+ codeSystemVersion: string

Adv erseEv entReportDetai lKind

+ id: + adverse EventReportDetailCo de: stri ng+ name: string+ descri ption : strin g+ codeSystem: stri ng+ codeSystemVersion: stri ng

ObservationValueKind

+ id: l ong+ observationValueCode : stri ng+ name: stri ng+ description : strin g+ code System: string+ code SystemVersion: string

1..*+in gredien tColle ction

1+pro duct

0..*+relation shipCol lecti on

1+targ etEntity

0..* +relat ionshipCollection

1+so urceEn tit y

0. .*+identifie rCollection

1

+assigningAutho rit y

1+person

0..*+tele phoneCol le ction

0.. *

+ide ntifierCol lecti on

1+assi gnin gAuthorit y

0..*+adverseEven tRep ortDetail Collecti on

1+adverseEven tRep ortDetail Kind

0..*+adverseEventRep ortDetailCollection

1

+adve rse EventReport

0..*

+ing redien tColle ction

1 +material

0..*

+identi fierCollection

1

+ent ity

1+parti ci patingEnt ityKind

0..*+entit yColl ection

0.. *+eve ntDetai lCol lect ion

1+adverseEven t

1

+eventDetailKi nd

0..*+eventDetai lCol lect ion

0..*

+AdverseEventReportCo llect io n

1

+adverse Event

0..*

+acti vi tyRelatio nshipCol le ctions

1+adve rseEvent

1

+act

0.. *

+participatio nCol lecti on

1

+ent ity

0..*

+pa rticipat ionCollection

0. .*

+relatio nshipCol lecti on

1

+targetAct ivity

0..*+observationColl ection

1

+observati onVal ueKind

1

+acti vityKi nd

0..*

+activityColl ection

0..*


1

+so urceActiv it y

1+organizat ion

0.. *+te le phoneColle ct ion

1+activity

+id entifierCollection

•Lab SIG Model•Study Calendar SIG Model•Financial SIG Model

caAERS

Implementation Specific Models

cd Comprehensiv e Model

Clinical Research Entities and Roles::Agent

+ id: Cod edConcept+ name: string+ descri pt ion: stri ng+ status: CodedConcept+ formCode: Cod edConcept+ lotNumber: int+ expirati onDate: DAT ET IME+ stabi lityTi me: DAT ETIME


AgentRole

Clinical Research En tities and Roles::

FundingSpons or


HealthCareSite


Inv estigator

+ certi fi cateLicenseT ext:


+ id: CodedConcept+ name: string+ descript ion: stri ng+ status: CodedConcept+ statusDate: DAT ETIME+ geog raphicAddr: addrType+ telecomAddr: TEL



+ paymentMethod: CodedConcept+ conf ident ialityCode: string


+ i d: CodedConce pt+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBi rth: DATETIME+ raceCode: BRIDGCodedConcept+ ethnicGro upCode: BRIDGCodedConce pt+ m aritalStatusCode: BRIDGCodedConce pt+ el ectroni cCommAddr: + househol dIncom eCategory: BRIDGCodedConcept+ educati onLevelCode: BRIDGCo dedCon cept+ telecomAddress: TEL+ name: e nt ityName+ dateOfDeath: DATET IME+ address: addrT ype

Clinic al Rese arch Entities and Roles::PersonRole

::Role+ id : CodedConcept+ code: CodedConcept+ status: + el ectroni cComm Addr: + geographicAddr: + te lecomAddr: + ef fect iveStartDate: DAT ETIME+ effect iveEndDate: DATETIME

Clinical Research En tities and Roles::TherapeuticAgent

Clinical Trials Activ ities::AdverseEve nt

+ onsetDate: date+ resolvedDate: da te+ ctcCategoryCode: string+ ctcCategoryCodeSystem: stri ng+ ctcTermT ypeCode: string+ ctcTermT ypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: stri ng+ seriousReasonCode: string+ outcomeCode: string+ acti onTakenCode: string+ condi tionPatternCode: string+ doseLimi ti ngToxi ci tyIndi cator: bool ean+ doseLimi ti ngToxi ci tyDescriptionT ext: string+ descripti onT ext: string

Clinical Tr ials Activ itie s::

Ad verseEventReport

+ id: i nt+ subm issi onDate: date+ fi ledIndi cator: boolean

Clinical Trials Activities::AdverseEv entTherapy

+ id: int+ treatmentDate: date+ del ayDurat ion: i nt+ del ayDurat ionUni tOfMeasureCode: stri ng+ intensityCode: stri ng

Clinical Trials Activities ::Assessment

+ id: int+ evaluationDate: date

Clinical Trials Activ ities::

AssessmentRelationship

+ id: int+ typeCode: string+ com mentTe xt: stri ng

Clinical Trials Activ ities::CancerStage

+ id: in t+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: stri ng+ stageCodeSystem: string

Clinical Trials Activ ities::ClinicalResult

+ panelName: string+ value: stri ng+ valueUni tOfMeasureCode: stri ng+ assayMethodCode: string+ bodyPosit ionCode: string+ labReferenceRangeCode: string+ labTechni queCod e: string+ meansVi tal StatusObtainedCod: stri ng+ abnormalIndicator: boole an+ bi omarkerInd: boolean+ signifi canceInd: boolean

Clinical Trials Activ ities::DeathSummary

+ deathDate: date+ deathCauseCode: char+ deathCauseT ext: stri ng+ autopsi edIndicator: boolean

Clinical Trials Activities ::Diagnosis

+ name: stri ng+ diseaseDi agno sisCode: stri ng+ diseaseDi agno sisCodeSystem: string+ ageAtDiagnosi s: int+ confirmationDate: date+ pri maryAnatom icSi teCode: string+ pri maryAnatom icSi teCodeSystem: string+ pri maryAnatom icSi teLateral ityCode: string+ recurrenceIndi cator: boolean+ diseaseStatusCode: string+ sourceCode: stri ng+ sourceOther: string+ diseaseExtentText: string

Clinical Trials Activ ities::DiseaseResponse

+ responseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasu reCode: string+ doseChangeIndicatorCode: int+ courseDispositi onCode: string+ commentT ext: string

Clinical Trials Activ ities::Histopathology

+ grossExamResultCode: stri ng+ reportDescriptiveText: stri ng+ involvedSurgi calM argi nIndi cator: bool ea n

Clinical Trials Activ ities::HistopathologyGrade

+ id : int+ gradingSystemName: string+ grade: string+ comments: string

Clinical Trials Activities::Imaging

+ ident ifi er: string+ contrastAgen tEnhancement: stri ng+ descriptiveText: string+ rateOfEnhancementVal ue: int

Clinical Trials Activities::LesionDescription

+ lesionNumber: stri ng+ evaluationNumber: int+ appearanceT ypeCode: string+ targetNonTargetCode: stri ng+ measurableIndicator: boolean+ methodCode : stri ng+ xDim ension: int+ yDim ension: int+ zDim ension: int+ di mensi onProduct: i nt+ anatomicSiteCode: stri ng+ anatomicSiteCodeSystem: string+ contactAnatomi cSite Code: string+ contactAnatomi cSite CodeSytem: stri ng+ previousl yIrradiatedSi teIndicator: b oolean Clinical Trials

Activities::LesionEv aluation

+ eval uat ionCode: char

Clinical Trials Activities::MetastasisSite

+ id: i nt+ anatomi cSiteCode: string+ anatomi cSiteCodeName: string

Clinical Trials Activities::Neoplasm

+ id: int+ cellT ype: stri ng

Clinical Trials Activities::Ob servation

+ id: int+ reporti ngDate: date+ conf ident ial ityCode: string+ uncertaintyCode: stri ng+ statusCode: string

Clinical Trials Activities::

Observ ationRelationship

+ id : i nt- type: string+ comments: string

Clinical Tr ials Activ ities::PerformedActivity

+ pl annnedUnplannedInd: boolean::Acti vi ty+ co de: PSMCodedConcept+ derivat ionExpression: TEXT+ description: PSMDescrip tion+ startDate: DATETIME+ status: PSMCodedConcept+ avai labil i tyTime: T imingSpeci fi cat ion+ priori tyCode: PSMCodedConcept+ co nf ident ial ityCode: PSMCodedConcept+ repeatNum ber: rangeOfIntegers+ interruptibl eIndicator: BOOLEAN+ uncertain tyCode: Coded Concept+ reasonCo de: PSM CodedConcept+ endDate: DAT ET IME

