CDISC: Interoperability and Beyond…....PharmaSUG Single Day Event: A CDISC Grab Bag CDISC:...

PharmaSUG Single Day Event: A CDISC Grab Bag

CDISC: Interoperability and Beyond….

C. David Butler, PharmD, MBA

Senior Business Consultant II, Healthcare

2 © 2016 Teradata

Agenda

• The CDISC Roadmap and the data explosion

• Tools and Techniques for Any Data, ALL Data

• How to Integrate CDISC Across the Enterprise to: “Reduce Costs and Speed the Development of Therapies for Patients”

• Discussion

3

The CDISC Roadmap and the Data Explosion

4 © 2016 Teradata

The CDISC Roadmap

CDISC Healthcare Link initiative will support

a future where the clinical researcher will

take full advantage of data from the EHR,

devices, wearables and registries; data will

be created "research-ready" …

Such processes include, but are not limited to registry

population (disclosure); generation and population of

eCRFs, clinical trial management systems and databases;

production of tables and analysis datasets for reporting

and/or eSubmissions; and facilitation of all types of

research, including outcomes, public health and nutrition.

5

Tools and Techniques for Any Data, ALL Data

6 © 2016 Teradata

Teradata Reference Information Architecture

Operational Metadata

Acquisition1..n Integrated Data Access1..n

Regional and Departmental

Views

ADS

Applications& Engines

OperationalAnalytics & Hot Views

Data Marts

Archive

EAIBus

Common Summary

and Derived Values

WWW

OLAP

Reporting

Ad hoc

Dashboard

Applications

External

Intracore

Data Mining

Downstream

Results Loop

Discovery &

Investigation

EAIBus

Tables

Master Data

Reference Data

Transaction Data

Independent

Dependent

Data LabCountry

1..nBU1..n

ExportFiles

User External

Files

Big Data Environment

Txn Txn

AppData

Full Dump Full

CDC Delta

Active Load Stream

RelationalData

StructuredBig Data

WWW

TIER 2 TIER 3TIER 1

DeliveryStructuredSources

DiversifiedSources

BigData

LogsText

Ad

ds C

on

text

Conformed Dimensions

ExportFiles

Audit & Lineage

7 © 2016 Teradata

Business

Focused

Data

Driven

TERADATA UNIFIED DATA ARCHITECTURE

Cost Optimization View

Security, Workload Management

Marketing

Executives

Operational

Systems

Frontline

Workers

Customers

Partners

Engineers

Data

Scientists

Business

AnalystsMath

and Stats

Data

Mining

Business

Intelligence

Applications

Languages

Marketing

USERS

Search

INTEGRATED DATA

WAREHOUSE

ANY-DATA

PLATFORM

INTEGRATED

DISCOVERY

Security, Workload ManagementREAL TIME PROCESSING

GREATER INSIGHTS

HIGHER VALUE

LOWERCOSTS

↓ STORAGE COSTS

↓ SOFTWARE COSTS

↓ INGESTION COSTS

↓ DEVELOPMENT COSTS

↓ SUPPORT & MAINTENANCE COSTS

↓ USAGE COSTS

↓ PEOPLE COSTS

TAILOR ED SECURITY/PRIVACY

HIGHEST INTEGRITY

↓ ANALYTICAL DEVELOPMENT COSTS

↓ PEOPLE COSTS

FAST COMPLEXQUERIESRESEARCH

GENOME

DOCUMENTS

IMAGES

Audio

and Video

Machine

Logs

Text

Web and

Social

SOURCES

Marketing

Executives

Operational

Systems

Frontline

Workers

Customers

Partners

Engineers

Data

Scientists

Business

Analysts

USERS

Executives

Operational

Systems

Knowledge

Workers

Customers

Partners

Lab

Technicians

Scientists

Business

Analysts

USERSANALYTIC

TOOLS & APPS

8 © 2016 Teradata

Life Sciences Logical Data Model (LS-LDM)A Complete Package

• LS-LDM Product:

> Normalized Logical Data Model in CA

ERwin modeling tool

– Entity & Attribute definitions

– Relationship verbs

– Establishes enterprise data integration

> Comprehensive Reference Guides

– PDF and hardcopy

Foundation Core LDM Modules

e.g., Party, Product, Event

Geography, Account, Channel. . .

HCLDMForecasting

/ ScoringTransportation

Financial

Management

LS-LDMBasic Research

LS-LDMClinical Trials

LS-LDMManufacturing

LS-LDMEMR

• Supports:

> Granular object and event data

> Granular traceability

> Industry Standards

(BRIDG, HL7, CDISC, OMOP)

> Easily extended

> Data reuse

9 © 2016 Teradata

Financial ManagementConsolidated GL, Fixed Asset, Project Management, AR, AP

Order FulfillmentSales, Adjustments, Funnel, Acknowledgement, POS/3rd Party Sale

Supply Chain LogisticsCarrier Rate, Logistics, Planning, Notification, Trip Detl., Transport Goal

ManufacturingForecast, Mfg/Work Ord., Production Actual/Standard, Warr./Recall

PurchasingProcurement, Goods Receipt, Invoice, Freight Bill Reconcilliation

Web/ClickstreamWeb Ops./Site, Clickstream

Marketing/AdvertisementCampaign, Promotion, Multimedia, Ads, Item Plans, Demographics

EventRFID Track and Trace

MeasurementTesting, Metrics, Evaluations, Inspections, Experiments, QA

CentralizedBid, Plan, Status, Term, Claim

New Product Design/Material ManagementInventory, Product, Service, Equipment, Vendor, Returns

Geo-location/Geo-politicalGeography, Geospatial, Location, Site, Bldg, Address, Econ. Measure

People and OrganizationsParty, Privacy, Contract, Associate, Internal Organization, Contacts

LEGAL CASE MANAGEMENT

TRADE FUND MANAGEMENT

ACTIVITY-BASED COSTING

PARTY PREFERENCES

ACCOUNT BUDGETS

PLANOGRAM

UNSTRUCTURED DATA CAPTURE

New in LS-LDM

LS-LDM Content At-a-Glance

10 © 2016 Teradata© 2014 Teradata

LS-LDM Example Conceptual View

11 © 2016 Teradata

BRIDG Model

• BRIDG stands for the Biomedical Research Integrated Domain Group

• BRIDG is a collaborative effort among the following four organizations:

– CDISC (Clinical Data Interchange Standards Consortium)

– HL7 Regulated Clinical Research Information Management Work Group (HL7 RCRIM WG)

– National Cancer Institute (NCI), including the Cancer Biomedical Informatics Grid (caBIG®) project

– Food and Drug Administration (FDA)

• The goal of the BRIDG Project is to produce a shared view of protocol-driven research and regulatory information

• This includes a shared understanding of the clinical study, its conduct, events and results

12 © 2016 Teradata

BRIDG Model

• The BRIDG model is a comprehensive model for clinical study information

• Important domains in the BRIDG model include:

– Study Conduct

– Protocol Representation

– Regulatory

– Adverse Event

• A Statistical Analysis domain exists in the BRIDG model for the planning of these analyses and that is represented in the LSDM 3.0 in the PLAN and DOCUMENT subject areas

• The BRIDG model is an object model intended to be directly implemented as data structures and program code (classes) in an object oriented programming language

• LSDM 3.0 modeling includes drug, device, biologic, food, cosmetic and any other materials research, development, experiments, studies and manufacturing

All are represented in detail in the LS-LDM 3.0, 2.0 and 1.0

13 © 2016 Teradata

BRIDG Model – High-Level Illustration

class UML-Based Comprehensiv e BRIDG Model Diagram

Common Sub-Domain::Organization

+ actualIndicator: BL [1...1]

+ description: ST [0..1]

+ effectiveDateRange: IVL<TS.DATETIME> [0..1]

+ name: DSET<ON> [0..*]

+ postalAddress: AD [0..1]

+ telecomAddress: BAG<TEL> [0..*]

+ typeCode: CD [0..1]

constraints

{Attribute Set actualIndicator Qualifier}

Common Sub-Domain::Person

+ educationLevelCode: CD [0..1]

+ ethnicGroupCode: DSET<CD> [0..*]

+ initials: ST [0..1]

+ maritalStatusCode: CD [0..1]

+ occupationDateRange: IVL<TS.DATE> [0..1]


+ primaryOccupationCode: CD [0..1]

+ raceCode: DSET<CD> [0..*]


::BiologicEntity


+ administrativeGenderCode: CD [0..1]

+ birthCountryCode: CD [0..1]

