BRIDG
The BRIDG Project: Creating a
model of the semantics of clinical
trials research
Douglas B. Fridsma, MD PhD
Center for Biomedical Informatics
University of Pittsburgh School of Medicine
Pittsburgh PA
fridsma@cbmi.pitt.edu
caBIG™, What is it?
• The cancer Biomedical Informatics Grid™, or caBIG™, is a virtual
network connecting individuals and organizations to enable the
sharing of data and tools, creating a World Wide Web of cancer
research.
• The goal is to speed the delivery of innovative approaches for the
prevention and treatment of cancer.
Analytical Service
Gene
Database
Grid-Enabled Client
Tool 1
Tool 2
caArray
Research
Center
NCICB
Protein
Database
Grid Data Service
Grid Services Infrastructure
(Metadata, Registry, Query,
Invocation, Security, etc.)
Tool 3
Tool 4
Image
Grid Portal
Microarray
Tool 2
Tool 3
Research
Center
caBIGTM Objectives
• Common, widely distributed infrastructure that
permits the cancer research community to focus
on innovation
• Shared, harmonized set of terminology, data
elements, and data models that facilitate
information exchange
• Collection of interoperable applications
developed to common standards
• Raw published cancer research data is available
for mining and integration
Standards – Why?
Cancer Research: Two Different Worlds
Patient
Data in
Proprietary
Format
BRIDG
Patient Care World
Clinical Research World
• Multiple data sources and types
• HL7 is a pervasive standard
• Data are organized around the
patient
• Protocol defines define elements
• Linear data flow
• CDISC is the emerging standard
• Data are organized around a trial
Acknowledgements:
Landen Bain, CDISC
So why do we need a model of the
semantics of clinical trials for caBIG?
“The Map is not the Territory”
(Bertrand Russell)
• Domain Experts have a “mental map” of the
problems that they hope technology can solve
• In gathering requirements, this map may have
flaws or distortions
• Databases schemas are not the territory
– Implicit semantics in the structure or value-attribute
pairs
Acknowledgment: Charlie Mead
The Map is not the Territory
•
Deletion (filtered/missing details)– “They use the system to find
information about clinical trials.”
– Challenge: “Who uses the system?”
– Response: “Clinical research coordinators, patients, and
investigators.”
• Distortion (incorrect or modified details) – “You can’t enter a clinical
trial protocol until you have an protocol identification number.”
– Challenge: “Are there any circumstances where you can enter a
protocol without an identification number?”
– Response: “Yes, two circumstances….”
• Generalization (abstractions via rules, beliefs, principles)– “Everyone
must have a log-on ID to access the information in the system.”
– Challenge: “Are there any system users that can access the
information without an log-on ID?”
– Response: “Organizations and cooperative groups may use the API to
access the information directly.”
Acknowledgment: Charlie Mead
“Protocol” and the Semiotic Triangle
Concept 2
Concept 1
“We need to sign off on
the protocol by Friday”
“Protocol XYZ has enrolled
73 patients”
Symbol
Thing 1
Thing 2
Study
“Protocol”
Document
Concept 3
“Per the protocol, you must be
at least 18 to be enrolled”
Source: John Speakman/Charlie Mead
Thing 3
Plan
Interoperability
• The ability of multiple systems to
exchange information
and to be able to use the information that
has been exchanged.
Syntactic
interoperability
Semantic
interoperability
The Pillars of (Semantic)
Interoperability
Necessary 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 conceptbased terminologies
– UML loader, semantic connector, Enterprise Vocabulary
Server
• A formally defined process for defining specific
structures to be exchanged between machines,
i.e. a “messaging standard”
– HL7 and implementation specifications
– 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 we get started?
• Desiderata
– We did not want to create “yet another
protocol representation”
• “the good thing about standards is that there are
so many to chose from…”
– We wanted the work to be
• Open
• Collaborative
• Standards-based
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
– CDISC started domain modeling in 2003 to integrate their own
modeling efforts and to link CDISC to HL7
• 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)
• 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
Current Organization of the BRIDG
project
FDA
• BRIDG Advisory Board
HL7
CDISC
caBIG
NCI
PhRMA
BRIDG
Advisory Board
– Representation from the current
stakeholders
– Help to identify priorities and
allocate resources
– Assist with vetting the model in the
various constituents
• Technical Harmonization Group
CDISC
caBIG
HL7
BRIDG
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 projects and contributors
BRIDG model
Study calendar
(caBIG)
EudraCT
FastTrack
SDTM
(CDISC)
CONSORT
(cancerGRID)
WHO
JANUS
(IBM)
SDTM
(CDISC)
PDQ
ClinicalTrials.gov
Protocol
Registration
Clinical Trials
Operations
Adverse
Events
caAERS
(caBIG)
FDA
(M. Walker)
HL7
(M Walker)
Protocol Authoring &
Trial Design
caBIG
NCI
Oracle
CDISC
ODM
Lab
Specification
SDTM
(CDISC)
CTOM
(caBIG)
ODM
(CDISC)
HL7
(M Walker)
JANUS
(IBM)
SDTM
(CDISC)
Lab SIG
(caBIG)
eDCI
CTLab std
(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 BRIDG
ad Conduct Clinical Trial
Name:
Package:
Version:
Author:
Scientific Team
Conduct Clinical Trial
Conduct Clinical Trial
1.0
Fridsma
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 responsibility for
leading the team who will write the study
and guiding it through the steps of
approval.
Operational Team
The study is planned by a principal investigator at a cancer center.
Operational Team
Clinical Management 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.
The clinical management team
is responsible for managing the
clinical trial subjects, data about
the subjects, and information
and processes related to the
execution of the study.
Organizations which may play this role
include:
Clinical Research Organization
Sponsoring Organization
Cooperative Group
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.
Plan Study
Clinical Management Team
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.
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.
Set-up Study
Execute Study
Analysis and Report
The proposal is submitted by the cooperative group on behalf of
the PI to NCI/CTEP, and once approved, the principal investigator
will set up the operational aspects of conducting the study through
the cooperative group that the cancer center is affiliated with.
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.
Behavioral Aspects of BRIDG
ad RegisterClinicalTrial
RegistrySteward
Compile Registry
Information
Receiv e Information
Registry
The entity that is
sending/transmitting a registry
message.
The entity (person, org or system)
that receives, processes and
publishes registry information .
For example, a pharmaceutical
organization/agent will authorize a
party to transmit information about
a trial to an external registry such
as clinicaltrials.gov.
For example, clinicaltrials.gov
PDQ, or EudraCT are considered
registries.
RegistryClea
For example, W
IFPMA (Interna
Federation of
Pharmaceutica
Manufacturers
Associations).
For example, in an academic
institution the principal investigator
will transmit information about a
trial to an external registry.
Transmit Information
Compile Registry
Information
Receiv e Information
Validate Information
Modify Information
Transmit Information
Validate Information
Modify Information
Receiv e error message
Send error message
Receiv e error message
No
Is information acceptable?
Send error message
No
Is information acceptable?
Yes
Receiv e
acknow ledgement
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
Release information
ActivityFinal
Send acknow ledgement
Model organization
• Logical View
– Contains three core packages
• Harmonized elements
• Staging Area
• Manual review area
– Addition resources
• HL7 V3 RIM
– Contains the semantics for the static
objects (data) that is used in clinical
trials research
– Currently have 9 subdomain models
in the process of harmonization
Current Classes in Core Elements
cd Comprehensive Class-only diagram
Participation
Study
+are performed by
StudyInv estigator
+participate in
+participate as
Person
+have
Inv estigator
Role
PersonRole
1
+is fulfiled by
the role
+participate in
0..*
Participation
StudyAuthor
+are
attributed
to
+are written by
Participant
Participation +are performed at
1
StudySite
+write
Document
StudyDocument
PlannedStudy
0..*
+describes
1
Organization
+have
Role
OrganizationRole
1
+are assigned by
1 +is described by1
HealthCareSite
+are
attributed
to
0..1
0..*
1..1
+is described by
+assign
Participation
+is operationalized by
0..1
Subj ectAssignment
PerformedStudy
FundingSponsor
Participation
TherapeuticAgent
StudyAgent
0..*
1
Role
Material
+have
MaterialRole
+are
attributed
to
1
0..*
Activity
+is operationalized by
PlannedActiv ity
1..1
0..1
+is described by
Drug
Dev ice
Activity
PerformedActiv ity
Harmonized BRIDG elements
cd Comprehensive Class and attribute diagram
BRIDG Shared Classes::Activity
BRIDG Shared Classes::Participation
BRIDG Shared Classes::
RoleRoleRelationship
+
+
+
has a
1
BRIDG Shared Classes::Role
+
+
+
+
+
+
+
+
source:
target:
type: CodedConcept
1..*
has a 1..*
Do we need this -what is the use
case? The thinking
is that this will be
used for caAERS. If
not, then it should
be deleted.
endDate: DATETIME
startDate: DATETIME
status: CodedConcept
statusDate: DATETIME
type: CodedConcept
+
::Role
+ code: BRIDGCodedConcept
+ effectiveEndDate: DATETIME
+have + effectiveStartDate: DATETIME
+ electronicCommAddr: BRIDGTelecomAddress
+ geographicAddr: BRIDGContactAddr
+ id: BRIDGCodedConcept
+ status: BRIDGStatus
+ telecomAddr: BRIDGTelecomAddress
1
+participate as
+ signatureCode: int
+ signatureText: string
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
certificateLicenseText: Text
+are written by
1
0..1
+assign
+are assigned by
+are attributed to
description: Text
expirationDate: DATETIME
name: Text
status: BRIDGStatus
+have
checkpointCode:
conjunctionCode:
joinCode:
negationIndicator: BOOLEAN
negationRule: AbstractRule
priorityNumber: NUMBER
relationshipCode: BRIDGCodedConcept
sequenceNumber: NUMBER
splitCode:
Needs additional work
and cleanup
Clinical Research
Entities and Roles::
HealthCareSite
Clinical Research
Entities and Roles::
MaterialRole
SDTM CTOM harmonization in process
Clinical Trials Activ ities::PlannedStudy
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
1
Clinical Trials Activ ities::
StudyAgent
Clinical Research
Entities and Roles::
TherapeuticAgent
1
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
0..* + status: CodedConcept
0..*
+ statusDate: DATETIME
+ type: CodedConcept
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
+is described by
+ uncertaintyCode: BRIDGCodedConcept
+are performed at
+ targetAccrualNumber: int
::Participation
+ endDate: DATETIME
0..* + startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
Clinical Research
Entities and Roles::
FundingSponsor
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
1..1
Clinical Research Entities and
Roles::Material
+
+
+
+
+
+
* +
+
*
+
+
+
+
0..*
1
Clinical Trials Activ ities::
StudySite
::Role
+ code: BRIDGCodedConcept
+ effectiveEndDate: DATETIME
+ effectiveStartDate: DATETIME
+have + electronicCommAddr: BRIDGTelecomAddress
+ geographicAddr: BRIDGContactAddr
+ id: BRIDGCodedConcept
+ status: BRIDGStatus
+ telecomAddr: BRIDGTelecomAddress
description: Text
+are attributed to
geographicAddr: BRIDGContactAddr
name: Text
status: BRIDGStatus
telecomAddr: BRIDGTelecomAddress
+ 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
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
confidentialityIndicator: boolean
paymentMethod: ENUM
+
+
+
+
+
+
+
+participate in +
+
+
+
+
+
+participate in
+
Clinical Trials Activ ities::
Subj ectAssignment
+are performed by
Clinical Trials Activ ities::
StudyAuthor
Clinical Research Entities and Roles::
Participant
+
+
Clinical Research Entities and Roles::
Organization
+target activity
Clinical Trials Activities::Study
0..*
Clinical Research Entities and Roles::
OrganizationRole
+
+
+
+
+
BRIDG Shared Classes::Activ ityActiv ityRelationship
+source activity
Clinical Trials Activ ities::
StudyInv estigator
Clinical Research Entities and Roles::
PersonRole
Clinical Research Entities and Roles::Person
We may or may not
need this class -- it
depends on the
number of shared
classes between the
two
performed/planned
activities
codedDescription: BRIDGCodedConcept
confidentialityCode: BRIDGCodedConcept
description: BRIDGDescription
endDate: DATETIME
priorityCode: BRIDGCodedConcept
reasonCode: BRIDGCodedConcept
startDate: DATETIME
status: BRIDGStatus
uncertaintyCode: BRIDGCodedConcept
This maybe an
Activity?
1
+is fulfiled by the role
address: BRIDGContactAddr
administrativeGenderCode: BRIDGCodedConcept
+are attributed to
dateOfBirth: DATETIME
dateOfDeath: DATETIME
educationLevelCode: BRIDGCodedConcept
electronicCommAddr: BRIDGTelecomAddress
ethnicGroupCode: BRIDGCodedConcept
householdIncomeCategory: BRIDGCodedConcept
maritalStatusCode: BRIDGCodedConcept
name: Text
raceCode: BRIDGCodedConcept
telecomAddress: BRIDGTelecomAddress
+
+
+
+
+
+
+
+
+
Attributes needs to be
reviewed -- need to be
domain oriented -- too
RIM like
code: BRIDGCodedConcept
effectiveEndDate: DATETIME
effectiveStartDate: DATETIME
electronicCommAddr: BRIDGTelecomAddress
geographicAddr: BRIDGContactAddr
id: BRIDGCodedConcept
status: BRIDGStatus
telecomAddr: BRIDGTelecomAddress
Clinical Research Entities
and Roles::Inv estigator
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ targetAccrualNumber: int
::Study
+ blindedInd: boolean
+ description: BRIDGDescription
+ diseaseCode: CodedConceptDataType
+is operationalized by +is described by + id: BRIDGID
+ intentCode: ENUM
0..1
1..1
+ longTitle: string
+ monitorCode: ENUM
+ multiInstitutionInd: boolean
+ phaseCode: ENUM
+write
+ randomizedInd: boolean
+ shortTitle: string
+ sponsorCode: CodedConceptDataType
+ SubjectType: BRIDGCodedConcept
+ type: BRIDGCodedConcept
+describes
PlannedObserv ation
CTOM Elements::
Observ ationRelationship
+is operationalized by
0..1
+
+
0..* -
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
1
comments: string
id: int
type: string
0..*
1
CTOM Elements::PerformedObserv ation
+
+
+
+
confidentialityCode: BRIDGCodedConcept
reportingDate: DATETIME
status: BRIDGStatus
uncertaintyCode: BRIDGCodedConcept
1
CTOM Elements::LesionDescription
1
1
0..*
SDTM::SDTMFinding
Specimen may
have to re-located
+
+
missingValueCode: CodedConceptDataType
name: CodedConceptDataType
We will need to MANUALLY keep
these two classes in synch with
their attributes.
BRIDG Shared Classes::Drug
+ formCode: BRIDGCodedConcept
+ lotNumber: int
+ stabilityTime: DATETIME
::Material
+ description: Text
+ expirationDate: DATETIME
+ name: Text
+ status: BRIDGStatus
BRIDG Shared Classes::
Dev ice
CTOM Elements::ClinicalResult
CTOM Elements::Histopathology
SDTM::Examination
::Material
+ description: Text
+ expirationDate: DATETIME
+ name: Text
+ status: BRIDGStatus
BRIDG Shared Classes::Document
+is described by 1
Clinical Trials Activ ities::StudyDocument
BRIDG Shared Classes::
BRIDGCodedConcept
BRIDG Shared Classes::BRIDGAnalysisVariable
+
+
+
+
businessProcessMode: PSMBusinessProcessMode
controlledName: PSMCodedConcept
name: TEXT
value:
BRIDG Shared Classes::BRIDGDescription
+
+
+
detailedDescription: EncapsulatedData
summaryDescription: EncapsulatedData
synopsis: EncapsulatedData
-
code: TEXT
codeSystem:
codeSystemName: TEXT
codeSystemVersion: NUMBER
displayName: TEXT
originalText: TEXT
translation: SET{PSMCodedConcept}
BRIDG Shared Classes::
BRIDGContactAddr
+
+
+
BRIDG Shared Classes::
BRIDGInterv al
effectiveTime: BRIDGInterval
type: BRIDGCodedConcept
usage: BRIDGCodedConcept
BRIDG Shared
Classes::
BRIDGID
+
+
+
source: Text
value: Text
version: Text
+
-
endTime: timestamp
startTime: timestamp
BRIDG Shared Classes:
:BRIDGStatus
+
+
+
effectiveEndDate:
effectiveStartDate:
statusValue:
BRIDG Shared Classes::
BRIDGTelecomAddress
-
addressType: ENUM
usageType: ENUM
value: Text
«abstraction»
Review the data
types -inconsistency in
definition and what
is used in the model
+ 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
+
+
+
+
+
+
confidentialityCode: CodedConcept
description: DAMDescription
documentID: BRIDGID
status: BRIDGStatus
type: ENUM
version: string
+
+
+
+ measurementTime: int
- resultDescription: SDTMFindingDescriptionDataType
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
grossExamResultCode: string
involvedSurgicalMarginIndicator: boolean
reportDescriptiveText: string
SDTM::Quantitativ eMeasurement
SDTM::OtherFindings
+ evaluationInterval: timing specification
+ measurementTime: DATETIME
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::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
SDTM::LaboratoryTest
Potential hook for
the eDCI model
+ fastingStatus: boolean
+ method: enum
::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
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
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
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
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
CT Registration message
cd External Registry
Document
Organi zati onRol e
Clinical Trials Activ ities::
StudyDocument
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+i s descri bed by
Acti vi ty
Clinical Research Entities and Roles::Registry
bl i ndedInd: bool ean
descri pti on: BRIDGDescri pti on
di seaseCode: CodedConceptDataT ype
i d: BRIDGID
i ntentCode: ENUM
l ongT i tl e: stri ng
m oni torCode: ENUM
m ul ti Insti tuti onInd: bool ean
phaseCode: ENUM
random i zedInd: bool ean
shortT i tl e: stri ng
sponsorCode: CodedConceptDataT ype
Subj ectT ype: BRIDGCodedConcept
targetAccrual Num ber: i nt
type: BRIDGCodedConcept
+
i sWHOCerti fi ed: bool ean
::Rol e
+
code: BRIDGCodedConcept
+
effecti veEndDate: DAT ET IM E
+
effecti veStartDate: DAT ET IM E
+
el ectroni cCom m Addr: BRIDGT el ecom Address
+
geographi cAddr: BRIDGContactAddr
+
i d: BRIDGCodedConcept
+
status: BRIDGStatus
+
tel ecom Addr: BRIDGT el ecom Address
+perform s
+i s perform ed by
Clinical Trials Activ ities::PerformedActiv ity
BRIDG Shared Classes::
Participation
StudyRegistration
+
i sPri m ary: bool ean
::Parti ci pati on
+
endDate: DAT ET IM E
+
startDate: DAT ET IM E =
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
type: CodedConcept
+
+
+
+
+
StudySponsor
+
pl annnedUnpl annedInd: bool ean
::Acti vi ty
+
codedDescri pti on: BRIDGCodedConcept
+
confi denti al i tyCode: BRIDGCodedConcept
+
descri pti on: BRIDGDescri pti on
+
endDate: DAT ET IM E
+
pri ori tyCode: BRIDGCodedConcept
+
reasonCode: BRIDGCodedConcept
+
startDate: DAT ET IM E
+
status: BRIDGStatus
+
uncertai ntyCode: BRIDGCodedConcept
::Parti ci pati on
+
endDate: DAT ET IM E
+
startDate: DAT ET IM E =
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
type: CodedConcept
endDate: DAT ET IM E
startDate: DAT ET IM E =
status: CodedConcept
statusDate: DAT ET IM E
type: CodedConcept
+regi sters
Cl i ni cal T ri al s Acti vi ti es::Perform edStudy
1
External Regi stry: Need an
1
attri bute
pl annedEnrol l m entStartDate
and
pl annedEnrol l m entEndDate
+
pl annedSubj ectInterventi onDurati on: DAT ET IM E
+
pl annedSubj ectParti ci pati onDurati on: DAT ET IM E
+
targetAccrual Num ber: i nt
::Study
+
bl i ndedInd: bool ean
+i s descri bed by
+i s operati onal i zed by
+
descri pti on: BRIDGDescri pti on
+
i d: BRIDGID
1..1
0..1
+
i ntentCode: ENUM
+
l ongT i tl e: stri ng
StudyObj ectiv e(w hat)
+
m oni torCode: ENUM
+
descri pti on: BRIDGDescri pti on
+
m ul ti Insti tuti onInd: bool ean
+
obj ecti veCode: SET ENUM ERAT ED
+
phaseCode: ENUM
+
obj
ecti
veT
ype:
ENUM
{Pri
m
ary,Secondary,Anci
l
l
ary}
+
popul ati onDescri pti on: BRIDGDescri pti on
+
random i zedInd: bool ean
+
shortT i tl e: stri ng
+defi nes 1..*
the purpose of
1..*
+
sponsorCode: CodedConceptDataT ype
+
status: BRIDGStatus
+
Subj ectT ype: BRIDGCodedConcept
+
targetCondi ti onCode: BRIDGCodedConcept
+
type: BRIDGCodedConcept
1..*
+descri bes
Clinical Trials Activ ities::PlannedStudy
+
Actual Accrual Num ber: i nt
+
enrol l m entEndDate: Date
+
enrol l m entstartDate: Date
::Study
+
bl i ndedInd: bool ean
+
descri pti on: BRIDGDescri pti on
+
i d: BRIDGID
+
i ntentCode: ENUM
+
l ongT i tl e: stri ng
+
m oni torCode: ENUM
+
m ul ti Insti tuti onInd: bool ean
+
phaseCode: ENUM
+
popul ati onDescri pti on: BRIDGDescri pti on
+
random i zedInd: bool ean
+
shortT i tl e: stri ng
+
sponsorCode: CodedConceptDataT ype
+
status: BRIDGStatus
+
Subj ectT ype: BRIDGCodedConcept
+
targetCondi ti onCode: BRIDGCodedConcept
+
type: BRIDGCodedConcept
1
CTOM Elements::Procedure
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
-
descri pti on: PSM Descri pti on
j usti fi cati onOfApproach: PSM Descri pti on
j usti fi cati onOfObj ecti ves: PSM Descri pti on
popul ati onDescri pti on: PSM Descri pti on
rati onal eForAnal ysi sApproach: PSM Descri pti on
rati onal eForControl : PSM Descri pti on
rati onal eForDesi gn: PSM Descri pti on
rati onal eForEndpoi nts: PSM Descri pti on
rati onal eForM aski ng: PSM Descri pti on
studyPurposeSum m ary: T ext
sum m aryOfPrevi ousFi ndi ngs: PSM Descri pti on
sum m aryOfRi sksAndBenefi ts: PSM Descri pti on
anal yti cM ethods: Set
asM easuredBy: Set
associ atedObj ecti ve: Set
descri pti on: BRIDGDescri pti on
outcom eT ype: ENUM {Pri m ary,Secondary,Anci l l ary}
outcom eVari abl e:
threshol d:
+i s regi stered through
+has 1
+
+
+
dose: stri ng
doseUni tOfM easure:
therapyT ype: stri ng
Clinical Trials Activ ities::StudySite
+
accrual Status: BRIDGStatus
+
el ectroni cCom m Addr: BRIDGT el ecom Address
+
geographi cAddr: BRIDGContactAddr
+
targetAccrual Num ber: i nt
+
tel ecom Addr: BRIDGT el ecom Address
::Parti ci pati on
+
endDate: DAT ET IM E
+
startDate: DAT ET IM E =
+
status: CodedConcept
+
statusDate: DAT ET IM E
+are perform
+parti cied
pate
at i n+
type: CodedConcept
Clinical Trials Activities::Study
SDTM ::SDTM Interv ention
+
+
+
+
+
+
descri pti on: SDT M Interventi onDescri pti onDataT ype
endT i m e: DAT ET IM E
eval uati onInterval : ti m i ng speci fi cati on
i ndi cati on: text
m i ssi ngVal ueCode: CodedConceptDataT ype
startT i m e: DAT ET IM E
Revi ew
SDT M and
CT OM
m odel s
+contai ns
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
bl i ndedInd: bool ean
descri pti on: BRIDGDescri pti on
i d: BRIDGID
i ntentCode: ENUM
l ongT i tl e: stri ng
m oni torCode: ENUM
m ul ti Insti tuti onInd: bool ean
phaseCode: ENUM
popul ati onDescri pti on: BRIDGDescri pti on
random i zedInd: bool ean
shortT i tl e: stri ng
sponsorCode: CodedConceptDataT ype
status: BRIDGStatus
Subj ectT ype: BRIDGCodedConcept
targetCondi ti onCode: BRIDGCodedConcept
type: BRIDGCodedConcept
status shoul d be BRIDG
status
Seri al i zabl e
+defi nes study popul ati on
1
SDTM ::StudyDrug
+
dose: num eri c
+
doseDescri pti on: text
+
doseForm : CodedConceptDataT ype
+
doseFrequency: CodedConceptDataT ype
+
doseT otal : num eri c
+
doseUni ts: CodedConceptDataT ype
+
l ocati onOfDoseAdm i ni strati on: CodedConceptDataT ype
+
reasonForDoseAdj ustm ent: text
+
routeOfAdm i ni strati on: text
+
treatm ent: text
+
treatm entVehi cl e: CodedConceptDataT ype
+
treatm entVehi cl eVol um e: num
+
treatm entVehi cl eVol um eUni ts: text
::SDTMInterventi on
+
descri pti on: SDT M Interventi onDescri pti onDataT ype
+
endT i m e: DAT ET IM E
+
eval uati onInterval : ti m i ng speci fi cati on
+
i ndi cati on: text
+
m i ssi ngVal ueCode: CodedConceptDataT ype
+
startT i m e: DAT ET IM E
::Parti ci pati on
+
endDate: DAT ET IM E
+
startDate: DAT ET IM E =
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
type: CodedConcept
+i s adm i ni stered accordi ng to
1..*
+descri bes adm i ni strati on of
0..1
sponsorCode i s a
CT OM speci fi c attri bute
and needs to be
harm oni zed wi th the
new StudySponsor
cl ass.