Clinical Trials Activities::PerformedStudy

+ id: BRIDGID+ longT itl e: stri ng+ shortTi tle : string+ phaseCode: ENUM+ intentCode: ENUM+ moni torCode: ENUM+ bl indedInd: boolean+ randomizedInd: boolean+ di seaseCode: CodedConceptDataType+ sponsorCode: CodedConceptDataType+ multi Insti tutionInd: bool ean+ targetAccrualNum ber: i nt

Clinic al Trials Activities::PlannedActivity

::Act ivity+ code: PSMCodedConcept+ deri vat ionExpression: TEXT+ description: PSMDescripti on+ startDate: DATETIM E+ status: PSMCoded Concept+ avai labil ityT ime: T imingSpeci ficat ion+ priori tyCode: PSM CodedConcept+ conf idential ityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME


::Acti vi ty+ code: PSMCodedConcept+ derivationExpression: TEXT+ descri pti on: PSMDescription+ startDate: DAT ETIME+ status: PSMCodedConcept+ avail abi lityTim e: T imi ngSpecifi cati on+ priorityCode: PSMCodedConcept+ confi denti al ityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interru pt ibl eIndi cator: BOOL EAN+ uncertai ntyCode: CodedCon cept+ reasonCode: PSMCodedConcept+ endDate: DAT ET IME

Clinical Trials Activities::Procedure


Clinical Trials Activities::Qualitativ eEvaluation

+ survival StatusCode: int+ survival StatusDescripti onT ext: string+ performanceStatusCode: int- performanceStatusCodeSystem : stri ng+ painIndexCode: int+ painIndexCodeSystem : stri ng+ anamResultAccuracyPe rcent: int+ menstru al PatternT ypeCode: stri ng+ menstru al Indicator: boolean

Clinical Tr ials Activities::Radiation

+ therapyType: string+ doseUn itOfMeasure: string+ dose: stri ng

Clinical Trials Activities::Specimen

+ id: int+ idNumber: i nt+ samplingT ype: string

Clinical Trials Activ itie s::

SpecimenCollection

+ si teCondi ti on: string+ m ethod: stri ng

Clinical Trials Activ itie s::Stud yAgent

::Parti cipation+ type: Co dedCon cept+ status: CodedCo ncept+ statusDate: DAT ETIME+ startDate: DAT ETIME+ endDate: DATETIME

Clinical Trials Activities::StudyInvestigator

+ sig natureCode: i nt+ sig natureText: stri ng::Parti ci pat ion+ type: CodedConcept+ sta tus: CodedConcept+ sta tusDate: DATETIME+ sta rtDate: DAT ET IME+ endDate: DATET IME

Clinical Trials Activities::StudySite

+ targetAccrual Number: int::Parti cipation+ type: CodedConcept+ sta tus: CodedConcept+ sta tusDate: DATETIME+ sta rtDate: DAT ET IME+ endDate: DAT ET IME

Clinical Trials Activ ities::Subje ctAssignment

+ studySubjectIdentif ier: i nt+ arm: string+ subgroupCode: stri ng+ informedConsentFormSi gnedDate: date+ offStudyDate: date+ studyAgentDo seLevel : stri ng+ el igi bi li tyWai verReason: string+ ageAtEnrol lm ent: int::Part i ci pati on+ type: CodedConcept+ status: CodedConcept+ statusDate: DAT ETIME+ startDate: DAT ETIME+ endDate: DATETIME

Clinical Trials Activities::SubstanceAdministration

+ doseQuant ity: i nt+ doseUnitOfMeasure: string+ route: string+ doseFrequency: stri ng+ doseModifi cati onT ype: string+ doseChangeType: int


Surgery


+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabil ityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME

BRIDG Sha red Classes::Activ ityActiv ityRelationship

+ relationshipCode: PSMCodedConcept- Obsol ete_relat ionQuali fier: BRIDGCodedConcept+ sequenceNumber: NUMBER+ pauseCri terion: + checkpoi ntCode: + priorityNumber: NUM BER+ spl itCode: - negat ionRul e: AbstractRule+ joinCode: + negat ionIndicator: BOOLEAN+ conjunctionCode:


+ type: CodedConcept+ status: CodedConcept+ statusDate: DAT ETIME+ startDate: DAT ETIME+ endDate: DAT ETIME


+ id: CodedConcept+ co de: CodedConcept+ status: + el ectroni cCommAddr: + geographicAddr: + telecomAddr: + ef fectiveStartDate: DAT ETIME+ effectiveEndDate: DATET IME


+ source: + type: CodedConcept+ target:


+ name: TEXT+ value: + controll edName: PSMCodedConcept+ businessProcessMode: PSMBusinessProcessMode

BRIDG Shared Classes::BRIDGBusinessProcessMode

+ modeVal ue: ENUM {Plan, Execute}


- code: TEXT- codeSystem: - codeSystemNam e: T EXT- codeSystemVersi on: NUMBER- displayName: T EXT- original T ext: T EXT- translati on: SET {PSMCodedConcept}

BRIDG Shared Class es::BRIDGContactAddr

+ type: BRIDGCodedConcep t+ effe ct iveT ime: BRIDGInte rval+ usage: BRIDGCodedConcept


+ synopsi s: Encapsu latedDa ta+ summaryDescription: EncapsulatedData+ detailedDescri pt ion : Enca psulatedData

BRIDG Shared Clas ses::BRIDGID

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


- startTim e: tim estamp+ endT ime: tim estamp

BRIDG Shared Classes ::BRIDGStatus

+ effect iveEndDate: + effect iveStartDate: + statusValue :

Protocol Concepts::StudyDocument

+ versi on: strin g+ author: SET+ ID: SET BRIDGID+ documentID: BRIDGID+ type : ENUM+ descript ion: BRIDGDescript ion+ tit le: string+ status: BRIDGStatus+ conf idential ityCode: CodedConcept

0..1

1

1

0..*

0. .1

1..*

1

0..* 0. .*

1

1..*

1

1

0..*

0..*

1

0..*

1

1 0..*

+source activity

*

*

+target act ivity

«abstract ion»

10..*

1

0..*

1has a

1..*

0..*

1

0..* 1

1..*

has a

1

1 0..*

0. .*+speci menCol lect ion

1+speci menCol lec tion

0..* 1

0..*1

0..*

1

1..* 0..*

0..11

0..*

1

0..*

1

CTOMcd Clinical Trials Obje ct Model (CTOM)

Protoc ol

+ id: in t+ nci Id enti f ier: stri ng+ amen dme ntIdentif ie r: int+ amen dme ntDate: date+ navyNCIId enti fi er: stri ng+ longT i tl eText: strin g+ shortT it le Text: stri ng+ preci sText: stri ng+ descri pti onText: string+ dise aseCo de: string+ intentCode : stri ng+ moni torCode: st ri ng+ phaseCode: strin g+ sponsorCo de: string+ bli ndedIndi cator: b oolean+ mul ti Insti tu ti onIndicator: bool ean+ rando mi zedIndi cator: bool ean+ targetAccrual Numbe r: int

Agent

+ id: in t+ name : stri ng+ descri pti onText: string+ statusCode: stri ng

StudyAgent

+ id : i nt+ in vestig ati onal Ind icator: bool ean+ in vestig ati onal NewDrugIdenti fi er: stri ng+ statusCode: stri ng+ statusDate: da te

Pa rticipant

+ ini ti al s: char+ zi pCo de: string+ paymentMethod Code : char+ confid ential it yIndi cat or: boo lea n

Ac tivity

+ id : in t+ name : stri ng+ type: stri ng+ descri pti onText: strin g+ startDate: date+ stop Date: date+ durati onVa lue : i nt+ durati onUn itOfMeasu reCode: st ri ng+ pl ann nedIndicat or: bool ean+ re asonCode: string