+ birthDate: TS.DATETIME [0..1]

+ birthOrder: INT.POS [0..1]

+ deathDate: TS.DATETIME [0..1]

+ deathDateEstimatedIndicator: BL [0..1]

+ deathIndicator: BL [0..1]

+ name: DSET<EN> [0..*]

constraints


::BiologicEntity

{ Attribute Set actualIndicator Qualifier }

{ functions as StudySubject Qualifier }

{ functions as PlannedStudySubject Qualifier }

Common Sub-Domain::HealthcareProv ider


+ identifier: II [0..1]



Study Conduct

Sub-Domain::

Laboratory

+ identifier: II

[0..1]

Common Sub-Domain::HealthcareFacility

+ effectiveDateRange: IVL<TS.DATETIME>

[0..1]




Study Conduct

Sub-Domain::

PerformingLaboratory

Study Conduct

Sub-Domain::

CollectingLaboratory

Study Conduct Sub-Domain::StudySite

+ dateRange: IVL<TS.DATETIME> [0..1]


+ leadIndicator: BL [0..1]

+ plannedDuration: PQ.TIME [0..1]

+ statusCode: CD [0..1]

+ statusDate: TS.DATETIME [0..1]

+ targetAccrualNumberRange:

URG<INT.NONNEG> [0..1]

«DEPRECATED»

+ accrualStatusCode: CD [0..1]

+ accrualStatusDate: TS.DATETIME [0..1]

constraints

{be a function performed by Exclusive Or}

{execute Mandatory Qualifier}

{be overseen by actualIndicator Qualifier}

{be a function performed by actualIndicator

Qualifier}

Study Conduct Sub-Domain::

StudyInv estigator


+ signatureText: ST [0..1]

::StudyPersonnel

+ effectiveDateRange:

IVL<TS.DATETIME> [0..1]


+ primaryIndicator: BL [0..1]

+ roleCode: CD [0..1]


constraints

{be a function performed by Qualifier}

::StudyPersonnel

{ be a function performed by Exclusive Or

}

Protocol Representation Sub-Domain::StudyProtocolVersion

+ accrualReportingMethodCode: CD [0..1]

+ acronym: ST [0..1]

+ adaptiveDesignIndicator: BL [0..1]

+ aeCodingSystem: OID [0..1]

+ amendmentGracePeriod: PQ.TIME [0..1]

+ companionCode: CD [0..1]

+ conditionCodingSystem: OID [0..1]

+ delayedRegistryPostingIndicator: BL [0..1]

+ designConfigurationCode: CD [0..1]

+ mandatoryIndicator: BL [0..1]

+ multiInstitutionIndicator: BL [0..1]

+ participatingLocationCode: DSET<CD> [0..*]

+ participatingOrganizationTypeCode: CD [0..1]

+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME> [0..1]

+ phaseCode: CD [0..1]


+ plannedSiteNumberRange: URG<INT.POS> [0..1]

+ plannedStudySubjectExperience: ST [0..1]

+ populationDescription: ST [0..1]

+ primaryPurposeTypeCode: CD [0..1]

+ purposeStatement: ST [0..1]

+ responsiblePartyCode: CD [0..1]

+ studySchematic: ED [0..1]

+ studySubjectTypeCode: CD [0..1]

+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]

+ targetAnatomicSiteCode: DSET<CD> [0..*]

+ therapeuticAreaCode: CD [0..1]

constraints

{be the responsibil ity of actualIndicator Qualifier}

Common Sub-Domain::Activity

+ comment: ST [0..1]


+ reasonCode: DSET<CD> [0..*]

constraints

{be participated in by Declaration}

Study Conduct Sub-Domain::ScheduledActiv ity

+ dateRange: IVL<TS.DATETIME> [1...1]

+ idealDateRange: IVL<TS.DATETIME> [0..1]

+ repetitionNumber: INT.POS [0..1]

+ statusChangeReasonCode: CD [0..1]



::Activity




constraints

{be participated in by actualIndicator Qualifier}

::Activity

{ be participated in by Declaration }

Study Conduct Sub-Domain::PerformedActiv ity


+ dateRangeValidationCode: CD [0..1]

+ /delayDuration: PQ.TIME [0..1]

+ /duration: PQ.TIME [0..1]

+ /fastingStatusIndicator: BL [0..1]

+ /medicalHistoryIndicator: BL [0..1]

+ negationIndicator: BL [0..1]

+ negationReason: DSET<SC> [0..*]

+ /repetitionNumber: INT.POS [0..1]



+ /studyDayRange: IVL<INT> [0..1]

::Activity




constraints


{instantiates Exclusive Or}

{occurs in the context of Qualifier}

{be performed by actualIndicator Qualifier}

{dateRange Qualifier}

{containingEpoch Qualifier}

::Activity



PerformedClinicalResult

+ asCollectedIndicator: BL [0..1]

+ biomarkerIndicator: BL [0..1]

+ /infectiousAgent: ST [0..1]

+ /normalRangeComparisonCode: CD [0..1]


+ targetBiomarkerCode: CD [0..1]

::PerformedObservationResult

+ baselineIndicator: BL [0..1]


+ confidentialityCode: CD [0..1]


+ reportedDate: TS.DATETIME [0..1]

+ resultClassificationCode: DSET<CD> [0..*]


+ uncertaintyCode: CD [0..1]

+ value: ANY [1...1]

+ valueCodeModifiedText: ST [0..1]

+ valueNullFlavorReason: ST [0..1]

«DEPRECATED»


+ targetAnatomicSiteLateralityCode: CD [0..1]

constraints

{reference Qualifier}

Common Sub-Domain::Subject

constraints

{be a function performed by

Exclusive Or}

Common Sub-Domain::Material


+ code: CD [0..1]



+ formCode: CD [0..1]

constraints


Common Sub-Domain::

ResourceProv ider




constraints


Exclusive Or}

«DEPRECATED»


ConcomitantAgent

Study Conduct Sub-Domain::Specimen

+ accessionNumberText: ST.SIMPLE [0..1]

+ /conditionCode: DSET<CD> [0..*]


Regulatory Sub-Domain::

RegulatoryApplicationSponsor


constraints


{be a function performed by actualIndicator

Qualifier}

Protocol Representation Sub-Domain::StudyAgent

+ blindedName: ST [0..1]

+ characteristicModifiedIndicator: BL [0..1]

+ expandedAccessIndicator: BL [0..1]

+ firstInHumanIndicator: BL [0..1]

+ firstInHumanRiskFactorCode: DSET<CD> [0..*]

+ functionCode: CD [0..1]

+ pediatricFormulationIndicator: BL [0..1]



+ substitutionAllowedIndicator: BL [0..1]

Study Conduct Sub-Domain::PerformedAdministrativ eActiv ity

+ varianceReasonCode: DSET<CD> [0..*]

+ varianceTypeCode: CD [0..1]

::PerformedActivity













::Activity




constraints

{be performed at actualIndicator Qualifier}

::PerformedActivity

{ be participated in by actualIndicator Qualifier }

{ instantiates Exclusive Or }

{ occurs in the context of Qualifier }

{ dateRange Qualifier }

{ be performed by actualIndicator Qualifier }

{ containingEpoch Qualifier }

::Activity



PerformedSpecimenCollection

::PerformedProcedure

+ approachAnatomicSiteCode: CD [0..1]

+ methodCode: CD [0..1]

+ nonReasonCode: DSET<CD> [0..*]

+ targetAnatomicSiteCode: CD [0..1]

+ targetAnatomicSiteConditionCode: CD [0..1]

::PerformedActivity













::Activity




«DEPRECATED»


+ approachAnatomicSiteLateralityCode: CD [0..1]


constraints

{results in actualIndicator Qualifier}

{be performed by (lab) actualIndicator Qualifier}


{ uses actualIndicator Qualifier }

::PerformedActivity







::Activity



PerformedSubstanceAdministration

+ /activeIngredientDose: PQ [0..1]

+ activeIngredientDoseDescription: ST [0..1]

+ changeReason: ST [0..1]

+ changeTypeCode: CD [0..1]

+ distinctProductCount: INT.POS [0..1]

+ doseFrequencyCode: CD [0..1]

+ dosePeriodCode: CD [0..1]

+ /endRelativeToReferenceCode: CD [0..1]

+ flowRate: RTO<PQ,PQ.TIME> [0..1]

+ interruptionDuration: PQ.TIME [0..1]

+ /periodActiveIngredientDoseTotal: PQ [0..1]

