cdisc standards update

© CDISC 2012

Pierre-Yves Lastic

Sanofi R&D,

Chair-Elect, CDISC Board of Directors

Réunion du Groupe des Utilisateurs Francophones des standards CDISC, Chilly-Mazarin, 17 December 2012

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CDISC Standards Update

© CDISC 2012

Programme de la réunion du GUF CDISC du 17/12/2012

© CDISC 2012

Topics

• The State of our Standards • The CDISC Technical Plan• The CDISC Technical Roadmap• CDISC SHARE• CDISC, CFAST and Therapeutic Area Standards

Development

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© CDISC 2012 5

The CDISC Standards Guide

© CDISC 2012 6

Breaking News

© CDISC 2012

1-Click Standards Guides

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© CDISC 2012

Key Technical Initiatives for 2012

Technical Strategy• Communicate updated

CDISC vision and roadmap• Incorporate BRIDG in

standards development• Begin transition to SHARE• Improve use of online

collaboration tools for standards development

• Increase involvement by global volunteers

Technical Projects• Increase transparency • Improve processes

Annual Planning Standards Review Council New Process Definition

• Coordinated new versions of foundational standards New provisional state

• Kickoff CFAST • Appreciate our volunteers

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© CDISC 2012

A New Process

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CDISC Technical Plan Oct. 2012

© CDISC 2012

Statistics DAM in BRIDGTracking Statistical topics thru-out the study lifecycle.

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© CDISC 2012

CDISC’s Healthcare Link Vision

A set of profiles and standards to automate the clinical trial process flow of EHR-enabled platforms from patient recruitment thru clinical trial data capture:

Clinical research protocol: Retrieve Process for Execution (RPE) Clinical Research Process Content (CRPC) Proposed Research Matching CDISC SDM-XML

•Clinical research documents (eCRF or adverse event reports) to be pre-populated by existing clinical data in EHRs:

Retrieve Form for Data Capture (RFD) Clinical Research Document (CRD) Drug Safety Content (DSC) Redaction Service Profile (RSP) Proposed Data Element Exchange and Patient Authored Note CDISC CDASH and ODM for data exchange and archive

•Confidentiality and security aspects Consistent Time (CT) Cross-Enterprise User Assertion (XUA) Audit Trail Node Authentication (ATNA)

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© CDISC 2012

CDISC Roadmap: A Work in Progress

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© CDISC 2012

Building Blocks of the CDISC Roadmap

• Programs - A related collection of products or product areas: Foundational Standards (SDTM, CDASH, ODM, ADaM, etc.) Semantics (BRIDG, SHARE) Therapeutic Areas Healthcare Link

• Teams – responsible for a foundational product family or product SDS, CDASH, ADaM, XML Tech, etc. Sub-teams are assigned to specific projects or product areas by a

standing team (Devices)

• Projects – Finite sets of activities involving members from 1 or more teams to deliver a specific product or deliverable

• Product deliverables: (Implementation Guides, schemas, models other documents)

Device IG, Virology IG, CDASH SAE, SDTM in XML, etc.

• A foundation based on BRIDG and SHARE.

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© CDISC 2012

CDISC Technical RoadmapFoundational Standards

Semantics

Therapeutic Areas

SDS Product Family

CDASH Product Family

SHARE

BRIDG

Track 1

Track 2

Track 3

SEND

PROTOCOL

Others

XML Technologies

Glossary

ADAM

Controlled Terminology

Health Care InteroperabilityIHE

ONC/Euro-rec

CRProcess/SHARE

Transport LayerXML, OWL, JSON…

Semantic LayerBRIDG/SHARE

Functional LayerSDTM, SEND, ADaM, CDASH

Implementation LayerTherapeutic Area Guides, Healthcare Interoperability Kits

SDTM v4

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© CDISC 2012

A global, accessible electronic metadata library, which through advanced technology, enables precise and standardized data element definitions and richer metadata that can be used in applications and studies to improve biomedical research and its link with healthcare.

http://www.cdisc.org/cdisc-share

CDISC SHARE VISION

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© CDISC 2012

Variations in the Concept of “Bleeding”

Source: Establishing and Maintaining Therapeutic Area Data Standards Draft White Paper

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© CDISC 201218

BRIDG – Part of the SHARE Foundation• BRIDG Purpose:

A collaborative effort to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest.

The semantic foundation for HL7/CDISC-based application and message development

• Domain-of-interest/scope: Protocol-driven research A Unified Modeling Language (UML) Model of the data (using ISO 21090

datatypes), organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required for or derived from this effort.

• Stakeholders:• Governance Process:

Board of Directors prioritizes projects and committee consults with projects and harmonizes project models into main model with help of project analysts/SMEs

© CDISC 2012

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BRIDG Model Content (Layer 2)class UML-Based Comprehensiv e BRIDG Model Diagram

Common Sub-Domain::Organization

+ identifier: DSET<II>+ name: DSET<ON>+ typeCode: CD+ actualIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ description: ST

Common Sub-Domain::Person{leaf}

+ name: PN+ initials: ST+ raceCode: DSET<CD>+ ethnicGroupCode: DSET<CD>+ postalAddress: AD+ telecomAddress: BAG<TEL>+ maritalStatusCode: CD+ educationLevelCode: CD+ primaryOccupationCode: CD+ occupationDateRange: IVL<TS.DATE>+ deathIndicator: BL::BiologicEntity+ actualIndicator: BL+ administrativeGenderCode: CD+ birthCountryCode: CD+ birthOrder: INT+ birthDate: TS.DATETIME+ deathDate: TS.DATETIME

Common Sub-Domain::HealthcareProv ider

+ identifier: II+ certificateLicenseText: ST+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>

Study Conduct Sub-Domain::

Laboratory

+ identifier: II

Common Sub-Domain::HealthcareFacility

+ identifier: II+ postalAddress: AD+ effectiveDateRange: IVL<TS.DATETIME>


PerformingLaboratory


CollectingLaboratory

Study Conduct Sub-Domain::StudySite

+ identifier: II+ leadIndicator: BL+ targetAccrualNumberRange: URG<INT>+ accrualStatusCode: CD+ accrualStatusDate: TS.DATETIME+ dateRange: IVL<TS.DATETIME>+ statusCode: CD+ statusDate: TS.DATETIME

constraints{Is a Function Performed By Exclusive Or}

Protocol Representation Sub-Domain::StudyInv estigator

{leaf}

+ identifier: II+ signatureText: ST+ effectiveDateRange: IVL<TS.DATETIME>::StudyContact+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

constraints{Is a Function Performed By Qualifier}{Is a Function Performed By Exclusive Or}