Ass essme nt

+ id: in t+ eval uatio nDate: date

Subs tanceAdministration

+ sin gleDose: int+ sin gleDoseUni tOfMeasureCo de: stri ng+ doseFrequen cyCod e: string+ doseFrequen cyText: st ri ng+ to tal Dose: i nt+ to tal DoseUni tO fMeasureCode: strin g+ doseChangeCode: stri ng+ doseChangeIndi catorCod e: int+ ro uteCode: stri ng

Histopathology

+ grossExamRe sultCode: strin g+ re portDescri pti ve Text: stri ng+ in vol ve dSurgi cal Marg inIndicator: boo lean

StudySite

+ id : i nt+ ro leCode: stri ng+ statusCode: st ri ng+ ta rgetAccrua lNumber: stri ng+ startDate: date+ stopDate: date+ irbApproval Date: date

Qualitative Ev aluation

+ survival StatusCo de: int+ survival StatusDe scrip ti onText: string+ performan ceStatusCode: in t+ performan ceStatusCodeSystem: strin g+ painI ndexCode: int+ painI ndexCodeSystem: stri ng+ anamResultAccuracyPercen t: i nt+ menstrualPatternTyp eCode: stri ng+ menstrualIndi cator: b oolean

Adve rseEv ent

+ onsetDate: date+ re solvedDate: date+ ctcCategoryCode : stri ng+ ctcCategoryCode System: strin g+ ctcTermTypeCode: stri ng+ ctcTermTypeCodeSystem: string+ ctcAttri buti onCode: stri ng+ ctcAttri buti onCodeSystem: string+ ctcGrad eCo de: string+ ctcGrad eCo deSystem: stri ng+ seriousReasonCo de: stri ng+ outcomeCode: stri ng+ acti onTakenCode: string+ co ndit i onPatte rnCode: stri ng+ doseLi mit in gToxici tyInd icator: bool ean+ doseLi mit in gToxici tyDescript i onText: string+ descri pt ionText: stri ng

SpecimenCollection

+ si teCondi ti onCode: stri ng+ metho dCo de: string

Disease Response

+ re ponseCode: cha r+ re sponseCodeSystem: string+ bestRe sponseCode: ch ar+ bestRe sponseDate: date+ progressionDate: date+ progressionPeriod : i nt+ progressionPeriod Uni tOfMeasureCo de: string+ doseChangeIndi ca torCo de: int+ co urseDi sposit i onCode: strin g+ co mmentText: string

LesionDescription

+ lesi onNumber: stri ng+ eval uation Number: i nt+ appearanceTypeCode: stri ng+ targetNonTargetCode : stri ng+ measurabl eI ndicator: bool ean+ methodCode: stri ng+ xDimensi on: int+ yDimensi on: int+ zDimensi on: int+ dimensi onProduct: i nt+ anato mi cSi teCode: stri ng+ anato mi cSi teCodeSystem: string+ contactAnatomi cSi te Code: stri ng+ contactAnatomi cSi te CodeSystem: strin g+ previo uslyIrradiatedS i teIndicator: st ri ng

He althcareSite

+ nci Insti tuteCode: stri ng

Proc edure

+ anatomicSi teCode: stri ng+ anatomicSi teCodeSystem: stri ng

Imaging

+ imageIdentif ier: string+ contra stAgentEn hance me ntIndicator: bool ean+ enhancementRat eVal ue: i nt+ enhancementDescri pt ionText: st ri ng

Ra diation

+ dose: stri ng+ doseUni tOfMeasureCode: stri ng+ sche dul eText: stri ng+ th erapyExtent Code : stri ng

Specimen

+ id: in t+ samp leIdent if ie r: int+ samp leType Code : string+ vol ume: i nt+ vol umeUni tOfMeasureCode: stri ng

Observ ation

+ id : i nt+ re po rt ing Date: date+ con fi dential ityCod e: stri ng+ uncertai ntyCod e: string+ sta tusCode: stri ng

ClinicalResult

+ panel Name: stri ng+ val ue: stri ng+ val ueUni tOfMe asureCod e: string+ assayMethodCode : stri ng+ bodyPosi t ionCode : stri ng+ la bRefere nceRange Code : stri ng+ la bT echni queCode: strin g+ mea nsVitalStatusO btai nedCode: stri ng+ abnorma lIndicator: bool ean+ bi omarkerIndi ca tor: boole an+ sig nif icanceInd icato r: bool ean

Diagnosis

+ name : stri ng+ dise aseDi agnosisCode: stri ng+ dise aseDi agnosisCodeSystem: string+ ageAtDia gnosis: i nt+ confi rmationDate : d ate+ pri ma ryAn atomicSiteCode: stri ng+ pri ma ryAn atomicSiteCodeSystem: stri ng+ pri ma ryAn atomicSiteLatera li tyCode: string+ recurrenceIndicator: bool ean+ dise aseStatusCo de: str ing+ sourceCode: stri ng+ sourceOther: st ri ng+ dise aseExtentT ext: stri ng

EligibilityCr iteria

+ id: in t+ questionText: stri ng+ questionNumber: i nt+ expe ctedAnswe rIndicator: bool ean

PersonOcc upation

+ id : i nt+ primaryType Cod e: string+ primaryType Cod eSystem: stri ng+ startDate: date+ stopDate: date

Surgery

Adv erseEv entReport

+ id: in t+ submissi onDate : date+ fi ledIndi cator: b oole an

Adve rseEv entThe rapy

+ id : i nt+ treatme ntDate: da te+ del ayDurati on: in t+ del ayDurati onUnitOfMea sureCode : stri ng+ in tensi tyCode: stri ng

Organiza tion

+ id : i nt+ name: strin g+ descri pt ionText: stri ng+ statusCode: stri ng+ statusDate: d ate+ street Address: string+ city: stri ng+ stateCode: stri ng+ postalCode: stri ng+ countryCode : stri ng+ te lecomAddress: stri ng

Person

+ id: in t+ lastNa me: stri ng+ fi rstNa me: stri ng+ birthDate: d ate+ tel eco mAddress: strin g+ admi ni strati veGende rCode: string+ countryCode: strin g+ educa ti onLevelCode : stri ng+ ethni cGroup Code : string+ househol dIn comeCode: stri ng+ marital Statu sCode : stri ng+ raceCode: string+ empl oyme ntStatusCode: stri ng+ empl oyme ntStatusOtherTe xt: stri ng

ActivityRelationship

+ id: in t+ typeCode: strin g+ sequenceNu mb er: int+ commentText: stri ng

StudyTimePoint

+ id: in t+ vi sit Name: stri ng+ courseNumber: i nt+ epoch Name: stri ng+ courseStartDate: date+ courseStop Date: date

CancerStage

+ id : i nt+ tn mStag e: string+ tn mStag eCo deSystem: stri ng+ stageCode: string+ stageCodeSystem: stri ng


+ id : i nt+ typeCode: stri ng+ co mmentText: string

Investigato r

+ nciIdentif ier: strin g

StudyPar ticipa ntAssignment

+ id : i nt+ stu dyPart i ci pantIde nti fi er: i nt+ armIdentif ier: string+ subgroupCode: stri ng+ in formed Con sentFormSi gned Date: date+ enro ll me ntAge: int+ stu dyAgentDo seLevel: in t+ stu dyAgentDo seLevelUnitOfMeasure Code : stri ng+ offStudyDate : date+ offStudyReasonCode: stri ng+ offStudyReasonOtherText: string+ el igi bil ityWai verReasonText: stri ng

StudyInv estigator

+ id : i nt+ re sponsi bil ityRol eCode: strin g+ startDate: date+ stopDate: date+ statusCode: stri ng+ si gnatu reIndi cator: bool ean+ si gnatu reText: stri ng

ExclusionIncl usion

Agen tSynonym

+ id: in t+ name : stri ng

Histopatholo gyG ra de

+ id : i nt+ grad eCo de: strin g+ grad eCo deSystem: stri ng+ co mmentText: stri ng

