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Transcript of BRIDG Model: A Comprehensive Information Model for Biomedical Research 25-April-2006 Douglas B....
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
Pro
toco
l
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
LAB
ODM
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
2
3 4
5
6
Computerized doesn’t mean syntactic interoperability
Semantic interoperability: “Protocol” and the Semiotic Triangle
Symbol
“Protocol”
“We need to sign off on the protocol by Friday”
Concept 1
Thing 1
Document Study
“Protocol XYZ has enrolled 73 patients”
Thing 2
Concept 2
“Per the protocol, you must be at least 18 to be enrolled”
Concept 3Thing 3
Plan
Source: John Speakman/Charlie Mead
Semantic Interoperability
• To understand the data being received you must know both:
• The definition of each element of data, and its relationship with each of the other elements – you must have a semantic model of the data
and– The terminology to be used to represent coded
elements, including the definitions, and relationships within the terminology
Source: HL7
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 affi l iated with.
Once the operational aspects are completed, the cancer centers responsible for executing the study will begin to enroll patients and execute the study according to the protocol plan.
At periodic intervals, cooperative groups, and PI will report back to the NCI the results of the study.
Note:
This storyboard is specific to the NCI and cancer research. For Pharmaceutical industry, the activities are similar, although there are different actors assigned to these tasks.
Operational Team
The operational team are responsible for turning the study plan into tasks and systems that can be executed by other investigators. This is the technical, legal, and other infrastructure that is necessary to have before a clinical trial can be executed.
Organizations which may play this roleinclude:
Clinical Research OrganizationSponsoring OrganizationCooperative Group
Scientific Team
This is the group that is responsible for authoring the study.
For example, at a cancer center, this team might be lead by the Principal Investigator, and consist of co-investigators.
In a pharmaceutical company, this team might consist of a medical writer, scientific leaders, statisticians and other administrative staff and be lead by an individual who takes responsibil ity for leading the team who will write the study and guiding it through the steps of approval.
This group identifies the research question to be answered, and then after the study is completed, analyzes the data, to see how the question was answered.
Clinical Management Team
The clinical management team is responsible for managing the clinical trial subjects, data aboutthe subjects, and information and processes related to the execution of the study.
For example, a data manager would be a participant in this team, managing data related to a clinical trial subject.
In addition, the data manager would be responsible for closing out the data base, reconciling the database, etc.
Name:Package:Version:Author:
Conduct Clinical TrialConduct Clinical Trial1.0Fridsma
Behavioral Aspects of BRIDGad RegisterClinicalTrial
RegistrySteward Registry RegistryClearinghouse
The entity that is sending/transmitting a registry message.
For example, a pharmaceutical organization/agent will authorize aparty to transmit information about a trial to an external registry such as clinicaltrials.gov.
For example, in an academic institution the principal investigatorwill transmit information about a trial to an external registry.
The entity (person, org or system) that receives, processes and publishes registry information .
For example, clinicaltrials.gov PDQ, or EudraCT are considered registries.
Storyboard: A pharmaceutical companyhasjust completed authoring a clinical trial protocol document, they are ready to register the clinical trial. A pharmaceutical company extracts information from the protocol and associated sources. This original or derived information may be entered directly from the protocol or entered from other sources. This information may require formatting or modification according to the registry institution. The information is transmitted to the registry. There is an acknowledgement of the transmission.
For example, WHO or IFPMA (International Federation of Pharmaceutical Manufacturers and Associations).
Compile RegistryInformation
Transmit Information
Receiv e Information
Validate Information
Is information acceptable?Is information acceptable?Receiv e error message
Modify Information
Receiv eacknowledgement
ActivityFinal
Release information
Send error message
Send acknowledgement
Yes
No
ad RegisterClinicalTrial
RegistrySteward Registry RegistryClearinghouse
The entity that is sending/transmitting a registry message.
For example, a pharmaceutical organization/agent will authorize aparty to transmit information about a trial to an external registry such as clinicaltrials.gov.
For example, in an academic institution the principal investigatorwill transmit information about a trial to an external registry.
Roles are defined in the swim lanes with examples drawn from discussions with the domain experts
Behavioral Aspects of BRIDGad RegisterClinicalTrial
RegistrySteward Registry RegistryClearinghouse
The entity that is sending/transmitting a registry message.
For example, a pharmaceutical organization/agent will authorize aparty to transmit information about a trial to an external registry such as clinicaltrials.gov.
For example, in an academic institution the principal investigatorwill transmit information about a trial to an external registry.
The entity (person, org or system) that receives, processes and publishes registry information .
For example, clinicaltrials.gov PDQ, or EudraCT are considered registries.
Storyboard: A pharmaceutical companyhasjust completed authoring a clinical trial protocol document, they are ready to register the clinical trial. A pharmaceutical company extracts information from the protocol and associated sources. This original or derived information may be entered directly from the protocol or entered from other sources. This information may require formatting or modification according to the registry institution. The information is transmitted to the registry. There is an acknowledgement of the transmission.
For example, WHO or IFPMA (International Federation of Pharmaceutical Manufacturers and Associations).
Compile RegistryInformation
Transmit Information
Receiv e Information
Validate Information
Is information acceptable?Is information acceptable?Receiv e error message
Modify Information
Receiv eacknowledgement
ActivityFinal
Release information
Send error message
Send acknowledgement
Yes
No
ad RegisterClinicalTrial
RegistrySteward Registry RegistryClearinghouse
Compile RegistryInformation
Transmit Information
Receiv e Information
Validate Information
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
Inv estigator
Organization Role
OrganizationRole
Participant
Person Role
PersonRole
TherapeuticAgent
Activity
PerformedActiv ity
PerformedStudy
Activity
PlannedActiv ity
PlannedStudy
Participation
StudyAgent
Participation
StudyInv estigator
Participation
StudySite
Participation
SubjectAssignment
Document
StudyDocument
Dev iceDrug
Study
Participation
StudyAuthor
+is described by1..1
+is operationalized 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+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
Clinical Research Entities and Roles::
MaterialRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::Investigator
+ certificateLicenseText: Text
Clinical Research Entities and Roles::Organization
+ description: Text+ geographicAddr: BRIDGContactAddr+ name: Text+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::OrganizationRole
::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::Participant
+ confidentialityIndicator: boolean+ paymentMethod: ENUM
Clinical Research Entities and Roles::Person
+ address: BRIDGContactAddr+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ dateOfDeath: DATETIME+ educationLevelCode: BRIDGCodedConcept+ electronicCommAddr: BRIDGTelecomAddress+ ethnicGroupCode: BRIDGCodedConcept+ householdIncomeCategory: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ name: Text+ raceCode: BRIDGCodedConcept+ telecomAddress: BRIDGTelecomAddress
Clinical Research Entities and Roles::PersonRole
::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::TherapeuticAgent
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
Clinical Trials Activities::PerformedStudy
+ ActualAccrualNumber: int+ enrollmentEndDate: Date+ enrollmentstartDate: Date::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::PlannedActiv ity
+ repeatNumber: rangeOfIntegers::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
Clinical Trials Activ ities::PlannedStudy
+ targetAccrualNumber: int::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::StudyAgent
::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::StudyInvestigator
+ signatureCode: int+ signatureText: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::SubjectAssignment
+ ageAtEnrollment: int+ arm: string+ eligibilityWaiverReason: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ studySubjectIdentifier: int+ subgroupCode: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Activity
+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
BRIDG Shared Classes::Activ ityActiv ityRelationship
+ checkpointCode: + conjunctionCode: + joinCode: + negationIndicator: BOOLEAN- negationRule: AbstractRule+ priorityNumber: NUMBER+ relationshipCode: BRIDGCodedConcept+ sequenceNumber: NUMBER+ splitCode:
BRIDG Shared Classes::Participation
+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Role
+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
BRIDG Shared Classes::RoleRoleRelationship
+ source: + target: + type: CodedConcept
BRIDG Shared Classes::BRIDGAnalysisVariable
+ businessProcessMode: PSMBusinessProcessMode+ controlledName: PSMCodedConcept+ name: TEXT+ value:
BRIDG Shared Classes::BRIDGCodedConcept
- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::BRIDGContactAddr
+ effectiveTime: BRIDGInterval+ type: BRIDGCodedConcept+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ detailedDescription: EncapsulatedData+ summaryDescription: EncapsulatedData+ synopsis: EncapsulatedData
BRIDG Shared Classes::BRIDGID
+ source: Text+ value: Text+ version: Text
BRIDG Shared Classes::BRIDGInterval
+ endTime: timestamp- startTime: timestamp
BRIDG Shared Classes::BRIDGStatus
+ effectiveEndDate: + effectiveStartDate: + statusValue:
Specimen may have to re-located
Needs additional work and cleanup
Clinical Trials Activ ities::StudyDocument
+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept::Document+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string
Potential hook for the eDCI model
Attributes needs to be reviewed -- need to be domain oriented -- too RIM like
Do we need this -- what is the use case? The thinking is that this will be used for caAERS. Ifnot, then it should be deleted.
This maybe an Activity?
Review the data types -- inconsistency in definition and what is used in the model
BRIDG Shared Classes::BRIDGTelecomAddress
- addressType: ENUM- usageType: ENUM- value: Text
BRIDG Shared Classes::Dev ice
::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
BRIDG Shared Classes::Drug
+ formCode: BRIDGCodedConcept+ lotNumber: int+ stabilityTime: DATETIME::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
Clinical Trials Activities::Study
+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::StudyAuthor
::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Document
+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string
We will need to MANUALLY keep these two classes in synch with their attributes.
CTOM Elements::PerformedObservation
+ confidentialityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
CTOM Elements::ObservationRelationship
+ comments: string+ id: int- type: string
PlannedObservation
We may or may not need this class -- it depends on the number of shared classes between thetwo performed/planned activities
CTOM Elements::Histopathology
+ grossExamResultCode: string+ involvedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
CTOM Elements::LesionDescription
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ appearanceTypeCode: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ dimensionProduct: int+ evaluationNumber: int+ lesionNumber: string+ measurableIndicator: boolean+ methodCode: string+ previouslyIrradiatedSiteIndicator: boolean+ targetNonTargetCode: string+ xDimension: int+ yDimension: int+ zDimension: int
SDTM::LaboratoryTest
+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::SDTMFinding
+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::OtherFindings
+ evaluationInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::QuantitativeMeasurement
+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::Examination
+ measurementTime: int- resultDescription: SDTMFindingDescriptionDataType::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
TestInterpretation
SDTM::InterpretedResults
::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
TestInterpretation
SDTM::VitalSign
+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPosition: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
+is fulfi led by the role
1
+participate as
0..*
+are attributed to +have
0..*
1
+are attributed to +have
1 0..*
+are written by
+write
0..*
1
+are attributed to +have
+is operationalized by
0..1
+is described by
1..1
+is described by 1
+describes 1
+source activity
*
*
+target activity
1
has a 1..*1..*has a
1
+assign 0..*+are assigned by 1
«abstraction»
0..* 1
1 0..*
+is described by
1..1
+is operationalized by 0..1
0..11
+are performed by+participate in
0..*
1
+are performed at
+participate in
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
Clinical Trials Activities::Study
+ blindedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multi InstitutionInd: boolean+ phaseCode: ENUM+ populationDescription: BRIDGDescription+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ status: BRIDGStatus+ SubjectType: BRIDGCodedConcept+ targetConditionCode: BRIDGCodedConcept+ type: BRIDGCodedConcept
Document
Clinical Trials Activ ities::StudyDocument
+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multi InstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept
Clinical Trials Activities::PerformedStudy
+ ActualAccrualNumber: int+ enrollmentEndDate: Date+ enrollmentstartDate: Date::Study+ blindedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multi InstitutionInd: boolean+ phaseCode: ENUM+ populationDescription: BRIDGDescription+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ status: BRIDGStatus+ SubjectType: BRIDGCodedConcept+ targetConditionCode: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::PlannedStudy
+ plannedSubjectInterventionDuration: DATETIME+ plannedSubjectParticipationDuration: DATETIME+ targetAccrualNumber: int::Study+ blindedInd: boolean+ description: BRIDGDescription+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multi InstitutionInd: 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: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Participation
+ endDate: DATETIME+ startDate: DATETIME = + 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
::Participation+ endDate: DATETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ 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
Clinical Trials Activ ities::StudySite
+ 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: timing specification+ indication: text+ missingValueCode: CodedConceptDataType+ startT ime: DATETIME
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: SDTMInterventionDescriptionDataType+ endTime: DATETIME+ evaluationInterval: timing specification+ indication: text+ missingValueCode: CodedConceptDataType+ startT ime: DATETIME::Participation+ endDate: DATETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::StudyAgent
::Participation+ endDate: DATETIME+ startDate: DATETIME = + status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
SDTM::DoseRegimen
CTOM Elements::Procedure
+ targetSiteCode: string
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
Activity
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ codedDescription: BRIDGCodedConcept+ confidential i tyCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
Review SDTM and CTOM models
Arm
+ plannedSubjectNumber: int+ type: text
StudyBackground(w hy)
+ description: PSMDescription+ justificationOfApproach: PSMDescription+ justificationOfObjectives: PSMDescription+ populationDescription: PSMDescription+ rationaleForAnalysisApproach: PSMDescription+ rationaleForControl: PSMDescription+ rationaleForDesign: PSMDescription+ rationaleForEndpoints: PSMDescription+ rationaleForMasking: PSMDescription+ studyPurposeSummary: Text+ summaryOfPreviousFindings: PSMDescription+ summaryOfRisksAndBenefits: PSMDescription
Serial izable
eligibilityCriteria::EligibilityCriterion
+ codedName: BRIDGCodedConcept+ comparisonOperator: Text+ description: Text+ eligibi l i tyType: String+ unit: Text+ value: Text
StudyObjectiv e(w hat)
+ description: BRIDGDescription+ objectiveCode: SET ENUMERATED+ objectiveType: ENUM{Primary,Secondary,Ancil lary}
Outcome
- analyticMethods: Set- asMeasuredBy: Set- associatedObjective: Set+ description: BRIDGDescription+ outcomeType: ENUM{Primary,Secondary,Ancil lary}- outcomeVariable: - threshold:
If the objective 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]+ HelpText: [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
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
BRIDG Shared Classes::Participation
+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Activity
Clinical Trials Activities::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::Activity+ 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
Each StudySubject is associated with only 1 site. A StudySite is associated with 1 or more StudySubject.