Protocol Representation Sub-Domain::Study{root}

+ acronym: ST+ phaseCode: CD+ primaryPurposeCode: CD+ purposeStatement: ST+ diseaseCode: DSET<CD>+ targetAnatomicSiteCode: DSET<CD>+ designConfigurationCode: CD+ studySchematic: ED+ populationDescription: ST+ studySubjectTypeCode: CD+ plannedStudySubjectExperience: ST+ targetAccrualNumberRange: URG<INT>+ periodicTargetAccrualNumber: RTO<INT,PQ>+ accrualReportingMethodCode: CD+ responsiblePartyCode: CD+ participatingOrganizationTypeCode: CD+ participatingCountryCode: DSET<CD>+ aeCodingSystem: II+ multiInstitutionIndicator: BL

constraints{mulitInstitutionalIndicator Qualifier}

Common Sub-Domain::Activity{root}

+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Study Conduct Sub-Domain::ScheduledActiv ity

{leaf}

+ dateRange: IVL<TS.DATETIME>+ /duration: PQ.TIME+ repeatQuantity: URG<INT>+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{actualIndicator Exclusive Or}

Study Conduct Sub-Domain::PerformedActiv ity{leaf}

+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Is a Function Performed By Qualifier}{actualIndicator Exclusive Or}{Instantiates Exclusive Or}{Occurs in the Context Of Qualifier}{actualDateRange Qualifier}

Study Conduct Sub-Domain::PerformedClinicalResult

{leaf}

+ /normalRangeComparisonCode: CD+ reportedResultStatusCode: CD+ biomarkerIndicator: BL+ asCollectedIndicator: BL::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Common Sub-Domain::Subject{root}

+ state: ST


Common Sub-Domain::Material{root}

+ identifier: DSET<II>+ name: DSET<TN>+ formCode: CD+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::ResourceProv ider{root}

+ identifier: II+ effectiveDateRange: IVL<TS.DATETIME>


Study Conduct Sub-Domain::ConcomitantAgent

Study Conduct Sub-Domain::BiologicSpecimen{leaf}

+ accessionNumberText: ST+ conditionCode: CD::Material+ identifier: DSET<II>+ name: DSET<TN>+ formCode: CD+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>

constraints{actualIndicator Qualifier}

Regulatory Sub-Domain::RegulatoryApplicationSponsor

+ effectiveDateRange: IVL<TS.DATETIME>


Protocol Representation Sub-Domain::StudyAgent

+ functionCode: CD+ statusCode: CD+ statusDate: TS.DATETIME

Study Conduct Sub-Domain::PerformedAdministrativ eActiv ity{leaf}

+ varianceTypeCode: CD+ varianceReason: ST::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Is a Function Performed By Qualifier}

Study Conduct Sub-Domain::PerformedSpecimenCollection

{leaf}

+ fastingStatusIndicator: BL::PerformedProcedure+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteConditionCode: CD::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Study Conduct Sub-Domain::PerformedSubstanceAdministration

{leaf}

+ dose: PQ+ doseDescription: ST+ doseFrequencyCode: CD+ dailyDoseTotal: PQ+ changeTypeCode: CD+ plannedChangeIndicator: BL+ changeReason: ST+ routeOfAdministrationCode: CD+ /startRelativeToReferenceCode: CD+ /endRelativeToReferenceCode: CD::PerformedProcedure+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteConditionCode: CD::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Is a Function Performed By Qualifier}{relativeToReference Qualifier}

Common Sub-Domain::StudySubject{leaf}

+ confidentialityIndicator: BL+ paymentMethodCode: CD+ statusCode: CD+ statusDate: TS.DATETIME::Subject+ state: ST

Common Sub-Domain::Document{root}

+ typeCode: CD+ officialTitle: ST+ text: ED+ keywordCode: DSET<CD>+ keywordText: DSET<ST>+ revisionReason: ST+ revisionNumberText: ST+ uniformResourceLocator: URL+ bibliographicDesignation: ST

Regulatory Sub-Domain::SubmissionUnit

+ typeCode: CD+ receiptDate: TS.DATETIME+ effectiveDateRange: IVL<TS.DATETIME>

constraints{Grouped Into Exclusive Or}

Regulatory Sub-Domain::RegulatoryApplication

+ identifier: II+ typeCode: CD

Regulatory Sub-Domain::Submission

+ typeCode: CD+ /receiptDate: TS.DATETIME+ statusCode: CD+ statusDate: TS.DATETIME

constraints{Groups Exclusive Or}

Common Sub-Domain::DocumentRelationship

+ typeCode: CD

Regulatory Sub-Domain::

Rev iewableUnit

+ typeCode: CD

Study Conduct Sub-Domain::PerformedObserv ationResult

+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Common Sub-Domain::Ov ersightCommittee{leaf}

+ typeCode: CD+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::AssociatedBiologicEntity

+ typeCode: DSET<CD>

Study Conduct Sub-Domain::PerformedClinicalInterpretation

{leaf}

+ toxicityTermCode: CD+ toxicityGradeCode: CD+ severityCode: CD+ clinicallySignificantIndicator: BL+ abnormalIndicator: BL::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Study Conduct Sub-Domain::PerformedStudyAgentTransfer

{leaf}

+ quantity: PQ+ originalQuantity: PQ::PerformedAdministrativeActivity+ varianceTypeCode: CD+ varianceReason: ST::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Study Conduct Sub-Domain::StudyResearchCoordinator

{leaf}

::StudyContact+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

Study Conduct Sub-Domain::PerformedProtocolDev iation

{leaf}

+ categoryCode: CD+ dateRange: IVL<TS.DATETIME>::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Study Conduct Sub-Domain::PerformedMedicalHistoryResult

{leaf}

+ endRelativeToReferenceCode: CD+ occurrenceDateRange: IVL<TS.DATETIME>::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

constraints{relativeToReference Qualifier}

Protocol Representation Sub-Domain::StudyObjectiv e

+ primaryIndicator: BL+ description: ST

Study Conduct Sub-Domain::PerformedObserv ation{leaf}

+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Protocol Representation Sub-Domain::DefinedActiv ity{leaf}