+ periodProductDoseTotal: PQ [0..1]

+ plannedChangeIndicator: BL [0..1]

+ productDose: PQ [0..1]

+ productDoseDescription: ST [0..1]

+ routeOfAdministrationCode: CD [0..1]

+ standardTimeIndicator: BL [0..1]

+ /startRelativeToReferenceCode: CD [0..1]

+ substanceUnknownIndicator: BL [0..1]

+ /treatmentVehicleQuantity: PQ [0..1]







::PerformedActivity













::Activity




«DEPRECATED»




constraints

{be participated in by Qualifier}

{relativeToReference Qualifier}

{Active Ingredient Qualifier}

{Dose Qualifier}

{substanceUnknownIndicator Qualifier}



::PerformedActivity







::Activity


Common Sub-Domain::StudySubject

+ confidentialityIndicator: BL [0..1]

+ paymentMethodCode: CD [0..1]



constraints

{be a function performed by Not Applicable}

::Subject

{ be a function performed by Exclusive Or }

Common Sub-Domain::

Document



SubmissionUnit



+ receiptDate: TS.DATETIME

[0..1]

+ typeCode: CD [1...1]

constraints

{be grouped into Exclusive Or}


RegulatoryApplication



Regulatory Sub-Domain::Submission

+ /receiptDate: TS.DATETIME [0..1]




constraints

{groups Exclusive Or}

{has as subject actualIndicator Qualifier}

Common Sub-Domain::

DocumentVersionRelationship

+ priorityNumber: REAL [0..1]



Rev iewableUnit


Study Conduct Sub-Domain::PerformedObserv ationResult












«DEPRECATED»


Common Sub-Domain::

Ov ersightCommittee




Common Sub-Domain::

AssociatedBiologicEntity

+ typeCode: DSET<CD> [0..*]

constraints

{Performer Scoper Type Unique}


PerformedClinicalInterpretation

+ /abnormalIndicator: BL [0..1]

+ /clinicallySignificantIndicator: BL

[0..1]

+ /severityCode: CD [0..1]

+ /toxicityGradeCode: CD [0..1]

+ toxicityTermCode: CD [0..1]







+ resultClassificationCode: DSET<CD>

[0..*]






«DEPRECATED»


+ targetAnatomicSiteLateralityCode: CD

[0..1]

constraints

{Derived Attribute Exclusive Or}

Study Conduct Sub-Domain::PerformedStudyAgentTransfer

+ /originalQuantity: PQ [0..1]

+ quantity: PQ [0..1]

::PerformedAdministrativeActivity



::PerformedActivity













::Activity




constraints


{is a transfer of Qualifier}

{is a transfer of actualIndicator Qualifier}

{be authorized by actualIndicator Qualifier}


{ be performed at actualIndicator Qualifier }

::PerformedActivity







::Activity



StudyResearchCoordinator

::StudyPersonnel







constraints

::StudyPersonnel

{ be a function performed by Exclusive

Or }


PerformedProtocolDev iation

+ categoryCode: CD [0..1]

+ occurrenceDateRange: IVL<TS.DATETIME> [0..1]

+ severityCode: CD [0..1]

+ subcategoryCode: CD [0..1]













«DEPRECATED»



constraints

{be authorized by actualIndicator Qualifier}

{be managed by actualIndicator Qualifier}

{be addressed by actualIndicator Qualifier}


PerformedMedicalConditionResult

+ /clinicallySignificantIndicator: BL [0..1]

+ endRelativeToReferenceCode: CD [0..1]



+ occurrenceDateRangeValidationCode: CD [0..1]














«DEPRECATED»



Protocol Representation

Sub-Domain::StudyObjectiv e



Study Conduct Sub-Domain::PerformedObserv ation


+ bodyPositionCode: CD [0..1]

+ bodySystemCode: CD [0..1]

+ /focalDateRange: IVL<TS.DATETIME> [0..1]

+ /focalDuration: PQ.TIME [0..1]



::PerformedActivity













::Activity




«DEPRECATED»



constraints

{be reported by actualIndicator Qualifier}

{be reported by Qualifier}

{be performed by (lab) actualIndicator Qualifier}

::PerformedActivity







::Activity


Protocol Representation Sub-Domain::DefinedActiv ity



+ nameCode: CD [1...1]

+ /repeatDuration: PQ.TIME [0..1]

+ repeatFrequencyCode: CD [0..1]

+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]

+ repeatQuantityRange: URG<INT.NONNEG> [0..1]




::Activity




constraints


{Repeat Frequency Exclusive Or}

{Repeat Duration or Quantity Exclusive Or}

::Activity


Common Sub-Domain::ResearchStaff



+ jobTitle: ST [0..1]



constraints

{Person-ResearchOrganization Pair Unique}

Common Sub-Domain::DocumentAuthor

constraints


{Study Author performed by Qualifier}


{Performer Document Pair Unique}


PerformedStudySubjectMilestone

+ /informedConsentDate: TS.DATETIME [0..1]

+ /informedConsentIndicator: BL [0..1]

+ /offStudyDate: TS.DATETIME [0..1]

+ /offStudyReasonCode: DSET<CD> [0..*]

+ /registrationDate: TS.DATETIME [0..1]

+ /studyReferenceDateRange:





::PerformedActivity













::Activity




constraints


{Date Exclusive Or}



::PerformedActivity







::Activity



PerformedStudyAdministrativ eActiv ity




::PerformedActivity













::Activity




constraints

{be participated in by Not Applicable}



::PerformedActivity







::Activity


Study Conduct Sub-Domain::PerformedDiagnosis


+ diseaseStatusCode: CD [0..1]

+ diseaseStatusMissingReasonCode: CD [0..1]

+ recurrenceIndicator: BL [0..1]













«DEPRECATED»




PerformedLesionDescription

+ appearanceTypeCode: CD [0..1]

+ contactAnatomicSiteCode: CD [0..1]

+ /dimensionProduct: PQ [0..1]

+ lesionNumber: INT.NONNEG [0..1]

+ measurableIndicator: BL [0..1]

+ xDimension: PQ [0..1]

+ yDimension: PQ [0..1]

+ zDimension: PQ [0..1]













«DEPRECATED»




PerformedHistopathology

+ differentiationGradeCode: DSET<CD> [0..*]

+ involvedSurgicalMarginIndicator: BL [0..1]













«DEPRECATED»



Common Sub-Domain::BiologicEntity










constraints


{functions as StudySubject Qualifier}

{functions as PlannedStudySubject

Qualifier}

Common Sub-Domain::BiologicEntityGroup


+ name: TN [0..1]

+ quantity: INT.NONNEG [0..1]


constraints


{contain actualIndicator Qualifier}

Common Sub-Domain::Animal

+ breedCode: CD [0..1]

+ description: ED [0..1]

+ reproductiveOrgansPresentIndicator: BL [0..1]

+ speciesCode: CD [0..1]

+ strain: ST [0..1]

::BiologicEntity










constraints

::BiologicEntity


{ functions as StudySubject Qualifier }

{ functions as PlannedStudySubject Qualifier }

Study Conduct Sub-Domain::PerformedProcedure






::PerformedActivity













::Activity




«DEPRECATED»



constraints

{uses actualIndicator Qualifier}

::PerformedActivity







::Activity


Common Sub-Domain::Product

+ classCode: DSET<CD> [0..*]

+ codeModifiedText: ST [0..1]

+ expirationDate: TS.DATE.FULL [0..1]

+ lotNumberText: ST.SIMPLE [0..1]

+ pre1938Indicator: BL [0..1]


::Material


+ code: CD [0..1]




constraints

{Distributor Qualifier}

{Processor Qualifier}

{ProcessingSite Qualifier}


::Material


Common Sub-Domain::Package

+ capacityQuantity: PQ [0..1]

+ capTypeCode: CD [0..1]

+ handlingCode: CD [0..1]

::Product







::Material


+ code: CD [0..1]




constraints

::Product

{ Distributor Qualifier }

{ Processor Qualifier }

{ ProcessingSite Qualifier }


Common Sub-Domain::Dev ice

+ /age: PQ.TIME [0..1]

+ availableForEvaluationIndicator: BL [0..1]

+ ceMarkIndicator: BL [0..1]


+ manufactureDate: TS.DATETIME [0..1]

+ overTheCounterProductIndicator: BL [0..1]

+ reprocessedDeviceCode: CD [0..1]

+ returnedToReprocessorDate: TS.DATETIME [0..1]

+ riskCode: CD [0..1]