Date and Time of Collection 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+ startTime: DATETIME+ endTime: DATETIME+ evaluationInterval: timing specification
SDTMInterv entionDescriptionDataType
+ verbatim: text+ decode: CodedConceptDataType+ modified: text+ class: CodedConceptDataType
Clinical Trials Activ ities::StudyAgent
::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+ startTime: 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: Revisit --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.
SDTMEv ent
+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startTime: DATETIME
Adv erseEv ent
+ isSerious: boolean+ location: CodedConceptDataType+ severity: enum+ actionTakenWithStudyTreatment: enum+ otherActionTaken: text+ relationshipToStudyTreatment: CodedConceptDataType+ actionTakenWithConcomitantTreatment: text+ toxicityGrade: CodedConceptDataType+ seriousnessCriteria: enum+ outcome: CodedConceptDataType::SDTMEvent+ description: SDTMEventDescriptionDataType+ endTime: DATETIME+ startTime: DATETIME
SDTMEv entDescriptionDataType
+ decode: CodedConceptDataType+ verbatim: text+ bodySystem: CodedConceptDataType+ modified: text
Action: Determinehow to handle PATTERN since itisn'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 will probably not harmonize into the BRIDG in this way but will probably be associated with Subject.
Could have NonAdverseEvent abstract class above MedicalHistory
Represent Concomicant Medications and Substance Use
SDTMFinding
+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType
Quantitativ eMeasurement
+ result: text+ units: text+ normalRangeLow: text+ normalRangeHigh: text::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType
Examination
- resultDescription: SDTMFindingDescriptionDataType+ measurementTime: int::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType
OtherFindings
+ measurementTime: 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 all 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+ collectionTime: DATETIME+ collectionMethod: 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::QuantitativeMeasurement+ result: text+ units: text+ normalRangeLow: text+ normalRangeHigh: text::SDTMFinding+ name: CodedConceptDataType+ missingValueCode: CodedConceptDataType
Action:; Need to determine how to handle baseline. 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::QuantitativeMeasurement+ 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+ collectionTime: 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 will require collection intervals -- for example, a 24 hour cortisone, a 24 hoururine collection, etc. We will 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
+ visitNum: 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)-- similar to Observation--SH
Harmonization notes -- similar to clinicalResults--SH
Harmonization Notes -- similar toActivity >SubstanceAdministration--SH
Harmonization Notes - similar to AEclasses --SH
Harmonization Notes -similar to Proceudre, SpecimenCollection, Sample --SH
Harmonization Notes: Move to Activities 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 theassociaitons -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 enrolls
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+collects
0..*+are collected at
0..*+is collected at
0..1+collects
0..*
+is collecte 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
caAERS
cd Logical Model
StudySubject
+ birthDate: date+ ethnicGroup: string+ sex: string+ race: string::Person+ namePrefix: string+ firstName: 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::ParticipatingEntity+ 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::Activity+ 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::Activity+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string
AdverseEvent
+ outcomeCode: string+ severity: 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::Activity+ 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::ActivityRelationship+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ProcedureTreatment
::Treatment+ courseNumber: string+ cycleNumber: string+ negationIndicator: boolean+ isContinuingIndicator: boolean+ treatmentAssignmentCode: string+ schedule: string+ totalCourseNumber: int::Activity+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string
ClincalStudy
+ type: string+ researchComment: string::Activity+ 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::ParticipatingEntity+ id: long
AdverseEventDetailKind
+ id: string+ adverseEventDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ParticipatingEntityIdentifier
+ id: long+ identifierValue: string+ identifierType: string
AdverseEventReport
+ sequenceIdentifier: int+ subjectDiscloserAllowed: boolean+ hasAmendedDataIndicator: boolean+ sentToFDAIndicator: boolean+ sentToManufacturerIndicator: boolean+ followUpNumber: int+ followUpType: string+ additionalInformationAttachedType: string+ reasonNoRelevantHistoryProvided: string+ containsCorrectedDataIndicator: boolean+ type: string+ sponsorNotifiedBeforeReportFilingIndicator: boolean+ sponsorNotificationDate: dateTime+ sponsorNotificationMethod: 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::Activity+ description: string+ durationTimeAmount: int+ durationTimeUnit: string+ endTime: dateTime+ id: long+ method: string+ reason: string+ startTime: dateTime+ status: string
Person
+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
+ isHealthProfessional() : boolean
Activ ityIdentifier
+ id: long+ identifierValue: string+ identifierType: string+ versionIdentifier: string+ versionEffectiveDate: dateTime
Activ ityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ParticipatingEntityRelationship
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ id: long+ relationshipStatus: string+ relationshipType: string
Protocol
+ phase: string+ title: 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+ availableForEvaluationIndicator: boolean+ labeledForSingleUseIndicator: boolean+ usage: string::Product+ name: string+ status: string::ParticipatingEntity+ id: long
Location
+ name: string+ description: string+ streetAddress: string+ city: string+ state: string+ postalCode: string::ParticipatingEntity+ id: long
DrugProduct
+ lotNumber: string+ expirationDate: date+ brandName: string::Product+ name: string+ status: string::ParticipatingEntity+ id: long
DrugProductIngredient
+ id: long+ quantity: float+ activeIngredientIndicator: boolean+ materialForm: string
Activ ityKind
+ id: long+ activityCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 1/24/2006 10:38:06 AM
Name: Logical ModelAuthor: AbdulMalik 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
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
AdverseEventReportDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
ParticipatingEntityKind
+ id: long+ entityType: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
AdverseEventReportDetailKind
+ id: + adverseEventReportDetailCode: 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+ title: string
ObservationValue
+ id: long
DiseaseHistory
+ category: string+ primaryDiseaseName: string+ primaryDiseaseSite: string+ dateOfInitialDiagnosis: date+ dateOfInitialPathologicDiagnosis: 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+ site: 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..*+identifierCollection
1
+entity
1+organization
0..*+telephoneCollection
0..*
+identifierCollection
1+assigningAuthority
0..*+identifierCollection
1
+assigningAuthority
1
+entity
0..*
+participationCollection
0..*+relationshipCollection
1
+targetEntity
1..*+ingredientCollection
1+product
1
+activityKind
0..*+activityCollection
1+person
0..*+telephoneCollection
0..*+adverseEventReportDetailCollection
1+adverseEventReportDetailKind
0..*
+adverseEventReportDetailCollection
1
+adverseEventReport
0..*
+ingredientCollection
1 +material
0..* +relationshipCollection
1
+sourceEntity
0..*
+eventDetailCollection
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..*
+AdverseEventReportCollection
1
+adverseEvent
0..*
+activityRelationshipCollections
1+adverseEvent
1
+act
0..*
+participationCollection
1
+activity
+identifierCollection
0..*
+relationshipCollection
1
+targetActivity
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
Name:Package:Version:Author:
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 Logical Model
StudySubject
+ birthDate: date+ gender: string+ race: string+ ethnicGroup: string+ deceaseDate: date::Person+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
Activity
+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Organization
+ name: string::ParticipatingEntity+ id: long
+ isFDA() : boolean
ParticipatingEntity
+ id: long
ActivityParticipation
+ id: long+ type: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ participantRole: string+ participantSignature: string+ participantSignatureDate: dateTime
Product
+ name: string+ status: string::ParticipatingEntity+ id: long
Observation
~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
PharmacuticalTreatment
+ administrationRoute: string+ totalDoseAdministered: int+ administrationDose: int+ administrationFrequency: string::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEvent
+ outcome: string+ seriousness: string::Observation~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean
AdverseEventActivityRelationship
+ expectedness: boolean+ attribution: int+ studyDesignBroken: boolean+ agentAdjustment: string+ administrationDelayed: boolean::ActivityRelationship+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ProcedureTreatment
::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
ClincalStudy
::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEventDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
MaterialKind
+ name: string::ParticipatingEntity+ id: long
AdverseEventDetailKind
+ id: string+ adverseEventDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ParticipatingEntityIdentifier
+ id: long+ identifierValue: string+ identifierType: string
AdverseEventReport
+ sequenceIdentifier: int+ subjectDiscloserAllowed: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ hasAmendedData() : boolean+ sentToFDA() : boolean+ initialSentToFDA() : boolean+ sentToManufacturer() : boolean+ treatmentDelayed() : boolean+ delayDuration() : real+ delayDurationUnits() : string
Treatment
+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean+ isAdjustment() : boolean
Person
+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
+ isHealthProfessional() : boolean
ActivityIdentifier
+ id: long+ identifierValue: string+ identifierType: string+ versionIdentifier: string+ versionEffectiveDate: dateTime
ActivityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ParticipatingEntityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceParticipantRole: string+ targetParticipantRole: string
Protocol
+ phase: string+ title: string::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Device
+ implantedDate: dateTime+ explantedDate: dateTime+ reprocessedIndicator: boolean+ availableForEvaluationIndicator: boolean::Product+ name: string+ status: string::ParticipatingEntity+ id: long
Location
+ name: string+ description: string+ streetAddress: string+ city: string+ state: string+ postalCode: string::ParticipatingEntity+ id: long
DrugProduct
+ lotNumber: string+ expirationDate: date::Product+ name: string+ status: string::ParticipatingEntity+ id: long
DrugProductIngredient
+ id: long+ quantity: float+ activeIngredientIndicator: boolean+ materialForm: string
ActivityKind
+ id: long+ activityCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
PersonTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
OrganizationTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
AdverseEventReportDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
ParticipatingEntityKind
+ id: long+ entityType: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
AdverseEventReportDetailKind
+ id: + adverseEventReportDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ObservationValueKind
+ id: long+ observationValueCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
1..*+ingredientCollection
1+product
0..*+relationshipCollection
1
+targetEntity
0..* +relationshipCollection
1
+sourceEntity
0..*+identifierCollection
1
+assigningAuthority
1+person
0..*+telephoneCollection
0..*
+identifierCollection
1+assigningAuthority
0..*+adverseEventReportDetailCollection
1+adverseEventReportDetailKind
0..*+adverseEventReportDetailCollection
1
+adverseEventReport
0..*
+ingredientCollection
1 +material
0..*
+identifierCollection
1
+entity
1+participatingEntityKind
0..*+entityCollection
0..*+eventDetailCollection
1+adverseEvent
1
+eventDetailKind
0..*+eventDetailCollection
0..*
+AdverseEventReportCollection
1
+adverseEvent
0..*
+activityRelationshipCollections
1+adverseEvent
1
+act
0..*
+participationCollection
1
+entity
0..*
+participationCollection
0..*
+relationshipCollection
1