+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{actualIndicator Qualifier}{Repeat Frequency Exclusive Or}{Repeat Duration or Quantity Exclusive Or}{categoryCode Qualifier}

Common Sub-Domain::ResearchStaff

+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>

constraints{Person-Org Pair Unique}

Common Sub-Domain::DocumentAuthor{root}

constraints{Is a Function Performed By Qualifier}{Study Author Performed By Qualifier}

Study Conduct Sub-Domain::PerformedStudySubjectMilestone

{leaf}

+ informedConsentDate: TS.DATETIME+ registrationDate: TS.DATETIME+ offStudyDate: TS.DATETIME+ offStudyReasonCode: CD+ studyReferenceDateRange: IVL<TS.DATETIME>::PerformedAdministrativeActivity+ varianceTypeCode: CD+ varianceReason: ST::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Is a Function Performed By Qualifier}{Date Exclusive Or}

Study Conduct Sub-Domain::PerformedStudyAdministrativ eActiv ity

{leaf}

::PerformedAdministrativeActivity+ varianceTypeCode: CD+ varianceReason: ST::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Study Conduct Sub-Domain::PerformedDiagnosis

{leaf}

+ diseaseStatusCode: CD+ recurrenceIndicator: BL::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Study Conduct Sub-Domain::PerformedLesionDescription

{leaf}

+ appearanceTypeCode: CD+ contactAnatomicSiteCode: CD+ lesionNumber: INT+ measurableIndicator: BL+ xDimension: PQ+ yDimension: PQ+ zDimension: PQ+ /dimensionProduct: PQ::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Study Conduct Sub-Domain::PerformedHistopathology

{leaf}

+ differentiationGradeCode: DSET<CD>+ cellTypeCode: DSET<CD>+ involvedSurgicalMarginIndicator: BL::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Common Sub-Domain::BiologicEntity{root}

+ actualIndicator: BL+ administrativeGenderCode: CD+ birthCountryCode: CD+ birthOrder: INT+ birthDate: TS.DATETIME+ deathDate: TS.DATETIME

Common Sub-Domain::BiologicEntityGroup

+ name: TN+ typeCode: CD+ quantity: INT+ actualIndicator: BL

Common Sub-Domain::Animal{leaf}

+ speciesCode: CD+ breedCode: CD+ strain: ST+ reproductiveOrgansPresentIndicator: BL+ description: ED::BiologicEntity+ actualIndicator: BL+ administrativeGenderCode: CD+ birthCountryCode: CD+ birthOrder: INT+ birthDate: TS.DATETIME+ deathDate: TS.DATETIME

Study Conduct Sub-Domain::PerformedProcedure{leaf}

+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteConditionCode: CD::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Common Sub-Domain::Product{leaf}

+ nameCode: CD+ nameModifiedText: ST+ typeCode: CD+ classCode: DSET<CD>+ pre1938Indicator: BL+ treatmentVehicleCode: CD+ treatmentVehicleVolume: PQ+ expirationDate: TS.DATE.FULL::Material+ identifier: DSET<II>+ name: DSET<TN>+ formCode: CD+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>

constraints{Distributor Qualifier}{Manufacturer Qualifier}{ManufacturingSite Qualifier}

Common Sub-Domain::Package

+ identifier: DSET<II>+ name: TN+ typeCode: CD+ formCode: CD+ lotNumberText: ST+ capTypeCode: CD+ capacityQuantity: PQ

Common Sub-Domain::Dev ice{leaf}

+ age: PQ+ manufactureDate: TS.DATETIME+ reprocessedDeviceCode: CD+ availableForEvaluationIndicator: BL+ overTheCounterProductIndicator: BL+ singleUseDeviceIndicator: BL::Product+ nameCode: CD+ nameModifiedText: ST+ typeCode: CD+ classCode: DSET<CD>+ pre1938Indicator: BL+ treatmentVehicleCode: CD+ treatmentVehicleVolume: PQ+ expirationDate: TS.DATE.FULL::Material+ identifier: DSET<II>+ name: DSET<TN>+ formCode: CD+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::Drug{leaf}

+ lotNumberText: ST::Product+ nameCode: CD+ nameModifiedText: ST+ typeCode: CD+ classCode: DSET<CD>+ pre1938Indicator: BL+ treatmentVehicleCode: CD+ treatmentVehicleVolume: PQ+ expirationDate: TS.DATE.FULL::Material+ identifier: DSET<II>+ name: DSET<TN>+ formCode: CD+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::Biologic{leaf}


Common Sub-Domain::FoodProduct{leaf}


Common Sub-Domain::Cosmetic{leaf}


Regulatory Sub-Domain::RegulatoryAssessment

+ identifier: DSET<II>+ assessmentCode: CD+ assessmentDate: TS.DATETIME

Common Sub-Domain::Manufacturer

Common Sub-Domain::

ManufacturingSite

Regulatory Sub-Domain::RegulatoryAuthority{leaf}

+ jurisdictionCode: CD+ effectiveDateRange: IVL<TS.DATETIME>

Adv erse Ev ent Sub-Domain::PerformedProductInv estigation

{leaf}

::PerformedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Adv erse Ev ent Sub-Domain::PerformedProductProblemDiscov ery

{leaf}

::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Study Conduct Sub-Domain::PerformedEligibilityCriterion

{leaf}

+ questionCode: CD+ displayOrder: INT+ notApplicableIndicator: BL::PerformedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Study Conduct Sub-Domain::PerformedInclusionCriterion

{leaf}

::PerformedEligibil i tyCriterion+ questionCode: CD+ displayOrder: INT+ notApplicableIndicator: BL::PerformedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Study Conduct Sub-Domain::PerformedExclusionCriterion

{leaf}

::PerformedEligibil i tyCriterion+ questionCode: CD+ displayOrder: INT+ notApplicableIndicator: BL::PerformedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

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

{leaf}

+ gradeCode: CD+ severityCode: CD+ seriousnessCode: CD+ categoryCode: CD+ subcategoryCode: CD+ occurrencePatternCode: CD+ endRelativeToReferenceCode: CD+ unexpectedReasonCode: DSET<CD>+ expectedIndicator: BL+ hospitalizationRequiredIndicator: BL+ highlightedIndicator: BL+ duration: PQ.TIME+ onsetDate: TS.DATETIME+ resolutionDate: TS.DATETIME::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Adv erse Ev ent Sub-Domain::Ev aluatedResultRelationship