0..*
Clinical Trials Activ ities::
StudyAgent
SDTM ::
DoseRegimen
+i s contai ned i n
Arm
+
+
pl annedSubj ectNum ber:
type: text
i nt
::Parti ci pati on
+
endDate: DAT ET IM E
+
startDate: DAT ET IM E =
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
type: CodedConcept
1
stri ng
CTOM Elements::Radiation
We need to address
regul atory i nform ati on
such as route of
adm i ni strati on,
substance, i ndi cati on.
Check wi th SDT M
Outcome
If the obj ecti ve i s of
type 'Pri m ary' then
there outcom e shoul d
be of type pri m ary.
StudyBackground(w hy)
targetSi teCode:
RegulatoryInv estigationalProductId
+study popul ati on i s defi ned by
1..*
eligibilityCriteria::EligibilityCriterion
+
+
+
+
+
+
codedNam e: BRIDGCodedConcept
com pari sonOperator: T ext
descri pti on: T ext
el i gi bi l i tyT ype: Stri ng
uni t: T ext
val ue: T ext
stri ng
CTOM
Elements::
Surgery
CTOM Elements::
SubstanceAdministration
+
+
+
+
+
+
doseChangeT ype: i nt
doseFrequency: stri ng
doseM odi fi cati onT ype: stri ng
doseQuanti ty: i nt
doseUni tOfM easure: stri ng
route: stri ng
0..*
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
Name:
Author:
Version:
Created:
Updated:
DCI Definition, v1.5.2
Don Kacher
1.0
6/7/2005 12:05:46 PM
11/2/2005 5:47:04 PM
DCI
Definition
(aka CRF)
«structure»
DciDefinition
+
+
+
+
+
+
+
+
+
+
+
+
+
«rendering»
DciPresentation
sizes "page"
MetadataRegistryDCIId:
MetadataRegistryDCIVersion:
MetadataRegistryLayoutId:
MetadataRegistryRAI:
Name:
IsTemplateDciFlag:
CreationTimestamp:
eDciStandardVersion:
ClinicalArea: [0..1]
ClinicalStudy: [0..1]
HelpText: [0..1]
DciDescription: [0..1]
LayoutDescription: [0..1]
0..1
«rendering»
0..* PersistentInformation
1..*
+
+
+
+
+
+
Id:
Name:
Datatype:
Description: [0..1]
DecimalPlaces: [0..1]
MaximumLength: [0..1]
ROASId: [0..1]
SasFormatName: [0..1]
«semantic content»
DataElementConcept
+
+
+
+
+
+
+
+ Id:
+ Name:
+ ROASId: [0..1]
Id:
Definition:
Name:
ObjectClassDefinition:
PropertyDefinition: [0..1]
SASDesignatedName: [0..1]
ROASId: [0..1]
0..*
+ SubsetNumber:
+ IsBaseSubsetFlag:
Id:
Name:
RepeatingGroupFlag:
ROASId: [0..1]
DataPersistenceEntityName: [0..1]
1..*
Id:
RegistryAuthorityId: [0..1]
ObjectId: [0..1]
ObjectVersion: [0..1]
«semantic content»
ItemDef
+
+
+
+
+
+
+
+
Id:
Name:
DataElementConceptId:
ValueDomainId:
ROASId: [0..1]
Definition: [0..1]
Comment: [0..1]
IsMandatoryFlag: [0..1]
+
+
+
+
+
+
Value:
SequenceNumber:
ValueMeaning: [0..1]
ValueMeaningDescription: [0..1]
RadioButtonLabel: [0..1]
HelpText: [0..1]
+
+
+ CheckValue:
1..* +
+
+
+ DataElementConceptId:
+
+
+
+
+ Source:
+
1..* +
+
+
+
+
+
+
+
ItemRef-specific specification +
«rendering»
ItemInstantiationOnAForm
+
+
+
+
+
+
+
+
+
0..1
+ ValueEditWidgetType:
«rendering»
ValueEditWidget
«semantic content»
ExplicitItemRefRepetition
FieldTypeFace:
FieldTypesize:
FieldTypeStyle:
FieldEnclosure:
0..1
0..1
0..*
+
+
+
0..* +
+
+
Action:
TargetId:
CriterionValue:
TriggerRelationship:
ForcedValue: [0..1]
EnumeratedValueDomainSubsetId: [0..1]
«rendering»
ValueEditField
+
+
+
+
+
FieldPage:
FieldULX:
FieldULY:
FieldHeight:
FieldWidth:
«rendering»
RadioButtonSet
0..*
for a specific explicit rep
ButtonLabelTypeFace:
ButtonLabelTypeSize:
ButtonLabelTypeStyle:
ButtonEnclosureStyle:
SymbolWhenSet:
«rendering»
RadioButtonPresentation
0..1
+ RepeatSequenceNumber:
+ RepeatSpecificDefaultValue: [0..1]
«logical behavior»
TriggeredAction
for a ref and any repetitions
PromptOrientation:
PromptTypeFace:
PromptTypeSize:
PromptTypeStyle:
Item-specific appearance setting
Id:
SectionRefId:
SequenceNumber:
Name: [0..1]
NavigateByItemInRepeatFlag: [0..1]
MaximumItemRefRepeats: [0..1]
HelpText: [0..1]
EncloseGroupRefInBoxFlag: [0..1]
Id:
ContainerType: [0..1]
ContainerId:
HelpText: [0..1]
NavigationSequenceNumber:
IsContextItemFlag:
PromptText:
EnumeratedValueDomainSubsetId: [0..1]
IsMandatoryFlag: [0..1]
ROASId: [0..1]
«rendering»
FieldAppearance
«rendering»
RadioButtonAppearance
DCI fields, in grouping
structures
«logical behavior»
RangeCheck
Id:
Comparator:
0..*
SoftHard:
ErrorMessage: [0..1]
UnitOfMeasure: [0..1]
0..2
«rendering»
ItemAppearance
0..1
reference
0..*
«logical behavior»
CheckValue
+
1..* +
+
+
+
+
+
+
InstructionText:
TypeFace: [0..1]
TypeSize: [0..1]
TypeStyle: [0..1]
0..*
«semantic content»
ItemRef
ItemDef-wide specification
1..*
«semantic content»
EVDSubsetElementRecord
reference
1..*
«semantic content»
RegistryObjectAttributeSet
+
+
+
+
Id:
Name:
NavigationSequenceNumber:
EncloseSectionRefInBoxFlag: [0..1]
DifferentiatorQuestionValue: [0..1]
HelpText: [0..1]
DifferentiatorQuestion: [0..1]
+
+
+
+
«rendering»
GraphicImage
«structure»
GroupRef
«semantic content»
NonEnumeratedValueDomain
VocabularyName:
VocabularyOID: [0..1]
VocabularyVersion: [0..1]
VocabularyCodeset: [0..1]
+
1..* +
+
+
+
+
+
AssociatedElement:
Page: [0..1]
ULX: [0..1]
ULY: [0..1]
LRY: [0..1]
LRX: [0..1]
«rendering»
Instruction
«semantic content»
ContextItem
«semantic content»
GroupDef
+
+
+
+
+
«semantic content»
EnumeratedValueDomainSubset
«structure»
SectionRef
reference
1..*
Definitions of
DCI component
base objects.
Global Metadata for
the eDCI
«semantic content»
EnumeratedValueDomain
1..*
«semantic content»
SectionDef
1..*
«semantic content»
ValueDomain
+
+
+
+
+ IntendedFormHeight:
+ IntendedFormWidth:
DCI-wide default appearance setting
1..*
+
+
+
+
+
+
+
+
Guidance on rendering the DCI as a
form. This information is of three sorts:
1. Logical behavior: TriggerAction
conveys business rules for interactions
among fields
2. Appearance of elements on the form
3. Postion of elements on the form.
All three are optional. However, if
position is sent, appearance should be
sent as well.
«rendering»
PromptRenderingLocation
+ Page:
+ PromptULX:
+ PromptULY:
+
+
+
+
1..* +
+
+
+
EVDSubsetElementRecordSN:
ButtonPage:
LabelULX:
LabelULY:
ButtonULX:
ButtonULY:
ButtonLRX:
ButtonLRY:
SDTM
• SDTM model
– Being harmonized with
adverse event
reporting, CTOM (NCI
clinical trial object
model) and HL7
SDTM Class Diagram
cd SDTM Analysis Model
Preliminary Techincial
Harrmonization notes
BRIDG Shared Classes::
Participation
+
+
+
+
+
type: CodedConcept
status: CodedConcept
statusDate: DATETIME
startDate: DATETIME
endDate: DATETIME
Harmonization
notes (HN)-- similar
to Observation--SH
+performs
+is collecte at
SDTMFinding
OtherFindings
+
+
+ measurementTime: DATETIME
+ evaluationInterval: timing specification
::SDTMFinding
+ name: CodedConceptDataType
+ missingValueCode: CodedConceptDataType
1
Note: The
variable
PEBODSYS may
apply to either
the test
description or the
result description.
Each StudySubject is
associated with only 1 site.
A StudySite is associated
with 1 or more
StudySubject.
+is responsible for
name: CodedConceptDataType
0..*
missingValueCode: CodedConceptDataType
+is assigned to 0..*
+ targetAccrualNumber: int
::Participation
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME
+ startDate: DATETIME
+ endDate: DATETIME
0..*
+is the
location for
participation
for
1
0..*
1
1
1
+is assigned to 0..*
StudySubj ect
+is screened for or
+ subjectID: CodedConceptDataType enrolled in
1..*
+ studyRefStartTime: DATETIME
+ ArmCode: CodedConceptDataType
+ studyRefStopTime: DATETIME
+may experience
::Participation
+has
+receives ::Participation
+ type: CodedConcept
1..
+may
have a
1
1 + type: CodedConcept
+ status: CodedConcept
+ status: CodedConcept Harmonization Notes:
+ statusDate: DATETIME
1
+ statusDate: DATETIME Move to Activities
+must
and
have
+ startDate: DATETIME
+ startDate: DATETIME Particiaptions package
+ endDate: DATETIME
1
+ endDate: DATETIME
HN: harmonize with
SubjectAssignment --SH
+has test performed
0..*
1
1
+is the source of
+screens or enrolls
ArmAssignment
Examination
- resultDescription: SDTMFindingDescriptionDataType
+ measurementTime: int
::SDTMFinding
+ name: CodedConceptDataType
+ missingValueCode: CodedConceptDataType
+ signatureCode: int
+ signatureText: string
::Participation
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME
+ startDate: DATETIME
+ endDate: DATETIME
Clinical Trials Activities::PerformedStudy
Clinical Trials Activ ities::
StudySite
Clinical Trials Activ ities::
StudyInv estigator
PerformingLaboratory
HN: Add as a Role to
Entities and Roles
::Participation
package--SH
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME
+ startDate: DATETIME
+ endDate: DATETIME
Activity
Harmonization
notes -- similar to
Quantitativ eMeasurement
Note: There are regulatory
requirements to report
original and standard
results, units, and normal
ranges. The primary
concept is denoted in tthe
QuantitativeMeasurement
class, and not all the
variations.
clinicalResults--SH
+ result: text
+ units: text
+ normalRangeLow: text
+ normalRangeHigh: text
::SDTMFinding
+ name: CodedConceptDataType
+ missingValueCode: CodedConceptDataType
1
+ 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
+ availabilityTime: TimingSpecification
+ priorityCode: PSMCodedConcept
+ confidentialityCode: PSMCodedConcept
+ repeatNumber: rangeOfIntegers
+ interruptibleIndicator: BOOLEAN
+ uncertaintyCode: CodedConcept
+ reasonCode: PSMCodedConcept
+ endDate: DATETIME
1
+is experienced
by
1..*
Harmonization Notes (HN):
PerformedSutdy .....review
subj ectVisit --duplicate of
plannedUnplannedInd--SH
+ visitNum: sequentiallist
+ plannedunplannedind: boolean
+collects
+ descriptionOfUnplannedVisit: text
0..1 ::SDTMEvent
+ description: SDTMEventDescriptionDataType
+ endTime: DATETIME
+ startTime: DATETIME
+collects
0..1
+collects
0..1
+are collected at
0..*
1..*
LaboratoryTest
VitalSign
+ method: enum
+ fastingStatus: boolean
::QuantitativeMeasurement
+ result: text
+ units: text
+ normalRangeLow: text
+ normalRangeHigh: text
::SDTMFinding
+ name: CodedConceptDataType
+ missingValueCode: CodedConceptDataType
+ 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
+is performed on
+
+
+
+
+
+
description: SDTMInterventionDescriptionDataType
missingValueCode: CodedConceptDataType
indication: text
startTime: DATETIME
endTime: DATETIME
evaluationInterval: timing specification
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.
Harmonization
Notes - similar to AE
Adv erseEv ent
classes --SH
+ isSerious: boolean
+ location: CodedConceptDataType
+may happen to + severity: enum
+ actionTakenWithStudyTreatment: enum
0..* + otherActionTaken: text
+ relationshipToStudyTreatment: CodedConceptDataType
+ actionTakenWithConcomitantTreatment: text
+ toxicityGrade: CodedConceptDataType
+ seriousnessCriteria: enum
+ outcome: CodedConceptDataType
::SDTMEvent
+ description: SDTMEventDescriptionDataType
+ endTime: DATETIME
+ startTime: DATETIME
Disposition
::SDTMEvent
+ description: SDTMEventDescriptionDataType
+ endTime: DATETIME
+ startTime: DATETIME
0..*+is collected at 0..*
SDTMInterv ention
ARMCD and ARM
are going to be
associated with
Trial Design.
Evaluator: ENUM
Value: string
variableName: string
Reference: string
Harmonization Notes:
description: SDTMEventDescriptionDataType
This maybe a Performed
endTime: DATETIME
Activty --SH
startTime: DATETIME
0..*
+is performed by
relationshipType: ENUM
Date and Time of
Collection are
probably going to
be attributes of the
CRF.
+receives Interventions
+are performed on
+
+
+
+
+
SDTMEv ent
+
+
+
MedicalHistory
+belongs to
Action:
Determine how
HL7 handles
units.--PQ data
type
SupplementalQualifiers
SDTMActActRelationship
Action: Check with
CTOM team about
what StudyAgent
means.
Action: Determine
how to handle
PATTERN since it
isn't included yet.
+ missingValueCode: CodedConceptDataType
+ negationIndicator: boolean
+ evaluationInterval: timing specification
::SDTMEvent
+ description: SDTMEventDescriptionDataType
+ endTime: DATETIME
+ startTime: DATETIME
0..*
Clinical Trials Activ ities::
StudyAgent
Could have
NonAdverseEvent
abstract class
above
MedicalHistory
::Participation
+ type: CodedConcept
+ status: CodedConcept
+ statusDate: DATETIME
+ startDate: DATETIME
+ endDate: DATETIME
Medical History
will probably not
harmonize into
the BRIDG in this
way but will
probably be
associated with
Subject.
1..*
TestInterpretation
+
+
normalRangeIndicator: enum
resultCategory: int
interpretedBy: enum
Action: Check with
RXNORM and
Structured Product
Label for the
standards to
describe drug
dosing.
InterpretedResults
::TestInterpretation
+ normalRangeIndicator: enum
- resultCategory: int
+ interpretedBy: enum
::QuantitativeMeasurement
+ result: text
+ units: text
+ normalRangeLow: text
+ normalRangeHigh: text
::SDTMFinding
+ name: CodedConceptDataType
+ missingValueCode: CodedConceptDataType
+interprets
InterpretedLaboratoryTest
1
Action:; Need to
determine how to
handle baseline.
The baseline is
an interpretation
based on many of
the test results.
+ 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
There are complex date times that will
require collection intervals -- for
example, a 24 hour cortisone, a 24 hour
urine collection, etc. We will need to
take a look at the HL7 date/time data
types to provide more information about
how best to represent the dates and
times.
type: enum
condition: text
collectionTime: DATETIME
collectionMethod: enum
id: CodedConceptDataType
Harmonization Notes similar to Proceudre,
SpecimenCollection,
Sample --SH
+is analyzed by
+is interpreted by
1
1..*
+is taken from
+Is performed on
Specimen
Image
1
+ id: URL
::Sample
+ type: enum
+ condition: text
+ collectionTime: DATETIME
+ collectionMethod: enum
HN: Good concept
defintion; similar to
Imaging class; review the
associaitons -SH
description: text
Action:
Determine how to
handle derived
tests or findings.
Sample
+
+
+
+
+
TestTestRelationship
+
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 is
an attribute of these
2 subclasses, but
not StudyDrug.
StudyDrug
Harmonization Notes -- similar to
+ dose: numeric
Activity
+ doseDescription: text
>SubstanceAdministration--SH
+ 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
+is administered according
+ type: CodedConcept
to
+describes administration of
+ status: CodedConcept
+ statusDate: DATETIME
1..*
0..1
+ startDate: DATETIME
+ endDate: DATETIME
::Sample
+ type: enum
+ condition: text
+ collectionTime: DATETIME
+ collectionMethod: enum
+ id: CodedConceptDataType
0..*
Action: Revisit --ADJ
(Reason for Dose
Adjustment) since
we haven't included
it yet.
DoseRegimen
Represent Concomicant
Medications and Substance Use
these are complex data types used to support the classes in the model.
SDTMInterv entionDescriptionDataType
+
+
+
+
verbatim: text
decode: CodedConceptDataType
modified: text
class: CodedConceptDataType
SDTMFindingDescriptionDataType
+
+
verbatim: text
modified: text
SDTMEv entDescriptionDataType
+
+
+
+
decode: CodedConceptDataType
verbatim: text
bodySystem: CodedConceptDataType
modified: text
In SDTM the RelRec table associates
observations to one another. This would be
represented as a ActAct Relationship
within BRIDG. The RelRec table does not
give the kind of relationship, just the
existence of the relationship.