+targetActivity
0..*+observationCollection
1
+observationValueKind
1
+activityKind
0..*
+activityCollection
0..*
+relationshipCollection
1
+sourceActivity
1+organization
0..*+telephoneCollection
1+activity
+identifierCollection
•Lab SIG Model•Study Calendar SIG Model•Financial SIG Model
caAERS
Implementation Specific Models
cd Comprehensive Model
Clinical Research Entities and Roles::Agent
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ formCode: CodedConcept+ lotNumber: int+ expirationDate: DATETIME+ stabilityTime: DATETIME
Clinical Research Entities and Roles::
AgentRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::
Investigator
+ certificateLicenseText:
Clinical Research Entities and Roles::Organization
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ statusDate: DATETIME+ geographicAddr: addrType+ telecomAddr: TEL
Clinical Research Entities and Roles::OrganizationRole
Clinical Research Entities and Roles::Participant
+ paymentMethod: CodedConcept+ confidentialityCode: string
Clinical Research Entities and Roles::Person
+ id: CodedConcept+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ raceCode: BRIDGCodedConcept+ ethnicGroupCode: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ electronicCommAddr: + householdIncomeCategory: BRIDGCodedConcept+ educationLevelCode: BRIDGCodedConcept+ telecomAddress: TEL+ name: entityName+ dateOfDeath: DATETIME+ address: addrType
Clinical Research Entities and Roles::PersonRole
::Role+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
Clinical Research Entities and Roles::TherapeuticAgent
Clinical Trials Activ ities::AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
Clinical Trials Activ ities::
AdverseEventReport
+ id: int+ submissionDate: date+ fi ledIndicator: boolean
Clinical Trials Activ ities::AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Clinical Trials Activities::Assessment
+ id: int+ evaluationDate: date
Clinical Trials Activ ities::
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
Clinical Trials Activ ities::CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
Clinical Trials Activ ities::ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ abnormalIndicator: boolean+ biomarkerInd: boolean+ significanceInd: boolean
Clinical Trials Activ ities::DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
Clinical Trials Activ ities::Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
Clinical Trials Activ ities::DiseaseResponse
+ responseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
Clinical Trials Activ ities::Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
Clinical Trials Activ ities::HistopathologyGrade
+ id: int+ gradingSystemName: string+ grade: string+ comments: string
Clinical Trials Activ ities::Imaging
+ identifier: string+ contrastAgentEnhancement: string+ descriptiveText: string+ rateOfEnhancementValue: int
Clinical Trials Activ ities::LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ previouslyIrradiatedSiteIndicator: boolean Clinical Trials
Activ ities::LesionEvaluation
+ evaluationCode: char
Clinical Trials Activ ities::MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeName: string
Clinical Trials Activ ities::Neoplasm
+ id: int+ cellType: string
Clinical Trials Activ ities::Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
Clinical Trials Activ ities::
ObservationRelationship
+ id: int- type: string+ comments: string
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
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
Clinical Trials Activ ities::PlannedActiv ity
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::PlannedStudy
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::Procedure
+ targetSiteCode: string
Clinical Trials Activ ities::QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int- performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
Clinical Trials Activ ities::Radiation
+ therapyType: string+ doseUnitOfMeasure: string+ dose: string
Clinical Trials Activ ities::Specimen
+ id: int+ idNumber: int+ samplingType: string
Clinical Trials Activ ities::
SpecimenCollection
+ siteCondition: string+ method: string
Clinical Trials Activ ities::StudyAgent
::Participation+ type: CodedConcept+ 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
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubjectAssignment
+ studySubjectIdentifier: int+ arm: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ eligibilityWaiverReason: string+ ageAtEnrollment: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubstanceAdministration
+ doseQuantity: int+ doseUnitOfMeasure: string+ route: string+ doseFrequency: string+ doseModificationType: string+ doseChangeType: int
Clinical Trials Activ ities::
Surgery
BRIDG Shared Classes::Activity
+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
BRIDG Shared Classes::Activ ityActiv ityRelationship
+ relationshipCode: PSMCodedConcept- Obsolete_relationQualifier: BRIDGCodedConcept+ sequenceNumber: NUMBER+ pauseCriterion: + checkpointCode: + priorityNumber: NUMBER+ splitCode: - negationRule: AbstractRule+ joinCode: + negationIndicator: BOOLEAN+ conjunctionCode:
BRIDG Shared Classes::Participation
+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
BRIDG Shared Classes::Role
+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
BRIDG Shared Classes::RoleRoleRelationship
+ source: + type: CodedConcept+ target:
BRIDG Shared Classes::BRIDGAnalysisVariable
+ name: TEXT+ value: + controlledName: PSMCodedConcept+ businessProcessMode: PSMBusinessProcessMode
BRIDG Shared Classes::BRIDGBusinessProcessMode
+ modeValue: ENUM {Plan, Execute}
BRIDG Shared Classes::BRIDGCodedConcept
- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::BRIDGContactAddr
+ type: BRIDGCodedConcept+ effectiveTime: BRIDGInterval+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ synopsis: EncapsulatedData+ summaryDescription: EncapsulatedData+ detailedDescription: EncapsulatedData
BRIDG Shared Classes::BRIDGID
+ source: Text+ version: Text+ value: Text
BRIDG Shared Classes::BRIDGInterval
- startTime: timestamp+ endTime: timestamp
BRIDG Shared Classes::BRIDGStatus
+ effectiveEndDate: + effectiveStartDate: + statusValue:
Protocol Concepts::StudyDocument
+ version: string+ author: SET+ ID: SET BRIDGID+ documentID: BRIDGID+ type: ENUM+ description: BRIDGDescription+ title: string+ status: BRIDGStatus+ confidentialityCode: 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 activity
«abstraction»
1
0..*
1
0..*
1has a
1..*
0..*
1
0..* 1
1..*
has a
1
1 0..*
0..*+specimenCollection
1+specimenCollection
0..* 1
0..*1
0..*
1
1..* 0..*
0..11
0..*
1
0..*
1
CTOMcd 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
Agent
+ id: int+ name: string+ descriptionText: string+ statusCode: string
StudyAgent
+ id: int+ investigationalIndicator: boolean+ investigationalNewDrugIdentifier: string+ statusCode: string+ statusDate: date
Participant
+ initials: char+ zipCode: string+ paymentMethodCode: char+ confidentialityIndicator: boolean
Activ ity
+ id: int+ name: string+ type: string+ descriptionText: string+ startDate: date+ stopDate: date+ durationValue: int+ durationUnitOfMeasureCode: string+ plannnedIndicator: boolean+ reasonCode: string
Assessment
+ id: int+ evaluationDate: date
SubstanceAdministration
+ singleDose: int+ singleDoseUnitOfMeasureCode: string+ doseFrequencyCode: string+ doseFrequencyText: string+ totalDose: int+ totalDoseUnitOfMeasureCode: string+ doseChangeCode: string+ doseChangeIndicatorCode: int+ routeCode: string
Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
StudySite
+ id: int+ roleCode: string+ statusCode: string+ targetAccrualNumber: string+ startDate: date+ stopDate: date+ irbApprovalDate: date
QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int+ performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
SpecimenCollection
+ siteConditionCode: string+ methodCode: string
DiseaseResponse
+ reponseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSystem: string+ previouslyIrradiatedSiteIndicator: string
HealthcareSite
+ nciInstituteCode: string
Procedure
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Imaging
+ imageIdentifier: string+ contrastAgentEnhancementIndicator: boolean+ enhancementRateValue: int+ enhancementDescriptionText: string
Radiation
+ dose: string+ doseUnitOfMeasureCode: string+ scheduleText: string+ therapyExtentCode: string
Specimen
+ id: int+ sampleIdentifier: int+ sampleTypeCode: string+ volume: int+ volumeUnitOfMeasureCode: string
Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCode: string+ abnormalIndicator: boolean+ biomarkerIndicator: boolean+ significanceIndicator: boolean
Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
EligibilityCriteria
+ id: int+ questionText: string+ questionNumber: int+ expectedAnswerIndicator: boolean
PersonOccupation
+ id: int+ primaryTypeCode: string+ primaryTypeCodeSystem: string+ startDate: date+ stopDate: date
Surgery
AdverseEventReport
+ id: int+ submissionDate: date+ filedIndicator: boolean
AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Organization
+ id: int+ name: string+ descriptionText: string+ statusCode: string+ statusDate: date+ streetAddress: string+ city: string+ stateCode: string+ postalCode: string+ countryCode: string+ telecomAddress: string
Person
+ id: int+ lastName: string+ firstName: string+ birthDate: date+ telecomAddress: string+ administrativeGenderCode: string+ countryCode: string+ educationLevelCode: string+ ethnicGroupCode: string+ householdIncomeCode: string+ maritalStatusCode: string+ raceCode: string+ employmentStatusCode: string+ employmentStatusOtherText: string
Activ ityRelationship
+ id: int+ typeCode: string+ sequenceNumber: int+ commentText: string
StudyTimePoint
+ id: int+ visitName: string+ courseNumber: int+ epochName: string+ courseStartDate: date+ courseStopDate: date
CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
ObservationRelationship
+ id: int+ typeCode: string+ commentText: string
Investigator
+ nciIdentifier: string
StudyParticipantAssignment
+ id: int+ studyParticipantIdentifier: int+ armIdentifier: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ enrollmentAge: int+ studyAgentDoseLevel: int+ studyAgentDoseLevelUnitOfMeasureCode: string+ offStudyDate: date+ offStudyReasonCode: string+ offStudyReasonOtherText: string+ eligibilityWaiverReasonText: string
StudyInvestigator
+ id: int+ responsibilityRoleCode: string+ startDate: date+ stopDate: date+ statusCode: string+ signatureIndicator: boolean+ signatureText: string
ExclusionInclusion
AgentSynonym
+ id: int+ name: string
HistopathologyGrade
+ id: int+ gradeCode: string+ gradeCodeSystem: string+ commentText: string
Neoplasm
+ id: int+ cellTypeCode: string
MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Name: Clinical Trials Object Model (CTOM) Author: ScenProVersion: 0.5Created: 7/1/2001 12:00:00 AMUpdated: 1/19/2006 5:06:46 PM
ConceptDescriptor
+ id: int+ code: string+ codeSystem: string+ codeSystemName: string+ codeSystemVersion: int+ displayText: string
FemaleReproductiveCharacteristic
+ id: int+ firstLiveBirthAge: int+ liveBirthCount: int+ stil lBirthCount: int+ abortionIndicator: boolean+ menopauseStartDate: date+ menopauseAge: int+ menopauseReasonCode: string+ menopauseReasonOtherText: string
DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
AgentOccurrence
+ id: int+ lotNumber: string+ formCode: string+ expirationDate: date
LesionEvaluation
+ evaluationCode: char
ProtocolStatus
+ id: int+ statusCode: string+ statusDate: date
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
HealthcareSiteParticipantRole
+ id: int+ roleCode: string
HealthcareSiteParticipant
+ id: int+ participantIdentifier: string
ParticipantEligibilityAnswer
+ id: int+ answerText: string+ checklistNumber: string
0..*
+agentSynonymCollection
1
+agent
0..*+neoplasmCollection
1+histopathology
0..1+adverseEventReport
1..*+adverseEventCollection
0..*+substanceAdministrationCollection
1
+studyAgent
0..*+substanceAdministrationCollection
1
+agent
1+conceptDescriptor
0..*+clinicalResultCollection
0..*
+studyAgentCollection
1
+agent
0..*+studyInvestigatorCollection
1+investigator
0..*+studySiteCollection
1+healthCareSite
0..*
+studyInvestigatorCollection
1
+protocol
1..*
+observationCollection
0..*
+assessmentCollection
1
+Agent
0..*
+AgentOccurrenceCollection
0..*
+activityCollection
1
+studyParticipantAssignment
0..1
+femaleReproductiveCharacteristic
1+participant
1..*
+eligibilityCriteriaCollection
1..*
+protocolCollection
0..*+studyAgentCollection
1
+study
1+participant
0..*+healthcareSiteParticipantCollection
1
+participant
0..*
+participantEligibilityAnswerCollection
0..1+cancerStage
1+diagnosis
0..*+adverseEventTherapyCollection
1+adverseEventCollection
1+eligibilityCriteria
0..*+participantEligibilityAnswerCollection
0..*+histopathologyGradeCollection
1+histopathology
0..*
+observationCollection
1
+activity
0..* +activityRelationshipCollection
1+activity
0..*+studyParticipantCollection