+ probabil i ty: REAL+ uncertaintyCode: CD

Adv erse Ev ent Sub-Domain::Ev aluatedActiv ityRelationship

+ probabil i ty: REAL+ uncertaintyCode: CD

Study Conduct Sub-Domain::AssessedResult

+ typeCode: CD+ comment: ST

Adv erse Ev ent Sub-Domain::PerformedProductInv estigationResult

{leaf}

+ defectTypeCode: CD+ deviceMalfunctionCode: CD+ evaluationConclusionCode: CD+ conclusion: ST::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Common Sub-Domain::DocumentReceiv er


Adverse Event Sub-Domain

Common Sub-Domain

Protocol Representation Sub-Domain

Regulatory Sub-Domain

Study Conduct Sub-Domain

Legend

Common Sub-Domain::Report{leaf}

+ communicationModeCode: CD::Document+ typeCode: CD+ officialTitle: ST+ text: ED+ keywordCode: DSET<CD>+ keywordText: DSET<ST>+ revisionReason: ST+ revisionNumberText: ST+ uniformResourceLocator: URL+ bibliographicDesignation: ST

Adv erse Ev ent Sub-Domain::SafetyReport{leaf}

+ subtypeCode: CD+ null i ficationReasonCode: CD+ null i ficationIndicator: BL::Report+ communicationModeCode: CD::Document+ typeCode: CD+ officialTitle: ST+ text: ED+ keywordCode: DSET<CD>+ keywordText: DSET<ST>+ revisionReason: ST+ revisionNumberText: ST+ uniformResourceLocator: URL+ bibliographicDesignation: ST

Protocol Representation Sub-Domain::Arm{root}

+ name: ST+ typeCode: CD+ targetAccrualNumberRange: URG<INT>+ randomizationWeightText: ST+ description: ST

constraints{name Unique}

Protocol Representation Sub-Domain::Epoch

{root}

+ name: ST+ typeCode: CD+ sequenceNumber: INT+ description: ST

constraints{name Unique}

Common Sub-Domain::Place

+ identifier: DSET<II>+ typeCode: CD

Common Sub-Domain::OrganizationalContact

+ typeCode: DSET<CD>+ title: ST+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::Administrativ eMemberCRA

Common Sub-Domain::Administrativ eMemberPI

Common Sub-Domain::Cooperativ eGroup

Common Sub-Domain::MemberInstitution

Common Sub-Domain::ResearchOrganization

+ typeCode: CD+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::TreatingSite

constraints{Is a Member Of Exclusive Or}

Common Sub-Domain::Distributor

Common Sub-Domain::OrganizationPart

+ identifier: II+ typeCode: CD+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::HealthcareProv iderGroup


Common Sub-Domain::HealthcareProv iderGroupMember


Protocol Representation Sub-Domain::RandomizationBookEntry

+ positionNumber: INT+ positionFil ledIndicator: BL

Protocol Representation

Sub-Domain::StratumGroup

+ groupNumber: INT

Common Sub-Domain::BiologicEntityIdentifier


Common Sub-Domain::DocumentIdentifier

+ identifier: II+ typeCode: CD+ primaryIndicator: BL

constraints{Is Issued By Exclusive Or}

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.

Study Conduct Sub-Domain::StudyOv erallStatus

+ studyStoppedReasonCode: CD+ anticipatedIndicator: BL+ comment: ST+ statusCode: CD+ statusDate: TS.DATETIME

Study Conduct Sub-Domain::StudyRecruitmentStatus

+ statusCode: CD+ statusDate: TS.DATETIME

Common Sub-Domain::DocumentWorkflowStatus

+ comment: ST+ statusCode: CD+ statusDate: TS.DATE.FULL

Protocol Representation Sub-Domain::

StudyOutcomeMeasure

+ name: ST+ typeCode: DSET<CD>+ primaryIndicator: BL+ timeFrameText: ST

Common Sub-Domain::StudyRegistry

+ name: ST+ acronym: ST

Protocol Representation Sub-Domain::StudyReference

+ publicationIdentifier: II+ publicationName: ST+ universalResourceLocator: URL+ citationDescription: ST+ linkPageDescription: ST

Protocol Representation Sub-Domain::Resource{root}

+ activeIndicator: BL+ inactiveComment: ST

Protocol Representation Sub-Domain::Gov ernmentFunding

{leaf}

+ fundingTypeCode: CD+ fundingMechanismCode: CD+ nihInstituteCode: CD+ serialNumberText: ST::Resource+ activeIndicator: BL+ inactiveComment: ST

Protocol Representation Sub-Domain::StudyLegalSponsor

+ primaryIndicator: BL



MaterialResource{leaf}

::Resource+ activeIndicator: BL+ inactiveComment: ST

Protocol Representation Sub-Domain::StudyContact

{root}

+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

Study Conduct Sub-Domain::StudySiteContact

{root}

+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

Study Conduct Sub-Domain::StudySiteInv estigator

{leaf}

::StudySiteContact+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

constraints{Is a Function Performed By Qualifier}{Is a Function Performed By Exclusive Or}

Protocol Representation Sub-Domain::Interv entionalStudy

{leaf}

+ controlTypeCode: CD+ controlConcurrencyTypeCode: CD+ allocationCode: CD+ blindingSchemaCode: CD+ blindedRoleCode: DSET<CD>+ interventionGroupQuantity: INT+ acceptsHealthyVolunteersIndicator: BL+ interventionDescription: ST::Study+ acronym: ST+ phaseCode: CD+ primaryPurposeCode: CD+ purposeStatement: ST+ diseaseCode: DSET<CD>+ targetAnatomicSiteCode: DSET<CD>+ designConfigurationCode: CD+ studySchematic: ED+ populationDescription: ST+ studySubjectTypeCode: CD+ plannedStudySubjectExperience: ST+ targetAccrualNumberRange: URG<INT>+ periodicTargetAccrualNumber: RTO<INT,PQ>+ accrualReportingMethodCode: CD+ responsiblePartyCode: CD+ participatingOrganizationTypeCode: CD+ participatingCountryCode: DSET<CD>+ aeCodingSystem: II+ multiInstitutionIndicator: BL

constraints{blindedRoleCode Qualifier}

Protocol Representation Sub-Domain::Observ ationalStudy

{leaf}

+ samplingMethodCode: CD+ timePerspectiveCode: CD::Study+ acronym: ST+ phaseCode: CD+ primaryPurposeCode: CD+ purposeStatement: ST+ diseaseCode: DSET<CD>+ targetAnatomicSiteCode: DSET<CD>+ designConfigurationCode: CD+ studySchematic: ED+ populationDescription: ST+ studySubjectTypeCode: CD+ plannedStudySubjectExperience: ST+ targetAccrualNumberRange: URG<INT>+ periodicTargetAccrualNumber: RTO<INT,PQ>+ accrualReportingMethodCode: CD+ responsiblePartyCode: CD+ participatingOrganizationTypeCode: CD+ participatingCountryCode: DSET<CD>+ aeCodingSystem: II+ multiInstitutionIndicator: BL