+ singleUseDeviceIndicator: BL [0..1]

::Product







::Material


+ code: CD [0..1]




constraints


::Product





Common Sub-Domain::Drug

+ actionModeCode: CD [0..1]



+ stabilityDuration: IVL<TS.DATETIME> [0..1]

::Product







::Material


+ code: CD [0..1]




constraints

::Product





Common Sub-Domain::Biologic




::Product







::Material


+ code: CD [0..1]




constraints

::Product





Common Sub-Domain::FoodProduct


::Product







::Material


+ code: CD [0..1]



[0..1]


constraints

::Product





Common Sub-Domain::Cosmetic


::Product







::Material


+ code: CD [0..1]



[0..1]


constraints

::Product





Regulatory Sub-Domain::RegulatoryAssessment

+ completionDate: TS.DATETIME [0..1]

+ expectedResubmissionDate: TS.DATETIME [0..1]

+ identifier: DSET<II> [0..*]

+ reasonCode: CD [0..1]

+ resultCode: CD [1...1]



constraints

{is a function performed by actualIndicator Qualifier}

Common Sub-Domain::Processor

Common Sub-Domain::

ProcessingSite

Regulatory Sub-Domain::RegulatoryAuthority


+ jurisdictionAuthorityCode: CD [0..1]

Adv erse Ev ent Sub-Domain::

PerformedProductInv estigation

::PerformedObservation








::PerformedActivity













::Activity




«DEPRECATED»




constraints


{is triggered by Exclusive Or}


{ be reported by Qualifier }

{ be reported by actualIndicator Qualifier }

{ be performed by (lab) actualIndicator Qualifier }

::PerformedActivity







::Activity



PerformedProductProblemDiscov ery













«DEPRECATED»



Study Conduct Sub-Domain::PerformedEligibilityCriterion

+ notApplicableIndicator: BL [0..1]









::PerformedActivity













::Activity




«DEPRECATED»

+ displayOrder: INT.NONNEG [0..1]




constraints






::PerformedActivity







::Activity



PerformedInclusionCriterion

::PerformedEligibil ityCriterion










::PerformedActivity













::Activity




«DEPRECATED»






constraints


{ be participated in by Qualifier }





::PerformedActivity







::Activity



PerformedExclusionCriterion











::PerformedActivity













::Activity




«DEPRECATED»






constraints







::PerformedActivity







::Activity


Adv erse Ev ent Sub-Domain::Adv erseEv ent


+ /endRelativeToReferenceCode: CD [0..1]

+ expectedIndicator: BL [0..1]

+ /gradeCode: CD [0..1]

+ highlightedIndicator: BL [0..1]

+ hospitalizationRequiredIndicator: BL [0..1]

+ locationDescription: ST [0..1]


+ occurrencePatternCode: CD [0..1]

+ postReportUpdateDate: TS.DATETIME [0..1]

+ /severityCode: CD [0..1]


+ summary: ST [0..1]

+ treatmentEmergentIndicator: BL [0..1]

+ unexpectedReasonCode: DSET<CD> [0..*]













«DEPRECATED»




Ev aluatedResultRelationship

+ probabilityCode: CD [0..1]

+ probabilityPercent: REAL [0..1]



Ev aluatedActiv ityRelationship

+ probabilityCode: CD [0..1]

+ probabilityPercent: REAL [0..1]



AssessedResultRelationship



PerformedProductInv estigationResult

+ conclusion: ST [0..1]

+ defectTypeCode: CD [0..1]

+ deviceMalfunctionCode: CD [0..1]

+ evaluationConclusionCode: CD [0..1]













«DEPRECATED»



Common Sub-Domain::ReportReceiv er

+ receivedDate: TS.DATETIME [0..1]

+ receivedIndicator: BL [0..1]

constraints


Adverse Event Sub-Domain

Common Sub-Domain

Protocol Representation Sub-Domain

Regulatory Sub-Domain

Statistical Analysis Sub-Domain

Study Conduct Sub-Domain

Legend

Common Sub-Domain::ReportVersion

+ communicationModeCode: CD [0..1]

+ dueDate: TS.DATETIME [0..1]

+ physicianSignOffIndicator: BL [0..1]

::DocumentVersion

+ bibliographicDesignation: ED [0..1]


+ date: TS.DATETIME [0..1]

+ keywordCode: DSET<CD> [0..*]

+ keywordText: DSET<ST> [0..*]

+ languageCode: CD [0..1]

+ numberText: ST.SIMPLE [0..1]

+ officialTitle: ST [0..1]

+ revisionReasonCode: DSET<CD> [0..*]

+ text: ED [0..1]

+ /uniformResourceLocator: TEL.URL [0..1]

constraints

::DocumentVersion

{ language Qualifier }


SafetyReportVersion

+ nullificationIndicator: BL [0..1]

+ nullificationReasonCode: CD [0..1]

+ subtypeCode: CD [0..1]

::ReportVersion

+ communicationModeCode: CD [0..1]

+ dueDate: TS.DATETIME [0..1]

+ physicianSignOffIndicator: BL [0..1]

::DocumentVersion










+ text: ED [0..1]


constraints

{describes Exclusive Or}

::DocumentVersion


Protocol Representation Sub-Domain::Arm


+ name: ST [0..1]

+ randomizationWeight:

RTO<INT.NONNEG,INT.POS> [0..1]

+ targetAccrualNumberRange:



constraints

{name Unique}

{Mandatory Attribute Qualifier}

{armType Qualifier}

Protocol Representation Sub-Domain::Epoch


+ name: ST [0..1]

+ sequenceNumber: INT.NONNEG [0..1]

+ /targetAccrualNumberRange: URG<INT.NONNEG> [0..1]


constraints

{name Unique}


Common Sub-Domain::Place


+ identifierCode: CD [0..1]

+ name: TN [0..1]

+ physicalAddress: AD [0..1]


constraints

{physicalAddress Qualifier}

Common Sub-Domain::

OrganizationalContact



+ postalAddress: BAG<AD> [0..*]



+ title: ST [0..1]


constraints


actualIndicator Qualifier}

{handles communication for


Common Sub-Domain::

Administrativ eMemberCRA

Common Sub-Domain::

Administrativ eMemberPI

Common Sub-Domain::

Cooperativ eGroup

Common Sub-Domain::

Cooperativ eGroupMember

Common Sub-Domain::

ResearchOrganization


IVL<TS.DATETIME>

[0..1]


Common Sub-Domain::TreatingSite

constraints

{be a member of Exclusive Or}

Common Sub-Domain::

DistributorCommon Sub-Domain::OrganizationRelationship



Common Sub-Domain::

HealthcareProv iderGroup



Common Sub-Domain::

HealthcareProv iderGroupMember



Protocol Representation Sub-Domain::

RandomizationBookEntry

+ positionFilledIndicator: BL [0..1]

+ positionNumber: INT.NONNEG [1...1]


StratumGroup


+ groupNumber: INT.NONNEG [0..1]

Common Sub-Domain::

BiologicEntityIdentifier



+ identifier: II [1...1]

+ missingIdentifierReasonCode: CD [0..1]


constraints

{identifies actualIndicator Qualifier}

{is assigned by actualIndicator Qualifier}

Common Sub-Domain::DocumentIdentifier




constraints

{be assigned by Exclusive Or}

{be assigned by actualIndicator Qualifier}

View Description:

This View shows the complete BRIDG Model (current Release)

and specifically shows, for each class where it's applicable, the

complete set of attributes for the class, partitioning the

attributes as to whether they are "local" to the class or inherited

from the class' super-type hierarchy.