1
+studySite0..*
+studySiteCollection
1
+protocol
0..*+studyParticipantAssignmentCollection
1+participant
1+healthcareSite 0..*
+healthcareSiteParticipant
1+healthcareSiteParticipant
0..*+healthcareSiteRoleCollection
1+observation
0..* +observationRelationshipCollection
0..*
+personOccupationCollection
1
+person
1..*
+metastasisSiteCollection
1
+cancerStage
0..*+specimenCollection
1+specimenCollection
0..*+observationRelationshipCollection
1+observation
0..1+studyTimePoint
1+activity
0..*+activityRelationshipCollection
1+activity
1
+protocol
1..*
+protocolStatusCollection
0..* +assessmentRelationship
1 +assessmentCollection1+assessment
0..*+assessmentRelationshipCollection
0..1
+agentOccurrence
1
+substanceAdministration
BRIDG - Implementation Independent Domain Analysis Model
cd Logical Model
StudySubject
+ birthDate: date+ gender: string+ race: string+ ethnicGroup: string+ deceaseDate: date::Person+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
Activity
+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Organization
+ name: string::ParticipatingEntity+ id: long
+ isFDA() : boolean
ParticipatingEntity
+ id: long
ActivityParticipation
+ id: long+ type: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ participantRole: string+ participantSignature: string+ participantSignatureDate: dateTime
Product
+ name: string+ status: string::ParticipatingEntity+ id: long
Observation
~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
PharmacuticalTreatment
+ administrationRoute: string+ totalDoseAdministered: int+ administrationDose: int+ administrationFrequency: string::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEvent
+ outcome: string+ seriousness: string::Observation~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean
AdverseEventActivityRelationship
+ expectedness: boolean+ attribution: int+ studyDesignBroken: boolean+ agentAdjustment: string+ administrationDelayed: boolean::ActivityRelationship+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ProcedureTreatment
::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
ClincalStudy
::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEventDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
MaterialKind
+ name: string::ParticipatingEntity+ id: long
AdverseEventDetailKind
+ id: string+ adverseEventDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ParticipatingEntityIdentifier
+ id: long+ identifierValue: string+ identifierType: string
AdverseEventReport
+ sequenceIdentifier: int+ subjectDiscloserAllowed: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ hasAmendedData() : boolean+ sentToFDA() : boolean+ initialSentToFDA() : boolean+ sentToManufacturer() : boolean+ treatmentDelayed() : boolean+ delayDuration() : real+ delayDurationUnits() : string
Treatment
+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean+ isAdjustment() : boolean
Person
+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
+ isHealthProfessional() : boolean
ActivityIdentifier
+ id: long+ identifierValue: string+ identifierType: string+ versionIdentifier: string+ versionEffectiveDate: dateTime
ActivityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ParticipatingEntityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceParticipantRole: string+ targetParticipantRole: string
Protocol
+ phase: string+ title: string::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Device
+ implantedDate: dateTime+ explantedDate: dateTime+ reprocessedIndicator: boolean+ availableForEvaluationIndicator: boolean::Product+ name: string+ status: string::ParticipatingEntity+ id: long
Location
+ name: string+ description: string+ streetAddress: string+ city: string+ state: string+ postalCode: string::ParticipatingEntity+ id: long
DrugProduct
+ lotNumber: string+ expirationDate: date::Product+ name: string+ status: string::ParticipatingEntity+ id: long
DrugProductIngredient
+ id: long+ quantity: float+ activeIngredientIndicator: boolean+ materialForm: string
ActivityKind
+ id: long+ activityCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
PersonTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
OrganizationTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
AdverseEventReportDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
ParticipatingEntityKind
+ id: long+ entityType: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
AdverseEventReportDetailKind
+ id: + adverseEventReportDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ObservationValueKind
+ id: long+ observationValueCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
1..*+ingredientCollection
1+product
0..*+relationshipCollection
1
+targetEntity
0..* +relationshipCollection
1
+sourceEntity
0..*+identifierCollection
1
+assigningAuthority
1+person
0..*+telephoneCollection
0..*
+identifierCollection
1+assigningAuthority
0..*+adverseEventReportDetailCollection
1+adverseEventReportDetailKind
0..*+adverseEventReportDetailCollection
1
+adverseEventReport
0..*
+ingredientCollection
1 +material
0..*
+identifierCollection
1
+entity
1+participatingEntityKind
0..*+entityCollection
0..*+eventDetailCollection
1+adverseEvent
1
+eventDetailKind
0..*+eventDetailCollection
0..*
+AdverseEventReportCollection
1
+adverseEvent
0..*
+activityRelationshipCollections
1+adverseEvent
1
+act
0..*
+participationCollection
1
+entity
0..*
+participationCollection
0..*
+relationshipCollection
1
+targetActivity
0..*+observationCollection
1
+observationValueKind
1
+activityKind
0..*
+activityCollection
0..*
+relationshipCollection
1
+sourceActivity
1+organization
0..*+telephoneCollection
1+activity
+identifierCollection
•Lab SIG Model•Study Calendar SIG Model•Financial SIG Model
caAERS
Implementation Specific Models
cd Comprehensive Model
Clinical Research Entities and Roles::Agent
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ formCode: CodedConcept+ lotNumber: int+ expirationDate: DATETIME+ stabilityTime: DATETIME
Clinical Research Entities and Roles::
AgentRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::
Investigator
+ certificateLicenseText:
Clinical Research Entities and Roles::Organization
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ statusDate: DATETIME+ geographicAddr: addrType+ telecomAddr: TEL
Clinical Research Entities and Roles::OrganizationRole
Clinical Research Entities and Roles::Participant
+ paymentMethod: CodedConcept+ confidentialityCode: string
Clinical Research Entities and Roles::Person
+ id: CodedConcept+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ raceCode: BRIDGCodedConcept+ ethnicGroupCode: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ electronicCommAddr: + householdIncomeCategory: BRIDGCodedConcept+ educationLevelCode: BRIDGCodedConcept+ telecomAddress: TEL+ name: entityName+ dateOfDeath: DATETIME+ address: addrType
Clinical Research Entities and Roles::PersonRole
::Role+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
Clinical Research Entities and Roles::TherapeuticAgent
Clinical Trials Activ ities::AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
Clinical Trials Activ ities::
AdverseEventReport
+ id: int+ submissionDate: date+ fi ledIndicator: boolean
Clinical Trials Activ ities::AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Clinical Trials Activities::Assessment
+ id: int+ evaluationDate: date
Clinical Trials Activ ities::
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
Clinical Trials Activ ities::CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
Clinical Trials Activ ities::ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ abnormalIndicator: boolean+ biomarkerInd: boolean+ significanceInd: boolean
Clinical Trials Activ ities::DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
Clinical Trials Activ ities::Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
Clinical Trials Activ ities::DiseaseResponse
+ responseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
Clinical Trials Activ ities::Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
Clinical Trials Activ ities::HistopathologyGrade
+ id: int+ gradingSystemName: string+ grade: string+ comments: string
Clinical Trials Activ ities::Imaging
+ identifier: string+ contrastAgentEnhancement: string+ descriptiveText: string+ rateOfEnhancementValue: int
Clinical Trials Activ ities::LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ previouslyIrradiatedSiteIndicator: boolean Clinical Trials
Activ ities::LesionEvaluation
+ evaluationCode: char
Clinical Trials Activ ities::MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeName: string
Clinical Trials Activ ities::Neoplasm
+ id: int+ cellType: string
Clinical Trials Activ ities::Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
Clinical Trials Activ ities::
ObservationRelationship
+ id: int- type: string+ comments: string
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
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
Clinical Trials Activ ities::PlannedActiv ity
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::PlannedStudy
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::Procedure
+ targetSiteCode: string
Clinical Trials Activ ities::QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int- performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
Clinical Trials Activ ities::Radiation
+ therapyType: string+ doseUnitOfMeasure: string+ dose: string
Clinical Trials Activ ities::Specimen
+ id: int+ idNumber: int+ samplingType: string
Clinical Trials Activ ities::
SpecimenCollection
+ siteCondition: string+ method: string
Clinical Trials Activ ities::StudyAgent
::Participation+ type: CodedConcept+ 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
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubjectAssignment
+ studySubjectIdentifier: int+ arm: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ eligibilityWaiverReason: string+ ageAtEnrollment: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubstanceAdministration
+ doseQuantity: int+ doseUnitOfMeasure: string+ route: string+ doseFrequency: string+ doseModificationType: string+ doseChangeType: int
Clinical Trials Activ ities::
Surgery
BRIDG Shared Classes::Activity
+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
BRIDG Shared Classes::Activ ityActiv ityRelationship
+ relationshipCode: PSMCodedConcept- Obsolete_relationQualifier: BRIDGCodedConcept+ sequenceNumber: NUMBER+ pauseCriterion: + checkpointCode: + priorityNumber: NUMBER+ splitCode: - negationRule: AbstractRule+ joinCode: + negationIndicator: BOOLEAN+ conjunctionCode:
BRIDG Shared Classes::Participation
+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
BRIDG Shared Classes::Role
+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
BRIDG Shared Classes::RoleRoleRelationship
+ source: + type: CodedConcept+ target:
BRIDG Shared Classes::BRIDGAnalysisVariable
+ name: TEXT+ value: + controlledName: PSMCodedConcept+ businessProcessMode: PSMBusinessProcessMode
BRIDG Shared Classes::BRIDGBusinessProcessMode
+ modeValue: ENUM {Plan, Execute}
BRIDG Shared Classes::BRIDGCodedConcept
- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::BRIDGContactAddr
+ type: BRIDGCodedConcept+ effectiveTime: BRIDGInterval+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ synopsis: EncapsulatedData+ summaryDescription: EncapsulatedData+ detailedDescription: EncapsulatedData
BRIDG Shared Classes::BRIDGID
+ source: Text+ version: Text+ value: Text
BRIDG Shared Classes::BRIDGInterval
- startTime: timestamp+ endTime: timestamp
BRIDG Shared Classes::BRIDGStatus
+ effectiveEndDate: + effectiveStartDate: + statusValue:
Protocol Concepts::StudyDocument
+ version: string+ author: SET+ ID: SET BRIDGID+ documentID: BRIDGID+ type: ENUM+ description: BRIDGDescription+ title: string+ status: BRIDGStatus+ confidentialityCode: 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 activity
«abstraction»
1
0..*
1
0..*
1has a
1..*
0..*
1
0..* 1
1..*
has a
1
1 0..*
0..*+specimenCollection
1+specimenCollection
0..* 1
0..*1
0..*
1
1..* 0..*
0..11
0..*
1
0..*
1
CTOMcd 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
Agent
+ id: int+ name: string+ descriptionText: string+ statusCode: string
StudyAgent
+ id: int+ investigationalIndicator: boolean+ investigationalNewDrugIdentifier: string+ statusCode: string+ statusDate: date
Participant
+ initials: char+ zipCode: string+ paymentMethodCode: char+ confidentialityIndicator: boolean
Activ ity
+ id: int+ name: string+ type: string+ descriptionText: string+ startDate: date+ stopDate: date+ durationValue: int+ durationUnitOfMeasureCode: string+ plannnedIndicator: boolean+ reasonCode: string
Assessment
+ id: int+ evaluationDate: date
SubstanceAdministration
+ singleDose: int+ singleDoseUnitOfMeasureCode: string+ doseFrequencyCode: string+ doseFrequencyText: string+ totalDose: int+ totalDoseUnitOfMeasureCode: string+ doseChangeCode: string+ doseChangeIndicatorCode: int+ routeCode: string
Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