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
Name:
Author:
Version:
Created:
Updated:
Logical Model
AbdulMalik Shakir
1.0
10/18/2005 8:40:14 PM
1/24/2006 10:38:06 AM
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
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
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
caAERS Conceptual Data Model v20060123.0
Dev ice
ParticipatingEntityRelationship
Protocol
+
+
+entityRelationship +
+
0..1 +
ClincalStudy
+ 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
+ type: string
+ researchComment: string
::Activity
+ description: string
+ durationTimeAmount: int
+ durationTimeUnit: string
+ endTime: dateTime
+ id: long
+ method: string
+ reason: string
+ startTime: dateTime
+ status: string
Location
effectiveFromTime: dateTime
effectiveThruTime: dateTime
id: long
relationshipStatus: string
relationshipType: string
+relationshipCollection0..*
+ name: string
+ description: string
+ streetAddress: string
+ city: string
+ state: string
+ postalCode: string
::ParticipatingEntity
+ id: long
0..* +relationshipCollection
+roleCollection 0..*
ParticipatingEntityRole
+
+
+
+
+
+
Product
effectiveFromTime: dateTime
effectiveThruTime: dateTime
id: long
roleType: string
+roleCollection
status: string
title: string
0..*
+role
0..1
+participationCollection
0..*
DrugProduct
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+targetEntity
+
+
+
+
+
+
+
+
id: long
relationshipType: string
effectiveFromTime: dateTime
effectiveThruTime: dateTime
relationshipStatus: string
sourceActivityRole: string
targetActivityRole: string
sequence: int
+
+
+sourceActivity
+
1 +
+targetActivity +
+
1
+
+
0..*
+
+activityCollection
+relationshipCollection
0..*
+relationshipCollection
0..*
description: string
durationTimeAmount: int
durationTimeUnit: string
endTime: dateTime
id: long
method: string
reason: string
startTime: dateTime
status: string
+
+
+participationCollection
+
0..* +
+
+
+entity
+act
1
+activity
1
effectiveFromTime: dateTime
effectiveThruTime: dateTime
+participationCollection
id: long
participantSignature: string
0..*
participantSignatureDate: dateTime
type: string
id: long
activityCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
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
DrugProductIngredient
+ name: string
::ParticipatingEntity
+ id: long
1
+ingredientCollection
1 +material
+entityCollection
0..*
+
+
+
+
id: long
quantity: float
activeIngredientIndicator: boolean
materialForm: string
0..*
id: long
identifierValue: string
identifierType: string
+identifierCollection
Observ ationKind
+
+
+
+
+
+
ObservationValue
+
id: long
StudySubj ect
0..*
Observ ation
id: long
+observationCollection
1
observationValueCode: string
0..*
name: string
+observationValueKind
description: string
codeSystem: string
codeSystemVersion: string
0..*
+observationValueCollection
+ 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
+observation
+ startTime: dateTime
+ status: string
1
Weight
+ value: real
+ unitOfMeasure: string
+ obtainedIndicator: boolean
::ObservationValue
+ id: long
DiagnosticTest
Height
+ name: string
+ datePerformed: dateTime
+ type: string
+ category: string
+ value: string
+ unitOfMeasure: string
::ObservationValue
+ id: long
+ value: real
+ obtainedIndicator: boolean
+ unitOfMeasure: string
::ObservationValue
+ id: long
+ causalAgentName: string
+ site: string
+ type: string
+ date: date
::ObservationValue
+ id: long
+identifierCollection
Adv erseEv entReport
+ 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
Person
1
+ 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
Activ ityIdentifier
+
+
+
+
+
+assigningAuthority
+participatingEntityKind
id: long
Organization
identifierValue: string
+identifierCollection
identifierType: string
+ name: string
versionIdentifier: string
+assigningAuthority
0..*
1 ::ParticipatingEntity
versionEffectiveDate: dateTime
+ id: long
+organization
1
ParticipatingEntityKind
+
+
+
+
+
+
id: long
entityType: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+ namePrefix: string
+ firstName: string
+ middleName: string
+ lastName: string
+ nameSuffix: string
+ occupation: string
+ emailAddress: string
::ParticipatingEntity
+ id: long
+
isHealthProfessional() : boolean
1
+person
+telephoneCollection
+telephoneCollection
0..*
OrganizationTelephone
+adverseEventReport
1
+adverseEventReportDetailCollection
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
1
0..*
+studySubject
PersonTelephone
+
+
+
+
+
1
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
0..*
Adv erseEv entReportDetail
+
+
+
+
0..*
+AdverseEventReportCollection
Adv erseEv ent
+ outcomeCode: string
+ severity: string
+ adverseEventVerbatimTerm: string
+ attributableEventOrEntityType: string
+ attributableEventName: string
+ isContinuingIndicator: boolean
+ comment: string
+ evaluationMethodCode: string
+ evaluationConclusionCode: string
+ evaluationResultCode: string
+ otherTypeOfReportableEvent: string
+adverseEvent
+ reportableEventType: string
+ otherReasonBeingSerious: string
1
+ reasonBeingSerious: string
+ ctcAdverseEventCategory: string
+adverseEvent 1 + ctcAdverseEventGrade: int
+ ctcAdverseEventTerm: string
+ medDRAcode: string
+ abatedAfterRemedialActionIndicator: boolean
+ locationOccurred: string
+ otherContributingCause: string
+ reappearedAfterAgentReintroductionIndicator: boolean
+ seriousAdverseEventIndicator: boolean
+ otherCTCAdverseEventTerm: string
+ seriousAdverseEventTreatmentDateApplicableIndicator: boolean
+ ageAtTimeOfEvent: int
+ removedFromStudyAfterAdverseEventIndicator: boolean
+adverseEvent
+ dateRemovedFromStudy: date
1
+ 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
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
+adverseEventReportDetailCollection
+adverseEventReportDetailKind
+studySubjectObervationCollection
1
id:
adverseEventReportDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
Adv erseEv entDetailKind
Adv erseEv entDetail
+eventDetailCollection
0..*
+
+
+
+
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
0..1
StudySubj ectObserv ation
+
+
+
0..*
Adv erseEv entReportDetailKind
+
+
+
+
+
+
+eventDetailKind
0..*
+eventDetailCollection
1
+
+
+
+
+
+
1
MaterialKind
ParticipatingEntityIdentifier
+
+
+
1
Infection
Adv erseEv entActiv ityRelationship
+ expectedness: boolean
+ attributionCode: int
+ studyDesignBroken: boolean
+ administrationDelayed: boolean
+ durationDelayedTimeUnitCode: string
+ delayedDurationTimeAmount: int
::ActivityRelationship
+activityRelationshipCollections
+ id: long
0..*
+ relationshipType: string
+ effectiveFromTime: dateTime
+ effectiveThruTime: dateTime
+ relationshipStatus: string
+ sourceActivityRole: string
+ targetActivityRole: string
+ sequence: int
+product
+ingredientCollection 1..*
id: long
+entity
+identifierCollection 0..*
+activityKind
Death
+ cause: string
+ deceasedDate: date
+ causeUnrelatedToAdverseEvent: string
+ otherCause: string
+ causalPrimaryOrganSystemFailure: string
+ autopsyPerformedIndicator: boolean
+ causeKnownIndicator: boolean
+ autopsyDate: date
::ObservationValue
+ id: long
1
ParticipatingEntity
1
Activ ityKind
+
+
+
+
+
+
1 +
+entity
+ lotNumber: string
+ expirationDate: date
+ brandName: string
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+sourceEntity
1
Activ ityParticipation
Activ ity
Activ ityRelationship
+ implantedDate: dateTime
+ explantedDate: dateTime
+ reprocessedIndicator: boolean
+ availableForEvaluationIndicator: boolean
+ labeledForSingleUseIndicator: boolean
+ usage: string
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
id: string
adverseEventDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
id: long
baselinePerformanceStatus: int
medicalHistoryDescription: string
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 Comprehensiv e M odel
BRIDG Shared Classes::Participation
BRIDG Shared Classes::Role
+
+
+
+
+
+
+
+
i d: CodedConcept
code: CodedConcept
status:
el ectroni cCom m Addr:
geographi cAddr:
tel ecom Addr:
effecti veStartDate: DAT ET IM E
effecti veEndDate: DAT ET IM E
has a
1
+
+
+
+
+
BRIDG Shared Classes::
RoleRoleRelationship
1..*
+
+
+
has a
1
source:
type: CodedConcept
target:
i d: CodedConcept
adm i ni strati veGenderCode: BRIDGCodedConcept
dateOfBi rth: DAT ET IM E
raceCode: BRIDGCodedConcept
ethni cGroupCode: BRIDGCodedConcept
m ari tal StatusCode: BRIDGCodedConcept
el ectroni cCom m Addr:
househol dIncom eCategory: BRIDGCodedConcept
educati onLevel Code: BRIDGCodedConcept
tel ecom Address: T EL
nam e: enti tyNam e
dateOfDeath: DAT ET IM E
address: addrT ype
Clinical Research Entities and Roles::
PersonRole
+
+
+
+
+
+
+
::Rol e
+
i d: CodedConcept
+
code: CodedConcept
+
status:
+
el ectroni cCom m Addr:
+
geographi cAddr:
+
tel ecom Addr:
+
effecti veStartDate: DAT ET IM E
+
effecti veEndDate: DAT ET IM E
paym entM ethod: CodedConcept
confi denti al i tyCode: stri ng
+
+
+
+
+
+
+
+
+
+
+
+
+
Clinical Trials Activ ities::Subj ectAssignment
+
si gnatureCode: i nt
+
si gnatureT ext: stri ng
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
0..*
1
0..1
+
studySubj ectIdenti fi er: i nt
+
arm : stri ng
+
subgroupCode: stri ng
+
i nform edConsentForm Si gnedDate:
+
offStudyDate: date
+
studyAgentDoseLevel : stri ng
+
el i gi bi l i tyWai verReason: stri ng
+
ageAtEnrol l m ent: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
+source acti vi ty
code: PSMCodedConcept
derivationExpres s ion: TEXT
des cription: PSMDes cription
s tartDate: DATETIME
s tatus : PSMCodedConcept
availabilityTim e: Tim ingSpecification
priorityCode: PSMCodedConcept
confidentialityCode: PSMCodedConcept
repeatNum ber: rangeOfIntegers
interruptibleIndicator: BOOLEAN
uncertaintyCode: CodedConcept
reas onCode: PSMCodedConcept
endDate: DATETIME
+target acti vi ty
*
rel ati onshi pCode: PSM CodedConcept
Obsol ete_rel ati onQual i fi er: BRIDGCodedConcept
sequenceNum ber: NUM BER
pauseCri teri on:
checkpoi ntCode:
pri ori tyNum ber: NUM BER
spl i tCode:
negati onRul e: AbstractRul e
j oi nCode:
negati onIndi cator: BOOLEAN
conj uncti onCode:
Clinical Trials Activ ities::PlannedStudy
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::PlannedActiv ity
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::PerformedActiv ity
1
+
pl annnedUnpl annedInd: bool ean
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::
StudySite
+
targetAccrual Num ber: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
1
+
+
+
+
+
+
+
+
+
*
date
0..*
Clinical Research
Entities and Roles::
FundingSponsor
Clinical Research
Entities and Roles::
HealthCareSite
0..*
0..*
Protocol Concepts::StudyDocument
+
+
+
+
+
+
+
+
+
Clinical Research
Entities and Roles::
TherapeuticAgent
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
form Code: CodedConcept
l otNum ber: i nt
expi rati onDate: DAT ET IM E
stabi l i tyT i m e: DAT ET IM E
1
0..*
versi on: stri ng
author: SET
ID: SET BRIDGID
docum entID: BRIDGID
type: ENUM
descri pti on: BRIDGDescri pti on
ti tl e: stri ng
status: BRIDGStatus
confi denti al i tyCode: CodedConcept
Clinical Trials
Activ ities::
AssessmentRelationship
Clinical Trials
Activ ities::
Observ ationRelationship
Clinical Trials Activ ities::
StudyAgent
Clinical Research
Entities and Roles::
AgentRole
Clinical Research Entities and
Roles::Agent
0..*
certi fi cateLi censeT ext:
Clinical Research Entities and
Roles::Participant
+
+
Clinical Research Entities and
Roles::OrganizationRole
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
statusDate: DAT ET IM E
geographi cAddr: addrT ype
tel ecom Addr: T EL
+
+
+
+
+
+
+
+
1
+
Clinical Research Entities
and Roles::Organization
Clinical Trials Activ ities::
StudyInv estigator
Clinical Research
Entities and Roles::
Inv estigator
BRIDG Shared Classes::
Activ ityActiv ityRelationship
BRIDG Shared Classes::Activity
type: CodedConcept
status: CodedConcept
statusDate: DAT ET IM E
startDate: DAT ET IM E
endDate: DAT ET IM E
1..*
Clinical Research Entities and Roles::Person
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
1
1
1
+
+
+
+
+
+
+
+
+
+
+
+
i d: BRIDGID
l ongT i tl e: stri ng
shortT i tl e: stri ng
phaseCode: ENUM
i ntentCode: ENUM
m oni torCode: ENUM
bl i ndedInd: bool ean
random i zedInd: bool ean
di seaseCode: CodedConceptDataT ype
sponsorCode: CodedConceptDataT ype
m ul ti Insti tuti onInd: bool ean
targetAccrual Num ber: i nt
+
+
+
i d: i nt
type: stri ng
com m ents: stri ng
Clinical Trials Activ ities::
PerformedStudy
1
0..*
1
0..*
0..*
1
1
+
+
+
+
+
0..*
+
+
+
+
BRIDG Shared Classes::
BRIDGCodedConcept
nam e: T EXT
val ue:
control l edNam e: PSM CodedConcept
busi nessProcessM ode: PSM Busi nessProcessM ode
-
BRIDG Shared Classes::
BRIDGContactAddr
code: T EXT
codeSystem :
codeSystem Nam e: T EXT
codeSystem Versi on: NUM BER
di spl ayNam e: T EXT
ori gi nal T ext: T EXT
transl ati on: SET {PSM CodedConcept}
BRIDG Shared Classes::BRIDGDescription
+
+
+
synopsi s: Encapsul atedData
sum m aryDescri pti on: Encapsul atedData
detai l edDescri pti on: Encapsul atedData
i d: i nt
reporti ngDate: date
confi denti al i tyCode: stri ng
uncertai ntyCode: stri ng
statusCode: stri ng
+
+
1..*
m odeVal ue:
+
+
+
ENUM {Pl an, Execute}
+
startT i m e:
endT i m e:
+
+
+
source: T ext
versi on: T ext
val ue: T ext
0..*
+
+
+
Clinical Trials Activ ities::
SubstanceAdministration
+
+
+
+
+
+
0..*
«abstracti on»
1
date
Clinical Trials Activ ities::Adv erseEv ent
Clinical Trials Activ ities::Histopathology
ti m estam p
ti m estam p
BRIDG Shared Classes::
BRIDGStatus
i d: i nt
eval uati onDate:
0..*
0..*
BRIDG Shared Classes:
:BRIDGInterv al
type: BRIDGCodedConcept
effecti veT i m e: BRIDGInterval
usage: BRIDGCodedConcept
BRIDG Shared
Classes::
BRIDGID
BRIDG Shared Classes::
BRIDGBusinessProcessM ode
+
+
+
+
0..*
Clinical Trials Activities::Assessment
1
BRIDG Shared Classes::BRIDGAnalysisVariable
i d: i nt
typeCode: stri ng
com m entT ext: stri ng
1
Clinical Trials Activ ities::Observ ation
doseQuanti ty: i nt
doseUni tOfM easure: stri ng
route: stri ng
doseFrequency: stri ng
doseM odi fi cati onT ype: stri ng
doseChangeT ype: i nt
grossExam Resul tCode: stri ng
reportDescri pti veT ext: stri ng
i nvol vedSurgi cal M argi nIndi cator:
1
0..*
Clinical Trials Activ ities::Procedure
effecti veEndDate:
effecti veStartDate:
statusVal ue:
+
targetSi teCode:
Clinical Trials Activ ities::
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
bool ean
1
Clinical Trials Activ ities::
HistopathologyGrade
stri ng
+
+
+
+
i d: i nt
gradi ngSystem Nam e:
grade: stri ng
com m ents: stri ng
stri ng
panel Nam e: stri ng
val ue: stri ng
val ueUni tOfM easureCode: stri ng
assayM ethodCode: stri ng
bodyPosi ti onCode: stri ng
l abReferenceRangeCode: stri ng
l abT echni queCode: stri ng
m eansVi tal StatusObtai nedCod: stri ng
abnorm al Indi cator: bool ean
bi om arkerInd: bool ean
si gni fi canceInd: bool ean
0..*
Clinical Trials Activ ities::
LesionDescription
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
l esi onNum ber: stri ng
eval uati onNum ber: i nt
appearanceT ypeCode: stri ng
targetNonT argetCode: stri ng
m easurabl eIndi cator: bool ean
m ethodCode: stri ng
xDi m ensi on: i nt
yDi m ensi on: i nt
zDi m ensi on: i nt
di m ensi onProduct: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeSystem : stri ng
contactAnatom i cSi teCode: stri ng
contactAnatom i cSi teCodeSytem : stri ng
previ ousl yIrradi atedSi teIndi cator: bool ean
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
1..*
Clinical Trials
Activ ities::
Neoplasm
Clinical Trials
Activ ities::
Surgery
Clinical Trials
Activ ities::
SpecimenCollection
+
+
Clinical Trials Activ ities::
Radiation
si teCondi ti on: stri ng
m ethod: stri ng
+speci m enCol l ecti on
+
+
+
therapyT ype: stri ng
doseUni tOfM easure:
dose: stri ng
+
+
i denti fi er: stri ng
contrastAgentEnhancem ent: stri ng
descri pti veT ext: stri ng
rateOfEnhancem entVal ue: i nt
i d: i nt
cel l T ype:
+
+
+
+
+
+
+
+
+
+
+
+
+
responseCode: char
responseCodeSystem : stri ng
bestResponseCode: char
bestResponseDate: date
progressi onDate: date
progressi onPeri od: i nt
progressi onPeri odUni tOfM easureCode:
doseChangeIndi catorCode: i nt
courseDi sposi ti onCode: stri ng
com m entT ext: stri ng
0..1
+
+
+
+
+
i d: i nt
subm i ssi onDate: date
fi l edIndi cator: bool ean
i d: i nt
tnm Stage: stri ng
tnm StageCodeSystem : stri ng
stageCode: stri ng
stageCodeSystem : stri ng
Clinical Trials Activ ities::
DeathSummary
+
+
+
+
deathDate: date
deathCauseCode: char
deathCauseT ext: stri ng
autopsi edIndi cator: bool ean
1
0..*
1..*
0..*
Clinical Trials Activ ities::
Adv erseEv entTherapy
Clinical Trials Activ ities:
:Specimen
i d: i nt
i dNum ber: i nt
sam pl i ngT ype:
+
+
+
+
+
stri ng
i d: i nt
treatm entDate: date
del ayDurati on: i nt
del ayDurati onUni tOfM easureCode:
i ntensi tyCode: stri ng
Clinical Trials Activ ities::
M etastasisSite
+
+
+
stri ng
stri ng
1
i d: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeNam e: stri ng
Clinical Trials
Activ ities::
LesionEv aluation
+
eval uati onCode:
char
Clinical Trials Activ ities::
Qualitativ eEv aluation
1
+speci m enCol l ecti on
+
+
+
Clinical Trials Activ ities::DiseaseResponse
nam e: stri ng
di seaseDi agnosi sCode: stri ng
di seaseDi agnosi sCodeSystem : stri ng
ageAtDi agnosi s: i nt
confi rm ati onDate: date
pri m aryAnatom i cSi teCode: stri ng
pri m aryAnatom i cSi teCodeSystem : stri ng
pri m aryAnatom i cSi teLateral i tyCode: stri ng
recurrenceIndi cator: bool ean
di seaseStatusCode: stri ng
sourceCode: stri ng
sourceOther: stri ng
di seaseExtentT ext: stri ng
Clinical Trials Activ ities::
CancerStage
0..1
stri ng
+
+
+
+
+
+
+
+
+
+
+
+
+
1
Clinical Trials
Activ ities::
Adv erseEv entReport
Clinical Trials Activ ities::Imaging
+
+
+
+
stri ng
onsetDate: date
resol vedDate: date
ctcCategoryCode: stri ng
ctcCategoryCodeSystem : stri ng
ctcT erm T ypeCode: stri ng
ctcT erm T ypeCodeSystem : stri ng
ctcAttri buti onCode: stri ng
ctcAttri buti onCodeSystem : stri ng
ctcGradeCode: stri ng
ctcGradeCodeSystem : stri ng
seri ousReasonCode: stri ng
outcom eCode: stri ng
acti onT akenCode: stri ng
condi ti onPatternCode: stri ng
doseLi m i ti ngT oxi ci tyIndi cator: bool ean
doseLi m i ti ngT oxi ci tyDescri pti onT ext: stri ng
descri pti onT ext: stri ng
Clinical Trials Activ ities::Diagnosis
+
+
+
+
+
+
+
+
survi val StatusCode: i nt
survi val StatusDescri pti onT ext: stri ng
perform anceStatusCode: i nt
perform anceStatusCodeSystem : stri ng
pai nIndexCode: i nt
pai nIndexCodeSystem : stri ng
anam Resul tAccuracyPercent: i nt
m enstrual PatternT ypeCode: stri ng
m enstrual Indi cator: bool ean
Implementation Specific Models
CTOM
caAERS
cd Logical Model
Name:
Author:
Version:
Created:
Updated:
cd Clinical Trials Object Model (CTOM)
Name:
Author:
Version:
Created:
Updated:
Clinical Trials Object Model (CTOM)
ScenPro
0.5
7/1/2001 12:00:00 AM
1/19/2006 5:06:46 PM
+protocol
Protocol
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
StudyInvestigator
+ i d: i nt
+ responsibilityRoleCode: string
+ startDate: date
+studyInvestigatorCollection + stopDate: date
+ statusCode: string
1 +eligibilityCriteriaCollection
0..* + signatureIndicator: boolean
+protocolCollection
+ signatureText: string
EligibilityCriteria