Protocol Representation Sub-Domain::ExpandedAccessStudy

{leaf}

+ interventionDescription: ST::Study+ acronym: ST+ phaseCode: CD+ primaryPurposeCode: CD+ purposeStatement: ST+ diseaseCode: DSET<CD>+ targetAnatomicSiteCode: DSET<CD>+ designConfigurationCode: CD+ studySchematic: ED+ populationDescription: ST+ studySubjectTypeCode: CD+ plannedStudySubjectExperience: ST+ targetAccrualNumberRange: URG<INT>+ periodicTargetAccrualNumber: RTO<INT,PQ>+ accrualReportingMethodCode: CD+ responsiblePartyCode: CD+ participatingOrganizationTypeCode: CD+ participatingCountryCode: DSET<CD>+ aeCodingSystem: II+ multiInstitutionIndicator: BL

NOTE: Unti l 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.

Regulatory Sub-Domain::Ov ersightAuthority

{root}


StudyOv ersightAuthority

Study Conduct Sub-Domain::StudySiteOv ersightStatus

+ reviewBoardApprovalNumberText: ST+ reviewBoardApprovalStatusCode: CD+ reviewBoardApprovalDate: TS.DATETIME

Common Sub-Domain::QualifiedPerson

+ identifier: II+ typeCode: CD+ certificateLicenseText: ST+ effectiveDateRange: IVL<TS.DATETIME>

Common Sub-Domain::ExperimentalUnit

+ identifier: DSET<II>+ subgroupCode: CD+ statusCode: CD+ statusDate: TS.DATETIME


Common Sub-Domain::ProductGroup

+ identifier: II+ quantity: INT+ actualIndicator: BL

Common Sub-Domain::Performer

+ identifier: II+ typeCode: CD+ actualIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ effectiveDateRange: IVL<TS.DATETIME>


Protocol Representation Sub-Domain::DefinedObserv ation

{leaf}

+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Common Sub-Domain::BiologicEntityPart

+ anatomicSiteCode: CD+ anatomicSiteLateralityCode: CD

Study Conduct Sub-Domain::ReferenceResult

+ typeCode: CD+ result: ANY+ targetAnatomicSiteCode: CD+ comment: ST

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

+ typeCode: CD+ delayDuration: PQ.TIME

Adv erse Ev ent Sub-Domain::CausalAssessment

{leaf}


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

{leaf}

::PerformedObservationResult+ identifier: II+ typeCode: CD+ result: ANY+ resultCodeModifiedText: ST+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ uncertaintyCode: CD+ reportedDate: TS.DATETIME+ comment: ST

Protocol Representation Sub-Domain::StudyResource

+ primaryIndicator: BL+ effectiveDateRange: IVL<TS.DATETIME>

Protocol Representation Sub-Domain::Funding

{leaf}

::Resource+ activeIndicator: BL+ inactiveComment: ST

Protocol Representation Sub-Domain::Serv ice

{leaf}

+ typeCode: CD::Resource+ activeIndicator: BL+ inactiveComment: ST

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

{leaf}


Adv erse Ev ent Sub-Domain::ProductActionTakenRelationship

+ delayDuration: PQ.TIME

Protocol Representation Sub-Domain::DefinedAdministrativ eActiv ity{leaf}

::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Study Conduct Sub-Domain::PerformedImaging{leaf}

+ imageIdentifier: II+ enhancementRateValue: RTO<PQ, PQ.TIME>+ enhancementDescription: ST+ contrastAgentEnhancementIndicator: BL::PerformedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ /focalDateRange: IVL<TS.DATETIME>::PerformedActivity+ /actualDuration: PQ.TIME+ actualDateRange: IVL<TS.DATETIME>+ /delayDuration: PQ.TIME+ missedReason: DSET<SC>+ missedIndicator: BL+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Protocol Representation Sub-Domain::StudyActiv ity

+ studyFocusIndicator: BL

Protocol Representation Sub-Domain::DefinedObserv ationResult

+ result: ANY+ typeCode: CD+ targetCodingSystem: II+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ derivationExpression: ST+ comment: ST

Protocol Representation Sub-Domain::DefinedStudySubjectMilestone

{leaf}



Protocol Representation Sub-Domain::DefinedStudyAdministrativ eActiv ity

{leaf}


constraints{Is a Function Performed By Not Applicable}

Protocol Representation Sub-Domain::DefinedExperimentalUnitAllocation

{leaf}

+ methodCode: CD::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Protocol Representation Sub-Domain::DefinedSpecimenStorage

{leaf}



Protocol Representation Sub-Domain::DefinedStudyAgentTransfer

{leaf}



Protocol Representation Sub-Domain::DefinedProcedure{leaf}

+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Uses Qualifier}

Protocol Representation Sub-Domain::DefinedSubstanceAdministration

{leaf}

+ dose: PQ+ doseFrequencyCode: CD+ doseRegimen: ST+ dailyDoseTotal: PQ+ routeOfAdministrationCode: CD::DefinedProcedure+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Protocol Representation Sub-Domain::DefinedSpecimenCollection

{leaf}

::DefinedProcedure+ methodCode: CD+ approachAnatomicSiteCode: CD+ targetAnatomicSiteCode: CD::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Protocol Representation Sub-Domain::DefinedEligibilityCriterion

{leaf}

+ requiredResponse: ANY+ displayOrder: INT::DefinedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


Protocol Representation Sub-Domain::DefinedStratificationCriterion

{leaf}

::DefinedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Is a Function Performed By Qualifier}{Permissible Result Qualifier}