StudySite
+ id: int+ roleCode: string+ statusCode: string+ targetAccrualNumber: string+ startDate: date+ stopDate: date+ irbApprovalDate: date
QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int+ performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
SpecimenCollection
+ siteConditionCode: string+ methodCode: string
DiseaseResponse
+ reponseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSystem: string+ previouslyIrradiatedSiteIndicator: string
HealthcareSite
+ nciInstituteCode: string
Procedure
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Imaging
+ imageIdentifier: string+ contrastAgentEnhancementIndicator: boolean+ enhancementRateValue: int+ enhancementDescriptionText: string
Radiation
+ dose: string+ doseUnitOfMeasureCode: string+ scheduleText: string+ therapyExtentCode: string
Specimen
+ id: int+ sampleIdentifier: int+ sampleTypeCode: string+ volume: int+ volumeUnitOfMeasureCode: string
Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCode: string+ abnormalIndicator: boolean+ biomarkerIndicator: boolean+ significanceIndicator: boolean
Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
EligibilityCriteria
+ id: int+ questionText: string+ questionNumber: int+ expectedAnswerIndicator: boolean
PersonOccupation
+ id: int+ primaryTypeCode: string+ primaryTypeCodeSystem: string+ startDate: date+ stopDate: date
Surgery
AdverseEventReport
+ id: int+ submissionDate: date+ filedIndicator: boolean
AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Organization
+ id: int+ name: string+ descriptionText: string+ statusCode: string+ statusDate: date+ streetAddress: string+ city: string+ stateCode: string+ postalCode: string+ countryCode: string+ telecomAddress: string
Person
+ id: int+ lastName: string+ firstName: string+ birthDate: date+ telecomAddress: string+ administrativeGenderCode: string+ countryCode: string+ educationLevelCode: string+ ethnicGroupCode: string+ householdIncomeCode: string+ maritalStatusCode: string+ raceCode: string+ employmentStatusCode: string+ employmentStatusOtherText: string
Activ ityRelationship
+ id: int+ typeCode: string+ sequenceNumber: int+ commentText: string
StudyTimePoint
+ id: int+ visitName: string+ courseNumber: int+ epochName: string+ courseStartDate: date+ courseStopDate: date
CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
ObservationRelationship
+ id: int+ typeCode: string+ commentText: string
Investigator
+ nciIdentifier: string
StudyParticipantAssignment
+ id: int+ studyParticipantIdentifier: int+ armIdentifier: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ enrollmentAge: int+ studyAgentDoseLevel: int+ studyAgentDoseLevelUnitOfMeasureCode: string+ offStudyDate: date+ offStudyReasonCode: string+ offStudyReasonOtherText: string+ eligibilityWaiverReasonText: string
StudyInvestigator
+ id: int+ responsibilityRoleCode: string+ startDate: date+ stopDate: date+ statusCode: string+ signatureIndicator: boolean+ signatureText: string
ExclusionInclusion
AgentSynonym
+ id: int+ name: string
HistopathologyGrade
+ id: int+ gradeCode: string+ gradeCodeSystem: string+ commentText: string
Neoplasm
+ id: int+ cellTypeCode: string
MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Name: Clinical Trials Object Model (CTOM) Author: ScenProVersion: 0.5Created: 7/1/2001 12:00:00 AMUpdated: 1/19/2006 5:06:46 PM
ConceptDescriptor
+ id: int+ code: string+ codeSystem: string+ codeSystemName: string+ codeSystemVersion: int+ displayText: string
FemaleReproductiveCharacteristic
+ id: int+ firstLiveBirthAge: int+ liveBirthCount: int+ stil lBirthCount: int+ abortionIndicator: boolean+ menopauseStartDate: date+ menopauseAge: int+ menopauseReasonCode: string+ menopauseReasonOtherText: string
DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
AgentOccurrence
+ id: int+ lotNumber: string+ formCode: string+ expirationDate: date
LesionEvaluation
+ evaluationCode: char
ProtocolStatus
+ id: int+ statusCode: string+ statusDate: date
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
HealthcareSiteParticipantRole
+ id: int+ roleCode: string
HealthcareSiteParticipant
+ id: int+ participantIdentifier: string
ParticipantEligibilityAnswer
+ id: int+ answerText: string+ checklistNumber: string
0..*
+agentSynonymCollection
1
+agent
0..*+neoplasmCollection
1+histopathology
0..1+adverseEventReport
1..*+adverseEventCollection
0..*+substanceAdministrationCollection
1
+studyAgent
0..*+substanceAdministrationCollection
1
+agent
1+conceptDescriptor
0..*+clinicalResultCollection
0..*
+studyAgentCollection
1
+agent
0..*+studyInvestigatorCollection
1+investigator
0..*+studySiteCollection
1+healthCareSite
0..*
+studyInvestigatorCollection
1
+protocol
1..*
+observationCollection
0..*
+assessmentCollection
1
+Agent
0..*
+AgentOccurrenceCollection
0..*
+activityCollection
1
+studyParticipantAssignment
0..1
+femaleReproductiveCharacteristic
1+participant
1..*
+eligibilityCriteriaCollection
1..*
+protocolCollection
0..*+studyAgentCollection
1
+study
1+participant
0..*+healthcareSiteParticipantCollection
1
+participant
0..*
+participantEligibilityAnswerCollection
0..1+cancerStage
1+diagnosis
0..*+adverseEventTherapyCollection
1+adverseEventCollection
1+eligibilityCriteria
0..*+participantEligibilityAnswerCollection
0..*+histopathologyGradeCollection
1+histopathology
0..*
+observationCollection
1
+activity
0..* +activityRelationshipCollection
1+activity
0..*+studyParticipantCollection
1
+studySite0..*
+studySiteCollection
1
+protocol
0..*+studyParticipantAssignmentCollection
1+participant
1+healthcareSite 0..*
+healthcareSiteParticipant
1+healthcareSiteParticipant
0..*+healthcareSiteRoleCollection
1+observation
0..* +observationRelationshipCollection
0..*
+personOccupationCollection
1
+person
1..*
+metastasisSiteCollection
1
+cancerStage
0..*+specimenCollection
1+specimenCollection
0..*+observationRelationshipCollection
1+observation
0..1+studyTimePoint
1+activity
0..*+activityRelationshipCollection
1+activity
1
+protocol
1..*
+protocolStatusCollection
0..* +assessmentRelationship
1 +assessmentCollection1+assessment
0..*+assessmentRelationshipCollection
0..1
+agentOccurrence
1
+substanceAdministration
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
BRIDG - Implementation Independent Domain Analysis Model
cd Logical Model
StudySubject
+ birthDate: date+ gender: string+ race: string+ ethnicGroup: string+ deceaseDate: date::Person+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
Activity
+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Organization
+ name: string::ParticipatingEntity+ id: long
+ isFDA() : boolean
ParticipatingEntity
+ id: long
ActivityParticipation
+ id: long+ type: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ participantRole: string+ participantSignature: string+ participantSignatureDate: dateTime
Product
+ name: string+ status: string::ParticipatingEntity+ id: long
Observation
~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
PharmacuticalTreatment
+ administrationRoute: string+ totalDoseAdministered: int+ administrationDose: int+ administrationFrequency: string::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEvent
+ outcome: string+ seriousness: string::Observation~ resultValue: string+ targetAnatomicalSite: string+ onsetDateTime: dateTime+ effectiveThuTime: dateTime+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean
AdverseEventActivityRelationship
+ expectedness: boolean+ attribution: int+ studyDesignBroken: boolean+ agentAdjustment: string+ administrationDelayed: boolean::ActivityRelationship+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ProcedureTreatment
::Treatment+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
ClincalStudy
::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
AdverseEventDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
MaterialKind
+ name: string::ParticipatingEntity+ id: long
AdverseEventDetailKind
+ id: string+ adverseEventDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ParticipatingEntityIdentifier
+ id: long+ identifierValue: string+ identifierType: string
AdverseEventReport
+ sequenceIdentifier: int+ subjectDiscloserAllowed: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ hasAmendedData() : boolean+ sentToFDA() : boolean+ initialSentToFDA() : boolean+ sentToManufacturer() : boolean+ treatmentDelayed() : boolean+ delayDuration() : real+ delayDurationUnits() : string
Treatment
+ courseNujmber: string+ cycleNumber: string+ negationIndicator: boolean::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
+ isContinuing() : boolean+ isAdjustment() : boolean
Person
+ namePrefix: string+ firstName: string+ middleName: string+ lastName: string+ nameSuffix: string+ occupation: string+ emailAddress: string::ParticipatingEntity+ id: long
+ isHealthProfessional() : boolean
ActivityIdentifier
+ id: long+ identifierValue: string+ identifierType: string+ versionIdentifier: string+ versionEffectiveDate: dateTime
ActivityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceActivityRole: string+ targetActivityRole: string+ sequence: int
ParticipatingEntityRelationship
+ id: long+ relationshipType: string+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ relationshipStatus: string+ sourceParticipantRole: string+ targetParticipantRole: string
Protocol
+ phase: string+ title: string::Activity+ id: long+ startTime: dateTime+ endTime: dateTime+ method: string+ reason: string+ description: string+ status: string
Device
+ implantedDate: dateTime+ explantedDate: dateTime+ reprocessedIndicator: boolean+ availableForEvaluationIndicator: boolean::Product+ name: string+ status: string::ParticipatingEntity+ id: long
Location
+ name: string+ description: string+ streetAddress: string+ city: string+ state: string+ postalCode: string::ParticipatingEntity+ id: long
DrugProduct
+ lotNumber: string+ expirationDate: date::Product+ name: string+ status: string::ParticipatingEntity+ id: long
DrugProductIngredient
+ id: long+ quantity: float+ activeIngredientIndicator: boolean+ materialForm: string
ActivityKind
+ id: long+ activityCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
Name: Logical ModelAuthor: AbdulMalik ShakirVersion: 1.0Created: 10/18/2005 8:40:14 PMUpdated: 12/4/2005 11:25:52 PM
PersonTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
OrganizationTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
AdverseEventReportDetail
+ effectiveFromTime: dateTime+ effectiveThruTime: dateTime+ booleanValue: boolean+ textValue: string
ParticipatingEntityKind
+ id: long+ entityType: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
AdverseEventReportDetailKind
+ id: + adverseEventReportDetailCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
ObservationValueKind
+ id: long+ observationValueCode: string+ name: string+ description: string+ codeSystem: string+ codeSystemVersion: string
1..*+ingredientCollection
1+product
0..*+relationshipCollection
1
+targetEntity
0..* +relationshipCollection
1
+sourceEntity
0..*+identifierCollection
1
+assigningAuthority
1+person
0..*+telephoneCollection
0..*
+identifierCollection
1+assigningAuthority
0..*+adverseEventReportDetailCollection
1+adverseEventReportDetailKind
0..*+adverseEventReportDetailCollection
1
+adverseEventReport
0..*
+ingredientCollection
1 +material
0..*
+identifierCollection
1
+entity
1+participatingEntityKind
0..*+entityCollection
0..*+eventDetailCollection
1+adverseEvent
1
+eventDetailKind
0..*+eventDetailCollection
0..*
+AdverseEventReportCollection
1
+adverseEvent
0..*
+activityRelationshipCollections
1+adverseEvent
1
+act
0..*
+participationCollection
1
+entity
0..*
+participationCollection
0..*
+relationshipCollection
1
+targetActivity
0..*+observationCollection
1
+observationValueKind
1
+activityKind
0..*
+activityCollection
0..*
+relationshipCollection
1
+sourceActivity
1+organization
0..*+telephoneCollection
1+activity
+identifierCollection
•Lab SIG Model•Study Calendar SIG Model•Financial SIG Model
caAERS
Implementation Specific Models
cd Comprehensive Model
Clinical Research Entities and Roles::Agent
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ formCode: CodedConcept+ lotNumber: int+ expirationDate: DATETIME+ stabilityTime: DATETIME
Clinical Research Entities and Roles::
AgentRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::
Investigator
+ certificateLicenseText:
Clinical Research Entities and Roles::Organization
+ id: CodedConcept+ name: string+ description: string+ status: CodedConcept+ statusDate: DATETIME+ geographicAddr: addrType+ telecomAddr: TEL
Clinical Research Entities and Roles::OrganizationRole
Clinical Research Entities and Roles::Participant
+ paymentMethod: CodedConcept+ confidentialityCode: string
Clinical Research Entities and Roles::Person
+ id: CodedConcept+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ raceCode: BRIDGCodedConcept+ ethnicGroupCode: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ electronicCommAddr: + householdIncomeCategory: BRIDGCodedConcept+ educationLevelCode: BRIDGCodedConcept+ telecomAddress: TEL+ name: entityName+ dateOfDeath: DATETIME+ address: addrType