Ne oplas m

+ id : i nt+ cell TypeCode: stri ng

Metas tasisSite

+ id : i nt+ anat omicSi te Code : string+ anat omicSi te Code System: stri ng

Name: Cl in ical Tri als Obj ect Mode l (CTOM) Author: ScenProVersi on: 0.5Created: 7/1/2001 12:00:0 0 AMUpd ated: 1/19/2006 5:06:4 6 PM

Conc eptDescriptor

+ id: in t+ code: stri ng+ codeSystem: stri ng+ codeSystemName: string+ codeSystemVersion: i nt+ displ ayText: st ring

FemaleReproductiv eCharacteristic

+ id: in t+ fi rstLi veBirth Age : i nt+ li veBi rthCou nt: i nt+ sti ll Bi rthCount: i nt+ abort i onIn dicato r: bool ean+ meno pauseStartDate: date+ meno pauseAge: int+ meno pauseReasonCode: stri ng+ meno pauseReasonO therText: string

DeathSummary

+ death Date: date+ death CauseCode : char+ death CauseText: stri ng+ autop siedIndi cator: b oolea n

Age ntOcc urrence

+ id : in t+ lo tNumbe r: stri ng+ fo rmCode : stri ng+ expi rati onDate: date

LesionEv aluation

+ eval uat i onCode : char

ProtocolStatus

+ id: in t+ statusCode: stri ng+ statusDate : date

AssessmentRel ationsh ip

+ id: in t+ typeCode: strin g+ comment Text: st ri ng

He althcareSiteParticipantRole

+ id: in t+ rol eCode: string

HealthcareSiteParticipant

+ id : i nt+ parti ci pantIde nti f ier: stri ng

Partic ipantEligibilityAnsw er

+ id : i nt+ answerText: stri ng+ ch eckl i stNumber: stri ng

0..*

+agentSynonymCol le ct ion

1

+agent

0..*+neopl asmCol l ect ion

1+hi stop atho logy

0..1+adverse EventReport

1..*+adverseEventCol l ect io n

0..*+substanceAd mi ni strati onColl ecti on

1

+studyAgent

0..*+substanceAdmini strati onCol lecti on

1

+agent

1+conceptDescrip tor

0..*+cl in icalResul tCol lect ion

0..*

+studyAgentColl ect i on

1

+agent

0..*+studyInvesti gatorCol le cti on

1+investiga tor

0..*+studyS iteCol lecti on

1+heal thCare Si te

0..*

+stu dyInvesti gato rCol lecti on

1

+protocol

1..*

+observatio nCo ll ect io n

0. .*

+assessmentCol l ect io n

1

+Agent

0..*

+Ag entOccurrenceCo ll ect io n

0..*

+activi tyCo ll ect io n

1

+stud yPart ici pantAssi gnment

0..1

+fema leReproducti veCharacterist ic

1+part i ci pant

1..*

+eli gi bil i tyCriteriaCol lecti on

1..*

+protocol Col lect io n

0..*+studyAgentColl ect i on

1

+stu dy

1+parti cipant

0..*+heal th careSi tePart icipa ntCol lecti on

1

+parti cipant

0..*

+parti cipantEl i gibi l ityAnswerCol lect ion

0..1+cancerStage

1+diag nosis

0..*+adverseEventThe rapyColl ecti on

1+adverse EventCol lect ion

1+eli gi bil it yCriteri a

0. .*+parti cipant Eli gib il ityAnswerCol lect ion

0..*+histopathol ogyGradeCol l ecti on

1+hi stopa tho logy

0..*

+observati onColl ecti on

1

+acti vi ty

0..* +acti vi tyRel ati onshi pCol l ecti on

1+acti vi ty

0..*+studyParti ci pantColl ect i on

1

+studySite0..*

+studySi te Col le ct ion1

+protocol

0..*+stud yPart ici pantAssi gnmentCol le ct ion

1+part i ci pant

1 +heal th careSi te 0.. *

+heal thcareSitePart icip ant

1+heal th careSi tePart icipa nt

0..*+heal thcareSi teRol eColl ecti on

1+observati on

0..* +observa ti onRelatio nship Col le ct ion

0..*

+personOccup ati onColl ecti on

1

+person

1..*

+metastasi sSi teCol l ect io n

1

+ca ncerStage

0..*+specimenCol lecti on

1+specimenColl ecti on

0..*+observati onRelation shipCol lect ion

1+observa ti on

0..1+studyT imePoi nt

1+acti vi ty

0..*+acti vi tyRe lat i onshi pCol lect ion

1+acti vi ty

1

+protocol

1..*

+proto col StatusColl ecti on

0..* +assessment Rel at ion ship

1 +asse ssmen tCol lecti on1+assessment

0..*+assessmentRe lat i onshipCol lect ion

0..1

+agen tOccurrence

1

+substanceAd mi ni strati on


cd Logic al Model

StudySubject


Activ ity


Organization


+ isFDA() : boolean

ParticipatingEntity

+ id: l ong



Product


Obs erv ation




Adv erseEv ent





Procedure Treatment


ClincalStudy




MaterialKind






Adverse EventReport



Tre atment



Person









Protocol


Device


Loc ation


DrugProduct




Activ ityKind




Pers onTelephone













1+pro duct


1+targ etEntity


1+so urceEn tit y


1


1+person


0.. *






1


0..*


1 +material

0..*


1

+ent ity




1+adverseEven t

1

+eventDetailKi nd


0..*


1

+adverse Event

0..*


1+adve rseEvent

1

+act

0.. *


1

+ent ity

0..*


0. .*


1

+targetAct ivity


1


1

+acti vityKi nd

0..*


0..*


1

+so urceActiv it y

1+organizat ion


1+activity



caAERS






AgentRole


FundingSpons or


HealthCareSite


Inv estigator















Ad verseEventReport























































SpecimenCollection













Surgery





























0..11

1

0..*

0. .1

1..*

1

0..* 0. .*

1

1..*

1

1

0..*

0..*

1

0..*

1

1 0..*

+source activity

*

*

+target act ivity

«abstract ion»

10..*

1

0..*

1has a

1..*

0..*

1

0..* 1

1..*

has a

1

1 0..*



0..* 1

0..*1

0..*

1

1..* 0..*

0..11

0..*

1

0..*

1


Protoc ol


Agent


StudyAgent


Pa rticipant


Ac tivity


Ass essme nt




Histopathology


StudySite




Adve rseEv ent


SpecimenCollection


Disease Response


LesionDescription


He althcareSite


Proc edure


Imaging


Ra diation


Specimen


Observ ation


ClinicalResult


Diagnosis




PersonOcc upation


Surgery





Organiza tion


Person




StudyTimePoint


CancerStage




Investigato r




StudyInv estigator


ExclusionIncl usion

Agen tSynonym




Ne oplas m


Metas tasisSite



Conc eptDescriptor




DeathSummary


Age ntOcc urrence


LesionEv aluation


ProtocolStatus










0..*


1

+agent


1+hi stop atho logy




1

+studyAgent


1

+agent



0..*


1

+agent


1+investiga tor


1+heal thCare Si te

0..*


1

+protocol

1..*


0. .*


1

+Agent

0..*


0..*


1


0..1


1+part i ci pant

1..*


1..*



1

+stu dy

1+parti cipant


1

+parti cipant

0..*


0..1+cancerStage

1+diag nosis






1+hi stopa tho logy

0..*


1

+acti vi ty


1+acti vi ty


1

+studySite0..*


+protocol


1+part i ci pant





1+observati on


0..*


1

+person

1..*


1

+ca ncerStage




1+observa ti on


1+acti vi ty


1+acti vi ty

1

+protocol

1..*





0..1

+agen tOccurrence

1


cd Comprehensive Model

Clinical Trials Activ ities::PerformedStudy

+ id: BRIDGID+ longTitle: string+ shortTitle: string+ phaseCode: ENUM+ intentCode: ENUM+ monitorCode: ENUM+ blindedInd: boolean+ randomizedInd: boolean+ diseaseCode: CodedConceptDataType+ sponsorCode: CodedConceptDataType+ multiInstitutionInd: boolean+ targetAccrualNumber: int

cd Logical Model

ClincalStudy

::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string

cd Clinical Trials Object Model (CTOM)