1..*
1..*
+studyInvestigatorCollection 0..*
+ i d: i nt
+ questionText: string
+investigator 1
+ questionNumber: int
+ expectedAnswerIndicator: boolean
Investigator
+
+
+
+
+
+
+
+
+
+
+
+
+
+ nciIdentifier: string +
Person
i d: i nt
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
Logical Model
AbdulMalik Shakir
1.0
10/18/2005 8:40:14 PM
12/4/2005 11:25:52 PM
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
PersonOccupation
+personOccupationCollection
+person
1
0..*
+ i d: i nt
+ primaryTypeCode: string
+ primaryTypeCodeSystem: string
+ startDate: date
+ stopDate: date
StudyTimePoint
+
+
+
+
+
+
i d: i nt
visitName: string
courseNumber: int
epochName: string
courseStartDate: date
courseStopDate: date
Activ ityRelationship
Dev ice
+ implantedDate: dateTime
+ explantedDate: dateTime
+ reprocessedIndicator: boolean
+ availableForEvaluationIndicator: boolean
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
ObservationRelationship
+ i d: i nt
+ typeCode: string
+ sequenceNumber: int
+ commentText: string
i d: i nt
nciIdentifier: string
amendmentIdentifier: int
FemaleReproductiv eCharacteristic
amendmentDate: date
+studyTimePoint 0..1
+activityRelationshipCollection 0..*
+ i d: i nt
navyNCIIdentifier: string
+ firstLiveBirthAge: int
longTitleText: string
+ liveBirthCount: int
shortTitleText: string
+ stil BirthCount: int
precisText: string
1
+eligibilityCriteria
+ abortionIndicator: boolean
descriptionText: string
+
menopauseSt
a
r
t
D
at
e
:
dat
e
diseaseCode: string
+femaleReproductiveCharacteristic
+participantEligibilityAnswerCollection
+activity 1
+activity 1
+ menopauseAge: int
Inclusion Exclusion 0..*
intentCode: string
+ menopauseReasonCode: string
+participantEligibilityAnswerCollection +participant
monitorCode: string
Participant
Activ ity
1 0..1 + menopauseReasonOtherText: string
phaseCode: string
ParticipantEligibilityAnswer
0..*
1 + initials: char
+participant
sponsorCode: string
+ i d: i nt
HealthcareSiteParticipantRole
+ zipCode: string
+protocolStatusCollection
blindedIndicator: boolean
+ i d: i nt
+ name: string
+ paymentMethodCode: char
multiInstitutionIndicator: boolean +protocol
+ answerText: string
+ i d: i nt
+ type: string
+ confidentialityIndicator: boolean
ProtocolStatus
randomizedIndicator: boolean 1
+ checklistNumber: string
+ roleCode: string
+ descriptionText: string
1..*
targetAccrualNumber: int
+ startDate: date
+ i d: i nt
+participant 1
1
+healthcareSiteRoleCollection 0..*
+activityCollection + stopDate: date
+participant
+ statusCode: string
+ durationValue: int
+ statusDate: date
0..*
+healthcareSiteParticipant 1 +healthcareSiteParticipantCollection 0..*
+ durationUnitOfMeasureCode: string
+ plannnedIndicator: boolean
HealthcareSite
HealthcareSiteParticipant
+ reasonCode: string
Organization
+healthcareSiteParticipant
+ nciInstituteCode: string
+ i d: i nt
+ i d: i nt
1+healthcareSite 0..* + participantIdentifier: string
+ name: string
+healthCareSite 1
+ descriptionText: string
SubstanceAdministration
+ statusCode: string
+ anatomicSiteCode: string
+studyParticipantAssignmentCollection 0..*
+ statusDate: date
+studyParticipantAssignment
+ singleDose: int
+ anatomicSiteCodeSystem: string
+ streetAddress: string
+ singleDoseUnitOfMeasureCode: string
+study
StudyParticipantAssignment
1
+ city: string
+ doseFrequencyCode: string
+studySiteCollection 0..*
+ stateCode: string
+ doseFrequencyText: string
1
+ i d: i nt
+ postalCode: string
+ totalDose: int
StudySite
+ studyParticipantIdentifier: int
+ countryCode: string
+ totalDoseUnitOfMeasureCode: string
+ armIdentifier: string
+ i d: i nt
+ telecomAddress: string
+ doseChangeCode: string
+ subgroupCode: string
+ roleCode: string
+ doseChangeIndicatorCode: int
SpecimenCollection
+ informedConsentFormSignedDate: date
+protocol
+ routeCode: string
+studySiteCollection + statusCode: string
+ enrol mentAge: int
+ targetAccrualNumber: string
+ siteConditionCode: string
1
+ studyAgentDoseLevel: int
+substanceAdministrationCollection 0..* 1
0..*
0..* + startDate: date
+ methodCode: string
+studyAgentCollection 0..*
+ studyAgentDoseLevelUnitOfMeasureCode: string
+studySite
+substanceAdministrationCollection
+ stopDate: date
+ offStudyDate: date
+ irbApprovalDate: date
StudyAgent
+specimenCollection 1
1
0..* + offStudyReasonCode: string
+subst
a
nceAdmi
n
i
s
t
r
a
t
i
o
n
+studyParticipantCollection + offStudyReasonOtherText: string
+ i d: i nt
+ eligibilityWaiverReasonText: string
+ investigationalIndicator: boolean
+studyAgent
+ investigationalNewDrugIdentifier: string
+specimenCollection 0..*
+ statusCode: string
1
+studyAgentCollection +agent
+agentOccurrence
+ statusDate: date
Specimen
AgentOccurrence
1
Agent
0..*
0..1
+ i d: i nt
+Agent
+AgentOccurrenceCollection + id: int
+ sampleIdentifier: int
+ i d: i nt
AgentSynonym +agentSynonymCollection
+ lotNumber: string
+agent
1
0..*
+ sampleTypeCode: string
+ name: string
+ formCode: string
+ i d: i nt
+ volume: int
0..*
1 + descriptionText: string +agent
+ expirationDate: date
+ name: string
+ volumeUnitOfMeasureCode: string
+ statusCode: string
1
+ i d: i nt
+ typeCode: string
+ commentText: string
+observationRelationshipCollection 0..*
0..* +activityRelationshipCollection
AssessmentRelationship
ParticipatingEntityRelationship
0..* +assessmentRelationship
+assessmentRelationshipCollection 0..*
Treatment
ProcedureTreatment
::Treatment
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+ i d: i nt
+ typeCode: string
+ commentText: string
0..* +observationRelationshipCollection
+
+
+observation 1 +observation 1
+activity 1
+activity
1
+observationCollection
0..* + id: int
+ reportingDate: date
+ confidentialityCode: string
+ uncertaintyCode: string
+ statusCode: string
1..*
+
+
+
+
+
+
+
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
Location
id: long
relationshipType: string
effectiveFromTime: dateTime
effectiveThruTime: dateTime
relationshipStatus: string
sourceParticipantRole: string
targetParticipantRole: string
+relationshipCollection 0..*
0..* +relationshipCollection
+ name: string
+ description: string
+ streetAddress: string
+ city: string
+ state: string
+ postalCode: string
::ParticipatingEntity
+ id: long
isContinuing() : boolean
isAdjustment() : boolean
+targetEntity
Activ ityRelationship
+
+
+
+
+
+
+
+
Activ ity
id: long
+relationshipCollection
relationshipType: string
effectiveFromTime: dateTime 0..*
effectiveThruTime: dateTime +relationshipCollection
relationshipStatus: string
sourceActivityRole: string
0..*
targetActivityRole: string
sequence: int
+sourceActivity +
+
1 +
+targetActivity +
+
1 +
+activityCollection +
Activ ityParticipation
id: long
startTime: dateTime
endTime: dateTime
method: string
reason: string
description: string
status: string
0..*
+
+participationCollection +
+
0..* +
+
+
+
+act
1
+activity
DrugProduct
+ lotNumber: string
+ expirationDate: date
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+sourceEntity
1
+ i d: i nt
+ evaluationDate: date
Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
Assessment
+assessmentCollection
0..*
ClincalStudy
+ phase: string
+ title: string
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
1 +assessmentCollection
+assessment 1
Observation
+observationCollection
Protocol
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+product
1
+ingredientCollection 1..*
+entity
+
id: long
MaterialKind
DrugProductIngredient
+ name: string
::ParticipatingEntity
+ id: long
1
+entity
1
1
+entityCollection
+ingredientCollection
1 +material
0..*
+
+
+
+
id: long
quantity: float
activeIngredientIndicator: boolean
materialForm: string
0..*
+identifierCollection
ParticipatingEntityIdentifier 0..*
Activ ityKind
+ grossExamResultCode: string
+ reportDescriptiveText: string
+ involvedSurgicalMarginIndicator: boolean
+histopathology 1
+histopathology 1
Radiation
Surgery
+ dose: string
+histopathologyGradeCollection 0..* +neoplasmCollection 0..*
+ doseUnitOfMeasureCode: string
+ scheduleText: string
HistopathologyGrade
Neoplasm
+ therapyExtentCode: string
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
panelName: string
value: string
valueUnitOfMeasureCode: string
assayMethodCode: string
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCode: string
abnormalIndicator: boolean
biomarkerIndicator: boolean
significanceIndicator: boolean
+ i d: i nt
+clinicalResultCollection 0..*
+ i d: i nt
+ gradeCode: string
+ cellTypeCode: string
+ gradeCodeSystem: string
+ commentText: string
+conceptDescriptor 1
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
previouslyIr adiatedSiteIndicator: string
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+adverseEventTherapyCollection 0..*
+ imageIdentifier: string
+ contrastAgentEnhancementIndicator: boolean
+ enhancementRateValue: int
+ enhancementDescriptionText: string
+
+
+
+
+
+
i d: i nt
code: string
codeSystem: string
codeSystemName: string
codeSystemVersion: int
displayText: string
1
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
+adverseEventReport 0..1
+diagnosis 1
+cancerStage 0..1
+
+
+
+
+
+
+
+
+
+ deathDate: date
Qualitativ eEvaluation
+ deathCauseCode: char
+ deathCauseText: string
survivalStatusCode: int
+ autopsiedIndicator: boolean
survivalStatusDescriptionText: string
performanceStatusCode: int
performanceStatusCodeSystem: string
painIndexCode: int
DiseaseResponse
painIndexCodeSystem: string
anamResultAccuracyPercent: int + reponseCode: char
menstrualPatternTypeCode: string + responseCodeSystem: string
menstrualIndicator: boolean
+ bestResponseCode: char
+ bestResponseDate: date
+ progressionDate: date
+ progressionPeriod: int
+ progressionPeriodUnitOfMeasureCode: string
+ doseChangeIndicatorCode: int
+ courseDispositionCode: string
+ commentText: string
+observationCollection
AdverseEventTherapy
AdverseEventReport
+ i d: i nt
+ submissionDate: date
+ filedIndicator: boolean
StudySubj ect
0..*
Person
1
Adv erseEv entReport
+ sequenceIdentifier: int
+ subjectDiscloserAllowed: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+assigningAuthority
+participatingEntityKind
+identifierCollection
Organization
+observationValueKind
id: long
observationValueCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
id: long
identifierValue: string
identifierType: string
versionIdentifier: string
versionEffectiveDate: dateTime
+identifierCollection
0..*
+assigningAuthority
1
+ name: string
::ParticipatingEntity
+ id: long
+
isFDA() : boolean
+ expectedness: boolean
+ attribution: int
+ studyDesignBroken: boolean
+ agentAdjustment: string
+ administrationDelayed: boolean
::ActivityRelationship
+activityRelationshipCollections
+ id: long
+adverseEvent
0..*
+ relationshipType: string
+ effectiveFromTime: dateTime
+ effectiveThruTime: dateTime
+ relationshipStatus: string
+ sourceActivityRole: string
+ targetActivityRole: string
+ sequence: int
+ outcome: string
+ seriousness: string
::Observation
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
1 + startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+
isContinuing() : boolean
1
+eventDetailCollection 0..*
Adv erseEv entDetailKind
+
+
+
+
+
+
id: string
adverseEventDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
Adv erseEv entDetail
+eventDetailKind
1
+
+eventDetailCollection 0..* +
+
+
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
1
0..*
Adv erseEv entReportDetail
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
+adverseEventReportDetailCollection
+adverseEventReportDetailKind
0..*
1
Adv erseEv entReportDetailKind
+
+
+
+
+
+
+ namePrefix: string
+ firstName: string
+ middleName: string
+ lastName: string
+ nameSuffix: string
+ occupation: string
+ emailAddress: string
::ParticipatingEntity
+ id: long
+
isHealthProfessional() : boolean
+person
0..*
OrganizationTelephone
+
+
+
+
id: long
entityType: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+telephoneCollection
+telephoneCollection
+adverseEvent
+
+
+
+
+
+
1
+adverseEventReport
1
+adverseEventReportDetailCollection
Adv erseEv ent
Adv erseEv entActiv ityRelationship
hasAmendedData() : boolean
sentToFDA() : boolean
initialSentToFDA() : boolean
sentToManufacturer() : boolean
treatmentDelayed() : boolean
delayDuration() : real
delayDurationUnits() : string
1
ParticipatingEntityKind
Activ ityIdentifier
+
+
+
+
+
+organization
+
+
+
+
+AdverseEventReportCollection +
+
0..*
+
Observ ationValueKind
+
+
+
+
+
+
CancerStage
MetastasisSite
+cancerStage +metastasisSiteCollection
+ i d: i nt
+ tnmStage: string
+ i d: i nt
1..*
+ tnmStageCodeSystem: string 1
+ anatomicSiteCode: string
+ stageCode: string
+ anatomicSiteCodeSystem: string
+ stageCodeSystem: string
id: long
identifierValue: string
identifierType: string
+identifierCollection
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
1
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
0..* + description: string
+ status: string
+adverseEvent
+ i d: i nt
+ treatmentDate: date
+ delayDuration: int
+ delayDurationUnitOfMeasureCode: string
+ intensityCode: string
+
+
+
Observ ation
+activityKind
id: long
activityCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
DeathSummary
+adverseEventCollection 1..*
ConceptDescriptor
Imaging
+ evaluationCode: char
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
+adverseEventCollection 1
+
+
+
+
+
+
LesionEvaluation
AdverseEvent
Histopathology
Procedure
id:
adverseEventReportDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
1
ParticipatingEntity
id: long
type: string
+participationCollection
effectiveFromTime: dateTime
effectiveThruTime: dateTime
0..*
participantRole: string
participantSignature: string
participantSignatureDate: dateTime
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
1
0..*
PersonTelephone
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
+ 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
•Lab SIG Model
•Study Calendar SIG Model
•Financial SIG Model
cd Comprehensiv e 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
BRIDG - Implementation Independent Domain Analysis Model
cd Comprehensiv e M odel
BRIDG Shared Classes::Participation
BRIDG Shared Classes::Role
+
+
+
+
+
+
+
+
i d: CodedConcept
code: CodedConcept
status:
el ectroni cCom m Addr:
geographi cAddr:
tel ecom Addr:
effecti veStartDate: DAT ET IM E
effecti veEndDate: DAT ET IM E
has a
1
+
+
+
+
+
BRIDG Shared Classes::
RoleRoleRelationship
1..*
+
+
+
has a
1
source:
type: CodedConcept
target:
i d: CodedConcept
adm i ni strati veGenderCode: BRIDGCodedConcept
dateOfBi rth: DAT ET IM E
raceCode: BRIDGCodedConcept
ethni cGroupCode: BRIDGCodedConcept
m ari tal StatusCode: BRIDGCodedConcept
el ectroni cCom m Addr:
househol dIncom eCategory: BRIDGCodedConcept
educati onLevel Code: BRIDGCodedConcept
tel ecom Address: T EL
nam e: enti tyNam e
dateOfDeath: DAT ET IM E
address: addrT ype
Clinical Research Entities and Roles::
PersonRole
::Rol e
+
i d: CodedConcept
+
code: CodedConcept
+
status:
+
el ectroni cCom m Addr:
+
geographi cAddr:
+
tel ecom Addr:
+
effecti veStartDate: DAT ET IM E
+
effecti veEndDate: DAT ET IM E
paym entM ethod: CodedConcept
confi denti al i tyCode: stri ng
+
+
+
+
+
+
+
+
+
+
+
+
+
Clinical Trials Activ ities::Subj ectAssignment
+
si gnatureCode: i nt
+
si gnatureT ext: stri ng
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
0..*
1
0..1
+
studySubj ectIdenti fi er: i nt
+
arm : stri ng
+
subgroupCode: stri ng
+
i nform edConsentForm Si gnedDate:
+
offStudyDate: date
+
studyAgentDoseLevel : stri ng
+
el i gi bi l i tyWai verReason: stri ng
+
ageAtEnrol l m ent: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
code: PSMCodedConcept
derivationExpres s ion: TEXT
des cription: PSMDes cription
s tartDate: DATETIME
s tatus : PSMCodedConcept
availabilityTim e: Tim ingSpecification
priorityCode: PSMCodedConcept
confidentialityCode: PSMCodedConcept
repeatNum ber: rangeOfIntegers
interruptibleIndicator: BOOLEAN
uncertaintyCode: CodedConcept
reas onCode: PSMCodedConcept
endDate: DATETIME
date
1
1
0..*
0..*
Clinical Research
Entities and Roles::
TherapeuticAgent
1
0..*
+target acti vi ty
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
Clinical Trials Activ ities::
PerformedStudy
1
1
1
0..*
1
1
+
+
+
+
+
+
+
+
+
+
+
+
i d: BRIDGID
l ongT i tl e: stri ng
shortT i tl e: stri ng
phaseCode: ENUM
i ntentCode: ENUM
m oni torCode: ENUM
bl i ndedInd: bool ean
random i zedInd: bool ean
di seaseCode: CodedConceptDataT ype
sponsorCode: CodedConceptDataT ype
m ul ti Insti tuti onInd: bool ean
targetAccrual Num ber: i nt
+
+
+
+
+
+
+
+
+
*
*
rel ati onshi pCode: PSM CodedConcept
Obsol ete_rel ati onQual i fi er: BRIDGCodedConcept
sequenceNum ber: NUM BER
pauseCri teri on:
checkpoi ntCode:
pri ori tyNum ber: NUM BER
spl i tCode:
negati onRul e: AbstractRul e
j oi nCode:
negati onIndi cator: BOOLEAN
conj uncti onCode:
Clinical Trials Activ ities::PlannedStudy
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::PlannedActiv ity
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
+
pl annnedUnpl annedInd: bool ean
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::
StudySite
+
targetAccrual Num ber: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
Clinical Trials Activ ities::
StudyAgent
Clinical Research
Entities and Roles::
AgentRole
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
form Code: CodedConcept
l otNum ber: i nt
expi rati onDate: DAT ET IM E
stabi l i tyT i m e: DAT ET IM E
+source acti vi ty
Clinical Trials Activ ities::PerformedActiv ity
0..*
Clinical Research
Entities and Roles::
FundingSponsor
Clinical Research
Entities and Roles::
HealthCareSite
Clinical Research Entities and
Roles::Agent
0..*
certi fi cateLi censeT ext:
Clinical Research Entities and
Roles::Participant
+
+
Clinical Research Entities and
Roles::OrganizationRole
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
statusDate: DAT ET IM E
geographi cAddr: addrT ype
tel ecom Addr: T EL
+
+
+
+
+
+
+
+
1
+
Clinical Research Entities
and Roles::Organization
+
+
+
+
+
+
+
Clinical Trials Activ ities::
StudyInv estigator
Clinical Research
Entities and Roles::
Inv estigator
BRIDG Shared Classes::
Activ ityActiv ityRelationship
BRIDG Shared Classes::Activity
type: CodedConcept
status: CodedConcept
statusDate: DAT ET IM E
startDate: DAT ET IM E
endDate: DAT ET IM E
1..*
Clinical Research Entities and Roles::Person
+
+
+
+
+
+
+
+
+
+
+
+
+
Protocol Concepts::StudyDocument
+
+
+
+
+
+
+
+
+
versi on: stri ng
author: SET
ID: SET BRIDGID
docum entID: BRIDGID
type: ENUM
descri pti on: BRIDGDescri pti on
ti tl e: stri ng
status: BRIDGStatus
confi denti al i tyCode: CodedConcept
Clinical Trials
Activ ities::
AssessmentRelationship
Clinical Trials
Activ ities::
Observ ationRelationship
+
+
+
+
+
i d: i nt
type: stri ng
com m ents: stri ng
0..*
0..*
1
1
0..*
BRIDG Shared Classes::
BRIDGCodedConcept
nam e: T EXT
val ue:
control l edNam e: PSM CodedConcept
busi nessProcessM ode: PSM Busi nessProcessM ode
-
BRIDG Shared Classes::
BRIDGContactAddr
code: T EXT
codeSystem :
codeSystem Nam e: T EXT
codeSystem Versi on: NUM BER
di spl ayNam e: T EXT
ori gi nal T ext: T EXT
transl ati on: SET {PSM CodedConcept}
BRIDG Shared Classes::BRIDGDescription
+
+
+
synopsi s: Encapsul atedData
sum m aryDescri pti on: Encapsul atedData