Clinical Research Entities and Roles::PersonRole
::Role+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
Clinical Research Entities and Roles::TherapeuticAgent
Clinical Trials Activ ities::AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
Clinical Trials Activ ities::
AdverseEventReport
+ id: int+ submissionDate: date+ fi ledIndicator: boolean
Clinical Trials Activ ities::AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Clinical Trials Activities::Assessment
+ id: int+ evaluationDate: date
Clinical Trials Activ ities::
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
Clinical Trials Activ ities::CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
Clinical Trials Activ ities::ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ abnormalIndicator: boolean+ biomarkerInd: boolean+ significanceInd: boolean
Clinical Trials Activ ities::DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
Clinical Trials Activ ities::Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
Clinical Trials Activ ities::DiseaseResponse
+ responseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
Clinical Trials Activ ities::Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
Clinical Trials Activ ities::HistopathologyGrade
+ id: int+ gradingSystemName: string+ grade: string+ comments: string
Clinical Trials Activ ities::Imaging
+ identifier: string+ contrastAgentEnhancement: string+ descriptiveText: string+ rateOfEnhancementValue: int
Clinical Trials Activ ities::LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ previouslyIrradiatedSiteIndicator: boolean Clinical Trials
Activ ities::LesionEvaluation
+ evaluationCode: char
Clinical Trials Activ ities::MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeName: string
Clinical Trials Activ ities::Neoplasm
+ id: int+ cellType: string
Clinical Trials Activ ities::Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
Clinical Trials Activ ities::
ObservationRelationship
+ id: int- type: string+ comments: string
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
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
Clinical Trials Activ ities::PlannedActiv ity
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::PlannedStudy
::Activity+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::Procedure
+ targetSiteCode: string
Clinical Trials Activ ities::QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int- performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
Clinical Trials Activ ities::Radiation
+ therapyType: string+ doseUnitOfMeasure: string+ dose: string
Clinical Trials Activ ities::Specimen
+ id: int+ idNumber: int+ samplingType: string
Clinical Trials Activ ities::
SpecimenCollection
+ siteCondition: string+ method: string
Clinical Trials Activ ities::StudyAgent
::Participation+ type: CodedConcept+ 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
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubjectAssignment
+ studySubjectIdentifier: int+ arm: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ eligibilityWaiverReason: string+ ageAtEnrollment: int::Participation+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::SubstanceAdministration
+ doseQuantity: int+ doseUnitOfMeasure: string+ route: string+ doseFrequency: string+ doseModificationType: string+ doseChangeType: int
Clinical Trials Activ ities::
Surgery
BRIDG Shared Classes::Activity
+ code: PSMCodedConcept+ derivationExpression: TEXT+ description: PSMDescription+ startDate: DATETIME+ status: PSMCodedConcept+ availabilityTime: TimingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
BRIDG Shared Classes::Activ ityActiv ityRelationship
+ relationshipCode: PSMCodedConcept- Obsolete_relationQualifier: BRIDGCodedConcept+ sequenceNumber: NUMBER+ pauseCriterion: + checkpointCode: + priorityNumber: NUMBER+ splitCode: - negationRule: AbstractRule+ joinCode: + negationIndicator: BOOLEAN+ conjunctionCode:
BRIDG Shared Classes::Participation
+ type: CodedConcept+ status: CodedConcept+ statusDate: DATETIME+ startDate: DATETIME+ endDate: DATETIME
BRIDG Shared Classes::Role
+ id: CodedConcept+ code: CodedConcept+ status: + electronicCommAddr: + geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
BRIDG Shared Classes::RoleRoleRelationship
+ source: + type: CodedConcept+ target:
BRIDG Shared Classes::BRIDGAnalysisVariable
+ name: TEXT+ value: + controlledName: PSMCodedConcept+ businessProcessMode: PSMBusinessProcessMode
BRIDG Shared Classes::BRIDGBusinessProcessMode
+ modeValue: ENUM {Plan, Execute}
BRIDG Shared Classes::BRIDGCodedConcept
- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::BRIDGContactAddr
+ type: BRIDGCodedConcept+ effectiveTime: BRIDGInterval+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ synopsis: EncapsulatedData+ summaryDescription: EncapsulatedData+ detailedDescription: EncapsulatedData
BRIDG Shared Classes::BRIDGID
+ source: Text+ version: Text+ value: Text
BRIDG Shared Classes::BRIDGInterval
- startTime: timestamp+ endTime: timestamp
BRIDG Shared Classes::BRIDGStatus
+ effectiveEndDate: + effectiveStartDate: + statusValue:
Protocol Concepts::StudyDocument
+ version: string+ author: SET+ ID: SET BRIDGID+ documentID: BRIDGID+ type: ENUM+ description: BRIDGDescription+ title: string+ status: BRIDGStatus+ confidentialityCode: 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 activity
«abstraction»
1
0..*
1
0..*
1has a
1..*
0..*
1
0..* 1
1..*
has a
1
1 0..*
0..*+specimenCollection
1+specimenCollection
0..* 1
0..*1
0..*
1
1..* 0..*
0..11
0..*
1
0..*
1
CTOMcd 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
Agent
+ id: int+ name: string+ descriptionText: string+ statusCode: string
StudyAgent
+ id: int+ investigationalIndicator: boolean+ investigationalNewDrugIdentifier: string+ statusCode: string+ statusDate: date
Participant
+ initials: char+ zipCode: string+ paymentMethodCode: char+ confidentialityIndicator: boolean
Activ ity
+ id: int+ name: string+ type: string+ descriptionText: string+ startDate: date+ stopDate: date+ durationValue: int+ durationUnitOfMeasureCode: string+ plannnedIndicator: boolean+ reasonCode: string
Assessment
+ id: int+ evaluationDate: date
SubstanceAdministration
+ singleDose: int+ singleDoseUnitOfMeasureCode: string+ doseFrequencyCode: string+ doseFrequencyText: string+ totalDose: int+ totalDoseUnitOfMeasureCode: string+ doseChangeCode: string+ doseChangeIndicatorCode: int+ routeCode: string
Histopathology
+ grossExamResultCode: string+ reportDescriptiveText: string+ involvedSurgicalMarginIndicator: boolean
StudySite
+ id: int+ roleCode: string+ statusCode: string+ targetAccrualNumber: string+ startDate: date+ stopDate: date+ irbApprovalDate: date
QualitativeEvaluation
+ survivalStatusCode: int+ survivalStatusDescriptionText: string+ performanceStatusCode: int+ performanceStatusCodeSystem: string+ painIndexCode: int+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int+ menstrualPatternTypeCode: string+ menstrualIndicator: boolean
AdverseEvent
+ onsetDate: date+ resolvedDate: date+ ctcCategoryCode: string+ ctcCategoryCodeSystem: string+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string+ ctcAttributionCode: string+ ctcAttributionCodeSystem: string+ ctcGradeCode: string+ ctcGradeCodeSystem: string+ seriousReasonCode: string+ outcomeCode: string+ actionTakenCode: string+ conditionPatternCode: string+ doseLimitingToxicityIndicator: boolean+ doseLimitingToxicityDescriptionText: string+ descriptionText: string
SpecimenCollection
+ siteConditionCode: string+ methodCode: string
DiseaseResponse
+ reponseCode: char+ responseCodeSystem: string+ bestResponseCode: char+ bestResponseDate: date+ progressionDate: date+ progressionPeriod: int+ progressionPeriodUnitOfMeasureCode: string+ doseChangeIndicatorCode: int+ courseDispositionCode: string+ commentText: string
LesionDescription
+ lesionNumber: string+ evaluationNumber: int+ appearanceTypeCode: string+ targetNonTargetCode: string+ measurableIndicator: boolean+ methodCode: string+ xDimension: int+ yDimension: int+ zDimension: int+ dimensionProduct: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSystem: string+ previouslyIrradiatedSiteIndicator: string
HealthcareSite
+ nciInstituteCode: string
Procedure
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Imaging
+ imageIdentifier: string+ contrastAgentEnhancementIndicator: boolean+ enhancementRateValue: int+ enhancementDescriptionText: string
Radiation
+ dose: string+ doseUnitOfMeasureCode: string+ scheduleText: string+ therapyExtentCode: string
Specimen
+ id: int+ sampleIdentifier: int+ sampleTypeCode: string+ volume: int+ volumeUnitOfMeasureCode: string
Observation
+ id: int+ reportingDate: date+ confidentialityCode: string+ uncertaintyCode: string+ statusCode: string
ClinicalResult
+ panelName: string+ value: string+ valueUnitOfMeasureCode: string+ assayMethodCode: string+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCode: string+ abnormalIndicator: boolean+ biomarkerIndicator: boolean+ significanceIndicator: boolean
Diagnosis
+ name: string+ diseaseDiagnosisCode: string+ diseaseDiagnosisCodeSystem: string+ ageAtDiagnosis: int+ confirmationDate: date+ primaryAnatomicSiteCode: string+ primaryAnatomicSiteCodeSystem: string+ primaryAnatomicSiteLateralityCode: string+ recurrenceIndicator: boolean+ diseaseStatusCode: string+ sourceCode: string+ sourceOther: string+ diseaseExtentText: string
EligibilityCriteria
+ id: int+ questionText: string+ questionNumber: int+ expectedAnswerIndicator: boolean
PersonOccupation
+ id: int+ primaryTypeCode: string+ primaryTypeCodeSystem: string+ startDate: date+ stopDate: date
Surgery
AdverseEventReport
+ id: int+ submissionDate: date+ filedIndicator: boolean
AdverseEventTherapy
+ id: int+ treatmentDate: date+ delayDuration: int+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Organization
+ id: int+ name: string+ descriptionText: string+ statusCode: string+ statusDate: date+ streetAddress: string+ city: string+ stateCode: string+ postalCode: string+ countryCode: string+ telecomAddress: string
Person
+ id: int+ lastName: string+ firstName: string+ birthDate: date+ telecomAddress: string+ administrativeGenderCode: string+ countryCode: string+ educationLevelCode: string+ ethnicGroupCode: string+ householdIncomeCode: string+ maritalStatusCode: string+ raceCode: string+ employmentStatusCode: string+ employmentStatusOtherText: string
Activ ityRelationship
+ id: int+ typeCode: string+ sequenceNumber: int+ commentText: string
StudyTimePoint
+ id: int+ visitName: string+ courseNumber: int+ epochName: string+ courseStartDate: date+ courseStopDate: date
CancerStage
+ id: int+ tnmStage: string+ tnmStageCodeSystem: string+ stageCode: string+ stageCodeSystem: string
ObservationRelationship
+ id: int+ typeCode: string+ commentText: string
Investigator
+ nciIdentifier: string
StudyParticipantAssignment
+ id: int+ studyParticipantIdentifier: int+ armIdentifier: string+ subgroupCode: string+ informedConsentFormSignedDate: date+ enrollmentAge: int+ studyAgentDoseLevel: int+ studyAgentDoseLevelUnitOfMeasureCode: string+ offStudyDate: date+ offStudyReasonCode: string+ offStudyReasonOtherText: string+ eligibilityWaiverReasonText: string
StudyInvestigator
+ id: int+ responsibilityRoleCode: string+ startDate: date+ stopDate: date+ statusCode: string+ signatureIndicator: boolean+ signatureText: string
ExclusionInclusion
AgentSynonym
+ id: int+ name: string
HistopathologyGrade
+ id: int+ gradeCode: string+ gradeCodeSystem: string+ commentText: string
Neoplasm
+ id: int+ cellTypeCode: string
MetastasisSite
+ id: int+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
Name: Clinical Trials Object Model (CTOM) Author: ScenProVersion: 0.5Created: 7/1/2001 12:00:00 AMUpdated: 1/19/2006 5:06:46 PM
ConceptDescriptor
+ id: int+ code: string+ codeSystem: string+ codeSystemName: string+ codeSystemVersion: int+ displayText: string
FemaleReproductiveCharacteristic
+ id: int+ firstLiveBirthAge: int+ liveBirthCount: int+ stil lBirthCount: int+ abortionIndicator: boolean+ menopauseStartDate: date+ menopauseAge: int+ menopauseReasonCode: string+ menopauseReasonOtherText: string
DeathSummary
+ deathDate: date+ deathCauseCode: char+ deathCauseText: string+ autopsiedIndicator: boolean
AgentOccurrence
+ id: int+ lotNumber: string+ formCode: string+ expirationDate: date
LesionEvaluation
+ evaluationCode: char
ProtocolStatus
+ id: int+ statusCode: string+ statusDate: date
AssessmentRelationship
+ id: int+ typeCode: string+ commentText: string
HealthcareSiteParticipantRole
+ id: int+ roleCode: string
HealthcareSiteParticipant
+ id: int+ participantIdentifier: string
ParticipantEligibilityAnswer
+ id: int+ answerText: string+ checklistNumber: string
0..*
+agentSynonymCollection
1
+agent
0..*+neoplasmCollection
1+histopathology
0..1+adverseEventReport
1..*+adverseEventCollection
0..*+substanceAdministrationCollection
1
+studyAgent