Protocol Representation Sub-Domain::DefinedImaging

{leaf}

+ enhancementRateValue: RTO<PQ, PQ.TIME>+ enhancementDescription: ST+ contrastAgentEnhancementIndicator: BL::DefinedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Protocol Representation Sub-Domain::DefinedExclusionCriterion

{leaf}

::DefinedEligibil i tyCriterion+ requiredResponse: ANY+ displayOrder: INT::DefinedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

Protocol Representation Sub-Domain::DefinedInclusionCriterion

{leaf}

::DefinedEligibil i tyCriterion+ requiredResponse: ANY+ displayOrder: INT::DefinedObservation+ methodCode: DSET<CD>+ bodyPositionCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteLateralityCode: CD+ /focalDuration: PQ.TIME+ focalDateRange: EXPR<IVL<TS.DATETIME>>::DefinedActivity+ nameCode: CD+ categoryCode: CD+ subcategoryCode: CD+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: URG<INT>+ /repeatDuration: PQ.TIME+ description: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST


DefinedCompositionRelationship

+ sequenceNumber: INT+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST


DefinedOptionRelationship

+ pauseQuantity: PQ.TIME+ priorityNumber: INT+ comment: ST

Protocol Representation Sub-Domain::DefinedContingentOnRelationship

+ evaluableExpression: ED+ pauseQuantity: PQ.TIME+ completionRequiredBeforeStartingIndicator: BL+ comment: ST

constraints{completionRequiredIndicator Qualifier}{Is Contingent Upon Exclusive Or}

Protocol Representation Sub-Domain::DefinedRepeatActiv ityUntilRule

+ cessationPauseQuantity: PQ.TIME+ checkpointCode: CD+ conjunctionCode: CD+ comment: ST

constraints{Is Repeated Until Exclusive Or}

Protocol Representation Sub-Domain::DefinedCriterionGroup

Protocol Representation Sub-Domain::DefinedCriterionGroupCompositionRelationship


constraints{Is the Component Of Exclusive Or}

Protocol Representation Sub-Domain::DefinedCriterionGroupOptionRelationship

+ pauseQuantity: PQ.TIME+ priorityNumber: INT+ comment: ST

constraints{Is the Choice that has as Option Exclusive Or}

Protocol Representation Sub-Domain::PlannedActivity

+ name: ST+ purpose: ST+ targetAccrualNumberRange: URG<INT>+ description: ST+ blindedDescription: ST+ plannedDuration: PQ.TIME+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: INT+ /repeatDuration: PQ.TIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{Repeat Frequency Exclusive Or}{Repeat Duration or Quantity Exclusive Or}{actualIndicator Qualifier}


PlannedCompositionRelationship



PlannedContingentOnRelationship

+ pauseQuantity: PQ.TIME+ evaluableExpression: ED+ comment: ST

constraints{Is Contingent Upon Exclusive Or}

Protocol Representation Sub-Domain::PlannedCriterionGroup

Protocol Representation Sub-Domain::PlannedCriterionGroupCompositionRelationship


constraints{Is the Parent Of Exclusive Or}

Protocol Representation Sub-Domain::PlannedCriterionGroupOptionRelationship

+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST

constraints{Is a Choice that has as Option Exclusive Or}


PlannedOptionRelationship

+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST

Protocol Representation Sub-Domain::PlannedRandomizationBookAllocation

{leaf}

::PlannedActivity+ name: ST+ purpose: ST+ targetAccrualNumberRange: URG<INT>+ description: ST+ blindedDescription: ST+ plannedDuration: PQ.TIME+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: INT+ /repeatDuration: PQ.TIME::Activity+ identifier: II+ reasonCode: DSET<CD>+ comment: ST

constraints{DefinedActivity Qualifier}{Repeat Not Applicable}

Protocol Representation Sub-Domain::PlannedRepeatActiv ityUntilRule

+ cessationPauseQuantity: PQ.TIME+ checkpointCode: CD+ conjunctionCode: CD+ comment: ST

constraints{Is Repeated Until Exclusive Or}


ReferenceToStudyResults

+ publicationIdentifier: II+ publicationName: ST+ universalResourceLocator: URL+ citationDescription: ST+ linkPageDescription: ST

Protocol Representation Sub-Domain::StudyProtocolDocument

{leaf}

+ publicTitle: ST+ publicDescription: ST+ scientificDescription: ST::Document+ typeCode: CD+ officialTitle: ST+ text: ED+ keywordCode: DSET<CD>+ keywordText: DSET<ST>+ revisionReason: ST+ revisionNumberText: ST+ uniformResourceLocator: URL+ bibliographicDesignation: ST

Protocol Representation Sub-Domain::DefinedStratificationCriterionPermissibleResult{leaf}

::DefinedObservationResult+ result: ANY+ typeCode: CD+ targetCodingSystem: II+ targetAnatomicSiteCode: CD+ confidentialityCode: CD+ derivationExpression: ST+ comment: ST

constraints{Association Cardinality Qualifier}

Common Sub-Domain::ProductPart

+ strength: RTO<PQ,PQ>+ activeIngredientIndicator: BL

Study Conduct Sub-Domain::StudySiteResearchCoordinator

::StudySiteContact+ roleCode: CD+ primaryIndicator: BL+ postalAddress: AD+ telecomAddress: BAG<TEL>+ statusCode: CD+ statusDate: TS.DATETIME