detai l edDescri pti on: Encapsul atedData
+
+
1..*
m odeVal ue:
+
+
+
ENUM {Pl an, Execute}
+
startT i m e:
endT i m e:
+
+
+
source: T ext
versi on: T ext
val ue: T ext
0..*
+
+
+
Clinical Trials Activ ities::
SubstanceAdministration
+
+
+
+
+
+
0..*
«abstracti on»
1
date
0..*
Clinical Trials Activ ities::Adv erseEv ent
Clinical Trials Activ ities::Histopathology
ti m estam p
ti m estam p
BRIDG Shared Classes::
BRIDGStatus
i d: i nt
eval uati onDate:
0..*
BRIDG Shared Classes:
:BRIDGInterv al
type: BRIDGCodedConcept
effecti veT i m e: BRIDGInterval
usage: BRIDGCodedConcept
BRIDG Shared
Classes::
BRIDGID
BRIDG Shared Classes::
BRIDGBusinessProcessM ode
+
+
+
+
0..*
Clinical Trials Activities::Assessment
i d: i nt
reporti ngDate: date
confi denti al i tyCode: stri ng
uncertai ntyCode: stri ng
statusCode: stri ng
1
BRIDG Shared Classes::BRIDGAnalysisVariable
+
+
+
+
i d: i nt
typeCode: stri ng
com m entT ext: stri ng
1
Clinical Trials Activ ities::Observ ation
+
+
+
+
+
doseQuanti ty: i nt
doseUni tOfM easure: stri ng
route: stri ng
doseFrequency: stri ng
doseM odi fi cati onT ype: stri ng
doseChangeT ype: i nt
grossExam Resul tCode: stri ng
reportDescri pti veT ext: stri ng
i nvol vedSurgi cal M argi nIndi cator:
1
0..*
effecti veEndDate:
effecti veStartDate:
statusVal ue:
+
targetSi teCode:
Clinical Trials Activ ities::
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
bool ean
1
Clinical Trials Activ ities::
HistopathologyGrade
Clinical Trials Activ ities::Procedure
stri ng
+
+
+
+
i d: i nt
gradi ngSystem Nam e:
grade: stri ng
com m ents: stri ng
stri ng
panel Nam e: stri ng
val ue: stri ng
val ueUni tOfM easureCode: stri ng
assayM ethodCode: stri ng
bodyPosi ti onCode: stri ng
l abReferenceRangeCode: stri ng
l abT echni queCode: stri ng
m eansVi tal StatusObtai nedCod: stri ng
abnorm al Indi cator: bool ean
bi om arkerInd: bool ean
si gni fi canceInd: bool ean
0..*
Clinical Trials Activ ities::
LesionDescription
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
l esi onNum ber: stri ng
eval uati onNum ber: i nt
appearanceT ypeCode: stri ng
targetNonT argetCode: stri ng
m easurabl eIndi cator: bool ean
m ethodCode: stri ng
xDi m ensi on: i nt
yDi m ensi on: i nt
zDi m ensi on: i nt
di m ensi onProduct: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeSystem : stri ng
contactAnatom i cSi teCode: stri ng
contactAnatom i cSi teCodeSytem : stri ng
previ ousl yIrradi atedSi teIndi cator: bool ean
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
onsetDate: date
resol vedDate: date
ctcCategoryCode: stri ng
ctcCategoryCodeSystem : stri ng
ctcT erm T ypeCode: stri ng
ctcT erm T ypeCodeSystem : stri ng
ctcAttri buti onCode: stri ng
ctcAttri buti onCodeSystem : stri ng
ctcGradeCode: stri ng
ctcGradeCodeSystem : stri ng
seri ousReasonCode: stri ng
outcom eCode: stri ng
acti onT akenCode: stri ng
condi ti onPatternCode: stri ng
doseLi m i ti ngT oxi ci tyIndi cator: bool ean
doseLi m i ti ngT oxi ci tyDescri pti onT ext: stri ng
descri pti onT ext: stri ng
1..*
Clinical Trials
Activ ities::
Neoplasm
Clinical Trials
Activ ities::
Surgery
Clinical Trials
Activ ities::
SpecimenCollection
+
+
Clinical Trials Activ ities::
Radiation
si teCondi ti on: stri ng
m ethod: stri ng
+speci m enCol l ecti on
+
+
+
therapyT ype: stri ng
doseUni tOfM easure:
dose: stri ng
+
+
i denti fi er: stri ng
contrastAgentEnhancem ent: stri ng
descri pti veT ext: stri ng
rateOfEnhancem entVal ue: i nt
i d: i nt
cel l T ype:
0..1
stri ng
+
+
+
+
+
+
+
+
+
+
+
+
+
responseCode: char
responseCodeSystem : stri ng
bestResponseCode: char
bestResponseDate: date
progressi onDate: date
progressi onPeri od: i nt
progressi onPeri odUni tOfM easureCode:
doseChangeIndi catorCode: i nt
courseDi sposi ti onCode: stri ng
com m entT ext: stri ng
+
+
+
+
+
i d: i nt
tnm Stage: stri ng
tnm StageCodeSystem : stri ng
stageCode: stri ng
stageCodeSystem : stri ng
i d: i nt
subm i ssi onDate: date
fi l edIndi cator: bool ean
Clinical Trials Activ ities::
DeathSummary
+
+
+
+
deathDate: date
deathCauseCode: char
deathCauseT ext: stri ng
autopsi edIndi cator: bool ean
1
0..*
1..*
0..*
Clinical Trials Activ ities::
Adv erseEv entTherapy
Clinical Trials Activ ities:
:Specimen
i d: i nt
i dNum ber: i nt
sam pl i ngT ype:
+
+
+
+
+
stri ng
i d: i nt
treatm entDate: date
del ayDurati on: i nt
del ayDurati onUni tOfM easureCode:
i ntensi tyCode: stri ng
stri ng
1
0..1
Clinical Trials Activ ities::
M etastasisSite
+
+
+
i d: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeNam e: stri ng
stri ng
Clinical Trials
Activ ities::
LesionEv aluation
+
eval uati onCode:
char
Clinical Trials Activ ities::
Qualitativ eEv aluation
1
+speci m enCol l ecti on
+
+
+
Clinical Trials Activ ities::DiseaseResponse
nam e: stri ng
di seaseDi agnosi sCode: stri ng
di seaseDi agnosi sCodeSystem : stri ng
ageAtDi agnosi s: i nt
confi rm ati onDate: date
pri m aryAnatom i cSi teCode: stri ng
pri m aryAnatom i cSi teCodeSystem : stri ng
pri m aryAnatom i cSi teLateral i tyCode: stri ng
recurrenceIndi cator: bool ean
di seaseStatusCode: stri ng
sourceCode: stri ng
sourceOther: stri ng
di seaseExtentT ext: stri ng
Clinical Trials Activ ities::
CancerStage
1
Clinical Trials
Activ ities::
Adv erseEv entReport
Clinical Trials Activ ities::Imaging
+
+
+
+
stri ng
Clinical Trials Activ ities::Diagnosis
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
survi val StatusCode: i nt
survi val StatusDescri pti onT ext: stri ng
perform anceStatusCode: i nt
perform anceStatusCodeSystem : stri ng
pai nIndexCode: i nt
pai nIndexCodeSystem : stri ng
anam Resul tAccuracyPercent: i nt
m enstrual PatternT ypeCode: stri ng
m enstrual Indi cator: bool ean
cd Logical Model
cd Clinical Trials Obj ect Model (CTOM)
Implementation Specific Models
Protocol
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
CTOM
cd Clinical Trials Object Model (CTOM)
Name:
Author:
Version:
Created:
Updated:
Clinical Trials Object Model (CTOM)
ScenPro
0.5
7/1/2001 12:00:00 AM
1/19/2006 5:06:46 PM
+protocol
Protocol
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Person
StudyInvestigator
+ i d: i nt
+ responsibilityRoleCode: string
+ startDate: date
+studyInvestigatorCollection + stopDate: date
+ statusCode: string
1 +eligibilityCriteriaCollection
0..* + signatureIndicator: boolean
+protocolCollection
+ signatureText: string
EligibilityCriteria
1..*
1..*
+studyInvestigatorCollection 0..*
+ i d: i nt
+ questionText: string
+investigator 1
+ questionNumber: int
+ expectedAnswerIndicator: boolean
Investigator
+
+
+
+
+
+
+
+
+
+
+
+
+
+ nciIdentifier: string +
i d: i nt
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
PersonOccupation
+personOccupationCollection
+person
1
0..*
i d: i nt
nciIdentifier: string
amendmentIdentifier: int
amendmentDate: date
navyNCIIdentifier: string
longTitleText: string
shortTitleText: string
precisText: string
1
+eligibilityCriteria
descriptionText: string
diseaseCode: string
+participantEligibilityAnswerCollection
Inclusion Exclusion 0..*
intentCode: string
+participantEligibilityAnswerCollection +participant
monitorCode: string
phaseCode: string
ParticipantEligibilityAnswer
0..*
1+
sponsorCode: string
HealthcareSiteParticipantRole
+
+protocolStatusCollection
blindedIndicator: boolean
+ i d: i nt
+
multiInstitutionIndicator: boolean +protocol
+ answerText: string
+ i d: i nt
+
ProtocolStatus
randomizedIndicator: boolean 1
+ checklistNumber: string
+ roleCode: string
1..*
targetAccrualNumber: int
+ i d: i nt
+healthcareSiteRoleCollection 0..*
+ statusCode: string
+ statusDate: date
Organization
+study
1
+
+
+
+
+
+
+
+
+
+
+
i d: i nt
name: string
descriptionText: string
statusCode: string
statusDate: date
streetAddress: string
city: string
stateCode: string
postalCode: string
countryCode: string
telecomAddress: string
FemaleReproductiv eCharacteristic
+studyParticipantAssignmentCollection 0..*
+studyParticipantAssignment
StudyParticipantAssignment
+studySiteCollection 0..*
StudySite
0..*
1
i d: i nt
studyParticipantIdentifier: int
armIdentifier: string
subgroupCode: string
informedConsentFormSignedDate: date
enrol mentAge: int
studyAgentDoseLevel: int
studyAgentDoseLevelUnitOfMeasureCode: string
offStudyDate: date
offStudyReasonCode: string
offStudyReasonOtherText: string
eligibilityWaiverReasonText: string
Agent
+Agent
AgentSynonym +agentSynonymCollection
0..*
StudyTimePoint
+
+
+
+
+
+
i d: i nt
visitName: string
courseNumber: int
epochName: string
courseStartDate: date
courseStopDate: date
Activ ityRelationship
+ i d: i nt
+ typeCode: string
+ sequenceNumber: int
+ commentText: string
+studyTimePoint 0..1
+activityRelationshipCollection 0..*
0..* +activityRelationshipCollection
+ i d: i nt
+ firstLiveBirthAge: int
+ liveBirthCount: int
+ stil BirthCount: int
+ abortionIndicator: boolean
+femaleReproductiveCharacteristic + menopauseStartDate: date
+activity 1
+activity 1 +activity 1
+ menopauseAge: int
+ menopauseReasonCode: string
Participant
Activ ity
+activity
1 0..1 + menopauseReasonOtherText: string
initials: char
+participant
+ i d: i nt
1
zipCode: string
+ name: string
paymentMethodCode: char
+ type: string
confidentialityIndicator: boolean
+ descriptionText: string
+ startDate: date
+participant 1
1
+activityCollection + stopDate: date
+participant
+ durationValue: int
0..*
+healthcareSiteParticipant 1 +healthcareSiteParticipantCollection 0..*
+ durationUnitOfMeasureCode: string
+ plannnedIndicator: boolean
HealthcareSite
HealthcareSiteParticipant
+ reasonCode: string
+healthcareSiteParticipant
+ nciInstituteCode: string
+ i d: i nt
1+healthcareSite 0..* + participantIdentifier: string
+healthCareSite 1
Procedure
SubstanceAdministration
+
+
+
+ i d: i nt
+
+ roleCode: string
+
+protocol
+studySiteCollection + statusCode: string
+
+ targetAccrualNumber: string
1
+
0.
.
*
+
st
a
r
t
D
at
e
:
dat
e
0.
.
*
+studyAgentCollection
+
+studySite
+ stopDate: date
+
+ irbApprovalDate: date
StudyAgent
1
0..* +
+studyParticipantCollection +
+ i d: i nt
+
+ investigationalIndicator: boolean
+studyAgent
+ investigationalNewDrugIdentifier: string
+ statusCode: string
1
+studyAgentCollection +agent
+ statusDate: date
+ i d: i nt
+ name: string
+ i d: i nt
+ primaryTypeCode: string
+ primaryTypeCodeSystem: string
+ startDate: date
+ stopDate: date
+agent
+ i d: i nt
1
+ name: string
1 + descriptionText: string +agent
+ statusCode: string
1
+
+
+
+
+
+
+
+
+
1
singleDose: int
singleDoseUnitOfMeasureCode: string
doseFrequencyCode: string
doseFrequencyText: string
totalDose: int
totalDoseUnitOfMeasureCode: string
doseChangeCode: string
doseChangeIndicatorCode: int
routeCode: string
+substanceAdministrationCollection 0..*
+ anatomicSiteCode: string
+ anatomicSiteCodeSystem: string
Radiation
Surgery
SpecimenCollection
+ siteConditionCode: string
1
0..*
+ methodCode: string
+substanceAdministrationCollection
+specimenCollection 1
+specimenCollection 0..*
+agentOccurrence
AgentOccurrence
+AgentOccurrenceCollection + id: int
+ lotNumber: string
0..*
+ formCode: string
+ expirationDate: date
0..1
Specimen
+
+
+
+
+
Imaging
+ imageIdentifier: string
i d: i nt
+ contrastAgentEnhancementIndicator: boolean
sampleIdentifier: int
+ enhancementRateValue: int
sampleTypeCode: string
+ enhancementDescriptionText: string
volume: int
volumeUnitOfMeasureCode: string
Name:
Author:
Version:
Created:
Updated:
Logical Model
AbdulMalik Shakir
1.0
10/18/2005 8:40:14 PM
12/4/2005 11:25:52 PM
cd Logical Model
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
Dev ice
+ implantedDate: dateTime
+ explantedDate: dateTime
+ reprocessedIndicator: boolean
+ availableForEvaluationIndicator: boolean
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
ObservationRelationship
+ i d: i nt
+ typeCode: string
+ commentText: string
+observationRelationshipCollection 0..*
AssessmentRelationship
0..* +observationRelationshipCollection
0..* +assessmentRelationship
+assessmentRelationshipCollection 0..*
Observation
+observationCollection
+observationCollection
0..* + id: int
+ reportingDate: date
+ confidentialityCode: string
+ uncertaintyCode: string
+ statusCode: string
1..*
+ i d: i nt
+ evaluationDate: date
+ grossExamResultCode: string
+ reportDescriptiveText: string
+ involvedSurgicalMarginIndicator: boolean
+histopathology 1
+histopathology 1
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
panelName: string
value: string
valueUnitOfMeasureCode: string
assayMethodCode: string
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCode: string
abnormalIndicator: boolean
biomarkerIndicator: boolean
significanceIndicator: boolean
+ i d: i nt
+clinicalResultCollection 0..*
+ i d: i nt
+ gradeCode: string
+ cellTypeCode: string
+ gradeCodeSystem: string
+ commentText: string
+conceptDescriptor 1
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
previouslyIr adiatedSiteIndicator: string
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+adverseEventCollection 1
+
+
+
+
+
+relationshipCollection 0..*
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
+adverseEventReport 0..1
AdverseEventTherapy
AdverseEventReport
i d: i nt
treatmentDate: date
delayDuration: int
delayDurationUnitOfMeasureCode: string
intensityCode: string
+ i d: i nt
+ submissionDate: date
+ filedIndicator: boolean
+diagnosis 1
+cancerStage 0..1
+
+
+
+
+
+
+
+
+
+ deathDate: date
Qualitativ eEvaluation
+ deathCauseCode: char
+ deathCauseText: string
survivalStatusCode: int
+ autopsiedIndicator: boolean
survivalStatusDescriptionText: string
performanceStatusCode: int
performanceStatusCodeSystem: string
painIndexCode: int
DiseaseResponse
painIndexCodeSystem: string
anamResultAccuracyPercent: int + reponseCode: char
menstrualPatternTypeCode: string + responseCodeSystem: string
menstrualIndicator: boolean
+ bestResponseCode: char
+ bestResponseDate: date
+ progressionDate: date
+ progressionPeriod: int
+ progressionPeriodUnitOfMeasureCode: string
+ doseChangeIndicatorCode: int
+ courseDispositionCode: string
+ commentText: string
+
+
+
+
+
+
+
+
id: long
+relationshipCollection
relationshipType: string
effectiveFromTime: dateTime 0..*
effectiveThruTime: dateTime +relationshipCollection
relationshipStatus: string
sourceActivityRole: string
0..*
targetActivityRole: string
sequence: int
+sourceActivity +
+
1 +
+targetActivity +
+
1 +
+activityCollection +
Activ ityParticipation
id: long
startTime: dateTime
endTime: dateTime
method: string
reason: string
description: string
status: string
0..*
+
+participationCollection +
+
0..* +
+
+
+
+act
1
+activity
Product
+sourceEntity
+
id: long
MaterialKind
DrugProductIngredient
+ name: string
::ParticipatingEntity
+ id: long
1
+entity
1
+entityCollection
0..*
+identifierCollection
Activ ityKind
Observ ation
+activityKind
id: long
activityCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
1
+observationCollection
id: long
identifierValue: string
identifierType: string
+identifierCollection
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
1
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
0..* + description: string
+ status: string
Person
1
+assigningAuthority
+participatingEntityKind
+identifierCollection
Organization
id: long
identifierValue: string
identifierType: string
versionIdentifier: string
versionEffectiveDate: dateTime
+identifierCollection
0..*
+assigningAuthority
1
+ name: string
::ParticipatingEntity
+ id: long
+
isFDA() : boolean
+organization
+
+
+
+
+AdverseEventReportCollection +
+
0..*
+
Observ ationValueKind
+observationValueKind
+
+
+
+
+
+
id: long
observationValueCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+ expectedness: boolean
+ attribution: int
+ studyDesignBroken: boolean
+ agentAdjustment: string
+ administrationDelayed: boolean
::ActivityRelationship
+activityRelationshipCollections
+ id: long
+adverseEvent
0..*
+ relationshipType: string
+ effectiveFromTime: dateTime
+ effectiveThruTime: dateTime
+ relationshipStatus: string
+ sourceActivityRole: string
+ targetActivityRole: string
+ sequence: int
+ outcome: string
+ seriousness: string
::Observation
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
1 + startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+
isContinuing() : boolean
+adverseEvent
1
+eventDetailCollection 0..*
Adv erseEv entDetailKind
+
+
+
+
+
+
id: string
adverseEventDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
Adv erseEv entDetail
+eventDetailKind
1
+
+eventDetailCollection 0..* +
+
+
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
1
0..*
Adv erseEv entReportDetail
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
+adverseEventReportDetailCollection
+adverseEventReportDetailKind
0..*
1
Adv erseEv entReportDetailKind
+
+
+
+
+
+
+ namePrefix: string
+ firstName: string
+ middleName: string
+ lastName: string
+ nameSuffix: string
+ occupation: string
+ emailAddress: string
::ParticipatingEntity
+ id: long
+
isHealthProfessional() : boolean
+person
0..*
OrganizationTelephone
+
+
+
+
id: long
entityType: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+telephoneCollection
+telephoneCollection
+adverseEvent
+
+
+
+
+
+
1
+adverseEventReport
1
+adverseEventReportDetailCollection
Adv erseEv ent
Adv erseEv entActiv ityRelationship
hasAmendedData() : boolean
sentToFDA() : boolean
initialSentToFDA() : boolean
sentToManufacturer() : boolean
treatmentDelayed() : boolean
delayDuration() : real
delayDurationUnits() : string
1
ParticipatingEntityKind
Activ ityIdentifier
+
+
+
+
+
id:
adverseEventReportDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+ingredientCollection
1 +material
0..*
+
+
+
+
id: long
quantity: float
activeIngredientIndicator: boolean
materialForm: string
StudySubj ect
0..*
Adv erseEv entReport
+ sequenceIdentifier: int
+ subjectDiscloserAllowed: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+
+
+
+
+
1
+ingredientCollection 1..*
+entity
ParticipatingEntityIdentifier 0..*
+
+
+
+
+
+
DrugProduct
+ lotNumber: string
+ expirationDate: date
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+product
1
ParticipatingEntity
id: long
type: string
+participationCollection
effectiveFromTime: dateTime
effectiveThruTime: dateTime
0..*
participantRole: string
participantSignature: string
participantSignatureDate: dateTime
1
+
+
+
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
1
CancerStage
MetastasisSite
+cancerStage +metastasisSiteCollection
+ i d: i nt
+ tnmStage: string
+ i d: i nt
1..*
+ tnmStageCodeSystem: string 1
+ anatomicSiteCode: string
+ stageCode: string
+ anatomicSiteCodeSystem: string
+ stageCodeSystem: string
0..* +relationshipCollection
+ name: string
+ description: string
+ streetAddress: string
+ city: string
+ state: string
+ postalCode: string
::ParticipatingEntity
+ id: long
Activ ity
DeathSummary
+adverseEventCollection 1..*
+adverseEventTherapyCollection 0..*
i d: i nt
code: string
codeSystem: string
codeSystemName: string
codeSystemVersion: int
displayText: string
Location
id: long
relationshipType: string
effectiveFromTime: dateTime
effectiveThruTime: dateTime
relationshipStatus: string
sourceParticipantRole: string
targetParticipantRole: string
+targetEntity
+ evaluationCode: char
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
ConceptDescriptor
+
+
+
+
+
+
+
+
+
+
+
+
+