0..*+substanceAdministrationCollection
1
+agent
1+conceptDescriptor
0..*+clinicalResultCollection
0..*
+studyAgentCollection
1
+agent
0..*+studyInvestigatorCollection
1+investigator
0..*+studySiteCollection
1+healthCareSite
0..*
+studyInvestigatorCollection
1
+protocol
1..*
+observationCollection
0..*
+assessmentCollection
1
+Agent
0..*
+AgentOccurrenceCollection
0..*
+activityCollection
1
+studyParticipantAssignment
0..1
+femaleReproductiveCharacteristic
1+participant
1..*
+eligibilityCriteriaCollection
1..*
+protocolCollection
0..*+studyAgentCollection
1
+study
1+participant
0..*+healthcareSiteParticipantCollection
1
+participant
0..*
+participantEligibilityAnswerCollection
0..1+cancerStage
1+diagnosis
0..*+adverseEventTherapyCollection
1+adverseEventCollection
1+eligibilityCriteria
0..*+participantEligibilityAnswerCollection
0..*+histopathologyGradeCollection
1+histopathology
0..*
+observationCollection
1
+activity
0..* +activityRelationshipCollection
1+activity
0..*+studyParticipantCollection
1
+studySite0..*
+studySiteCollection
1
+protocol
0..*+studyParticipantAssignmentCollection
1+participant
1+healthcareSite 0..*
+healthcareSiteParticipant
1+healthcareSiteParticipant
0..*+healthcareSiteRoleCollection
1+observation
0..* +observationRelationshipCollection
0..*
+personOccupationCollection
1
+person
1..*
+metastasisSiteCollection
1
+cancerStage
0..*+specimenCollection
1+specimenCollection
0..*+observationRelationshipCollection
1+observation
0..1+studyTimePoint
1+activity
0..*+activityRelationshipCollection
1+activity
1
+protocol
1..*
+protocolStatusCollection
0..* +assessmentRelationship
1 +assessmentCollection1+assessment
0..*+assessmentRelationshipCollection
0..1
+agentOccurrence
1
+substanceAdministration
cd Logical Model
Organization
+ name: string::ParticipatingEntity+ id: long
+ isFDA() : boolean
cd Logical Model
OrganizationTelephone
+ id: long+ usageType: string+ equipmentType: string+ phoneNumber: string+ extendedPhoneNumber: string
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
Clinical Research Entities and Roles::Organization
+ 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+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
Clinical Research Entities and Roles::
MaterialRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::Investigator
+ certificateLicenseText: Text
Clinical Research Entities and Roles::Organization
+ description: Text+ geographicAddr: BRIDGContactAddr+ name: Text+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::OrganizationRole
::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::Participant
+ confidentialityIndicator: boolean+ paymentMethod: ENUM
Clinical Research Entities and Roles::Person
+ address: BRIDGContactAddr+ administrativeGenderCode: BRIDGCodedConcept+ dateOfBirth: DATETIME+ dateOfDeath: DATETIME+ educationLevelCode: BRIDGCodedConcept+ electronicCommAddr: BRIDGTelecomAddress+ ethnicGroupCode: BRIDGCodedConcept+ householdIncomeCategory: BRIDGCodedConcept+ maritalStatusCode: BRIDGCodedConcept+ name: Text+ raceCode: BRIDGCodedConcept+ telecomAddress: BRIDGTelecomAddress
Clinical Research Entities and Roles::PersonRole
::Role+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
Clinical Research Entities and Roles::TherapeuticAgent
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
Clinical Trials Activities::PerformedStudy
+ ActualAccrualNumber: int+ enrollmentEndDate: Date+ enrollmentstartDate: Date::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::PlannedActiv ity
+ repeatNumber: rangeOfIntegers::Activity+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
Clinical Trials Activ ities::PlannedStudy
+ targetAccrualNumber: int::Study+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::StudyAgent
::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::StudyInvestigator
+ signatureCode: int+ signatureText: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::StudySite
+ targetAccrualNumber: int::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
Clinical Trials Activ ities::SubjectAssignment
+ ageAtEnrollment: int+ arm: string+ eligibilityWaiverReason: string+ informedConsentFormSignedDate: date+ offStudyDate: date+ studyAgentDoseLevel: string+ studySubjectIdentifier: int+ subgroupCode: string::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Activity
+ codedDescription: BRIDGCodedConcept+ confidentialityCode: BRIDGCodedConcept+ description: BRIDGDescription+ endDate: DATETIME+ priorityCode: BRIDGCodedConcept+ reasonCode: BRIDGCodedConcept+ startDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
BRIDG Shared Classes::Activ ityActiv ityRelationship
+ checkpointCode: + conjunctionCode: + joinCode: + negationIndicator: BOOLEAN- negationRule: AbstractRule+ priorityNumber: NUMBER+ relationshipCode: BRIDGCodedConcept+ sequenceNumber: NUMBER+ splitCode:
BRIDG Shared Classes::Participation
+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Role
+ code: BRIDGCodedConcept+ effectiveEndDate: DATETIME+ effectiveStartDate: DATETIME+ electronicCommAddr: BRIDGTelecomAddress+ geographicAddr: BRIDGContactAddr+ id: BRIDGCodedConcept+ status: BRIDGStatus+ telecomAddr: BRIDGTelecomAddress
BRIDG Shared Classes::RoleRoleRelationship
+ source: + target: + type: CodedConcept
BRIDG Shared Classes::BRIDGAnalysisVariable
+ businessProcessMode: PSMBusinessProcessMode+ controlledName: PSMCodedConcept+ name: TEXT+ value:
BRIDG Shared Classes::BRIDGCodedConcept
- code: TEXT- codeSystem: - codeSystemName: TEXT- codeSystemVersion: NUMBER- displayName: TEXT- originalText: TEXT- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::BRIDGContactAddr
+ effectiveTime: BRIDGInterval+ type: BRIDGCodedConcept+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ detailedDescription: EncapsulatedData+ summaryDescription: EncapsulatedData+ synopsis: EncapsulatedData
BRIDG Shared Classes::BRIDGID
+ source: Text+ value: Text+ version: Text
BRIDG Shared Classes::BRIDGInterval
+ endTime: timestamp- startTime: timestamp
BRIDG Shared Classes::BRIDGStatus
+ effectiveEndDate: + effectiveStartDate: + statusValue:
Specimen may have to re-located
Needs additional work and cleanup
Clinical Trials Activ ities::StudyDocument
+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ targetAccrualNumber: int+ type: BRIDGCodedConcept::Document+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string
Potential hook for the eDCI model
Attributes needs to be reviewed -- need to be domain oriented -- too RIM like
Do we need this -- what is the use case? The thinking is that this will be used for caAERS. Ifnot, then it should be deleted.
This maybe an Activity?
Review the data types -- inconsistency in definition and what is used in the model
BRIDG Shared Classes::BRIDGTelecomAddress
- addressType: ENUM- usageType: ENUM- value: Text
BRIDG Shared Classes::Dev ice
::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
BRIDG Shared Classes::Drug
+ formCode: BRIDGCodedConcept+ lotNumber: int+ stabilityTime: DATETIME::Material+ description: Text+ expirationDate: DATETIME+ name: Text+ status: BRIDGStatus
Clinical Trials Activities::Study
+ blindedInd: boolean+ description: BRIDGDescription+ diseaseCode: CodedConceptDataType+ id: BRIDGID+ intentCode: ENUM+ longTitle: string+ monitorCode: ENUM+ multiInstitutionInd: boolean+ phaseCode: ENUM+ randomizedInd: boolean+ shortTitle: string+ sponsorCode: CodedConceptDataType+ SubjectType: BRIDGCodedConcept+ type: BRIDGCodedConcept
Clinical Trials Activ ities::StudyAuthor
::Participation+ endDate: DATETIME+ startDate: DATETIME+ status: CodedConcept+ statusDate: DATETIME+ type: CodedConcept
BRIDG Shared Classes::Document
+ confidentialityCode: CodedConcept+ description: DAMDescription+ documentID: BRIDGID+ status: BRIDGStatus+ type: ENUM+ version: string
We will need to MANUALLY keep these two classes in synch with their attributes.
CTOM Elements::PerformedObservation
+ confidentialityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
CTOM Elements::ObservationRelationship
+ comments: string+ id: int- type: string
PlannedObservation
We may or may not need this class -- it depends on the number of shared classes between thetwo performed/planned activities
CTOM Elements::Histopathology
+ grossExamResultCode: string+ involvedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
CTOM Elements::LesionDescription
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ appearanceTypeCode: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ dimensionProduct: int+ evaluationNumber: int+ lesionNumber: string+ measurableIndicator: boolean+ methodCode: string+ previouslyIrradiatedSiteIndicator: boolean+ targetNonTargetCode: string+ xDimension: int+ yDimension: int+ zDimension: int
SDTM::LaboratoryTest
+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::SDTMFinding
+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::OtherFindings
+ evaluationInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::QuantitativeMeasurement
+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::Examination
+ measurementTime: int- resultDescription: SDTMFindingDescriptionDataType::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
TestInterpretation
SDTM::InterpretedResults
::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
TestInterpretation
SDTM::VitalSign
+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPosition: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
+is fulfi led by the role
1
+participate as
0..*
+are attributed to +have
0..*
1
+are attributed to +have
1 0..*
+are written by
+write
0..*
1
+are attributed to +have
+is operationalized by
0..1
+is described by
1..1
+is described by 1
+describes 1
+source activity
*
*
+target activity
1
has a 1..*1..*has a
1
+assign 0..*+are assigned by 1
«abstraction»
0..* 1
1 0..*
+is described by
1..1
+is operationalized by 0..1
0..11
+are performed by+participate in
0..*
1
+are performed at
+participate in
Observation Classes from CTOM and SDTM
CTOM and SDTM harmonization (work in progress)
cd CTOM observ ations and SDTM
CTOM Elements::PerformedObserv ation
+ confidentialityCode: BRIDGCodedConcept+ reportingDate: DATETIME+ status: BRIDGStatus+ uncertaintyCode: BRIDGCodedConcept
CTOM Elements::Observ ationRelationship
+ comments: string+ id: int- type: string
Harmonized Elements::
PlannedObserv ation
CTOM Elements::Histopathology
+ grossExamResultCode: string+ involvedSurgicalMarginIndicator: boolean+ reportDescriptiveText: string
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
CTOM Elements::LesionDescription
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string+ appearanceTypeCode: string+ contactAnatomicSiteCode: string+ contactAnatomicSiteCodeSytem: string+ dimensionProduct: int+ evaluationNumber: int+ lesionNumber: string+ measurableIndicator: boolean+ methodCode: string+ previouslyIrradiatedSiteIndicator: boolean+ targetNonTargetCode: string+ xDimension: int+ yDimension: int+ zDimension: int
SDTM::LaboratoryTest
+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::SDTMFinding
+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::OtherFindings
+ evaluationInterval: timing specification+ measurementTime: DATETIME::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
SDTM::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
TestInterpretation
SDTM::InterpretedResults
::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
TestInterpretation
SDTM::VitalSign
+ bodyLocation: CodedConceptDataType+ measureTime: DATETIME+ subjectPosition: enum::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
0..*1 0..*1
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
Harmonizing attributes
cd CTOM observ ations and SDTM
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
SDTM::LaboratoryTest
+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
Adding tags to provide semantic traceability (and notes)
cd CTOM observ ations and SDTM
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
SDTM::LaboratoryTest
+ fastingStatus: boolean+ method: enum::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
Simple semantic can be tracked in tagged values
cd CTOM observ ations and SDTM
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
This linking can be extended down to the CDE level
cd CTOM observ ations and SDTM
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
More complex relationships
cd CTOM observ ations and SDTM
CTOM Elements::ClinicalResult
+ abnormalIndicator: boolean+ assayMethodCode: string+ biomarkerInd: boolean+ bodyPositionCode: string+ labReferenceRangeCode: string+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string+ panelName: string+ significanceInd: boolean+ value: string+ valueUnitOfMeasureCode: string
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
TestInterpretation
SDTM::InterpretedResults
::TestInterpretation+ interpretedBy: enum+ normalRangeIndicator: enum- resultCategory: int::QuantitativeMeasurement+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd CTOM observ ations and SDTM