Common Sub-Domain::StudySubjectIdentifier



RegistrationCenter{leaf}

+ telecomAddress: TEL

Study Conduct Sub-Domain::Assessor

+ actualIndicator: BL


0..*

oversees

{is overseen by}

1

0..*

handlescommunicationsfor

{has communicationshandled by}

1

0..*

is a functionperformed by

{functions as}

0..1

0..*

is a function performed by

{functions as}0..1

0..*


{functions as}0..1

0..*

is credentialed by

{credentials}

1

0..*


{functions as}

1

0..*

describes

{is described by} 1

0..*


{functions as}

0..1

0..*


{functions as}1

0..*


{functions as}0..1

0..1


{functions as}

1

0..*

is triggered by

{triggers} 1

0..*

is assigned by

{assigns}1

0..*

is triggered by

{triggers} 1

0..*

is a member of

{has as a member}

1

0..*

is triggered by

{triggers} 1

0..*

associates a resource to

{is associated to a resource by} 1

0..*

associates a study to

{is associated to a study by}

1

0..*


{functions as}0..1

0..*

is triggered by

{triggers} 1

0..1


{functions as}0..*

0..*

triggers

{is triggered by}

1

0..*

is part of

{has}1

0..*

performs

{is performed by} 1..*

0..*


{functions as}0..1

0..*


{functions as}0..1

0..*


{functions as}

0..1

0..*

provides

{is provided by}

1..*

0..*


{functions as}

0..1

0..*

randomizes

{is randomized by}1

0..*

is assigned to

{contains}

1

1..*

belongs to

{contains}

1

0..*


{functions as}

1

0..1is a function performed by

{functions as}1

0..*

is used togroup staff for

{groups staff into}

1

1..*

is defined by

{defines}1..*

+performed 0..1


{functions as}

+performing 1

0..*

identifies

{is identifiedby}

1

0..1


{functions as}

1

0..*

functions asan outlet for

{has as an outlet}

1..*

0..*is a member of

{has as a member}

0..1

1..*

is a member of

{has as a member}

0..1

0..*


{functions as}

1

0..1


{functions as}

1

+subdividing 0..*

has as parent

{is the parent for}

+subdivided 1

1..*

measures

{is measured by}

1..*

1..*

handles communications for

{has communications handled by} 1

0..*


{functions as}0..1

0..*

is responsible for

{is the responsibil i ty of}

1

0..*


{functions as}0..1

0..1


{functions as}

0..1

1..*

is defined by{defines}

1

0..*


{functions as}1

0..*

triggers

{is triggered by}1

0..*

describes{is described by}

1

0..*

describes

{is described by} 1

1..*

describes

{is described by} 1

0..*

is issued by

{issues}

0..1

0..*

identifies

{is identifiedby}

1

0..*

is issued by

{issues}

0..1

0..*

is assigned by

{assigns}

1

1..

is provided by

{provides}1

0..*

is the parent of

{is the component of}

1

0..*

is a choice that has as option

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

+component 0..*

is the component of

{is the parent of}

+composite 1

+composite 0..*

is the parent of


+component 0..1

0..*

is the parent of


0..1

0..*

is contingent upon{is a condition for}

0..1

0..*

is contingent upon

{is a condition for}

0..1

+contingent 0..*

is contingentupon


+prerequisite 0..1

+choice 0..*


{is an option that can satisfy}

+option 0..1

0..*

is the component of

{is the parent of}

1

0..*



0..1 1..*

occurs in

{contains}

0..1

0..*

is a use of

{is used as}

1

1..*

occurs in

{contains}

1..*

+option 0..*

is an option thatcan satisfy

{is a choice thathas as option}

+choice 1

+choice 0..*is a choice thathas as option

{is an option thatcan satisfy}

+option 0..1

+prerequisite 0..*

is a condition for

{is contingent upon}

+contingent 1

+triggering 1

is repeated unti l

{triggers thecessation of}

+repeated 1

0..*

is assigned by

{assigns}

0..1

0..*

identifies

{is identifiedby}

1

0..*

is part of

{has as part}1

0..*


{functions as}1

0..*

is the parent of


0..1

0..*

is repeated unti l

{triggers the cessation of}

0..1

+component 0..*

is thecomponent of

{is the parent of}

+composite

1

+repeated 0..*

triggers the cessation of

{is repeated unti l}

+triggering 1

0..*

is repeated unti l

{triggers the cessation of}0..1

+option 0..*

is an option that can satisfy

{is a choice that has as option}

+choice 1

+choice 0..*



+option 1

0..*


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

+option 0..*

is an option that can satisfy

{is a choice that has as option}

+choice 1

0..*

references the results of

{has results referenced in} 1

0..*

is a choicethat has asoption

{is an optionthat can satisfy}

0..1

0..*

results in

{is a result of}1

0..*

uses

{is used during}0..*

0..*

is a result of

{results in}

10..*

associates an activity to

{is associated to an activity by}

1

0..*

associates a study to

{is associated toa study by}

1

0..*

stores

{is stored during}1

+contingent0..*

is contingent upon


+prerequisite0..1

+composite 0..*is the parentof

{is thecomponent of}

+component0..1

0..*

is the parentof


0..1

0..*

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{is the component of}0..1

0..*

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{triggers the cessation of} 0..1

0..*

is repeated unti l


0..1

+triggering 0..*triggers thecessation of

{is repeated unti l}

+repeated 1

+repeated0..*

is repeated unti l


+triggering 1

0..*

is contingent upon{is a condition for}

0..1

+credentialed 0..*

is credentialed by

{credentials}

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is a condition for

{is contingent upon}

+contingent 1

+choice 0..*

is a choice thathas as option

{is an option thatcan satisfy}

+option 1

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is an option thatcan satisfy

{is a choice thathas as option}

+choice 1

+component 0..*

is thecomponent of

{is the parent of}

+composite 1

+composite0..*

is theparent of


+component1

0..*

is contingent upon


0..1

0..1


{functions as}1

0..*

is grouped into{groups}

0..1

1..*

is grouped into

{groups}0..1

0..*

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{is includedin}

1..*

0..*

is assigned to

{is the assignedlocation for}

1

1..*

is evaluated in

{evaluates}0..1

1..*

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{groups}1

0..*

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{performs}

0..1

0..*

is evaluated by

{is evaluating}

1

0..*


{functions as}1

0..*


{functions as}

0..1

0..*


{functions as}

0..1

1..*

is a result of

{results in}

0..1 0..*

is managed by

{manages}

1

1..

is performed at

{performs}0..1

0..*


{functions as}

1

0..*

is authorized by

{authorizes}

1

0..*

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{authorizes}

1

0..*

is a transfer of

{is transferred during}1

0..*

has as subject

{is the subject for}1

+scoped

0..*

is scoped by

{scopes}

+scoping

1

0..1


{functions as}0..1

0..*

oversees

{is overseen by} 0..*

0..*

oversees

{is overseen by}1..*

0..*

is a result of

{results in}

1

0..*

is grouped into

{groups}

1

+source 0..*

has as target

{is the target for}

+target 1

+target 0..*

has as source

{is the source for}

+source 1

1..*

is submitted by

{submits}1

+performed

0..*


{functions as}

+performing

1

0..*

staffs

{is staffed by}

1

0..*

executes

{is executed at}

1

0..*


{functions as}0..1

0..*


{functions as}0..1

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{functions as}1

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{functions as}1

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{functions as}

1

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{functions as}1

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{is referenced by}0..*

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{functions as}

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{functions as}

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{functions as}

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{functions as}

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{functions as}

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{is instantiated by}0..1

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{functions as}0..1

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{functions as}0..1

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{functions as}

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{is converted into}is converted from