Protocol

+ id: int+ nciIdentifier: string+ amendmentIdentifier: int+ amendmentDate: date+ navyNCIIdentifier: string+ longTitleText: string+ shortTitleText: string+ precisText: string+ descriptionText: string+ diseaseCode: string+ intentCode: string+ monitorCode: string+ phaseCode: string+ sponsorCode: string+ blindedIndicator: boolean+ multiInstitutionIndicator: boolean+ randomizedIndicator: boolean+ targetAccrualNumber: int

cd Logical Model

Protocol

+ phase: string+ title: string::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string


cd Logic al Model

StudySubject


Activ ity


Organization


+ isFDA() : boolean

ParticipatingEntity

+ id: l ong



Product


Obs erv ation




Adv erseEv ent





Procedure Treatment


ClincalStudy




MaterialKind






Adverse EventReport



Tre atment



Person









Protocol


Device


Loc ation


DrugProduct




Activ ityKind




Pers onTelephone













1+pro duct


1+targ etEntity


1+so urceEn tit y


1


1+person


0.. *






1


0..*


1 +material

0..*


1

+ent ity




1+adverseEven t

1

+eventDetailKi nd


0..*


1

+adverse Event

0..*


1+adve rseEvent

1

+act

0.. *


1

+ent ity

0..*


0. .*


1

+targetAct ivity


1


1

+acti vityKi nd

0..*


0..*


1

+so urceActiv it y

1+organizat ion


1+activity



caAERS






AgentRole


FundingSpons or


HealthCareSite


Inv estigator















Ad verseEventReport























































SpecimenCollection













Surgery





























0..11

1

0..*

0. .1

1..*

1

0..* 0. .*

1

1..*

1

1

0..*

0..*

1

0..*

1

1 0..*

+source activity

*

*

+target act ivity

«abstract ion»

10..*

1

0..*

1has a

1..*

0..*

1

0..* 1

1..*

has a

1

1 0..*



0..* 1

0..*1

0..*

1

1..* 0..*

0..11

0..*

1

0..*

1


Protoc ol


Agent


StudyAgent


Pa rticipant


Ac tivity


Ass essme nt




Histopathology


StudySite




Adve rseEv ent


SpecimenCollection


Disease Response


LesionDescription


He althcareSite


Proc edure


Imaging


Ra diation


Specimen


Observ ation


ClinicalResult


Diagnosis




PersonOcc upation


Surgery





Organiza tion


Person




StudyTimePoint


CancerStage




Investigato r




StudyInv estigator


ExclusionIncl usion

Agen tSynonym




Ne oplas m


Metas tasisSite



Conc eptDescriptor




DeathSummary


Age ntOcc urrence


LesionEv aluation


ProtocolStatus










0..*


1

+agent


1+hi stop atho logy




1

+studyAgent


1

+agent



0..*


1

+agent


1+investiga tor


1+heal thCare Si te

0..*


1

+protocol

1..*


0. .*


1

+Agent

0..*


0..*


1


0..1


1+part i ci pant

1..*


1..*



1

+stu dy

1+parti cipant


1

+parti cipant

0..*


0..1+cancerStage

1+diag nosis






1+hi stopa tho logy

0..*


1

+acti vi ty


1+acti vi ty


1

+studySite0..*


+protocol


1+part i ci pant





1+observati on


0..*


1

+person

1..*


1

+ca ncerStage




1+observa ti on


1+acti vi ty


1+acti vi ty

1

+protocol

1..*





0..1

+agen tOccurrence

1


cd Logical Model

Organization

+ name: string::ParticipatingEntity+ id: long

+ isFDA() : boolean

cd Logical Model



cd Clinical Trials Object Model (CTOM)

Organization

+ id: int+ name: string+ descriptionText: string+ statusCode: string+ statusDate: date+ streetAddress: string+ city: string+ stateCode: string+ postalCode: string+ countryCode: string+ telecomAddress: string

cd Comprehensive Model


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

Harmonized BRIDG elements

cd Comprehensive Class and attribute diagram

SDTM CTOM harmonization in process

Clinical Research Entities and Roles::Material

+ description: Text+ expi rationDate: DATETIME+ name: Text+ status: BRIDGStatus


MaterialRole


FundingSponsor


HealthCareSite

Clinical Research Entities and Roles::Inv estigator

+ certif icateLicenseText: Text


+ description: Text+ geographi cAddr: BRIDGContactAddr+ name: Text+ status: BRIDGStatus+ tel ecomAddr: BRIDGTelecomAddress


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


+ confi denti alityIndicator: boolean+ paymentMethod: ENUM


+ address: BRIDGContactAddr+ admini strativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ dateOfDeath: DATETIME+ educationLevelCode: BRIDGCodedConcept+ electronicCommAddr: BRIDGTelecomAddress+ ethnicGroupCode: BRIDGCodedConcept+ householdIncomeCategory: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ name: Text+ raceCode: BRIDGCodedConcept+ tel ecomAddress: BRIDGTelecomAddress

Clinical Research Entities and Roles::PersonRole

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

Clinical Research Entities and Roles::TherapeuticAgent

Clinical Trials Activ ities::PerformedActivity

+ plannnedUnplannedInd: boolean::Activity+ codedDescripti on: BRIDGCodedConcept+ confidential ityCode: BRIDGCodedConcept+ description: BRIDGDescri ption+ endDate: DATETIME+ pri orityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Cl inical Trials Activiti es::PerformedStudy

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

Clinical Trials Activities::PlannedActivity

+ repeatNumber: rangeOfIntegers::Activity+ codedDescription: BRIDGCodedConcept+ confi dentiali tyCode: BRIDGCodedConcept+ descripti on: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept

Clinical Trials Activ ities::PlannedStudy

+ targetAccrualNumber: int::Study+ blindedInd: boolean+ descripti on: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ mul tiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept


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

Clinical Trials Activities::StudyInv estigator

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


+ targetAccrualNumber: int::Parti cipation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept

Clinical Trials Activ ities::Subj ectAssignment

+ ageAtEnrollment: i nt+ arm: string+ eligibil ityWaiverReason: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ studySubjectIdentif ier: int+ subgroupCode: stri ng::Parti cipation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept


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

BRIDG Shared Classes::ActivityActivityRelationship

+ checkpointCode: + conjunctionCode: + joi nCode: + negati onIndicator: BOOLEAN- negati onRule: AbstractRule+ pri orityNumber: NUMBER+ relationshipCode: BRIDGCodedConcept+ sequenceNumber: NUMBER+ splitCode:


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


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


+ source: + target: + type: CodedConcept


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


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

BRIDG Shared Classes::BRIDGContactAddr

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


+ detailedDescri ption: EncapsulatedData+ summaryDescription: EncapsulatedData+ synopsis: EncapsulatedData

BRIDG Shared Classes::BRIDGID

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


+ endTime: timestamp- startTime: timestamp

BRIDG Shared Classes::BRIDGStatus

+ effectiveEndDate: + effectiveStartDate: + statusValue:

Specimen may have to re-located

Needs additi onal work and cleanup

Clinical Trials Activ ities::StudyDocument

+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ mul tiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept::Document+ confi dentiali tyCode: 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 thi nking is that this will be used for caAERS. Ifnot, then it should be deleted.

This maybe an Acti vity?

Review the data types -- inconsistency in definit ion and what is used i n the model

BRIDG Shared Classes::BRIDGTelecomAddress

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

BRIDG Shared Classes::Dev ice

::Material+ descripti on: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus

BRIDG Shared Classes::Drug

+ formCode: BRIDGCodedConcept+ lotNumber: i nt+ stabili tyTime: DATETIME::Material+ description: Text+ expi rationDate: DATETIME+ name: Text+ status: BRIDGStatus


+ blindedInd: boolean+ descripti on: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTi tle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept

Clinical Trials Activ ities::StudyAuthor

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

BRIDG Shared Classes::Document

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

We wi ll need to MANUALLY keep these two classes in synch with thei r attributes.