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text+ normalRangeLow: text+ result: text+ units: text::SDTMFinding+ missingValueCode: CodedConceptDataType+ name: CodedConceptDataType
Name:Package:Version:Author:
CTOM observations and SDTMCTOM (imported package)1.0Fridsma
cd Comprehensiv e Model
Clinical Research Entities and
Roles::Agent
+ id: CodedConcept+ name: string
+ description: string
+ status: CodedConcept
+ formCode: CodedConcept+ lotNumber: int
+ expirationDate: DATETIME
+ stabi l i tyT ime: DATETIME
Clinical Research
Entities and Roles::
AgentRole
Clinical Research Entities and Roles::
FundingSponsor
Clinical Research
Entities and Roles::
HealthCareSite
Clinical Research Entities and Roles::
Inv estigator
+ certi ficateLicenseText:
Clinical Research Entities
and Roles::Organization
+ id: CodedConcept
+ name: string+ description: string
+ status: CodedConcept
+ statusDate: DATETIME
+ geographicAddr: addrType+ telecomAddr: TEL
Clinical Research Entities and
Roles::OrganizationRole
Clinical Research Entities and
Roles::Participant
+ paymentMethod: CodedConcept
+ confidential i tyCode: string
Clinical Research Entities and Roles::Person
+ id: CodedConcept
+ administrativeGenderCode: BRIDGCodedConcept
+ dateOfBirth: DATETIME+ raceCode: BRIDGCodedConcept
+ ethnicGroupCode: BRIDGCodedConcept
+ maritalStatusCode: BRIDGCodedConcept
+ electronicCommAddr: + householdIncomeCategory: BRIDGCodedConcept
+ educationLevelCode: BRIDGCodedConcept
+ telecomAddress: TEL
+ name: enti tyName+ dateOfDeath: DATETIME
+ address: addrType
Clinical Research Entities and Roles::
PersonRole
::Role
+ id: CodedConcept
+ code: CodedConcept+ status:
+ electronicCommAddr:
+ geographicAddr: + telecomAddr: + effectiveStartDate: DATETIME
+ effectiveEndDate: DATETIME
Clinical Research
Entities and Roles::
TherapeuticAgent
Clinical Trials Activ ities::Adv erseEv ent
+ onsetDate: date+ resolvedDate: date
+ ctcCategoryCode: string
+ ctcCategoryCodeSystem: string
+ ctcTermTypeCode: string+ ctcTermTypeCodeSystem: string
+ ctcAttributionCode: string
+ ctcAttributionCodeSystem: string
+ ctcGradeCode: string+ ctcGradeCodeSystem: string
+ seriousReasonCode: string
+ outcomeCode: string
+ actionTakenCode: string
+ conditionPatternCode: string+ doseLimitingToxici tyIndicator: boolean
+ doseLimitingToxici tyDescriptionText: string
+ descriptionText: string
Clinical Trials Activ ities::
Adv erseEv entReport
+ id: int
+ submissionDate: date
+ fi ledIndicator: boolean
Clinical Trials Activ ities::
Adv erseEv entTherapy
+ id: int
+ treatmentDate: date
+ delayDuration: int
+ delayDurationUnitOfMeasureCode: string+ intensityCode: string
Clinical Trials Activities::Assessment
+ id: int
+ evaluationDate: date
Clinical Trials
Activ ities::AssessmentRelationship
+ id: int
+ typeCode: string
+ commentText: string
Clinical Trials Activ ities::
CancerStage
+ id: int
+ tnmStage: string+ tnmStageCodeSystem: string
+ stageCode: string
+ stageCodeSystem: string
Clinical Trials Activ ities::
ClinicalResult
+ panelName: string
+ value: string
+ valueUnitOfMeasureCode: string+ assayMethodCode: string
+ bodyPositionCode: string
+ labReferenceRangeCode: string
+ labTechniqueCode: string+ meansVitalStatusObtainedCod: string
+ abnormalIndicator: boolean
+ biomarkerInd: boolean
+ significanceInd: boolean
Clinical Trials Activ ities::
DeathSummary
+ deathDate: date
+ deathCauseCode: char+ deathCauseText: string
+ autopsiedIndicator: boolean
Clinical Trials Activ ities::Diagnosis
+ name: string+ diseaseDiagnosisCode: string
+ diseaseDiagnosisCodeSystem: string
+ ageAtDiagnosis: int
+ confirmationDate: date+ primaryAnatomicSiteCode: string
+ primaryAnatomicSiteCodeSystem: string
+ primaryAnatomicSiteLateral i tyCode: string
+ recurrenceIndicator: boolean+ diseaseStatusCode: string
+ sourceCode: string
+ sourceOther: string
+ diseaseExtentText: string
Clinical Trials Activ ities::DiseaseResponse
+ responseCode: char+ responseCodeSystem: string
+ bestResponseCode: char
+ bestResponseDate: date
+ progressionDate: date+ progressionPeriod: int
+ progressionPeriodUnitOfMeasureCode: string
+ doseChangeIndicatorCode: int
+ courseDispositionCode: string+ commentText: string
Clinical Trials Activ ities::Histopathology
+ grossExamResultCode: string
+ reportDescriptiveText: string
+ involvedSurgicalMarginIndicator: boolean
Clinical Trials Activ ities::
HistopathologyGrade
+ id: int
+ gradingSystemName: string
+ grade: string+ comments: string
Clinical Trials Activ ities::Imaging
+ identi fier: string
+ contrastAgentEnhancement: string
+ descriptiveText: string
+ rateOfEnhancementValue: int
Clinical Trials Activ ities::
LesionDescription
+ lesionNumber: string
+ evaluationNumber: int
+ appearanceTypeCode: string+ targetNonTargetCode: string
+ measurableIndicator: boolean
+ methodCode: string
+ xDimension: int+ yDimension: int
+ zDimension: int
+ dimensionProduct: int
+ anatomicSiteCode: string+ anatomicSiteCodeSystem: string
+ contactAnatomicSiteCode: string
+ contactAnatomicSiteCodeSytem: string
+ previouslyIrradiatedSiteIndicator: boolean Clinical Trials
Activ ities::
LesionEv aluation
+ evaluationCode: char
Clinical Trials Activ ities::
MetastasisSite
+ id: int
+ anatomicSiteCode: string
+ anatomicSiteCodeName: string
Clinical Trials
Activ ities::Neoplasm
+ id: int
+ cel lType: string
Clinical Trials Activ ities::Observ ation
+ id: int
+ reportingDate: date
+ confidential i tyCode: string+ uncertaintyCode: string
+ statusCode: string
Clinical Trials Activ ities::
Observ ationRelationship
+ id: int
- type: string
+ comments: string
Clinical Trials Activ ities::PerformedActiv ity
+ plannnedUnplannedInd: boolean
::Activi ty
+ code: PSMCodedConcept+ derivationExpression: TEXT
+ description: PSMDescription
+ startDate: DATETIME
+ status: PSMCodedConcept+ avai labi l i tyT ime: T imingSpecification
+ priori tyCode: PSMCodedConcept
+ confidential i tyCode: PSMCodedConcept
+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN
+ uncertaintyCode: CodedConcept
+ reasonCode: PSMCodedConcept
+ endDate: DATETIME
Clinical Trials Activ ities::PerformedStudy
+ id: BRIDGID+ longT itle: string
+ shortT i tle: string+ phaseCode: ENUM
+ intentCode: ENUM+ monitorCode: ENUM
+ bl indedInd: boolean
+ randomizedInd: boolean+ diseaseCode: CodedConceptDataType
+ sponsorCode: CodedConceptDataType
+ multi Insti tutionInd: boolean
+ targetAccrualNumber: int
Clinical Trials Activ ities::PlannedActiv ity
::Activi ty
+ code: PSMCodedConcept
+ derivationExpression: TEXT+ description: PSMDescription
+ startDate: DATETIME
+ status: PSMCodedConcept
+ avai labi l i tyT ime: T imingSpecification+ priori tyCode: PSMCodedConcept
+ confidential i tyCode: PSMCodedConcept
+ repeatNumber: rangeOfIntegers
+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept
+ reasonCode: PSMCodedConcept
+ endDate: DATETIME
Clinical Trials Activ ities::PlannedStudy
::Activi ty
+ code: PSMCodedConcept
+ derivationExpression: TEXT
+ description: PSMDescription+ startDate: DATETIME
+ status: PSMCodedConcept
+ avai labi l i tyT ime: T imingSpecification
+ priori tyCode: PSMCodedConcept
+ confidential i tyCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers
+ interruptibleIndicator: BOOLEAN
+ uncertaintyCode: CodedConcept
+ reasonCode: PSMCodedConcept+ endDate: DATETIME
Clinical Trials Activ ities::Procedure
+ targetSiteCode: string
Clinical Trials Activ ities::
Qualitativ eEv aluation
+ survivalStatusCode: int
+ survivalStatusDescriptionText: string+ performanceStatusCode: int
- performanceStatusCodeSystem: string
+ painIndexCode: int
+ painIndexCodeSystem: string+ anamResultAccuracyPercent: int
+ menstrualPatternTypeCode: string
+ menstrualIndicator: boolean
Clinical Trials Activ ities::
Radiation
+ therapyType: string
+ doseUnitOfMeasure: string
+ dose: string
Clinical Trials Activ ities:
:Specimen
+ id: int
+ idNumber: int
+ samplingType: string
Clinical Trials
Activ ities::
SpecimenCollection
+ siteCondition: string
+ method: string
Clinical Trials Activ ities::StudyAgent
::Participation
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME+ startDate: DATETIME
+ endDate: DATETIME
Clinical Trials Activ ities::
StudyInv estigator
+ signatureCode: int
+ signatureText: string
::Participation+ type: CodedConcept
+ status: CodedConcept+ statusDate: DATETIME
+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::
StudySite
+ targetAccrualNumber: int
::Participation+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME
+ startDate: DATETIME+ endDate: DATETIME
Clinical Trials Activ ities::Subj ectAssignment
+ studySubjectIdenti fier: int
+ arm: string
+ subgroupCode: string
+ informedConsentFormSignedDate: date+ offStudyDate: date
+ studyAgentDoseLevel: string+ el igibi l i tyWaiverReason: string
+ ageAtEnrol lment: int::Participation
+ type: CodedConcept+ status: CodedConcept
+ statusDate: DATETIME+ startDate: DATETIME
+ endDate: DATETIME
Clinical Trials Activ ities::
SubstanceAdministration
+ doseQuanti ty: int
+ doseUnitOfMeasure: string
+ route: string+ doseFrequency: string
+ doseModificationType: string+ doseChangeType: int
Clinical Trials
Activ ities::
Surgery
BRIDG Shared Classes::Activity
+ code: PSMCodedConcept+ derivationExpress ion: TEXT+ description: PSMDescription+ s tartDate: DATETIME+ s tatus: PSMCodedConcept+ availabilityTime: Tim ingSpecification+ priorityCode: PSMCodedConcept+ confidentialityCode: PSMCodedConcept+ repeatNumber: rangeOfIntegers+ interruptibleIndicator: BOOLEAN+ uncertaintyCode: CodedConcept+ reasonCode: PSMCodedConcept+ endDate: DATETIME
BRIDG Shared Classes::
Activ ityActiv ityRelationship
+ relationshipCode: PSMCodedConcept
- Obsolete_relationQuali fier: BRIDGCodedConcept+ sequenceNumber: NUMBER
+ pauseCri terion:
+ checkpointCode:
+ priori tyNumber: NUMBER
+ spl i tCode: - negationRule: AbstractRule
+ joinCode:
+ negationIndicator: BOOLEAN
+ conjunctionCode:
BRIDG Shared Classes::Participation
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME+ startDate: DATETIME
+ endDate: DATETIME
BRIDG Shared Classes::Role
+ id: CodedConcept
+ code: CodedConcept
+ status: + electronicCommAddr:
+ geographicAddr:
+ telecomAddr:
+ effectiveStartDate: DATETIME+ effectiveEndDate: DATETIME
BRIDG Shared Classes::
RoleRoleRelationship
+ source: + type: CodedConcept
+ target:
BRIDG Shared Classes::BRIDGAnalysisVariable
+ name: TEXT
+ value: + control ledName: PSMCodedConcept
+ businessProcessMode: PSMBusinessProcessMode
BRIDG Shared Classes::
BRIDGBusinessProcessMode
+ modeValue: ENUM {Plan, Execute}
BRIDG Shared Classes::
BRIDGCodedConcept
- code: TEXT- codeSystem:
- codeSystemName: TEXT
- codeSystemVersion: NUMBER
- displayName: TEXT- originalText: TEXT
- translation: SET{PSMCodedConcept}
BRIDG Shared Classes::
BRIDGContactAddr
+ type: BRIDGCodedConcept+ effectiveT ime: BRIDGInterval
+ usage: BRIDGCodedConcept
BRIDG Shared Classes::BRIDGDescription
+ synopsis: EncapsulatedData
+ summaryDescription: EncapsulatedData+ detai ledDescription: EncapsulatedData
BRIDG Shared Classes::
BRIDGID
+ source: Text
+ version: Text
+ value: Text
BRIDG Shared Classes:
:BRIDGInterv al
- startT ime: timestamp+ endT ime: timestamp
BRIDG Shared Classes::
BRIDGStatus
+ effectiveEndDate: + effectiveStartDate:
+ statusValue:
Protocol Concepts::StudyDocument
+ version: string
+ author: SET+ ID: SET BRIDGID
+ documentID: BRIDGID
+ type: ENUM
+ description: BRIDGDescription+ ti tle: string
+ status: BRIDGStatus
+ confidential i tyCode: CodedConcept
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+target activi ty
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BRIDG – Domain Analysis Model for Clinical Research
FO
UN
DA
TIO
NM
OD
EL
CDISC
ST
AK
EH
OL
DE
RS
NCI/caBIG HL7 (RCRIM)
Application Development
caCORE Tooling
V3 Message DevelopmentHL7 Tooling
xml data Exchange
CDISC xml
IMP
LE
ME
NT
AT
ION
SO
LU
TIO
NS
Interoperability Interoperability
Achieving interoperability
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
guidelinesRefer to best practices for modeling in BRIDG environment
Submit BRIDG Harmonization
Package to THC
Harmonization Package artifacts – the EAP file, package level xmiExport, Modeling analysis & harmonization document)
Submit BRIDG Harmonization
Package to THC
Meet with BRIDG THC to harmonize project model (virtual or F2Fmeeting)
BRIDG THC Activities
Review the Project Registration material.
Assign Mentorto project
Take project to BAB andassign priority and timelinefor harmonization
BRIDG mentor will be available to answer questions
Inform Project POC May require some negotiations based on other efforts
Schedule project Harmonization meeting
Review harmonizationPackage submission
Develop harmonizationResults package for project team
Perform analysis and prepare for harmonization meeting
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
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.
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.
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]