StudyOv erallStatus

+ anticipatedIndicator: BL [0..1]

+ code: CD [0..1]



+ studyStoppedReasonCode: CD [0..1]


StudyRecruitmentStatus

+ code: CD [0..1]


Common Sub-Domain::

DocumentVersionWorkflowStatus

+ code: CD [0..1]


+ date: TS.DATE.FULL [0..1]

Protocol Representation Sub-Domain:

:StudyOutcomeMeasure


+ name: ST [0..1]


+ timeFrameText: ST [0..1]


constraints


Common Sub-Domain::

StudyRegistry


+ name: ST [0..1]


StudyReference

+ citationDescription: ST [0..1]

+ linkPageDescription: ST [0..1]

+ publicationIdentifier: II [0..1]

+ publicationName: ST [0..1]

+ uniformResourceLocator: TEL.URL [0..1]

constraints


Study Conduct Sub-Domain::Resource

+ activeIndicator: BL [0..1]


Gov ernmentFunding

+ fundingCategoryCode: CD [0..1]

+ fundingMechanismCode: CD [0..1]

+ nciProgramCode: CD [0..1]

+ nihInstituteCode: CD [0..1]

+ serialNumberText: ST.SIMPLE [0..1]


::Resource



Sub-Domain::StudyLegalSponsor


constraints


Exclusive Or}


MaterialResource

::Resource



StudyPersonnel







constraints



StudySitePersonnel







constraints

{be a function performed by Exclusive

Or}


StudySiteInv estigator


::StudySitePersonnel







constraints



{ be a function performed by Exclusive

Or }


Interv entionalStudyProtocolVersion

+ acceptsHealthyVolunteersIndicator: BL [0..1]

+ allocationCode: CD [0..1]

+ blindedRoleCode: DSET<CD> [0..*]

+ blindingSchemaCode: CD [0..1]

+ controlConcurrencyTypeCode: CD [0..1]

+ controlTypeCode: CD [0..1]

+ /dataMonitoringCommitteeIndicator: BL [0..1]

+ interventionDescription: ST [0..1]

+ interventionGroupQuantity: INT.NONNEG [0..1]

+ interventionTypeCode: CD [0..1]

+ studyAgentRandomizationFraction: REAL [0..1]

::StudyProtocolVersion














+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME>

[0..1]














constraints

{blindedRoleCode Qualifier}

{dataMonitoringCommitteeIndicator Qualifier}


{ be the responsibil ity of actualIndicator Qualifier }

Protocol Representation Sub-Domain::Observ ationalStudyProtocolVersion

+ samplingMethodCode: CD [0..1]

+ specimenAvailableForDNAExtractionIndicator: BL [0..1]

+ specimenRetentionIndicator: BL [0..1]

+ timePerspectiveCode: CD [0..1]





























constraints



«DEPRECATED»

Protocol Representation Sub-Domain::ExpandedAccessStudyProtocolVersion





























«DEPRECATED»

+ interventionDescription: ST [0..1]

constraints



NOTE: Until further clarification, the

BRIDG SCC believes the IND/IDE

regulatory application serial number is the

number assigned by the applicant/sponsor

to a document that is either a supplement

or an amendment to the original

submission unit and is represented using

DocumentIdentifier.identifer.

Common Sub-Domain::Ov ersightAuthority


StudyOv ersightAuthority

constraints

{oversee Mandatory Qualifier}

Study Conduct Sub-Domain::StudySiteOv ersightStatus

+ reviewBoardApprovalNumberText: ST.SIMPLE

[0..1]

+ reviewBoardProcessCode: CD [0..1]

+ reviewBoardProcessDate: TS.DATETIME [0..1]

constraints


Common Sub-Domain::

QualifiedPerson

+ certificateLicenseText:

ST [0..1]


IVL<TS.DATETIME>

[0..1]



constraints

{Mandatory Attribute

Qualifier}

Common Sub-Domain::ExperimentalUnit




+ subgroupCode: CD [0..1]

constraints


Common Sub-Domain::ProductGroup



+ quantity: INT.NONNEG [0..1]

constraints


Common Sub-Domain::

Performer





+ telecomAddress:

BAG<TEL> [0..*]


constraints


Exclusive Or}

Protocol Representation Sub-Domain::DefinedObserv ation



+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]




::DefinedActivity











::Activity




«DEPRECATED»


constraints

::DefinedActivity


{ Repeat Frequency Exclusive Or }

{ Repeat Duration or Quantity Exclusive Or }

::Activity


Common Sub-Domain::BiologicEntityPart

+ anatomicSiteCode: CD [0..1]

+ quantityRange: URG<INT.POS> [0..1]

«DEPRECATED»

+ anatomicSiteLateralityCode: CD [0..1]

constraints

{quantity actualIndicator Qualifier}


ReferenceResult


+ fastingStatusIndicator: BL [0..1]

+ populationScopeCode: CD [0..1]

+ referenceTypeCode: CD [1...1]



+ valueTypeCode: CD [0..1]

«DEPRECATED»

+ targetAnatomicSiteLateralityCode:

CD [0..1]

constraints

{apply to results produced by


Adv erse Ev ent Sub-Domain::CausalAssessment









::PerformedActivity













::Activity




«DEPRECATED»




constraints






::PerformedActivity







::Activity



Adv erseEv entOutcomeResult













«DEPRECATED»



Study Conduct Sub-Domain::StudyResource


[0..1]

+ inactiveComment: ST [0..1]



Funding

::Resource



Serv ice


::Resource


Adv erse Ev ent Sub-Domain::Adv erseEv entOutcomeAssessment









::PerformedActivity













::Activity




«DEPRECATED»




constraints






::PerformedActivity







::Activity



DefinedAdministrativ eActiv ity

::DefinedActivity






+ repeatFrequencyRatio:

RTO<INT.NONNEG,PQ.TIME> [0..1]

+ repeatQuantityRange: URG<INT.NONNEG>

[0..1]




::Activity




constraints

::DefinedActivity




::Activity


Study Conduct Sub-Domain::PerformedImaging

+ contrastAgentEnhancementIndicator: BL [0..1]

+ enhancementDescription: ST [0..1]

+ enhancementRate: RTO<PQ,PQ.TIME> [0..1]









::PerformedActivity













::Activity




«DEPRECATED»




constraints






::PerformedActivity







::Activity



StudyActiv ity

+ studyFocusIndicator: BL [0..1]

Protocol Representation Sub-Domain::DefinedObserv ationResult


+ derivationExpression: ST [0..1]


+ targetCodingSystem: OID [0..1]


+ value: ANY [0..1]

+ valueNegationIndicator: BL [0..1]

«DEPRECATED»




DefinedStudySubjectMilestone

::DefinedActivity









[0..1]




::Activity




constraints


::DefinedActivity




::Activity



DefinedStudyAdministrativ eActiv ity

::DefinedActivity












::Activity




constraints

{be participated in by Not Applicable}

::DefinedActivity




::Activity



DefinedExperimentalUnitAllocation


::DefinedActivity








+ repeatQuantityRange:





::Activity




constraints


{Repeat Not Applicable}

::DefinedActivity

{ be participated in by actualIndicator

Qualifier }


{ Repeat Duration or Quantity Exclusive Or

}

::Activity



DefinedMaterialStorage

::DefinedActivity












::Activity




constraints


::DefinedActivity




::Activity



DefinedStudyAgentTransfer

::DefinedActivity












::Activity




constraints


{is a transfer of actualIndicator Qualifier}

{is a transfer of Qualifier}

::DefinedActivity




::Activity


Protocol Representation Sub-Domain::DefinedProcedure



+ nameCodeModifiedText: ST [0..1]


::DefinedActivity











::Activity




«DEPRECATED»



constraints

{use actualIndicator Qualifier}

::DefinedActivity




::Activity


Protocol Representation Sub-Domain::DefinedSubstanceAdministration

+ doseFrequencyCode: CD [0..1]

+ dosePeriodCode: CD [0..1]

+ doseRegimen: ST [0..1]

+ flowRate: RTO<PQ,PQ.TIME> [0..1]

+ periodProductDoseTotal: EXPR<PQ> [0..1]

+ productDose: EXPR<PQ> [0..1]

+ routeOfAdministrationCode: CD [0..1]

::DefinedProcedure





::DefinedActivity











::Activity




«DEPRECATED»

::DefinedProcedure



constraints


{Dose Qualifier}

{Dose Expression Qualifier}

::DefinedProcedure

{ use actualIndicator Qualifier }

::DefinedActivity




::Activity



DefinedSpecimenCollection

::DefinedProcedure





::DefinedActivity









[0..1]




::Activity




«DEPRECATED»

::DefinedProcedure



constraints

{results in actualIndicator Qualifier}

::DefinedProcedure


::DefinedActivity




::Activity


Protocol Representation Sub-Domain::DefinedEligibilityCriterion

::DefinedObservation







::DefinedActivity











::Activity




«DEPRECATED»

+ requiredResponse: ANY [0..1]



constraints


::DefinedActivity




::Activity



DefinedStratificationCriterion








::DefinedActivity






+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME>

[0..1]





::Activity




«DEPRECATED»



constraints


{Permissible Result Qualifier}

::DefinedActivity




::Activity


Protocol Representation Sub-Domain::DefinedImaging

+ contrastAgentEnhancementIndicator: BL [0..1]

+ enhancementDescription: ST [0..1]

+ enhancementRate: RTO<PQ,PQ.TIME> [0..1]