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
isContinuing() : boolean
isAdjustment() : boolean
Activ ityRelationship
LesionEvaluation
AdverseEvent
Histopathology
+
+
ClincalStudy
+ phase: string
+ title: string
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
Assessment
+assessmentCollection
0..*
Protocol
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
1 +assessmentCollection
+assessment 1
ClincalStudy
ParticipatingEntityRelationship
Treatment
ProcedureTreatment
::Treatment
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+ i d: i nt
+ typeCode: string
+ commentText: string
+observation 1 +observation 1
+ dose: string
+histopathologyGradeCollection 0..* +neoplasmCollection 0..*
+ doseUnitOfMeasureCode: string
+ scheduleText: string
HistopathologyGrade
Neoplasm
+ therapyExtentCode: string
+substanceAdministration
caAERS
cd Logical Model
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
1
0..*
PersonTelephone
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
+ 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
+ phase: string
+ title: string
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
•Lab SIG Model
•Study Calendar SIG Model
•Financial SIG Model
BRIDG - Implementation Independent Domain Analysis Model
cd Comprehensiv e Model
cd Comprehensiv e M odel
BRIDG Shared Classes::Participation
BRIDG Shared Classes::Role
+
+
+
+
+
+
+
+
i d: CodedConcept
code: CodedConcept
status:
el ectroni cCom m Addr:
geographi cAddr:
tel ecom Addr:
effecti veStartDate: DAT ET IM E
effecti veEndDate: DAT ET IM E
i d: CodedConcept
adm i ni strati veGenderCode: BRIDGCodedConcept
dateOfBi rth: DAT ET IM E
raceCode: BRIDGCodedConcept
ethni cGroupCode: BRIDGCodedConcept
m ari tal StatusCode: BRIDGCodedConcept
el ectroni cCom m Addr:
househol dIncom eCategory: BRIDGCodedConcept
educati onLevel Code: BRIDGCodedConcept
tel ecom Address: T EL
nam e: enti tyNam e
dateOfDeath: DAT ET IM E
address: addrT ype
+
+
+
+
+
Clinical Research
Entities and Roles::
AgentRole
1
BRIDG Shared Classes::BRIDGAnalysisVariable
-
Clinical Research Entities and
Roles::Participant
+
+
paym entM ethod: CodedConcept
confi denti al i tyCode: stri ng
0..1
+source acti vi ty
code: PSMCodedConcept
derivationExpres s ion: TEXT
des cription: PSMDes cription
s tartDate: DATETIME
s tatus : PSMCodedConcept
availabilityTim e: Tim ingSpecification
priorityCode: PSMCodedConcept
confidentialityCode: PSMCodedConcept
repeatNum ber: rangeOfIntegers
interruptibleIndicator: BOOLEAN
uncertaintyCode: CodedConcept
reas onCode: PSMCodedConcept
endDate: DATETIME
+target acti vi ty
*
rel ati onshi pCode: PSM CodedConcept
Obsol ete_rel ati onQual i fi er: BRIDGCodedConcept
sequenceNum ber: NUM BER
pauseCri teri on:
checkpoi ntCode:
pri ori tyNum ber: NUM BER
spl i tCode:
negati onRul e: AbstractRul e
j oi nCode:
negati onIndi cator: BOOLEAN
conj uncti onCode:
Clinical Trials Activ ities::PlannedStudy
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
date
Clinical Trials Activ ities::PlannedActiv ity
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::PerformedActiv ity
0..*
1
+
pl annnedUnpl annedInd: bool ean
::Acti vi ty
+
code: PSM CodedConcept
+
deri vati onExpressi on: T EXT
+
descri pti on: PSM Descri pti on
+
startDate: DAT ET IM E
+
status: PSM CodedConcept
+
avai l abi l i tyT i m e: T i m i ngSpeci fi cati on
+
pri ori tyCode: PSM CodedConcept
+
confi denti al i tyCode: PSM CodedConcept
+
repeatNum ber: rangeOfIntegers
+
i nterrupti bl eIndi cator: BOOLEAN
+
uncertai ntyCode: CodedConcept
+
reasonCode: PSM CodedConcept
+
endDate: DAT ET IM E
Clinical Trials Activ ities::
StudySite
+
targetAccrual Num ber: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
1
+
+
+
+
+
+
+
+
+
*
0..*
0..*
Protocol Concepts::StudyDocument
+
+
+
+
+
+
+
+
+
Clinical Research
Entities and Roles::
TherapeuticAgent
1
0..*
+
+
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
1
1
BRIDG Shared Classes::
BRIDGContactAddr
+
+
+
ENUM {Pl an, Execute}
+
startT i m e:
endT i m e:
+
+
+
i d: BRIDGID
l ongT i tl e: stri ng
shortT i tl e: stri ng
phaseCode: ENUM
i ntentCode: ENUM
m oni torCode: ENUM
bl i ndedInd: bool ean
random i zedInd: bool ean
di seaseCode: CodedConceptDataT ype
sponsorCode: CodedConceptDataT ype
m ul ti Insti tuti onInd: bool ean
targetAccrual Num ber: i nt
0..*
0..*
1
1
+
+
+
0..*
+
+
1..*
i d: i nt
eval uati onDate:
1
date
0..*
0..*
Clinical Trials Activ ities::Adv erseEv ent
+
+
+
Clinical Trials Activ ities::
SubstanceAdministration
+
+
+
+
+
+
0..*
0..*
Clinical Trials Activities::Assessment
i d: i nt
reporti ngDate: date
confi denti al i tyCode: stri ng
uncertai ntyCode: stri ng
statusCode: stri ng
Clinical Trials Activ ities::Histopathology
0..*
«abstracti on»
i d: i nt
typeCode: stri ng
com m entT ext: stri ng
1
Clinical Trials Activ ities::Observ ation
+
+
+
+
+
1
ti m estam p
ti m estam p
BRIDG Shared Classes::
BRIDGStatus
source: T ext
versi on: T ext
val ue: T ext
+
+
+
+
+
+
+
+
+
+
+
+
BRIDG Shared Classes:
:BRIDGInterv al
type: BRIDGCodedConcept
effecti veT i m e: BRIDGInterval
usage: BRIDGCodedConcept
BRIDG Shared
Classes::
BRIDGID
Clinical Trials
Activ ities::
AssessmentRelationship
i d: i nt
type: stri ng
com m ents: stri ng
Clinical Trials Activ ities::
PerformedStudy
1
0..*
1
+
+
+
versi on: stri ng
author: SET
ID: SET BRIDGID
docum entID: BRIDGID
type: ENUM
descri pti on: BRIDGDescri pti on
ti tl e: stri ng
status: BRIDGStatus
confi denti al i tyCode: CodedConcept
Clinical Trials
Activ ities::
Observ ationRelationship
Clinical Trials Activ ities::
StudyAgent
BRIDG Shared Classes::
BRIDGBusinessProcessM ode
m odeVal ue:
0..*
1
+
studySubj ectIdenti fi er: i nt
+
arm : stri ng
+
subgroupCode: stri ng
+
i nform edConsentForm Si gnedDate:
+
offStudyDate: date
+
studyAgentDoseLevel : stri ng
+
el i gi bi l i tyWai verReason: stri ng
+
ageAtEnrol l m ent: i nt
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
Clinical Research
Entities and Roles::
FundingSponsor
code: T EXT
codeSystem :
codeSystem Nam e: T EXT
codeSystem Versi on: NUM BER
di spl ayNam e: T EXT
ori gi nal T ext: T EXT
transl ati on: SET {PSM CodedConcept}
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Clinical Trials Activ ities::Subj ectAssignment
name: Text
description: Text
status: BRIDGStatus
geographicAddr: BRIDGContactAddr
telecomAddr: BRIDGTelecomAddress
BRIDG Shared Classes::BRIDGDescription
synopsi s: Encapsul atedData
sum m aryDescri pti on: Encapsul atedData
detai l edDescri pti on: Encapsul atedData
0..*
certi fi cateLi censeT ext:
Clinical Research
Entities and Roles::
HealthCareSite
BRIDG Shared Classes::
BRIDGCodedConcept
nam e: T EXT
val ue:
control l edNam e: PSM CodedConcept
busi nessProcessM ode: PSM Busi nessProcessM ode
Clinical Trials Activ ities::
StudyInv estigator
+
si gnatureCode: i nt
+
si gnatureT ext: stri ng
::Parti ci pati on
+
type: CodedConcept
+
status: CodedConcept
+
statusDate: DAT ET IM E
+
startDate: DAT ET IM E
+
endDate: DAT ET IM E
BRIDG Shared Classes::
Activ ityActiv ityRelationship
BRIDG Shared Classes::Activity
type: CodedConcept
status: CodedConcept
statusDate: DAT ET IM E
startDate: DAT ET IM E
endDate: DAT ET IM E
1
+
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
form Code: CodedConcept
l otNum ber: i nt
expi rati onDate: DAT ET IM E
stabi l i tyT i m e: DAT ET IM E
+
+
+
source:
type: CodedConcept
target:
Clinical Research
Entities and Roles::
Inv estigator
Clinical Research Entities and
Roles::OrganizationRole
Clinical Research Entities and
Roles::Agent
+
+
+
+
+
+
+
1..*
Clinical Research Entities and Roles::
PersonRole
i d: CodedConcept
nam e: stri ng
descri pti on: stri ng
status: CodedConcept
statusDate: DAT ET IM E
geographi cAddr: addrT ype
tel ecom Addr: T EL
+
+
+
+
+
+
+
+
+
+
+
+
+
BRIDG Shared Classes::
RoleRoleRelationship
1..*
has a
1
::Rol e
+
i d: CodedConcept
+
code: CodedConcept
+
status:
+
el ectroni cCom m Addr:
+
geographi cAddr:
+
tel ecom Addr:
+
effecti veStartDate: DAT ET IM E
+
effecti veEndDate: DAT ET IM E
Clinical Research Entities
and Roles::Organization
+
+
+
+
+
+
+
has a
1
Clinical Research Entities and Roles::
Organization
Clinical Research Entities and Roles::Person
+
+
+
+
+
+
+
+
+
+
+
+
+
doseQuanti ty: i nt
doseUni tOfM easure: stri ng
route: stri ng
doseFrequency: stri ng
doseM odi fi cati onT ype: stri ng
doseChangeT ype: i nt
grossExam Resul tCode: stri ng
reportDescri pti veT ext: stri ng
i nvol vedSurgi cal M argi nIndi cator:
1
0..*
effecti veEndDate:
effecti veStartDate:
statusVal ue:
+
targetSi teCode:
Clinical Trials Activ ities::
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
bool ean
1
Clinical Trials Activ ities::
HistopathologyGrade
Clinical Trials Activ ities::Procedure
stri ng
+
+
+
+
i d: i nt
gradi ngSystem Nam e:
grade: stri ng
com m ents: stri ng
stri ng
panel Nam e: stri ng
val ue: stri ng
val ueUni tOfM easureCode: stri ng
assayM ethodCode: stri ng
bodyPosi ti onCode: stri ng
l abReferenceRangeCode: stri ng
l abT echni queCode: stri ng
m eansVi tal StatusObtai nedCod: stri ng
abnorm al Indi cator: bool ean
bi om arkerInd: bool ean
si gni fi canceInd: bool ean
0..*
Clinical Trials Activ ities::
LesionDescription
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
l esi onNum ber: stri ng
eval uati onNum ber: i nt
appearanceT ypeCode: stri ng
targetNonT argetCode: stri ng
m easurabl eIndi cator: bool ean
m ethodCode: stri ng
xDi m ensi on: i nt
yDi m ensi on: i nt
zDi m ensi on: i nt
di m ensi onProduct: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeSystem : stri ng
contactAnatom i cSi teCode: stri ng
contactAnatom i cSi teCodeSytem : stri ng
previ ousl yIrradi atedSi teIndi cator: bool ean
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
1..*
Clinical Trials
Activ ities::
Neoplasm
Clinical Trials
Activ ities::
Surgery
Clinical Trials
Activ ities::
SpecimenCollection
+
+
Clinical Trials Activ ities::
Radiation
si teCondi ti on: stri ng
m ethod: stri ng
+speci m enCol l ecti on
+
+
+
therapyT ype: stri ng
doseUni tOfM easure:
dose: stri ng
+
+
i denti fi er: stri ng
contrastAgentEnhancem ent: stri ng
descri pti veT ext: stri ng
rateOfEnhancem entVal ue: i nt
i d: i nt
cel l T ype:
+
+
+
+
+
+
+
+
+
+
+
+
+
responseCode: char
responseCodeSystem : stri ng
bestResponseCode: char
bestResponseDate: date
progressi onDate: date
progressi onPeri od: i nt
progressi onPeri odUni tOfM easureCode:
doseChangeIndi catorCode: i nt
courseDi sposi ti onCode: stri ng
com m entT ext: stri ng
i d: i nt
subm i ssi onDate: date
fi l edIndi cator: bool ean
Clinical Trials Activ ities::
DeathSummary
+
+
+
+
deathDate: date
deathCauseCode: char
deathCauseT ext: stri ng
autopsi edIndi cator: bool ean
1
0..*
1..*
0..*
Clinical Trials Activ ities::
Adv erseEv entTherapy
Clinical Trials Activ ities:
:Specimen
i d: i nt
i dNum ber: i nt
sam pl i ngT ype:
+
+
+
+
+
stri ng
Implementation Specific
Models
cd Logical
Model
cd Clinical Trials Obj ect Model (CTOM)
i d: i nt
treatm entDate: date
del ayDurati on: i nt
del ayDurati onUni tOfM easureCode:
i ntensi tyCode: stri ng
stri ng
1
0..1
i d: i nt
tnm Stage: stri ng
tnm StageCodeSystem : stri ng
stageCode: stri ng
stageCodeSystem : stri ng
Clinical Trials Activ ities::
M etastasisSite
+
+
+
i d: i nt
anatom i cSi teCode: stri ng
anatom i cSi teCodeNam e: stri ng
stri ng
Clinical Trials
Activ ities::
LesionEv aluation
+
eval uati onCode:
char
Clinical Trials Activ ities::
Qualitativ eEv aluation
1
+speci m enCol l ecti on
+
+
+
Clinical Trials Activ ities::DiseaseResponse
nam e: stri ng
di seaseDi agnosi sCode: stri ng
di seaseDi agnosi sCodeSystem : stri ng
ageAtDi agnosi s: i nt
confi rm ati onDate: date
pri m aryAnatom i cSi teCode: stri ng
pri m aryAnatom i cSi teCodeSystem : stri ng
pri m aryAnatom i cSi teLateral i tyCode: stri ng
recurrenceIndi cator: bool ean
di seaseStatusCode: stri ng
sourceCode: stri ng
sourceOther: stri ng
di seaseExtentT ext: stri ng
Clinical Trials Activ ities::
CancerStage
+
+
+
+
+
Clinical Trials
Activ ities::
Adv erseEv entReport
stri ng
Clinical Trials Activ ities::Diagnosis
+
+
+
+
+
+
+
+
+
+
+
+
+
1
0..1
Clinical Trials Activ ities::Imaging
+
+
+
+
stri ng
onsetDate: date
resol vedDate: date
ctcCategoryCode: stri ng
ctcCategoryCodeSystem : stri ng
ctcT erm T ypeCode: stri ng
ctcT erm T ypeCodeSystem : stri ng
ctcAttri buti onCode: stri ng
ctcAttri buti onCodeSystem : stri ng
ctcGradeCode: stri ng
ctcGradeCodeSystem : stri ng
seri ousReasonCode: stri ng
outcom eCode: stri ng
acti onT akenCode: stri ng
condi ti onPatternCode: stri ng
doseLi m i ti ngT oxi ci tyIndi cator: bool ean
doseLi m i ti ngT oxi ci tyDescri pti onT ext: stri ng
descri pti onT ext: stri ng
+
+
+
+
+
+
+
+
survi val StatusCode: i nt
survi val StatusDescri pti onT ext: stri ng
perform anceStatusCode: i nt
perform anceStatusCodeSystem : stri ng
pai nIndexCode: i nt
pai nIndexCodeSystem : stri ng
anam Resul tAccuracyPercent: i nt
m enstrual PatternT ypeCode: stri ng
m enstrual Indi cator: bool ean
cd Logical Model
OrganizationTelephone
CTOM
caAERS
Organization
Name: Clinical Trials Object Model (CTOM)
Author: ScenPro
Version: 0.5
Created: 7/1/2001 12:00:00 AM
Updated: 1/19/2006 5:06:46 PM
+protocol
Protocol
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Person
StudyInvestigator
+ i d: i nt
+ responsibilityRoleCode: string
+ startDate: date
+studyInvestigatorCollection + stopDate: date
+ statusCode: string
1 +eligibilityCriteriaCollection
0..* + signatureIndicator: boolean
+protocolCollection
+ signatureText: string
EligibilityCriteria
1..*
1..*
+studyInvestigatorCollection 0..*
+ i d: i nt
+ questionText: string
+investigator 1
+ questionNumber: int
+ expectedAnswerIndicator: boolean
Investigator
+
+
+
+
+
+
+
+
+
+
+
+
+
+ nciIdentifier: string +
i d: i nt
nciIdentifier: string
amendmentIdentifier: int
amendmentDate: date
navyNCIIdentifier: string
longTitleText: string
shortTitleText: string
precisText: string
1
+eligibilityCriteria
descriptionText: string
diseaseCode: string
+participantEligibilityAnswerCollection
Inclusion Exclusion 0..*
intentCode: string
+participantEligibilityAnswerCollection +participant
monitorCode: string
phaseCode: string
ParticipantEligibilityAnswer
0..*
1+
sponsorCode: string
HealthcareSiteParticipantRole
+
+protocolStatusCollection
blindedIndicator: boolean
+ i d: i nt
+
multiInstitutionIndicator: boolean +protocol
+ answerText: string
+ i d: i nt
+
ProtocolStatus
randomizedIndicator: boolean 1
+
checkl
i
s
t
N
umber
:
st
r
i
n
g
+ roleCode: string
1..*
targetAccrualNumber: int
+ i d: i nt
+healthcareSiteRoleCollection 0..*
+ statusCode: string
+ statusDate: date
1
i d: i nt
name: string
descriptionText: string
statusCode: string
statusDate: date
streetAddress: string
city: string
stateCode: string
postalCode: string
countryCode: string
telecomAddress: string
+person
1
i d: i nt
primaryTypeCode: string
primaryTypeCodeSystem: string
startDate: date
stopDate: date
FemaleReproductiv eCharacteristic
+
+
+
+
+
+femaleReproductiveCharacteristic +
+
+
Participant
1 0..1 +
initials: char
+participant
zipCode: string
paymentMethodCode: char
confidentialityIndicator: boolean
+participant 1
1
+participant
i d: i nt
visitName: string
courseNumber: int
epochName: string
courseStartDate: date
courseStopDate: date
+studyTimePoint 0..1
i d: i nt
firstLiveBirthAge: int
liveBirthCount: int
stil BirthCount: int
abortionIndicator: boolean
menopauseStartDate: date
menopauseAge: int
menopauseReasonCode: string
menopauseReasonOtherText: string
HealthcareSiteParticipant
1+healthcareSite
Activ ityRelationship
+ i d: i nt
+ typeCode: string
+ sequenceNumber: int
+ commentText: string
+activity 1 +activity 1
+activity 1
Activ ity
+
+
+
+
+
+activityCollection +
+
0..*
+
+
+
+activity
i d: i nt
name: string
type: string
descriptionText: string
startDate: date
stopDate: date
durationValue: int
durationUnitOfMeasureCode: string
plannnedIndicator: boolean
reasonCode: string
1
+ i d: i nt
0..* + participantIdentifier: string
+studyParticipantAssignmentCollection 0..*
+studyParticipantAssignment
StudyParticipantAssignment
+studySiteCollection 0..*
StudySite
0..*
0..* +activityRelationshipCollection
+activityRelationshipCollection 0..*
1
+agent
i d: i nt
studyParticipantIdentifier: int
armIdentifier: string
subgroupCode: string
informedConsentFormSignedDate: date
enrol mentAge: int
studyAgentDoseLevel: int
studyAgentDoseLevelUnitOfMeasureCode: string
offStudyDate: date
offStudyReasonCode: string
offStudyReasonOtherText: string
eligibilityWaiverReasonText: string
Agent
+Agent
+ i d: i nt
1
+ name: string
1 + descriptionText: string +agent
+ statusCode: string
1
+
+
+
+
+
+
+
+
+
1
singleDose: int
singleDoseUnitOfMeasureCode: string
doseFrequencyCode: string
doseFrequencyText: string
totalDose: int
totalDoseUnitOfMeasureCode: string
doseChangeCode: string
doseChangeIndicatorCode: int
routeCode: string
+substanceAdministrationCollection 0..*
+observationCollection
+
+
+
+
+
+
+
+
+
+
+
+ i d: i nt
+ typeCode: string
+ commentText: string
+observationRelationshipCollection 0..*
1..*
+histopathology 1
ClinicalResult
+
+
+
+
+
+
+
+
+
+
+
panelName: string
value: string
valueUnitOfMeasureCode: string
assayMethodCode: string
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCode: string
abnormalIndicator: boolean
biomarkerIndicator: boolean
significanceIndicator: boolean
+specimenCollection 0..*
+agentOccurrence
AgentOccurrence
+AgentOccurrenceCollection + id: int
+ lotNumber: string
0..*
+ formCode: string
+ expirationDate: date
0..1
Specimen
0..*
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
previouslyIr adiatedSiteIndicator: string
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+adverseEventCollection 1
i d: i nt
code: string
codeSystem: string
codeSystemName: string
codeSystemVersion: int
displayText: string
+
+
+
+
+
+
+
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
Diagnosis
+
+
+
+
+
+
+
+
+
+
+
+
+
Qualitativ eEvaluation
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
+adverseEventReport 0..1
+diagnosis 1
+cancerStage 0..1
+
+
+
+
+
+
+
+
+
AdverseEventTherapy
AdverseEventReport
i d: i nt
treatmentDate: date
delayDuration: int
delayDurationUnitOfMeasureCode: string
intensityCode: string
+ i d: i nt
+ submissionDate: date
+ filedIndicator: boolean
+relationshipCollection 0..*
0..* +relationshipCollection
Activ ity
id: long
+relationshipCollection
relationshipType: string
effectiveFromTime: dateTime 0..*
effectiveThruTime: dateTime +relationshipCollection
relationshipStatus: string
sourceActivityRole: string
0..*
targetActivityRole: string
sequence: int
+sourceActivity +
+
1 +
+targetActivity +
+
1 +
+activityCollection +
Activ ityParticipation
id: long
startTime: dateTime
endTime: dateTime
method: string
reason: string
description: string
status: string
0..*
+
+participationCollection +
+
0..* +
+
+
+
+act
1
+activity
Product
DrugProduct
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+ lotNumber: string
+ expirationDate: date
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
+sourceEntity
1
Activ ityRelationship
+
+
+
+
+
+
+
+
+product
1
+ingredientCollection 1..*
+entity
+
id: long
MaterialKind
DrugProductIngredient
+ name: string
::ParticipatingEntity
+ id: long
1