+ confi denti alityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept



PlannedObserv ation

We may or may not need thi s cl ass -- it depends on the number of shared cl asses between thetwo performed/planned activiti es

CTOM Elements::Histopathology

+ grossExamResultCode: string+ invol vedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string


+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositi onCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVi talStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string


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



SDTM::SDTMFinding


SDTM::OtherFindings

+ evaluati onInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType



SDTM::Examination



::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resul tCategory: i nt::Quanti tativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ resul t: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

TestInterpretationSDTM::VitalSign

+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPositi on: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndi cator: enum- resultCategory: int::Quanti tativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType

+is fulf iled by the role

1

+participate as

0..*


0..*

1


1 0..*

+are written by

+write

0..*

1


+is operati onalized by

0..1

+is descri bed by

1..1

+is descri bed by 1

+describes 1

+source activity

*

*

+target activi ty

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

Observation Classes from CTOM and SDTM

CTOM and SDTM harmonization (work in progress)

cd CTOM observ ations and SDTM


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



Harmonized Elements::

PlannedObserv ationCTOM Elements::Histopathology

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


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


+ 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::SDTMFinding


SDTM::OtherFindings

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



SDTM::Examination



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

TestInterpretationSDTM::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

0..*1 0..*1


CTOM observations and SDTMCTOM (imported package)1.0Fridsma

Harmonizing attributes











Adding tags to provide semantic traceability (and notes)











Simple semantic can be tracked in tagged values











This linking can be extended down to the CDE level











More complex relationships








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








cd Compre hensiv e M odel

Cl inical Resea rch Enti ties and Roles::Agent

+ i d: Coded Concep t+ name: stri ng+ descript i on: st ring+ sta tus: CodedCon cept+ formCode: CodedConcept+ l otNumber: i nt+ expi rati onDate: DATET IM E+ sta bil ityTi m e: DAT ETIM E

Cl inical Research Entities and Role s::

AgentRole

Clinical Research Enti ties and Roles::

FundingSponso r

Clinical Research Enti ties and Roles::

He althCareS ite

Cl inical Research Entities and Roles::

Inves tigator

+ cert i fi cateLice nseText:

Cl inical Research Entities and Roles::Or ganization

+ i d: Cod edConcept+ name : st ri ng+ descri pti on: st ri ng+ status: CodedConcept+ statusDate: DATETIME+ geographicAddr: addrType+ telecomAddr: TEL

Clinical Research Entities a nd Roles::OrganizationRole

Cl inical Research Entities and Ro les::Par ticipant

+ paym entM eth od: Coded Concep t+ conf id ent ial it yCode: st ri ng

Clinical Research Entities a nd Roles::Pe rson

+ i d: CodedConcept+ adm ini strati veGe nderCode : BRIDGCoded Concept+ dateOfB irth : DATETIME+ raceCode: BRIDGCodedCon cept+ ethnicGroupCode: BRIDGCodedConcept+ m ari tal StatusCode: BRIDG CodedCo ncept+ el ect roni cComm Ad dr: + househol dIncomeCategory: BRIDGCoded Concept+ educati onLevel Code: BRIDGCo dedConcept+ telecomAddress: T EL+ nam e: ent i tyName+ dateOfDeath: DAT ETIM E+ address: addrType

Clinical Research Enti ties and Roles::PersonRole

: :Role+ i d: CodedCo ncept+ code: CodedConcept+ status: + e lect ronicCom mAddr: + g eographi cAddr: + telecom Addr: + e ffect iveS tartDate: DAT ET IM E+ e ffect iveEndDate: DATET IME

Clinical Research Enti ties and Roles::TherapeuticAgent

Cl inical Trials Activ ities::Adv ers eEv ent

+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermT ypeCode: st ri ng+ ctcTermT ypeCodeSyste m: st ri ng+ ctcAt tribut ionCode: st ri ng+ ctcAt tribut ionCodeSyste m: st ri ng+ ctcGradeCode: st ri ng+ ctcGradeCodeSystem : st ri ng+ seriousReasonCode: string+ outcom eCode: string+ acti onTakenCode: st ri ng+ condit ionPatternCode: st ri ng+ doseLi mi ti ngToxic it yIndicator: bool ean+ doseLi mi ti ngToxic it yDescript i onT ext : string+ descri pti onText: string

Cl inical Trials Ac tivi ties::

AdverseEventReport

+ i d: i nt+ sub missi onDate: d ate+ f i ledIndi cator: boolea n

Clinical Trials Activ ities::Adve rse Eve ntThe ra py

+ i d: i nt+ t reatmentDate: date+ del ayDurat ion: int

+ del ayDurat ionUnitOfMeasureCode: string+ i ntensi tyCode: st ring

Cl inical Trials Activities ::Assessment

+ i d: i nt+ evaluat ionDate: date

Cl inical Trials Activi ties::

AssessmentRelationsh ip

+ id: int+ typeCode: string+ com mentText: string

Clinical Trials Activi ties::CancerStage

+ id: i nt+ tnmStage : st ri ng+ tnmStage CodeSystem: string+ stageCode: stri ng+ stageCodeSystem : st ri ng

Cl inical Trials Activ ities::ClinicalResul t

+ panel Nam e: st ri ng+ value: string+ valueUnitOfM easure Code: st ri ng+ assayMethodCod e: string+ bodyPosi ti onCod e: string+ l abReferenceRangeCode: string+ l abTechniqueCode: st ri ng+ m eansVi tal StatusOb tainedCod: string+ abnormal Indi cator: bool ean+ bi omarkerInd: bool ean+ si gnif icanceInd: bool ean

Cl inical Trials Activ itie s::DeathSummary

+ deathDate: date+ deathCauseCode: char+ deathCauseT ext: string+ autopsiedIndi cato r: bool ean

Cl inical Trials Activ ities::Diagnosis

+ nam e: string+ diseaseDiagnosi sCode: string+ diseaseDiagnosi sCodeSystem: string+ ageA tDi ag nosis: int+ conf irmati onDate: date+ prim aryAnatom icSi teCode: st ri ng+ prim aryAnatom icSi teCodeSystem : st ri ng+ prim aryAnatom icSi teLateral it yCode: st ri ng+ recurrenceIndicator: bool ean+ diseaseS tatusCode: string+ sourceCode: string+ sourceOther: st ri ng+ diseaseExtentT ext : st ri ng

Cl inical Trials Activi ties::DiseaseResponse

+ responseCode : cha r+ responseCode System : st rin g+ bestResponseCode: char+ bestResponseDate: date+ progre ssionDa te: date+ progre ssionPe ri od: in t+ progre ssionPe ri odUni tOfMeasureCode: string+ doseChangeIndicatorCode: int+ course Dispo si t ionCode: stri ng+ com mentT ext: string

Cl inical Trials Activ ities::Histopathology

+ g rossExamResultCode : st ri ng+ reportDescript ive Text: stri ng+ i nvol vedSurgi cal M argi nIndi cato r: boolean

Clinical Tria ls Activ ities::HistopathologyGrade

+ i d: i nt+ g radingSystemName: st ri ng+ g rade: st ri ng+ comm ents: st ring

Cl inica l Trials Activ ities::Imaging

+ i dent i fi er: string+ con trastAgentEnha ncem ent: string+ descri pti veTe xt : st rin g+ rateOfEnhancementVal ue: i nt

Cl inical Trials Activ itie s::LesionDescriptio n

+ lesi onNum ber: strin g+ eval uati onNum ber: int+ appearanceTypeCo de: string+ targetNonTargetCode: st ri ng+ measurableIndicato r: bool ean+ methodCode: string+ xDim ension: int+ yDim ension: int+ zDim ension: int+ dim ensionProduct: int+ anatom icSi teCode: st ri ng+ anatom icSi teCodeSystem : stri ng+ contactAnatomi cS iteCode: stri ng+ contactAnatomi cS iteCodeSytem: strin g+ previousl yI rradiatedSi teIndi cator: bool ean Clinical Tr ials

Activ ities::Le sionEvaluation

+ eval uat i onCode: char

Clinical Trials Activ ities::MetastasisSi te

+ i d: i nt+ anatomi cS iteCode: string+ anatomi cS iteCodeName: st ri ng

Clinical Trials Activ ities::Neop lasm

+ i d: i nt+ cell Type: stri ng

Cl inical Trials Activ ities::Observ ation

+ id : int+ re porti ngDa te: date+ conf id ential it yCode: st ri ng+ uncertaintyCo de: st ring+ statusCod e: st ring