+ focalDateRange: IVL<EXPR<TS.DATETIME>>

[0..1]




::DefinedActivity












::Activity




«DEPRECATED»



constraints


::DefinedActivity




::Activity



DefinedExclusionCriterion








::DefinedActivity












::Activity




«DEPRECATED»

::DefinedEligibil ityCriterion




constraints



::DefinedActivity




::Activity



DefinedInclusionCriterion








::DefinedActivity






+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME>

[0..1]





::Activity




«DEPRECATED»





constraints



::DefinedActivity




::Activity



DefinedCompositionRelationship

+ joinCode: CD [0..1]

+ pauseQuantityRange: URG<PQ.TIME> [0..1]



DefinedOptionRelationship




DefinedContingentOnRelationship

+ checkpointCode: CD [0..1]

+ completionRequiredBeforeStartingIndicator: BL [0..1]



constraints

{completionRequiredIndicator Qualifier}

{be contingent upon Exclusive Or}


DefinedRepeatActiv ityUntilRule

+ cessationPauseQuantityRange:

URG<PQ.TIME> [0..1]



constraints

{be repeated until Exclusive Or}

Protocol Representation Sub-Domain::DefinedCriterionGroup


DefinedCriterionGroupCompositionRelationship




constraints

{is the component of Exclusive Or}


DefinedCriterionGroupOptionRelationship



constraints

{be the choice that has as option Exclusive Or}

Protocol Representation Sub-Domain::PlannedActiv ity

+ agentAdministrationCareSettingTypeCode: CD [0..1]

+ blindedDescription: ST [0..1]


+ duration: PQ.TIME [0..1]

+ interruptibleIndicator: BL [0..1]

+ name: ST [0..1]






::Activity




«DEPRECATED»

+ purpose: ST [0..1]

constraints

{Repeat Frequency Exclusive Or}

{Repeat Duration or Quantity Exclusive Or}


::Activity



PlannedCompositionRelationship





PlannedContingentOnRelationship


+ completionRequiredBeforeStartingIndicator: BL [0..1]



constraints

{be contingent upon Exclusive Or}

{completionRequiredIndicator Qualifier}

Protocol Representation Sub-Domain::PlannedCriterionGroup


PlannedCriterionGroupCompositionRelationship




constraints

{be the parent of Exclusive Or}


PlannedCriterionGroupOptionRelationship



constraints

{is a choice that has as option Exclusive Or}


PlannedOptionRelationship




PlannedRandomizationBookAllocation

::PlannedActivity






+ name: ST [0..1]






::Activity




«DEPRECATED»

::PlannedActivity


constraints

{DefinedActivity Qualifier}

{Repeat Not Applicable}


::PlannedActivity




::Activity



PlannedRepeatActiv ityUntilRule

+ cessationPauseQuantityRange:

URG<PQ.TIME> [0..1]



constraints

{be repeated until Exclusive Or}


ReferenceToStudyResults

+ citationDescription: ST [0..1]

+ linkPageDescription: ST [0..1]

+ publicationIdentifier: II [0..1]

+ publicationName: ST [0..1]

+ uniformResourceLocator:

TEL.URL [0..1]


Sub-Domain::

StudyProtocolDocument

::Document



DefinedStratificationCriterionPermissibleResult

::DefinedObservationResult






+ value: ANY [0..1]


«DEPRECATED»




constraints

{Association Cardinality Qualifier}

Common Sub-Domain::ProductRelationship

+ activeIngredientIndicator: BL [0..1]

+ confidentialityCode: DSET<CD> [0..*]




+ quantity: RTO<PQ,PQ> [0..1]


constraints

{identifier Qualifier}


StudySiteResearchCoordinator








constraints


{ be a function performed by

Exclusive Or }

Common Sub-Domain::SubjectIdentifier






constraints



{identifies actualIndicator Qualifier}


RegistrationCenter

+ telecomAddress: TEL [0..1]

::Service


::Resource


Study Conduct Sub-Domain::Assessor

constraints



DefinedSubjectActiv ityGroup

::DefinedActivity









[0..1]




::Activity




constraints


::DefinedActivity




::Activity


Common Sub-Domain::

OrganizationIdentifier




constraints


{identifies actualIndicator

Qualifier}

{be assigned by actualIndicator

Qualifier}

Common Sub-Domain::NotificationReceiv er

constraints



DefinedNotification

+ deliveryMechanismCode: CD [0..1]

+ message: ST [0..1]

+ messageTitle: ST [0..1]

::DefinedActivity









[0..1]




::Activity




constraints


{be received by actualIndicator Qualifier}

::DefinedActivity




::Activity



PerformedNotification






::PerformedActivity













::Activity




constraints





::PerformedActivity


Qualifier }






::Activity



Sub-Domain::StudyCondition

+ code: CD [1...1]



CompanionStudyRelationship

+ registrationRequiredIndicator: BL [0..1]


PlannedNotification

+ studyAccrualThresholdPercent: INT.POS [0..1]

+ studySiteAccrualThresholdPercent: INT.POS [0..1]

::PlannedActivity






+ name: ST [0..1]







::Activity




«DEPRECATED»

::PlannedActivity


constraints

{Accrual Threshold Percent Exclusive Or}



::PlannedActivity




::Activity


Common Sub-Domain::DocumentVersion










+ text: ED [0..1]


constraints

{language Qualifier}


StudyProtocolDocumentVersion

+ publicDescription: ST [0..1]

+ publicTitle: ST [0..1]

+ scientificDescription: ST [0..1]

::DocumentVersion










+ text: ED [0..1]


constraints

{is a version of Qualifier}

{DocumentAuthor actualIndicator Qualifier}

::DocumentVersion



StudyProtocol


Sub-Domain::PlannedStudySite



constraints

{be a function planned to be

performed by Exclusive Or}

Study Conduct Sub-Domain::StudyExecution

+ /effectiveDateRange: IVL<TS.DATE.FULL> [0..1]

+ /enrolledStudySubjectNumber: INT.POS [0..1]

constraints

{be overseen by actualIndicator Qualifier}

{use actualIndicator Qualifier}


StudySiteProtocolVersionRelationship



StudySubjectProtocolVersionRelationship




AmendmentChangeSummaryVersion

::DocumentVersion










+ text: ED [0..1]

+ /uniformResourceLocator: TEL.URL

[0..1]

constraints

::DocumentVersion


Common Sub-Domain::

SystemOfRecord

+ name: ST [1...1]

Common Sub-Domain::

MaterialName

+ name: TN [0..1]


Common Sub-Domain::

Manufacturer

Common Sub-Domain::

Reprocessor

Common Sub-Domain::

MaterialIdentifier



constraints

{be assigned by



Adv erseEv entSeriousness

+ code: CD [0..1]


Common Sub-Domain::

ReportSubmitter


ScheduledNotification



::ScheduledActivity







::Activity




constraints



::ScheduledActivity


::Activity


NOTE: BRIDG SCC acknowledges that there are two ways to represent the

relationship between a study protocol and a document that is cited by the

study protocol: 1) use the StudyProtocolVersion to StudyReference

association; 2) use the StudyProtocolVersion >

StudyProtocolDocumentVersion > DocumentVersionRelationship

associations. The first is more direct and uses domain terminology, while

the second is more consistent with other document-to-document

associations. The SCC hopes to clarify this ambiguity in a future release

when a project dealing with publications or a related area comes to

harmonization.