+entity
1
+entityCollection
+ingredientCollection
1 +material
0..*
+
+
+
+
id: long
quantity: float
activeIngredientIndicator: boolean
materialForm: string
0..*
+identifierCollection
Activ ityKind
+
+
+
+
+
+
1
+ deathDate: date
+ deathCauseCode: char
+ deathCauseText: string
+ autopsiedIndicator: boolean
survivalStatusCode: int
survivalStatusDescriptionText: string
performanceStatusCode: int
performanceStatusCodeSystem: string
painIndexCode: int
DiseaseResponse
painIndexCodeSystem: string
anamResultAccuracyPercent: int + reponseCode: char
menstrualPatternTypeCode: string + responseCodeSystem: string
menstrualIndicator: boolean
+ bestResponseCode: char
+ bestResponseDate: date
+ progressionDate: date
+ progressionPeriod: int
+ progressionPeriodUnitOfMeasureCode: string
+ doseChangeIndicatorCode: int
+ courseDispositionCode: string
+ commentText: string
+observationCollection
id: long
identifierValue: string
identifierType: string
+identifierCollection
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
1
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
0..* + description: string
+ status: string
StudySubj ect
0..*
Person
1
Adv erseEv entReport
+ sequenceIdentifier: int
+ subjectDiscloserAllowed: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+assigningAuthority
+participatingEntityKind
+identifierCollection
Organization
+observationValueKind
id: long
observationValueCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+
+
+
+
+
id: long
identifierValue: string
identifierType: string
versionIdentifier: string
versionEffectiveDate: dateTime
+identifierCollection
0..*
+assigningAuthority
1
+ name: string
::ParticipatingEntity
+ id: long
+
isFDA() : boolean
Adv erseEv entActiv ityRelationship
+ outcome: string
+ seriousness: string
::Observation
~ resultValue: string
+ targetAnatomicalSite: string
+ onsetDateTime: dateTime
+ effectiveThuTime: dateTime
+ negationIndicator: boolean
::Activity
+ id: long
1 + startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+
isContinuing() : boolean
1
Adv erseEv entDetailKind
+
+
+
+
+
+
id: string
adverseEventDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
Adv erseEv entDetail
+eventDetailKind
1
+
+eventDetailCollection 0..* +
+
+
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
Adv erseEv entReportDetail
+
+
+
+
effectiveFromTime: dateTime
effectiveThruTime: dateTime
booleanValue: boolean
textValue: string
+adverseEventReportDetailKind
0..*
1
Adv erseEv entReportDetailKind
+
+
+
+
+
+
+ namePrefix: string
+ firstName: string
+ middleName: string
+ lastName: string
+ nameSuffix: string
+ occupation: string
+ emailAddress: string
::ParticipatingEntity
+ id: long
+
isHealthProfessional() : boolean
+person
0..*
OrganizationTelephone
+adverseEventReportDetailCollection
id: long
entityType: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
+telephoneCollection
+telephoneCollection
0..*
+adverseEvent
1
+
+
+
+
+
+
1
+adverseEventReport
1
+adverseEventReportDetailCollection
Adv erseEv ent
+ expectedness: boolean
+ attribution: int
+ studyDesignBroken: boolean
+ agentAdjustment: string
+ administrationDelayed: boolean
::ActivityRelationship
+activityRelationshipCollections
+ id: long
+adverseEvent
0..*
+ relationshipType: string
+ effectiveFromTime: dateTime
+ effectiveThruTime: dateTime
+ relationshipStatus: string
+ sourceActivityRole: string
+ targetActivityRole: string
+ sequence: int
hasAmendedData() : boolean
sentToFDA() : boolean
initialSentToFDA() : boolean
sentToManufacturer() : boolean
treatmentDelayed() : boolean
delayDuration() : real
delayDurationUnits() : string
1
ParticipatingEntityKind
Activ ityIdentifier
+organization
+
+
+
+
+AdverseEventReportCollection +
+
0..*
+
Observ ationValueKind
+
+
+
+
+
+
+eventDetailCollection 0..*
MetastasisSite
+cancerStage +metastasisSiteCollection
i d: i nt
tnmStage: string
+ i d: i nt
1..*
tnmStageCodeSystem: string 1
+ anatomicSiteCode: string
stageCode: string
+ anatomicSiteCodeSystem: string
stageCodeSystem: string
+
+
+
Observ ation
+activityKind
id: long
activityCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
DeathSummary
id:
adverseEventReportDetailCode: string
name: string
description: string
codeSystem: string
codeSystemVersion: string
1
ParticipatingEntity
id: long
type: string
+participationCollection
effectiveFromTime: dateTime
effectiveThruTime: dateTime
0..*
participantRole: string
participantSignature: string
participantSignatureDate: dateTime
1
ParticipatingEntityIdentifier 0..*
CancerStage
+
+
+
+
+
id: long
relationshipType: string
effectiveFromTime: dateTime
effectiveThruTime: dateTime
relationshipStatus: string
sourceParticipantRole: string
targetParticipantRole: string
+ isFDA() : boolean
Location
+ name: string
+ description: string
+ streetAddress: string
+ city: string
+ state: string
+ postalCode: string
::ParticipatingEntity
+ id: long
isContinuing() : boolean
isAdjustment() : boolean
+adverseEvent
+
+
+
+
+
ClincalStudy
+ phase: string
+ title: string
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+targetEntity
LesionEvaluation
+adverseEventCollection 1..*
+adverseEventTherapyCollection 0..*
+
+
+
+
+
+
Protocol
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
+
+
+ evaluationCode: char
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
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
ParticipatingEntityRelationship
Treatment
ProcedureTreatment
+ i d: i nt
+ evaluationDate: date
ConceptDescriptor
Imaging
+ imageIdentifier: string
+ i d: i nt
+ contrastAgentEnhancementIndicator: boolean
+ sampleIdentifier: int
+ enhancementRateValue: int
+ sampleTypeCode: string
+ enhancementDescriptionText: string
+ volume: int
+ volumeUnitOfMeasureCode: string
Dev ice
+ implantedDate: dateTime
+ explantedDate: dateTime
+ reprocessedIndicator: boolean
+ availableForEvaluationIndicator: boolean
::Product
+ name: string
+ status: string
::ParticipatingEntity
+ id: long
Assessment
+assessmentCollection
AdverseEvent
+ i d: i nt
+clinicalResultCollection 0..*
+ i d: i nt
+ gradeCode: string
+ cellTypeCode: string
+ gradeCodeSystem: string
+ commentText: string
+conceptDescriptor 1
+specimenCollection 1
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
1 +assessmentCollection
+assessment 1
+observationCollection
+ dose: string
+histopathologyGradeCollection 0..* +neoplasmCollection 0..*
+ doseUnitOfMeasureCode: string
+ scheduleText: string
HistopathologyGrade
Neoplasm
+ therapyExtentCode: string
+ siteConditionCode: string
1
0..*
+ methodCode: string
+substanceAdministrationCollection
+substanceAdministration
Logical Model
AbdulMalik Shakir
1.0
10/18/2005 8:40:14 PM
12/4/2005 11:25:52 PM
::Treatment
+ courseNujmber: string
+ cycleNumber: string
+ negationIndicator: boolean
::Activity
+ id: long
+ startTime: dateTime
+ endTime: dateTime
+ method: string
+ reason: string
+ description: string
+ status: string
0..* +assessmentRelationship
Observation
Radiation
Surgery
SpecimenCollection
AssessmentRelationship
+observation 1 +observation 1
0..* + id: int
+ reportingDate: date
+ confidentialityCode: string
+ uncertaintyCode: string
+ statusCode: string
+histopathology 1
Name:
Author:
Version:
Created:
Updated:
+ i d: i nt
+ typeCode: string
+ commentText: string
0..* +observationRelationshipCollection
+assessmentRelationshipCollection 0..*
+ grossExamResultCode: string
+ reportDescriptiveText: string
+ involvedSurgicalMarginIndicator: boolean
+ anatomicSiteCode: string
+ anatomicSiteCodeSystem: string
id: int
name: string
descriptionText: string
statusCode: string
statusDate: date
streetAddress: string
city: string
stateCode: string
postalCode: string
countryCode: string
telecomAddress: string
ObservationRelationship
Histopathology
Procedure
SubstanceAdministration
AgentSynonym +agentSynonymCollection
0..*
StudyTimePoint
+
+
+
+
+
+
+healthCareSite 1
+
+
+
+ i d: i nt
+
+ roleCode: string
+
+protocol
+studySiteCollection + statusCode: string
+
+ targetAccrualNumber: string
1
+
0..* + startDate: date
+studyAgentCollection 0..*
+
+studySite
+ stopDate: date
+
+ irbApprovalDate: date
StudyAgent
1
0..* +
+studyParticipantCollection +
+ i d: i nt
+
+ investigationalIndicator: boolean
+studyAgent
+ investigationalNewDrugIdentifier: string
+ statusCode: string
1
+studyAgentCollection +agent
+ statusDate: date
+ i d: i nt
+ name: string
+
+
+
0..*
+
+
+healthcareSiteParticipant
+ nciInstituteCode: string
+study
+personOccupationCollection
+healthcareSiteParticipant 1 +healthcareSiteParticipantCollection 0..*
HealthcareSite
Organization
+
+
+
+
+
+
+
+
+
+
+
PersonOccupation
i d: i nt
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
+
+
+
+
+
+ name: string
::ParticipatingEntity
+ id: long
cd Logical Model
cd Clinical Trials Object Model (CTOM)
Organization
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
1
0..*
PersonTelephone
+
+
+
+
+
id: long
usageType: string
equipmentType: string
phoneNumber: string
extendedPhoneNumber: string
+ 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
•Lab SIG Model
•Study Calendar SIG Model
•Financial SIG Model
Harmonized BRIDG elements
cd Comprehensive Class and attribute diagram
BRIDG Shared Classes::Activity
BRIDG Shared Classes::Participation
BRIDG Shared Classes::
RoleRoleRelationship
+
+
+
has a
1
BRIDG Shared Classes::Role
+
+
+
+
+
+
+
+
source:
target:
type: CodedConcept
1..*
has a 1..*
Do we need this -what is the use
case? The thinking
is that this will be
used for caAERS. If
not, then it should
be deleted.
endDate: DATETIME
startDate: DATETIME
status: CodedConcept
statusDate: DATETIME
type: CodedConcept
+
::Role
+ code: BRIDGCodedConcept
+ effectiveEndDate: DATETIME
+have + effectiveStartDate: DATETIME
+ electronicCommAddr: BRIDGTelecomAddress
+ geographicAddr: BRIDGContactAddr
+ id: BRIDGCodedConcept
+ status: BRIDGStatus
+ telecomAddr: BRIDGTelecomAddress
1
+participate as
+ signatureCode: int
+ signatureText: string
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
certificateLicenseText: Text
+are written by
1
0..1
+assign
+are assigned by
+are attributed to
description: Text
expirationDate: DATETIME
name: Text
status: BRIDGStatus
+have
checkpointCode:
conjunctionCode:
joinCode:
negationIndicator: BOOLEAN
negationRule: AbstractRule
priorityNumber: NUMBER
relationshipCode: BRIDGCodedConcept
sequenceNumber: NUMBER
splitCode:
Needs additional work
and cleanup
Clinical Research
Entities and Roles::
HealthCareSite
Clinical Research
Entities and Roles::
MaterialRole
SDTM CTOM harmonization in process
Clinical Trials Activ ities::PlannedStudy
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
1
Clinical Trials Activ ities::
StudyAgent
Clinical Research
Entities and Roles::
TherapeuticAgent
1
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
0..* + status: CodedConcept
0..*
+ statusDate: DATETIME
+ type: CodedConcept
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
+is described by
+ uncertaintyCode: BRIDGCodedConcept
+are performed at
+ targetAccrualNumber: int
::Participation
+ endDate: DATETIME
0..* + startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
Clinical Research
Entities and Roles::
FundingSponsor
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
1..1
Clinical Research Entities and
Roles::Material
+
+
+
+
+
+
* +
+
*
+
+
+
+
0..*
1
Clinical Trials Activ ities::
StudySite
::Role
+ code: BRIDGCodedConcept
+ effectiveEndDate: DATETIME
+ effectiveStartDate: DATETIME
+have + electronicCommAddr: BRIDGTelecomAddress
+ geographicAddr: BRIDGContactAddr
+ id: BRIDGCodedConcept
+ status: BRIDGStatus
+ telecomAddr: BRIDGTelecomAddress
description: Text
+are attributed to
geographicAddr: BRIDGContactAddr
name: Text
status: BRIDGStatus
telecomAddr: BRIDGTelecomAddress
+ 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
::Participation
+ endDate: DATETIME
+ startDate: DATETIME
+ status: CodedConcept
+ statusDate: DATETIME
+ type: CodedConcept
confidentialityIndicator: boolean
paymentMethod: ENUM
+
+
+
+
+
+
+
+participate in +
+
+
+
+
+
+participate in
+
Clinical Trials Activ ities::
Subj ectAssignment
+are performed by
Clinical Trials Activ ities::
StudyAuthor
Clinical Research Entities and Roles::
Participant
+
+
Clinical Research Entities and Roles::
Organization
+target activity
Clinical Trials Activities::Study
0..*
Clinical Research Entities and Roles::
OrganizationRole
+
+
+
+
+
BRIDG Shared Classes::Activ ityActiv ityRelationship
+source activity
Clinical Trials Activ ities::
StudyInv estigator
Clinical Research Entities and Roles::
PersonRole
Clinical Research Entities and Roles::Person
We may or may not
need this class -- it
depends on the
number of shared
classes between the
two
performed/planned
activities
codedDescription: BRIDGCodedConcept
confidentialityCode: BRIDGCodedConcept
description: BRIDGDescription
endDate: DATETIME
priorityCode: BRIDGCodedConcept
reasonCode: BRIDGCodedConcept
startDate: DATETIME
status: BRIDGStatus
uncertaintyCode: BRIDGCodedConcept
This maybe an
Activity?
1
+is fulfiled by the role
address: BRIDGContactAddr
administrativeGenderCode: BRIDGCodedConcept
+are attributed to
dateOfBirth: DATETIME
dateOfDeath: DATETIME
educationLevelCode: BRIDGCodedConcept
electronicCommAddr: BRIDGTelecomAddress
ethnicGroupCode: BRIDGCodedConcept
householdIncomeCategory: BRIDGCodedConcept
maritalStatusCode: BRIDGCodedConcept
name: Text
raceCode: BRIDGCodedConcept
telecomAddress: BRIDGTelecomAddress
+
+
+
+
+
+
+
+
+
Attributes needs to be
reviewed -- need to be
domain oriented -- too
RIM like
code: BRIDGCodedConcept
effectiveEndDate: DATETIME
effectiveStartDate: DATETIME
electronicCommAddr: BRIDGTelecomAddress
geographicAddr: BRIDGContactAddr
id: BRIDGCodedConcept
status: BRIDGStatus
telecomAddr: BRIDGTelecomAddress
Clinical Research Entities
and Roles::Inv estigator
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ targetAccrualNumber: int
::Study
+ blindedInd: boolean
+ description: BRIDGDescription
+ diseaseCode: CodedConceptDataType
+is operationalized by +is described by + id: BRIDGID
+ intentCode: ENUM
0..1
1..1
+ longTitle: string
+ monitorCode: ENUM
+ multiInstitutionInd: boolean
+ phaseCode: ENUM
+write
+ randomizedInd: boolean
+ shortTitle: string
+ sponsorCode: CodedConceptDataType
+ SubjectType: BRIDGCodedConcept
+ type: BRIDGCodedConcept
+describes
PlannedObserv ation
CTOM Elements::
Observ ationRelationship
+is operationalized by
0..1
+
+
0..* -
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
1
comments: string
id: int
type: string
0..*
1
CTOM Elements::PerformedObserv ation
+
+
+
+
confidentialityCode: BRIDGCodedConcept
reportingDate: DATETIME
status: BRIDGStatus
uncertaintyCode: BRIDGCodedConcept
1
CTOM Elements::LesionDescription
1
1
0..*
SDTM::SDTMFinding
Specimen may
have to re-located
+
+
missingValueCode: CodedConceptDataType
name: CodedConceptDataType
We will need to MANUALLY keep
these two classes in synch with
their attributes.
BRIDG Shared Classes::Drug
+ formCode: BRIDGCodedConcept
+ lotNumber: int
+ stabilityTime: DATETIME
::Material
+ description: Text
+ expirationDate: DATETIME
+ name: Text
+ status: BRIDGStatus
BRIDG Shared Classes::
Dev ice
CTOM Elements::ClinicalResult
CTOM Elements::Histopathology
SDTM::Examination
::Material
+ description: Text
+ expirationDate: DATETIME
+ name: Text
+ status: BRIDGStatus
BRIDG Shared Classes::Document
+is described by 1
Clinical Trials Activ ities::StudyDocument
BRIDG Shared Classes::
BRIDGCodedConcept
BRIDG Shared Classes::BRIDGAnalysisVariable
+
+
+
+
businessProcessMode: PSMBusinessProcessMode
controlledName: PSMCodedConcept
name: TEXT
value:
BRIDG Shared Classes::BRIDGDescription
+
+
+
detailedDescription: EncapsulatedData
summaryDescription: EncapsulatedData
synopsis: EncapsulatedData
-
code: TEXT
codeSystem:
codeSystemName: TEXT
codeSystemVersion: NUMBER
displayName: TEXT
originalText: TEXT
translation: SET{PSMCodedConcept}
BRIDG Shared Classes::
BRIDGContactAddr
+
+
+
BRIDG Shared Classes::
BRIDGInterv al
effectiveTime: BRIDGInterval
type: BRIDGCodedConcept
usage: BRIDGCodedConcept
BRIDG Shared
Classes::
BRIDGID
+
+
+
source: Text
value: Text
version: Text
+
-
endTime: timestamp
startTime: timestamp
BRIDG Shared Classes:
:BRIDGStatus
+
+
+
effectiveEndDate:
effectiveStartDate:
statusValue:
BRIDG Shared Classes::
BRIDGTelecomAddress
-
addressType: ENUM
usageType: ENUM
value: Text
«abstraction»
Review the data
types -inconsistency in
definition and what
is used in the model
+ 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
+
+
+
+
+
+
confidentialityCode: CodedConcept
description: DAMDescription
documentID: BRIDGID
status: BRIDGStatus
type: ENUM
version: string
+
+
+
+ measurementTime: int
- resultDescription: SDTMFindingDescriptionDataType
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
grossExamResultCode: string
involvedSurgicalMarginIndicator: boolean
reportDescriptiveText: string
SDTM::Quantitativ eMeasurement
SDTM::OtherFindings
+ evaluationInterval: timing specification
+ measurementTime: DATETIME
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::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
SDTM::LaboratoryTest
Potential hook for
the eDCI model
+ fastingStatus: boolean
+ method: enum
::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
Observation Classes
from CTOM and SDTM
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
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
Name:
Package:
Version:
Author:
CTOM observations and SDTM
CTOM (imported package)
1.0
Fridsma
CTOM and SDTM harmonization
(work in progress)
SDTM::OtherFindings
+ evaluationInterval: timing specification
+ measurementTime: DATETIME
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
Harmonized
Elements::
PlannedObserv ation
CTOM Elements::
Observ ationRelationship
CTOM Elements::Histopathology
+
+
-
comments: string
id: int
type: string
1 0..*
1
0..*
+
+
+
grossExamResultCode: string
involvedSurgicalMarginIndicator: boolean
reportDescriptiveText: string
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
anatomicSiteCode: string
anatomicSiteCodeSystem: string
appearanceTypeCode: string
contactAnatomicSiteCode: string
contactAnatomicSiteCodeSytem: string
dimensionProduct: int
evaluationNumber: int
lesionNumber: string
measurableIndicator: boolean
methodCode: string
previouslyIrradiatedSiteIndicator: boolean
targetNonTargetCode: string
xDimension: int
yDimension: int
zDimension: int
CTOM Elements::PerformedObserv ation
SDTM::Examination
SDTM::SDTMFinding
+ measurementTime: int
- resultDescription: SDTMFindingDescriptionDataType
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
missingValueCode: CodedConceptDataType
name: CodedConceptDataType
+
+
+
+
confidentialityCode: BRIDGCodedConcept
reportingDate: DATETIME
status: BRIDGStatus
uncertaintyCode: BRIDGCodedConcept
CTOM Elements::ClinicalResult
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
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
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
TestInterpretation
SDTM::InterpretedResults
SDTM::LaboratoryTest
+ fastingStatus: boolean
+ method: enum
::QuantitativeMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
::TestInterpretation
+ interpretedBy: enum
+ normalRangeIndicator: enum