Clinic al Trials Activ ities::


+ i d: int- t ype: string+ com m ents: string

Cl inical Trials Activ ities::PerformedActiv ity

+ pl annnedUnpl annedInd: boole an: :Act iv it y+ code: PSM CodedConcep t+ derivati onExpressi on: T EXT+ descri pti on: PSM Descri pti on+ startDate: DAT ET IM E+ status: PSMCodedConcept+ avail abil it yT im e: T im ingSpeci fi cation+ priorit yCode: PSM CodedConcept+ confi denti ali tyCode: PSMCodedCon cept+ repeatNumber: rangeOfInteg ers+ i nterrupt ibl eIndi cator: BO OLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedCon cept+ endDate: DATETIME

Clinical Trials Activ ities::PerformedStudy

+ i d: BRIDGID+ l ongTi tl e: st ri ng+ shortT it le: string+ phaseCode: ENUM+ i ntentCode: ENUM+ m onitorCode: ENUM

+ bl indedInd: bool ean+ randomi zedInd: bool ean+ di seaseCod e: CodedConceptDa taT ype

+ sponsorCod e: CodedConceptDa taT ype+ m ult iInsti tut ionInd: bo olean+ targetAccrualNumb er: i nt

Clinical Trials Activ ities::PlannedActiv ity

: :Act iv it y+ code: PSMCodedConcept+ deri vat ionExpression: TEXT

+ descript ion: PSM Descript io n+ startDate: DATETIME+ status: PSM Code dConce pt

+ avai labi li tyTi me: T imi ngSpecif icat ion+ pri ori tyCode: PSMCodedConcept+ conf ident ial it yCode: PSM Coded Concep t

+ repeatNum ber: rangeOf Integers+ interrupti bleIndicator: BOOLEAN+ uncertai ntyCode: CodedConcept+ reasonCode: PSM Coded Concep t+ endDate: DAT ET IM E

Clinical Trials Activi ties::PlannedStudy

::Act iv i ty+ code: PSM CodedConcept+ derivati onExpressi on: T EXT+ descri pti on: PSM Descri pti on+ startDate: DAT ET IM E+ status: PSMCodedConcept+ avail abil it yT im e: T im ingSpeci fi cat ion+ priorit yCode: PSM CodedConcept+ confi denti ali tyCode: PSMCodedConcept+ re peatNumber: rangeOfIntegers+ in terrupt ibl eIndi cator: BOOL EAN+ uncertaintyCode: CodedCon cept+ re asonCode: PSMCodedConcept+ endDate: DATETIME

Cl inical Trials Activ itie s::Procedure

+ targetSi teCode: st ri ng

Clinical Tria ls Activi ties::Quali tativ eEv aluation

+ survi val S tatusCode: int+ survi val S tatusDescrip ti onT ext: string+ performa nceStatusCode: i nt- performa nceStatusCodeSystem : string+ pai nInde xCode: i nt+ pai nInde xCodeSystem: strin g+ anam Resul tAccura cyPercent : i nt+ m enstrualPat ternT yp eCode: st ri ng+ m enstrualIndicator: boo lean

Cl inica l Trials Activ ities::Radiation

+ therapyType: st ri ng+ doseUni tOfM easure: string+ dose: st ring

Clinical Tria ls Activ ities::Specimen

+ i d: i nt+ i dNumb er: int+ sam plin gType: st ri ng

Cl inical Trials Activi ties::

SpecimenCol lection

+ siteCondit i on: st ri ng+ metho d: st ri ng

Cl in ical Trials Activ ities ::StudyAgent

: :Part ic ipat ion+ type : CodedConcept+ status: CodedConcept+ statusDate: DAT ET IM E+ startDate: DATETIME+ endDate: DATET IM E

Clinical Trials Activ ities::S tudyInv estigator

+ signa tureCode: int+ signa tureT ext: string: :Part ic ipat i on+ type: CodedConcept+ status: CodedConcept+ statusDate: DAT ET IM E+ startDate : DATETIM E+ endDate: DAT ETIME

Cl inic al Trials Activ ities::S tudySi te

+ targetAccrualNum ber: i nt

: :Part ic ip at ion+ type: Cod edConcept+ statu s: Co dedConcept

+ statu sDate : DATETIME+ startDate: DATET IM E+ en dDate: DATET IM E

Clinical Tria ls Activ ities::SubjectAssignment

+ studySub ject Id enti fier: int+ arm: st ri ng+ subgroup Code: string+ i nform edConsentFormS ignedDate: date+ of fS tudyDate: date+ studyAge ntDoseLevel : st ri ng+ el igibi l it yWa iverRea so n: st ri ng+ ageAtEnroll m ent: i nt::Partic i pati on+ type: CodedCon cept+ status: CodedCo ncept+ statusDate: DATETIME+ startDate: DAT ET IM E+ endDate: DAT ETIME

Cl inical Trials Activ itie s::Su bstanceAd ministration

+ doseQuant ity: int+ doseUnitOfM easure: st ring+ route: st ri ng+ doseFrequ ency: st ri ng+ doseModi f icat io nType: st ri ng+ doseChangeT ype: in t

Clinical Tria ls Activi ties::

Surgery


+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescriptio n+ startDate: DATETIME+ status: PSMCodedConcep t+ ava ilabilityTim e: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntege rs+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedCo ncept+ reasonCode: PSMCodedConcept+ endDate: DATETIME

BRIDG Shared Classes ::Activ ityActivi tyRelationship

+ rel ati onshipCode: PSMCodedConcept- Obsolete_rel ati onQuali fi er: BRIDGCode dConce pt+ sequenceNum ber: NUM BER+ pauseCriteri on: + checkpointCode: + pri ori tyNum ber: NUMBER+ spli tCode: - negati onRul e: Abst ractRul e+ joi nCode: + negati onIndi cator: BOOLEAN+ conj unct ionCode:

BRIDG Shared Classes ::Participation

+ type: CodedConcept+ status: CodedConcept+ statusDate: DAT ETIM E+ startDate: DATETIME+ endDate: DATET IM E


+ i d: CodedConcept+ co de: CodedConcept+ status: + el ect roni cComm Addr: + geographicAddr: + telecomAddr: + ef fecti veS tartDate: DATET IME+ ef fecti veEndDate: DAT ET IME

BRIDG Shared Classes::RoleRoleRelations hip

+ source : + type : CodedConcept+ target :

BRIDG Shared Classes::BRIDGAn alysisVariable

+ name: TEXT+ val ue: + cont rol ledName: PSMCodedConcept+ businessProcessMode: PSMBusinessProcessMod e

BRIDG Shared Classe s::BRIDGBusinessProcessM ode

+ m odeVal ue: ENUM {Pl an, Exe cute}


- code: TEXT- codeSystem: - codeSystemNam e: TEXT- codeSystemVersi on: NUM BER- d ispl ayNam e: T EXT- o rigi nalT ext: T EXT- t ranslati on: SET {PSMCod edConcept}

BRIDG Shar ed Classes::BRIDGContactAddr

+ typ e: BRIDGCodedConcept+ effect iveTi me: BRIDGInterval+ usage: BRIDGCodedConcept

BRIDG Sh ared Classes::BRIDGDescription

+ synop si s: EncapsulatedData+ sum maryDescript ion: EncapsulatedDa ta+ detai l edDescri pti on: Encapsul atedData

BRIDG Shared Classes::BRIDG ID

+ source: T ext+ version: Text+ val ue: T ext

BRIDG Shared Classes::BRIDGInterval

- startT im e: t im estam p+ endTi me: ti mestamp

BRIDG Shared Class es::BRIDGStatus

+ ef fect iveEndDate: + ef fect iveStartDate: + statusVal ue:

Proto col Concepts::StudyDocument

+ version: string+ author: SET+ ID: SET BRIDGID+ docum entID: BRIDGID+ type: ENUM+ descript ion: BRIDGDescri pti on+ ti tl e: st ri ng+ status: BRIDGStatus+ conf ident ial it yCode: CodedCon cept

0. .11

1

0..*

0. .1

1 ..*

1

0..* 0. . *

1

1. .*

1

1

0. .*

0.. *

1

0..*

1

1 0. .*

+source act ivi ty

*

*

+target acti vit y

«abstracti on»

10. .*

1

0. . *

1has a

1..*

0. .*

1

0.. * 1

1..*

has a

1

1 0. .*

0. .*+speci me nCol lecti on

1+speci menColl ect ion

0. .* 1

0 ..*1

0..*

1

1.. * 0.. *

0 ..11

0.. *

1

0.. *

1

BRIDG – Domain Analysis Model for Clinical Research

FOU

ND

ATI

ON

MO

DEL

CDISC

STA

KEH

OLD

ERS

NCI/caBIG HL7 (RCRIM)

Application Development

caCORE Tooling

V3 Message DevelopmentHL7 Tooling

xml data Exchange

CDISC xml

IMPL

EMEN

TATI

ON

SOLU

TIO

NS

Interoperability Interoperability

Achieving interoperability

BRIDG development

Top-Down scaffolding Development

Use case driven, subproject Development

BRIDG

Cumulative Registered Users

What have we accomplished?