PlannedSubjectActiv ityGroup

+ /sequenceNumber: INT.NONNEG [0..1]


::PlannedActivity






+ name: ST [0..1]






::Activity




«DEPRECATED»

::PlannedActivity


constraints


::PlannedActivity




::Activity



ScheduledSubstanceAdministration

+ activeIngredientDose: PQ [0..1]

::ScheduledActivity







::Activity




constraints


{activeIngredientDose Qualifier}

::ScheduledActivity


::Activity



DefinedExpressionVariableRelationship

+ localVariableName: ST.SIMPLE

[1...1]


DefinedAdv erseEv ent










+ value: ANY [0..1]


«DEPRECATED»




Common Sub-Domain::

Serv iceDeliv eryLocation

+ code: CD [0..1]

+ postalAddress: BAG<AD> [0..*]


Common Sub-Domain::

ProcessedProduct



PerformedProductTransport



::PerformedActivity













::Activity




constraints


{ServiceDeliveryLocation Qualifier}

{originates at actualIndicator Qualifier}

{have destination actualIndicator Qualifier}

::PerformedActivity


Qualifier }






::Activity



DefinedMedicalConditionResult







+ value: ANY [0..1]


«DEPRECATED»




[0..1]

Study Conduct Sub-Domain::PerformedSubstanceExtraction







::PerformedActivity













::Activity




«DEPRECATED»




constraints

{produces actualIndicator Qualifier}



::PerformedActivity







::Activity



SubstanceExtractionAdministrationRelationship

+ donorTypeCode: CD [0..1]

+ relationCode: CD [0..1]


PerformedExperimentalUnitAllocation




::PerformedActivity













::Activity




constraints




::PerformedActivity







::Activity



DefinedEligibilityCriterionAnswer

+ requiredIndicator: BL [0..1]







+ value: ANY [0..1]


«DEPRECATED»





PlannedEligibilityCriterion

::PlannedActivity

+ agentAdministrationCareSettingTypeCode:

CD [0..1]





+ name: ST [0..1]








::Activity




«DEPRECATED»

::PlannedActivity


constraints

::PlannedActivity




Qualifier }

::Activity



PlannedInclusionCriterion

::PlannedActivity

+ agentAdministrationCareSettingTypeCode: CD

[0..1]





+ name: ST [0..1]







::Activity




«DEPRECATED»

::PlannedActivity


constraints

::PlannedActivity




::Activity



PlannedExclusionCriterion

::PlannedActivity

+ agentAdministrationCareSettingTypeCode: CD

[0..1]





+ name: ST [0..1]






[0..1]


::Activity




«DEPRECATED»

::PlannedActivity


constraints

::PlannedActivity




::Activity



Observ ationResultActionTakenRelationship

+ delayDuration: PQ.TIME [0..1]


StudySiteRecruitmentStatus

+ code: CD [1...1]



StudySubjectExperienceDocumentVersion

::DocumentVersion










+ text: ED [0..1]


constraints

{be participated in by actualIndicator

Qualifier}

::DocumentVersion



PlannedStudySubject

+ quantityRange: URG<INT.POS> [0..1]

constraints

{be a function performed by actualIndicator Qualifier}

::Subject

{ be a function performed by Exclusive Or }


Relev antRegulation

+ applicableIndicator: BL [0..1]

+ code: CD [0..1]

Statistical Analysis Sub-Domain::

DataMonitoringCommitteeCharterVersion


::DocumentVersion










+ text: ED [0..1]


constraints

::DocumentVersion



StatisticalAnalysisPlanDocumentVersion

::DocumentVersion










+ text: ED [0..1]


constraints

::DocumentVersion


Statistical Analysis Sub-Domain::StatisticalAnalysisPlanVersion




constraints

{addresses the needs of Qualifier}

Statistical Analysis

Sub-Domain::

StatisticalAnalysisPlan


IntegratedStatisticalAnalysisPlan


StudySpecificStatisticalAnalysisPlan


StatisticalAnalysisPlanVersionModificationSummary



+ text: ED [0..1]

+ timingDescription: ST [0..1]


StatisticalAnalysisPlanVersionStatus

+ code: CD [0..1]



GeneralStatisticalConsideration

+ text: ED [0..1]


Statistical Analysis

Sub-Domain::

SampleSizeConsideration

+ text: ED [0..1]


PrincipalStatisticalAnalysisPlanVersion

::StatisticalAnalysisPlanVersion




constraints


{ addresses the needs of Qualifier }


SupplementalStatisticalAnalysisPlanVersion






constraints


{ addresses the needs of Qualifier }

Study Conduct

Sub-Domain::

StudySiteResource


PerformedCompositionRelationship

constraints

{Composition Relationship Qualifier}


AssessedActiv ityRelationship


PerformedMaterialProcessStep








::PerformedActivity













::Activity




«DEPRECATED»




constraints




::PerformedActivity







::Activity



DefinedMaterialProcessStep

::DefinedProcedure





::DefinedActivity













::Activity




«DEPRECATED»

::DefinedProcedure

+ approachAnatomicSiteLateralityCode:

CD [0..1]


[0..1]

constraints

::DefinedProcedure


::DefinedActivity


Qualifier }


{ Repeat Duration or Quantity Exclusive Or

}

::Activity


Common

Sub-Domain::

DonorRegistry


PerformedMaterialStorage


+ temperatureRange: URG<PQ> [0..1]




::PerformedActivity













::Activity




constraints




::PerformedActivity

{ be participated in by actualIndicator Qualifier

}






::Activity



TargetAnatomicSite

+ code: CD [1...1]



PerformedDiagnosisProcedureRelationship


0..*

take place in

{be the location for}

0..1

0..*

is the component of

{be the parent of}

1

0..*be the parent of

{be the component of}

0..1

0..*be the parent of


0..1

0..*

be the parent of


0..1

0..*

be contingent upon

{be a condition for}

0..1

0..*

be contingent upon


0..1

0..*

is a condition for

{be contingent upon}

1

0..*

be contingent upon


0..1

0..*

is the component of

{be the parent

of}

1

0..*

is the parent of

{be the

component of}

1

0..*

is a use of{be used

as}

1

0..*be repeated until

{trigger the cessation of}0..1

0..*

occur in

{contain}

0..1

0..*

be a choice that has as option

{be an option that can satisfy}

0..1

0..*

be a choice

that has as

option

{be an option

that can satisfy}

0..1

0..*is an option that

can satisfy

{be a choice that

has as option}1

0..*

be a choice that

has as option

{be an option

that can satisfy}0..1

0..*

be a choice that has as option

{be an option that can satisfy}0..1

0..*

be the

parent of

{be the

component of}

0..1

0..*is the

component of

{be the parent of}

1

0..*be the parent

of{be the

component of}

0..1

0..*

be the parent of

{be the component of}0..1

0..*

be repeated until

{trigger the cessation of}

0..1

0..*

be repeated until

{trigger the

cessation of}0..1

0..*

be a function performed by

{function as}

0..1

0..*


{function as}

0..1

0..*

be a function

performed by

{function as}

0..1

0..*


{function as}

0..1

0..*

be a function

performed by

{function as}

0..1

0..*

be a function

performed by{function as}

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{infer} be

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{function as}

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during}1

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use

{be used

during}

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0..*

{be contained in}

contain

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0..1

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groups

{be grouped by}1..*

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on{be commented on by}

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{be transformed from} be transformed into

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use

{be used for}

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{function as}

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authors

{is authored by}

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{be staffed

by}

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performed by

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has as subject

{be the subject for}

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{has as a version} 1

+originalPerformedClinicalResult

0..1

{be converted from}

be converted into

+convertedPerformedClinicalResult

0..*

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{be instantiated

by}

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under

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place

in{be the

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for}

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{be instantiated by}

1

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{submits}1

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by{participate

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{function as}

1

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by{participate

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«DEPRECATED» {use}

1

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«DEPRECATED» {function as}1

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{function as}0..1

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performed by

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produced by

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produced}

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{refer to}1..*

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by}

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by

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in

{be the location in

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{be specialized by}

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into}

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is a function


1

14 © 2016 Teradata

• Teradata LS-LDM statistics

– 235 Subject areas, 4,006 Entities, 15,663 Attributes

• Lines of Business/Areas of Business

– Drug (Materials) Discovery

– Product & Other Materials R&D

– Biologic Entity (animals, plants, bacteria, etc.) Experiments & Studies Management

– Human Clinical Study Management

– Genetics, Proteomics & Pathways

– Legal/Regulatory Compliance

– Product Manufacturing

– Sales & Marketing

– Finance & Performance Management

– Human Capital Management

• Subject Area Examples

> Strategy - Genetics - Shipment/Logistics - Production

> Study - Bioassay - Activity Based Costing - Marketing

> Study Event - Material - Quality Assurance/Metrics - Regulatory

> Adverse Event - Inventory - Human Capital Management

> Protocol - Customs - Biomaterial - Experiment

> Pathways - Forecasts - Observational Medical Outcomes (OMOP)

Life Sciences Data Model 3.0 Overview

INCLUDES:

• Mapping from LSDM to BRIDG

• Quick-Start Physical Model

15 © 2016 Teradata

A Robust Set Of Analytic CapabilitiesDeep internal capability, plus a range of partnerships

• Before: Customer SAS standalone application runtime:

18-20+ Hours

• After: SAS / Teradata In-Database combined runtime:

3 Hours 39 Minutes (approx. 80% improvement)

• Achieved impact in 6 weeks from Teradata hardware delivery to results

• Approximately 97% of SAS Code in application UNMODIFED0

5

10

15

20

Processing Time for 1.67M records(Hours)