- resultCategory: int
::QuantitativeMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
Harmonizing attributes
CTOM Elements::ClinicalResult
SDTM::LaboratoryTest
+ fastingStatus: boolean
+ method: enum
::QuantitativeMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
Adding tags to provide semantic traceability (and notes)
CTOM Elements::ClinicalResult
SDTM::LaboratoryTest
+ fastingStatus: boolean
+ method: enum
::QuantitativeMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
Simple semantic can be tracked in tagged
values
CTOM Elements::ClinicalResult
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
This linking can be extended down to
the CDE level
CTOM Elements::ClinicalResult
SDTM::Quantitativ eMeasurement
+ normalRangeHigh: text
+ normalRangeLow: text
+ result: text
+ units: text
::SDTMFinding
+ missingValueCode: CodedConceptDataType
+ name: CodedConceptDataType
+
+
+
+
+
+
+
+
+
+
+
abnormalIndicator: boolean
assayMethodCode: string
biomarkerInd: boolean
bodyPositionCode: string
labReferenceRangeCode: string
labTechniqueCode: string
meansVitalStatusObtainedCod: string
panelName: string
significanceInd: boolean
value: string
valueUnitOfMeasureCode: string
IMPLEMENTATION
SOLUTIONS
Achieving interoperability
Application
Development
xml data
Exchange
HL7 Tooling
caCORE Tooling
CDISC xml
Interoperability
STAKEHOLDERS
FOUNDATION
MODEL
V3 Message
Development
Interoperability
HL7 (RCRIM)
NCI/caBIG
CDISC
c d Compre he ns iv e M ode l
BRIDG Sha re d Cla s s e s ::Pa rtic ipa tion
BRIDG Sha re d Cla s s e s ::Role
+
+
+
+
+
+
+
+
i d:
Co d e d Co n ce p t
co d e :
Co d e d Co n ce p t
sta tu s:
e l e ctro n i cCo m m Ad d r:
g e o g ra p h i cAd d r:
te l e co m Ad d r:
e ffe cti ve Sta rtDa te :
DAT ET IM E
e ffe cti ve En d Da te :
DAT ET IM E
has a
1
1 ..*
has a
1
+
+
+
+
+
BRIDG Sha re d Cla s s e s ::
Role Role Re la tions hip
+
+
+
so u rce :
typ e :
Co d e d Co n ce p t
ta rg e t:
+
ce rti fi ca te L i ce n se T e xt:
i d:
Co d e d Co n ce p t
a d m i n i stra ti ve Ge n d e rCo d e :
BRIDGCo d e d Co n ce p t
d a te OfBi rth :
DAT ET IM E
ra ce Co d e :
BRIDGCo d e d Co n ce p t
e th n i cGro u p Co d e :
BRIDGCo d e d Co n ce p t
m a ri ta l Sta tu sCo d e :
BRIDGCo d e d Co n ce p t
e l e ctro n i cCo m m Ad d r:
h o u se h o l d In co m e Ca te g o ry:
BRIDGCo d e d Co n ce p t
e d u ca ti o n L e ve l Co d e :
BRIDGCo d e d Co n ce p t
te l e co m Ad d re ss:
T EL
nam e:
e n ti tyNa m e
d a te OfDe a th :
DAT ET IM E
a d d re ss:
a d d rT yp e
Clinic a l Re s e a rc h Entitie s
a nd Role s ::Orga niza tion
+
+
+
+
+
+
+
1
0 ..*
Clinic a l Re s e a rc h Entitie s a nd
Role s ::Pa rtic ipa nt
+
+
p a ym e n tM e th o d :
Co d e d Co n ce p t
co n fi d e n ti a l i tyCo d e :
stri n g
+
+
+
+
+
+
+
+
+
+
+
+
+
Clinic a l Re s e a rc h
Entitie s a nd Role s ::
He a lthCa re Site
Clinic a l Tria ls Ac tiv itie s ::Subj e c tAs s ignme nt
+
si g n a tu re Co d e :
i nt
+
si g n a tu re T e xt:
stri n g
::Pa rti ci p a ti o n
+
typ e :
Co d e d Co n ce p t
+
sta tu s:
Co d e d Co n ce p t
+
sta tu sDa te :
DAT ET IM E
+
sta rtDa te :
DAT ET IM E
+
e n d Da te :
DAT ET IM E
0 ..*
1
0 ..1
+
stu d ySu b j e ctId e n ti fi e r:
i nt
+
a rm :
stri n g
+
su b g ro u p Co d e :
stri n g
+
i n fo rm e d Co n se n tFo rm Si g n e d Da te :
+
o ffStu d yDa te :
d a te
+
stu d yAg e n tDo se L e ve l :
stri n g
+
e l i g i b i l i tyWa i ve rRe a so n :
stri n g
+
a g e AtEn ro l l m e n t:
i nt
::Pa rti ci p a ti o n
+
typ e :
Co d e d Co n ce p t
+
sta tu s:
Co d e d Co n ce p t
+
sta tu sDa te :
DAT ET IM E
+
sta rtDa te :
DAT ET IM E
+
e n d Da te :
DAT ET IM E
+ta rg e t a cti vi ty
*
*
+
+
+
+
+
+
+
+
+
re l a ti o n sh i p Co d e :
PSM Co d e d Co n ce p t
Ob so l e te _ re l a ti o n Qu a l i fi e r:
BRIDGCo d e d Co n ce p t
se q u e n ce Nu m b e r:
NUM BER
p a u se Cri te ri o n :
ch e ckp o i n tCo d e :
p ri o ri tyNu m b e r:
NUM BER
sp l i tCo d e :
n e g a ti o n Ru l e :
Ab stra ctRu l e
j o i n Co d e :
n e g a ti o n In d i ca to r:
BOOL EAN
co n j u n cti o n Co d e :
Clinic a l Tria ls Ac tiv itie s ::Pla nne dStudy
::Acti vi ty
+
co d e :
PSM Co d e d Co n ce p t
+
d e ri va ti o n Exp re ssi o n :
T EXT
+
d e scri p ti o n :
PSM De scri p ti o n
+
sta rtDa te :
DAT ET IM E
+
sta tu s:
PSM Co d e d Co n ce p t
+
a va i l a b i l i tyT i m e :
T i m i n g Sp e ci fi ca ti o n
+
p ri o ri tyCo d e :
PSM Co d e d Co n ce p t
+
co n fi d e n ti a l i tyCo d e :
PSM Co d e d Co n ce p t
+
re p e a tNu m b e r:
ra n g e OfIn te g e rs
+
i n te rru p ti b l e In d i ca to r:
BOOL EAN
+
u n ce rta i n tyCo d e :
Co d e d Co n ce p t
+
re a so n Co d e :
PSM Co d e d Co n ce p t
+
e n d Da te :
DAT ET IM E
Clinic a l Tria ls Ac tiv itie s ::Pla nne dAc tiv ity
::Acti vi ty
+
co d e :
PSM Co d e d Co n ce p t
+
d e ri va ti o n Exp re ssi o n :
T EXT
+
d e scri p ti o n :
PSM De scri p ti o n
+
sta rtDa te :
DAT ET IM E
+
sta tu s:
PSM Co d e d Co n ce p t
+
a va i l a b i l i tyT i m e :
T i m i n g Sp e ci fi ca ti o n
+
p ri o ri tyCo d e :
PSM Co d e d Co n ce p t
+
co n fi d e n ti a l i tyCo d e :
PSM Co d e d Co n ce p t
+
re p e a tNu m b e r:
ra n g e OfIn te g e rs
+
i n te rru p ti b l e In d i ca to r:
BOOL EAN
+
u n ce rta i n tyCo d e :
Co d e d Co n ce p t
+
re a so n Co d e :
PSM Co d e d Co n ce p t
+
e n d Da te :
DAT ET IM E
Clinic a l Tria ls Ac tiv itie s ::Pe rforme dAc tiv ity
1
+
p l a n n n e d Un p l a n n e d In d :
bool ean
::Acti vi ty
+
co d e :
PSM Co d e d Co n ce p t
+
d e ri va ti o n Exp re ssi o n :
T EXT
+
d e scri p ti o n :
PSM De scri p ti o n
+
sta rtDa te :
DAT ET IM E
+
sta tu s:
PSM Co d e d Co n ce p t
+
a va i l a b i l i tyT i m e :
T i m i n g Sp e ci fi ca ti o n
+
p ri o ri tyCo d e :
PSM Co d e d Co n ce p t
+
co n fi d e n ti a l i tyCo d e :
PSM Co d e d Co n ce p t
+
re p e a tNu m b e r:
ra n g e OfIn te g e rs
+
i n te rru p ti b l e In d i ca to r:
BOOL EAN
+
u n ce rta i n tyCo d e :
Co d e d Co n ce p t
+
re a so n Co d e :
PSM Co d e d Co n ce p t
+
e n d Da te :
DAT ET IM E
Clinic a l Tria ls Ac tiv itie s ::
StudySite
+
ta rg e tAccru a l Nu m b e r:
i nt
::Pa rti ci p a ti o n
+
typ e :
Co d e d Co n ce p t
+
sta tu s:
Co d e d Co n ce p t
+
sta tu sDa te :
DAT ET IM E
+
sta rtDa te :
DAT ET IM E
+
e n d Da te :
DAT ET IM E
1
BRIDG Sha re d Cla s s e s ::
Ac tiv ityAc tiv ityRe la tions hip
+so u rce a cti vi ty
code: PSMCodedConcept
derivationExpres s ion: TEXT
des cription: PSMDes cription
s tartDate: DATETIME
s tatus : PSMCodedConcept
availabilityTim e: Tim ingSpecification
priorityCode: PSMCodedConcept
confidentialityCode: PSMCodedConcept
repeatNum ber: rangeOfIntegers
interruptibleIndicator: BOOLEAN
uncertaintyCode: CodedConcept
reas onCode: PSMCodedConcept
endDate: DATETIME
d a te
0 ..*
Clinic a l Re s e a rc h
Entitie s a nd Role s ::
FundingSpons or
Clinic a l Re s e a rc h Entitie s a nd
Role s ::Orga niza tionRole
i d:
Co d e d Co n ce p t
nam e:
stri n g
d e scri p ti o n :
stri n g
sta tu s:
Co d e d Co n ce p t
sta tu sDa te :
DAT ET IM E
g e o g ra p h i cAd d r:
a d d rT yp e
te l e co m Ad d r:
T EL
0 ..*
0 ..*
Protoc ol Conc e pts ::StudyDoc ume nt
+
+
+
+
+
+
+
+
+
Clinic a l Re s e a rc h
Entitie s a nd Role s ::
The ra pe utic Age nt
i d:
Co d e d Co n ce p t
nam e:
stri n g
d e scri p ti o n :
stri n g
sta tu s:
Co d e d Co n ce p t
fo rm Co d e :
Co d e d Co n ce p t
l o tNu m b e r:
i nt
e xp i ra ti o n Da te :
DAT ET IM E
sta b i l i tyT i m e :
DAT ET IM E
1
0 ..*
ve rsi o n :
stri n g
a u th o r:
SET
ID:
SET BRIDGID
d o cu m e n tID:
BRIDGID
typ e :
ENUM
d e scri p ti o n :
BRIDGDe scri p ti o n
ti tl e :
stri n g
sta tu s:
BRIDGSta tu s
co n fi d e n ti a l i tyCo d e :
Co d e d Co n ce p t
Clinic a l Tria ls
Ac tiv itie s ::
As s e s s me ntRe la tions hip
Clinic a l Tria ls
Ac tiv itie s ::
Obs e rv a tionRe la tions hip
Clinic a l Tria ls Ac tiv itie s ::
StudyAge nt
Clinic a l Re s e a rc h
Entitie s a nd Role s ::
Age ntRole
Clinic a l Re s e a rc h Entitie s a nd
Role s ::Age nt
+
+
+
+
+
+
+
+
Clinic a l Tria ls Ac tiv itie s ::
StudyInv e s tiga tor
Clinic a l Re s e a rc h
Entitie s a nd Role s ::
Inv e s tiga tor
Clinic a l Re s e a rc h Entitie s a nd Role s ::
Pe rs onRole
::Ro l e
+
i d:
Co d e d Co n ce p t
+
co d e :
Co d e d Co n ce p t
+
sta tu s:
+
e l e ctro n i cCo m m Ad d r:
+
g e o g ra p h i cAd d r:
+
te l e co m Ad d r:
+
e ffe cti ve Sta rtDa te :
DAT ET IM E
+
e ffe cti ve En d Da te :
DAT ET IM E
BRIDG Shared Classes::Activity
typ e :
Co d e d Co n ce p t
sta tu s:
Co d e d Co n ce p t
sta tu sDa te :
DAT ET IM E
sta rtDa te :
DAT ET IM E
e n d Da te :
DAT ET IM E
1 ..*
Clinic a l Re s e a rc h Entitie s a nd Role s ::Pe rs on
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
::Pa rti ci p a ti o n
+
typ e :
Co d e d Co n ce p t
+
sta tu s:
Co d e d Co n ce p t
+
sta tu sDa te :
DAT ET IM E
+
sta rtDa te :
DAT ET IM E
+
e n d Da te :
DAT ET IM E
1
1
0 ..*
1
1
+
+
+
+
+
+
+
+
+
+
+
+
i d:
BRIDGID
l o n g T i tl e :
stri n g
sh o rtT i tl e :
stri n g
p h a se Co d e :
ENUM
i n te n tCo d e :
ENUM
m o n i to rCo d e :
ENUM
b l i n d e d In d :
bool ean
ra n d o m i ze d In d :
bool ean
d i se a se Co d e :
Co d e d Co n ce p tDa ta T yp e
sp o n so rCo d e :
Co d e d Co n ce p tDa ta T yp e
m u l ti In sti tu ti o n In d :
bool ean
ta rg e tAccru a l Nu m b e r:
i nt
+
+
+
i d:
i nt
typ e :
stri n g
co m m e n ts:
stri n g
Clinic a l Tria ls Ac tiv itie s ::
Pe rforme dStudy
1
0 ..*
0 ..*
1
1
0 ..*
nam e:
T EXT
va l u e :
co n tro l l e d Na m e :
PSM Co d e d Co n ce p t
b u si n e ssPro ce ssM o d e :
PSM Bu si n e ssPro ce ssM o d e
BRIDG Sha re d Cla s s e s ::
BRIDGCode dConc e pt
-
co d e :
T EXT
co d e Syste m :
co d e Syste m Na m e :
T EXT
co d e Syste m Ve rsi o n :
NUM BER
d i sp l a yNa m e :
T EXT
o ri g i n a l T e xt:
T EXT
tra n sl a ti o n :
SET {PSM Co d e d Co n ce p t}
BRIDG Sha re d Cla s s e s ::BRIDGDe s c ription
+
+
+
syn o p si s:
En ca p su l a te d Da ta
su m m a ryDe scri p ti o n :
En ca p su l a te d Da ta
d e ta i l e d De scri p ti o n :
En ca p su l a te d Da ta
BRIDG Sha re d Cla s s e s ::
BRIDGBus ine s s Proc e s s M ode
+
m o d e Va l u e :
ENUM {Pl a n , Exe cu te }
BRIDG Sha re d Cla s s e s ::
BRIDGConta c tAddr
+
+
+
+
+
1 ..*
BRIDG Sha re d
Cla s s e s ::
BRIDGID
+
+
+
so u rce :
T e xt
ve rsi o n :
T e xt
va l u e :
T e xt
+
sta rtT i m e :
endT i m e:
BRIDG Sha re d Cla s s e s ::
BRIDGSta tus
+
+
+
e ffe cti ve En d Da te :
e ffe cti ve Sta rtDa te :
sta tu sVa l u e :
ti m e sta m p
ti m e sta m p
« a b stra cti o n »
0 ..*
+
+
+
Clinic a l Tria ls Ac tiv itie s ::
Subs ta nc e Adminis tra tion
+
+
+
+
+
+
0 ..*
d a te
Clinic a l Tria ls Ac tiv itie s ::Adv e rs e Ev e nt
Clinic a l Tria ls Ac tiv itie s ::His topa thology
0 ..*
i d:
i nt
e va l u a ti o n Da te :
0 ..*
BRIDG Sha re d Cla s s e s :
:BRIDGInte rv a l
typ e :
BRIDGCo d e d Co n ce p t
e ffe cti ve T i m e :
BRIDGIn te rva l
u sa g e :
BRIDGCo d e d Co n ce p t
1
Clinic a l Tria ls Ac tiv itie s ::As s e s s me nt
i d:
i nt
re p o rti n g Da te :
d a te
co n fi d e n ti a l i tyCo d e :
stri n g
u n ce rta i n tyCo d e :
stri n g
sta tu sCo d e :
stri n g
1
BRIDG Sha re d Cla s s e s ::BRIDGAna lys is Va ria ble
+
+
+
+
i d:
i nt
typ e Co d e :
stri n g
co m m e n tT e xt:
stri n g
1
Clinic a l Tria ls Ac tiv itie s ::Obs e rv a tion
+
+
+
+
+
0 ..*
d o se Qu a n ti ty:
i nt
d o se Un i tOfM e a su re :
stri n g
ro u te :
stri n g
d o se Fre q u e n cy:
stri n g
d o se M o d i fi ca ti o n T yp e :
stri n g
d o se Ch a n g e T yp e :
i nt
g ro ssExa m Re su l tCo d e :
stri n g
re p o rtDe scri p ti ve T e xt:
stri n g
i n vo l ve d Su rg i ca l M a rg i n In d i ca to r:
1
0 ..*
ta rg e tSi te Co d e :
bool ean
1
Clinic a l Tria ls Ac tiv itie s ::
His topa thologyGra de
Clinic a l Tria ls Ac tiv itie s ::Proc e dure
+
stri n g
+
+
+
+
i d:
i nt
g ra d i n g Syste m Na m e :
g ra d e :
stri n g
co m m e n ts:
stri n g
stri n g
0 ..*
Clinic a l Tria ls Ac tiv itie s ::
Clinic a lRe s ult
+
+
+
+
+
+
+
+
+
+
+
p a n e l Na m e :
stri n g
va l u e :
stri n g
va l u e Un i tOfM e a su re Co d e :
stri n g
a ssa yM e th o d Co d e :
stri n g
b o d yPo si ti o n Co d e :
stri n g
l a b Re fe re n ce Ra n g e Co d e :
stri n g
l a b T e ch n i q u e Co d e :
stri n g
m e a n sVi ta l Sta tu sOb ta i n e d Co d :
stri n g
a b n o rm a l In d i ca to r:
bool ean
b i o m a rke rIn d :
bool ean
si g n i fi ca n ce In d :
bool ean
Clinic a l Tria ls Ac tiv itie s ::
Le s ionDe s c ription
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
l e si o n Nu m b e r:
stri n g
e va l u a ti o n Nu m b e r:
i nt
a p p e a ra n ce T yp e Co d e :
stri n g
ta rg e tNo n T a rg e tCo d e :
stri n g
m e a su ra b l e In d i ca to r:
bool ean
m e th o d Co d e :
stri n g
xDi m e n si o n :
i nt
yDi m e n si o n :
i nt
zDi m e n si o n :
i nt
d i m e n si o n Pro d u ct:
i nt
a n a to m i cSi te Co d e :
stri n g
a n a to m i cSi te Co d e Syste m :
stri n g
co n ta ctAn a to m i cSi te Co d e :
stri n g
co n ta ctAn a to m i cSi te Co d e Syte m :
p re vi o u sl yIrra d i a te d Si te In d i ca to r:
stri n g
bool ean
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
1 ..*
Clinic a l Tria ls
Ac tiv itie s ::
Ne opla s m
Clinic a l Tria ls
Ac tiv itie s ::
Surge ry
Clinic a l Tria ls
Ac tiv itie s ::
Spe c ime nColle c tion
+
+
si te Co n d i ti o n :
stri n g
m e th o d :
stri n g
+sp e ci m e n Co l l e cti o n
Clinic a l Tria ls Ac tiv itie s ::
Ra dia tion
+
+
+
th e ra p yT yp e :
stri n g
d o se Un i tOfM e a su re :
d o se :
stri n g
stri n g
i d e n ti fi e r:
stri n g
co n tra stAg e n tEn h a n ce m e n t:
stri n g
d e scri p ti ve T e xt:
stri n g
ra te OfEn h a n ce m e n tVa l u e :
i nt
+
+
i d:
i nt
ce l l T yp e :
+
+
+
+
+
+
+
+
i d:
i nt
su b m i ssi o n Da te :
d a te
fi l e d In d i ca to r:
bool ean
i d:
i nt
tn m Sta g e :
stri n g
tn m Sta g e Co d e Syste m :
stri n g
sta g e Co d e :
stri n g
sta g e Co d e Syste m :
stri n g
re sp o n se Co d e :
ch a r
re sp o n se Co d e Syste m :
stri n g
b e stRe sp o n se Co d e :
ch a r
b e stRe sp o n se Da te :
d a te
p ro g re ssi o n Da te :
d a te
p ro g re ssi o n Pe ri o d :
i nt
p ro g re ssi o n Pe ri o d Un i tOfM e a su re Co d e :
d o se Ch a n g e In d i ca to rCo d e :
i nt
co u rse Di sp o si ti o n Co d e :
stri n g
co m m e n tT e xt:
stri n g
Clinic a l Tria ls Ac tiv itie s ::
De a thSumma ry
+
+
+
+
d e a th Da te :
d a te
d e a th Ca u se Co d e :
ch a r
d e a th Ca u se T e xt:
stri n g
a u to p si e d In d i ca to r:
bool ean
1
i d:
i nt
i d Nu m b e r:
i nt
sa m p l i n g T yp e :
stri n g
1 ..*
Clinic a l Tria ls Ac tiv itie s ::
Adv e rs e Ev e ntThe ra py
+
+
+
+
+
i d:
i nt
tre a tm e n tDa te :
d a te
d e l a yDu ra ti o n :
i nt
d e l a yDu ra ti o n Un i tOfM e a su re Co d e :
i n te n si tyCo d e :
stri n g
stri n g
Clinic a l Tria ls Ac tiv itie s ::
M e ta s ta s is Site
+
+
+
i d:
i nt
a n a to m i cSi te Co d e :
stri n g
a n a to m i cSi te Co d e Na m e :
stri n g
stri n g
BRIDG – Domain Analysis Model for Clinical Research
Clinic a l Tria ls
Ac tiv itie s ::
Le s ionEv a lua tion
+
e va l u a ti o n Co d e :
ch a r
Clinic a l Tria ls Ac tiv itie s ::
Qua lita tiv e Ev a lua tion
1
0 ..*
Clinic a l Tria ls Ac tiv itie s :
:Spe c ime n
+
+
+
+
+
+
+
+
+
+
+
+
+
1
0 ..1
0 ..*
+sp e ci m e n Co l l e cti o n
Clinic a l Tria ls Ac tiv itie s ::Dis e a s e Re s pons e
nam e:
stri n g
d i se a se Di a g n o si sCo d e :
stri n g
d i se a se Di a g n o si sCo d e Syste m :
stri n g
a g e AtDi a g n o si s:
i nt
co n fi rm a ti o n Da te :
d a te
p ri m a ryAn a to m i cSi te Co d e :
stri n g
p ri m a ryAn a to m i cSi te Co d e Syste m :
stri n g
p ri m a ryAn a to m i cSi te L a te ra l i tyCo d e :
stri n g
re cu rre n ce In d i ca to r:
bool ean
d i se a se Sta tu sCo d e :
stri n g
so u rce Co d e :
stri n g
so u rce Oth e r:
stri n g
d i se a se Exte n tT e xt:
stri n g
Clinic a l Tria ls Ac tiv itie s ::
Ca nc e rSta ge
0 ..1
stri n g
Clinic a l Tria ls Ac tiv itie s ::Dia gnos is
+
+
+
+
+
+
+
+
+
+
+
+
+
1
Clinic a l Tria ls
Ac tiv itie s ::
Adv e rs e Ev e ntRe port
Clinic a l Tria ls Ac tiv itie s ::Ima ging
+
+
+
+
o n se tDa te :
d a te
re so l ve d Da te :
d a te
ctcCa te g o ryCo d e :
stri n g
ctcCa te g o ryCo d e Syste m :
stri n g
ctcT e rm T yp e Co d e :
stri n g
ctcT e rm T yp e Co d e Syste m :
stri n g
ctcAttri b u ti o n Co d e :
stri n g
ctcAttri b u ti o n Co d e Syste m :
stri n g
ctcGra d e Co d e :
stri n g
ctcGra d e Co d e Syste m :
stri n g
se ri o u sRe a so n Co d e :
stri n g
o u tco m e Co d e :
stri n g
a cti o n T a ke n Co d e :
stri n g
co n d i ti o n Pa tte rn Co d e :
stri n g
d o se L i m i ti n g T o xi ci tyIn d i ca to r:
bool ean
d o se L i m i ti n g T o xi ci tyDe scri p ti o n T e xt:
stri n g
d e scri p ti o n T e xt:
stri n g
+
+
+
+
+
+
+
+
su rvi va l Sta tu sCo d e :
i nt
su rvi va l Sta tu sDe scri p ti o n T e xt:
stri n g
p e rfo rm a n ce Sta tu sCo d e :
i nt
p e rfo rm a n ce Sta tu sCo d e Syste m :
stri n g
p a i n In d e xCo d e :
i nt
p a i n In d e xCo d e Syste m :
stri n g
a n a m Re su l tAccu ra cyPe rce n t:
i nt
m e n stru a l Pa tte rn T yp e Co d e :
stri n g
m e n stru a l In d i ca to r:
bool ean
BRIDG development
Top-Down scaffolding Development
BRIDG
Use case driven, subproject Development
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 developed processes and organization of the model that will support
more scaleable collaborative development
– Demonstrated semantic reuse for subproject development
• We hope that this model will serve as a resource for application and
message development within a unified framework, and will define the
shared semantics of clinical trials research
– caBIG for application development
– HL7 for V3 RIM message development
– “Semantic traceability” to link analysis model to design and
implementation-specific models
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
Acknowledgements –leadership
• Leadership and collaboration
– CDISC board members
– Becky Kush, CDISC
– Sue Dubman, Christo Andonyadis, Peter
Covitz NCI
– Charlie Mead, HL7, BAH
– Barbara Tardiff, Linda Quade, Randy Levine
(FDA), RCRIM technical committee of HL7
Acknowledgements –modelers
•
•
•
•
•
•
•
•
•
•
•
Christo Andonyadis
Greg Anglin
Lisa Chatterjee
Julie Evans
Douglas B Fridsma
Smita Hastak
Joyce Niland
John Speakman
Cara Willoughby
Diane Wold
Peter Ambramovich
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Ed Helton
Pierre-Yves Lastic
Tony Friebel
Don Kacher
Barbara Tardiff
Chuck Jaffe
Frank Newby
Sally Cassels
Nitin Gupta
Landen Bain
Laura Altshuler
Steve Ruberg
Elaine Job
Becky Kush
Sylvia Collins
Udo Siegman
David Hardison
David Iberson-Hurst
Acknowledgements—Organizations
• Pharmaceutical
companies
– AstraZeneca
– BoehringerIngelheim
– Eli Lilly
– GlaxoSmithKline
– Merck
– Novartis
– Pfizer
– Sanofi-Aventis
• Technology
companies
–
–
–
–
–
–
–
ScenPro
IBM
SAS
Fast track
SAIC
BAH
Oracle
Further Information
•
•
•
•
ncicb.nci.nih.gov
caBIG.nci.nih.gov
www.BRIDGproject.org
fridsma@cbmi.pitt.edu