• BRIDG– Established excellent collaboration with CDISC, HL7 and other

caBIG modelers– Constructed the initial pieces of a comprehensive model – still

much to do– Have established this model as the HL7 Domain analysis model– Have developed processes and organization of the model that will

support more scaleable collaborative development

• This model will serve as the semantic foundation for all data interchange specifications in HL7, CDISC, the NCI, and caBIG

Final thoughts: our approach to modeling

• Scope – keep it clear and focused (ie, solve a problem that exists) and standardize to the extend needed– Refine through experience, and not endless discussions. This keeps the

modeling effort clear and focused– BRIDG is not complete – but the scaffolding is there to help organize

the analysis and model development in subprojects• Keep it generic, faithful, free of implementation specific formalisms,

and supporting the requirements• If the tools and models don’t work with reality – it is probably the

tools and the models that need to change• If it’s broke, fix it

– The model is in evolution with known problems – the problems should be an opportunities for improvement and a call to arms, not barriers to use

• Model in the open• Collaborate until it hurts

With thanks to Dipak Kalra for discussion

BRIDG

• Supports semantic interoperability– Defines the semantic of static and dynamic

structures in context• Provides a mechanism and focus for

collaborating around shared semantics

• BRIDG Best Practices – draft!– Developing New Models– Harmonizing existing Models

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

guidelines Refer to best practices for modeling in BRIDG environment

Submit BRIDG Harmonization

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

Submit BRIDG Harmonization

Package to THCMeet 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

Ways to interact with BRIDG

De-novo modeling (starting with BRIDG)

• Register the project– Provide POC and some minimal project info

• BRIDG mentor is assigned to you and your project is scheduled for review with the BAB for assignment of priority schedule

• Download the BRIDG replica• Create a new project package in Staging area

(for both dynamic and static)

De-novo modeling (starting with BRIDG) (II)

• Begin Modeling– Model in small groups, vet in large groups– Identify classes that can be re-used– Construction of a strawman (possibly using some existing BRIDG

classes)– Annotate existing classes with notes on the diagram (do not alter core

classes or other classes in Staging area)

• Develop a modeling analysis and harmonization document that identifies updates, additions, deletions, change in definitions, comments, etc.– Periodic review with BRIDG mentor – Submit the complete pacakge to BRIDG THC/BAB– xmi export file, EAP file, analysis and harmonization document

• Schedule a harmonization meeting between project memebers and THC (centra sessions or F2F meeting)

Existing models

• Register the project– Provide POC and some minimal project info

• BRIDG mentor is assigned to you and your project is scheduled for review with the BAB for assignment of priority schedule

• Download the BRIDG replica

• Create a new project package in Staging area (for both dynamic and static) and import model

• Identify points of intersection– Link model elements from other packages in the harmonized elements

(realize that these elements will not be exported when the model is exported)

– Annotate with notes (do not alter core classes or other classes in Staging area)

Existing Models (II)

• Develop analysis and harmonization document that identifies updates, additions, deletions, change in definitions, comments, etc.

• Periodic review with BRIDG mentor

• Submit the complete package to BRIDG THC/BAB– xmi export file, EAP file, analysis and harmonization document

• Schedule a harmonization meeting between project memebers and THC (centra sessions or F2F meeting)

• Best Practices for Class Modeling– Annotate Annotate Annotate – Definitions– Associations and names

• BRIDG Harmonization

• BRIDG Access– Collaborative Space (GForge)– Model Management

Collaborative tools

• GForge site – www.BRIDGproject.org was the first GForge implementation

within the CTMS workspace– Recently, NCI has developed a comprehensive GForge site to

support caBIG• Risk is that subproject domain modeling will occur in isolation, and

not have the level of integration into the BRIDG model• Possible to harmonize these models, but will take more time and

resources– Goal: – A single place for all analysis modeling related to BRIDG

• Shared forums, • Shared documents• Shared learning • Shared models

http://www.bridgproject.org/

Goal: A single place for domain modeling

– Collaborative analysis modeling, with the range of stakeholders in the BRIDG project, required extensions of the GForge functionality

• Completed a requirements and gap analysis • Working with the other BRIDG stakeholders to

develop processes to support not only caBIG but others

– Once these issues have been resolved, anticipate moving to a shared site for modeling

Model Management

• Tools – CVS repository

• Organizes file-level coordination and versioning control• Implemented in the BRIDG GForge site

– Enterprise Architect• Useful model-level (class/attribute) coordination and

versioning• Equivalent to dif and merge of text based files, but applies to

the model– Two parts of the same issue– Different than model vetting or voting

Replication

• Replication allows different users to work independently of one another, and to merge their changes at a later time.

• This is inherently a hazardous exercise, and so there is no substitution for good collaboration and communication

Enterprise Architect Merge Rules

• Additions are cumulative - i.e. Two replicas creating 3 new classes each will result in 6 new classes after merging.

• Deletions prevail over modifications, if one replica changes a class name and other deletes the class, performing a merge will result in both files losing the class.

• EA can generate an interactive dialogue that allows a user to review conflicts in the replication process.

• EA also allows the construction of a “baseline” that can be used to compare changes within a particular file – This is useful to know what has changed as a group has made changes to a particular file.

Using Replication

• Convert the base project to a Design Master using the Make Design Master option in the Tools | Manage .EAP File submenu).

• Create replicas from the design master using the Create New Replica option in the Tools | Manage .EAP File submenu.

• Take the replica away and work on it as required, then bring it back for synchronization with the design master.

• Synchronize the replicas. During synchronization, all changes to both the master and the replica are propagated in both directions, so at the end they both contain the same information.

mk:@MSITStore:C:%5CPROGRA~1%5CSPARXS~1%5CEA%5CEA.chm::/designmaster.htm

mk:@MSITStore:C:%5CPROGRA~1%5CSPARXS~1%5CEA%5CEA.chm::/synchreplica.htm

Avoid Change Collisions

• If two or more people make changes to the same element, eg. a class, Enterprise Architect will arbitrarily overwrite one person's change with other other's. To avoid this, different users should work on different packages whenever possible

• However, since Enterprise Architect does not enforce this rule, it is possible for users' work to conflict. To minimize the difficulties this causes, please note the following guidelines:– If users are likely to have worked in the same area of the model -

they should both witness the synchronization and confirm that they are happy with the net result.

– If small pieces of information have been lost, they should be typed into one of the merged models after synchronization.

– If a large piece of information has been lost - for example, a large class note that was overwritten by another user who had made a minor change to the same class use the Resolve Replication Conflicts dialog.

mk:@MSITStore:C:%5CPROGRA~1%5CSPARXS~1%5CEA%5CEA.chm::/resolveconflicts.htm

BRIDG model replica

• BRIDG has a model master and a replica – the replica is where all of the modeling is currently taking place

• Using BRIDG as a starting point allows users to take advantage of the EA infrastructure to support collaborative model development

Further Information

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

http://www.cdisc.org/

http://www.bridgproject.org/

mailto:[email protected]

mailto:[email protected]

Documents

BRIDG Model