16

How to Integrate CDISC Across The Enterprise to: “Reduce Costs and Speed the Development of Therapies for

Patients”

17 © 2016 Teradata

FIPCO FIPNETRisk

Management

Product

Commercializat

ion

Competitive

Intelligence

Data

Integration &

Analysis

Data

Governance,

Privacy,

Security

Business

Continuity

Financial

Reporting &

Analysis

Improvement

Financial

Process

Optimization

Enterprise

Performance

Management

Operational

Analysis &

Reporting

Enhancement

Consistent

Financial

Compliance

Mfg Quality

Optimization

Supply Chain

Visibility &

Lead/Cycle Time

Mgmt

Vendor Mgmt/

Score Carding

Reliability and

Maintenance

Planning

Demand Driven

Supply Network

DSCSA

(Track and

Trace)

Research Data

Profiling,

Integration &

Analysis

Detail Clinical

Data

Integration

(Part 11)

Product

Portfolio

Management

Safety Data

Tracking and

Analysis

Collaborative

Data

Integration

(Translational

Medicine)

Evidence-

based

Outcomes

Analysis

Syndicated

Data Processing

& Integration

360° Customer

View /

Targeting

Event-based

Customer

Messaging

Contract &

Rebate

Management

Channel

Management

Sales & Marketing

Research & Development

Manufacturing

Financial Management

Other

Business Improvement Opportunities Key Business

Processes

Step 1: Identify Business Improvement Opportunities (BIOs)Life Sciences BIO Framework

18 © 2016 Teradata 18

Regulatory MarketingResearch &

DevelopmentFinance

The Superior Business Value of Integrated Analytics (IA)

Step 2: Prioritize BIOs via a Business-Focused, Analytics-Driven Roadmap Incorporating All Applicable Data

Business value

compounds exponentially…

…while IA investment grows incrementally

Valu

e

Finance

Manufacturing

Marketing

Regulatory

ResearchEvolution

to anEnterprise View

Business Value ROI

Integrated Analytics

Investment

Manufacturing

Regulatory

Research Research Research Research

Manufacturing Manufacturing

Marketing

Business-Driven Analytics Gains

MARGIN GAIN

FROM

INTEGRATED

ANALYTICS

Modular growth should be business-focused to speed gains, maximize ROI

Regulatory Regulatory

19 © 2016 Teradata

2855

Tightly Coupled

Loosely Coupled

Non Coupled

Step 3: Appropriately Identify, Value, Utilize and Maximize Gains from ANY and ALL Data

20 © 2016 Teradata

Unified Data Architecture

Disease Management

Manufacturing

Hospitals

Finance

Consumers

Claims

PatientsSales

Physicians

Government

HR/Benefits

Marketing

Contracts

HR

Population Demographics

Products/Services

Call Center/Communication

Disease Mgmt/Wellness

R&D

Finance/GL

HR/Benefits

Sales/Marketing

Drug/Medical

Patient/Consumer

Step 4: Create and Maintain A Unified Data ArchitectureA Single View of the Enterprise Built on an Integrated LDM

Deliver a “single view of data” to a variety of internal and external stakeholders

R&D

21 © 2016 Teradata

The critical step of

operational

deployment is often

overlooked

Step 5: Continually Evolve The Analytics Path to Achieve High Impact Business Outcomes for Everyone in the Enterprise

Frame the Problem

Select & Visualize the Data

Hypothesize the SolutionTest the

Hypothesis (POV)

Implement and Industrialize

Communicate Results

The critical step of

operational deployment

is often overlooked

22 © 2016 Teradata

Q&A Teradata as Analytics Partner

• We coordinate with your business and IT personnel to ensure decisions are:o business-driveno founded on analyticso correctly implemented

• We offer vast experience and brain trust around both retail analytics and the organizational transformation required for success

• We customize analytics to your needs, using ANY and ALL data pertinent to growing business

• We place our services where you want them: in-house, off-site, cloud

• We provide end-to-end support:o strategic planningo organizational assessmento analytics developmento interface usability and testingo operational implementation o ROI assessment

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Appendix

25 © 2016 Teradata

• Clinical study modeling is now extended to non-human study subjects to accommodate, for example, companies that create drugs/devices/biologics/foods or other materials for animals and plants. Those study subjects can be:

– An Animal

– A Plant

– Groups of Animals

– Groups of Plants

– Animal Parts

– Plant Parts

– Parts can be to the cellular and subcellular level including DNA

• Experiment modeling remains primarily for non-human study subjects although, for example, human cells could be used as study subjects for experiments

LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates

26 © 2016 Teradata

• BRIDG focuses on behaviors, functions, structure elements and growth stages as observations to track. Models associate those characteristics with:

– Animals

– Plants

– Groups of Animals

– Groups of Plants

– Animal Parts

– Plant Parts

– Viruses

– Bacteria

– Cells and Parts of Cells

– Nucleic acids (DNA, xRNA)

• These characteristics are associated with BIOLOGIC ENTITYs (as a record of having been seen) and BIOLOGIC ENTITY INSTANCEs (as a record of specific observations of BIOLOGIC ENTITY INSTANCE individuals)

• Any additional observations of any type can be associated with BIOLOGIC ENTITYs and BIOLOGIC ENTITY INSTANCEs using OBSERVATION EVENT:


27 © 2016 Teradata

• Confidentiality indicators for some entities including, for example, INDIVIDUALs participating in STUDYs

• Death indicators and death data such as cause of death associated with INDIVIDUALs and BIOLOGIC ENTITIES (animals, plants, parts of animals and plants, viruses, and bacteria down to the cellular and sub-cellular level)

• Occupation entities with a Primary Indicator in INDIVIDUAL OCCUPATION

• Start and end dates and datetimes in appropriate entities

• Study subject minimum and maximum accrual numbers to studies

• Identifiers assigned by organizations to many entities such as studies, study subjects and drugs

• A status date associated with every entity that can be an experimental unit or a study subject

• Expanded the definition of CONVEYANCE to include helicopters and ambulances because those are specified in BRIDG definitions


28 © 2016 Teradata

• A CONFIDENTIALITY entity and associated it with DOCUMENT and DOCUMENT CONTENT (an extension as BRIDG only associates it with DOCUMENT)

• DOCUMENT SIGNOFF EVENT

• Flow rate for TREATMENT STUDY EVENT and ACTIVITY

• TREATMENT INTERRUPTION EVENT and TREATMENT CHANGE EVENT

• TOXICITY GRADE entity and TOXICITY DAMAGE ABILITY entity, associated with CLINICAL INTERPRETATION EVENT

• A relationship between UNCERTAINTY and EVENT and role named the Uncertainty Cd (FK) to Date Uncertainty

• A Negation Indicator to the TREATMENT STUDY EVENT to indicate a scheduled treatment event that did not occur

• A NEGATION REASON and associated Negation Reason Cd with TREATMENT STUDY EVENT and ACTIVITY. If Negation Reason Cd foreign key is not null, the event or activity did not take place


29 © 2016 Teradata

• Created a REGULATORY ASSESSMENT EVENT as a subtype of EVENT

• Associated REGULATORY ASSESSMENT with REGULATORY ASSESSMENT EVENT

• Added a REGULATORY ASSESSMENT EVENT REASON entity and associated it with REGULATORY ASSESSMENT EVENT

• Added a REGULATORY ASSESSMENT RESULT entity and associated it with REGULATORY ASSESSMENT EVENT

• Added a PRODUCT APPROVAL PROCESS entity to the model and associated it with PRODUCT APPROVAL EVENT

• Added FUNDING CATEGORY entity and related it to STUDY FUNDING EVENT

• Added FUNDING MECHANISM entity and related it to STUDY FUNDING EVENT

• Added a FUNDING MECHANISM IDENTIFIER associated with a FUNDING MECHANISM which is assigned by an ORGANIZATION


30 © 2016 Teradata

• MEASUREMENT STATUS entity associated with LIFE SCIENCES MEASUREMENT

• Life Sciences Measurement Biomarker Indicator for LIFE SCIENCES MEASUREMENT

• Contrast Enhancement Indicator and Enhancement Description for IMAGE

• MATERIAL STORAGE METHOD associated with MATERIAL STORED EVENT

• REGULATION associated to STUDY using STUDY REGULATION. The regulation is associated with the governing and/or enforcement organization, as well as with EXPERIMENT using EXPERIMENT REGULATION

• A Registration Required Indicator for STUDY


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