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{is referenced by}

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{is instantiated by}

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{functions as}0..1

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{provides context to}

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takes place in

{is the location for}0..1

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{is instantiated by}1

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is participated inby{participates in}

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is the executionof

{is the plan for}

1

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instantiates

{is instantiated by}0..1

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fabricates

{is fabricated by}

1..*

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has as subject

{is the subject of} 1

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evaluates

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{triggers}

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{is dividedinto}

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{is staffed by}

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{has communications handled by}

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describes

{is described by}

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{is described by}

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{is received by}

1

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{contains} iscontained in

+containing0..1

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uses

{is used for}0..1

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authors

{is authored by}

1

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0..*staffs

{is staffed by}

1

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is reported by

{reports}

0..1

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is performed at

{performs}0..1

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{is tested during}0..*

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{aims to achieve} 1

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{functions as}

0..1

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{groups} 0..*

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manufactures for

{manufactures at}

1..*

0..1

is afunctionperformedby

{functions as}

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{is produced by}

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{performs}1

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uses


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Products and Study Agents

Regulatory

Specimens

Organizations and their

Roles

People and their Roles

Study Subjects

Documents

Studies

Study Design

Study Activities, Observations and

Results

Specimen Collection

Adverse Events

© CDISC 201221

• Single, trusted, authoritative source for CDISC data standards

• Concepts, metadata, collections, relationships, value sets across the full spectrum of CDISC content

• Links research to healthcare concepts to support interoperability

• Aligned with NCI Semantic Systems

Graphics adapted from Source by Sue Dubman, Sanofi-Aventis

21

brid

g

© CDISC 2012

SHARE Top-Level Functions

22

• Manage User Roles

• Manage User Profiles

• Manage Password

• Manage User Dashboard

• Manage Work Items

• Manage Standard Objects

• Manage Audit Trail

• Search and Browse

• Import• Export• Print

• Send Notificationsto users re object changes

• Manage listserv

• Manage SHARE MDR Framework Components

• Monitor User Activity

• Maintain Metrics

• Manage System Availability

© CDISC 2012

CDISC SHARE Library Contents

• Metadata (including BRIDG, SDTM and CDASH) Trial Design Metadata Definitions Datatypes (ISO 21090)

• Links to controlled terminology (CT) dictionaries via the NCIt (which links to CDISC CT, SNOMED, ICD9, ICD10, UMLS, etc.)

• Implementation instructions• Links to analysis concepts.

23

© CDISC 2012 24

BRIDGISO 21090

data types

Integrated BRIDG / ISO 21090 Templates

Research Concepts

Operational Collections

Versioned Standards

A Versioned Standard is comprised of a set of Operational Collections and associated variables and rules for a specific use case (e.g., SDTM, CDASH)

An Operational Collection is a grouping of Research Concepts. There may be additional rules between objects within the Operational Collection. An Operational Collection may be analogous with a SDTM Domain, a CRF, an ADaM data set, or a similar level of operational structure.

Integrated BRIDG / ISO 21090 Templates use BRIDG classes and relationships to fashion small re-usable patterns that are commonly needed in clinical research

Basic elements that are the foundation for the content described in the SHARE repository. A Research Concept defines one or more related pieces of clinical data, which is developed using an Integrated BRIDG / ISO 21090 Template.

BRIDG is the foundation model for SHARE that provides classes, attributes and associations use to creates core building blocks.

SHARE MDR Framework

Oth

er E

xtern

al R

eso

urce

s (e

.g. va

lue

Sets)

© CDISC 2012

Relationship

Relationship

Relationship

SHARE - Describes the Links between the Metadata

Diagram – Dave Iberson-Hurst

© CDISC 2012

The CDISC SHARE MODEL

SDTM VariablesSDTM Variables

CDASH VariablesCDASH Variables

Controlled TerminologyControlled Terminology

BRIDG ClassesBRIDG Classes

21090 Data types21090 Data types

CDISC SHARE MODEL

26

© CDISC 2012

Content Mapping

© CDISC 2012

SHARE Concept-Based View

28


Definitions


Definitions

SHARE FOUNDATIONSHARE FOUNDATIONDefine.XML

Define.XML

TFLs/SDTMTFLs/SDTM

Analysis/ADaM

Analysis/ADaM

CRFs/CDASHCRFs/CDASH

Protocol/TDMProtocol/TDM

VIEWSVIEWS

BRIDG

21090 Data Types

BRIDG

21090 Data Types

Share Concepts

(e.g. blood pressure)

Share Concepts

(e.g. blood pressure)

© CDISC 2012

SHARE Status Update

• RFI issued in August – 24 responses; 10 short-listed Software vendors, academics, system integrators

• Draft RFP due to be released in December - targeting a decision by Q1 2013

• Updated business requirements will soon be posted on CDISC website

• Currently exploring additional partnership and funding options.

• Goal is to have a release 1 prototype environment in initial use by end of 2013.

29

© CDISC 2012

Coalition For Accelerating Standards and Therapies

CFAST is an initiative of CDISC and the Critical Path Institute to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health.

Launch of

© CDISC 2012

C-Path, A Public-Private Partnership with the FDA: Why ?

• The number of new drugs approved per billion USD spenton R&D has halved every 9 years since 1950

• Costs have grown steadily

• Requires >$1B and ±15 years to bring a new drug to market

• “The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion.”

The Truly Staggering Cost of Inventing New Drugs. Forbes 2/20/12

• Process improvement is needed

• Solutions require collaborative approaches that include both the public and the private sector

32

© CDISC 2012

What’s Wrong with the Process??

• Throughout the drug development enterprise:

o Data to demonstrate efficacy & safety are defined and collected differently

o Measurements of efficacy and safety are based on differing criteria

o Methodologies for design of clinical trials for new drugs differ widely

• Standards are needed

33

© CDISC 2012

C-Path: What

•DEVELOP INTERNATIONAL STANDARDS• Measurement standards

o Molecular biomarkers for efficacy and patient classification

o Molecular biomarkers for toxicityo Imaging biomarkers for efficacy and patient

classificationo Patient-, observer-, clinician- reported outcomes

• Methods standards

o Disease models and clinical trial simulation toolso In vitro models

•ACQUIRE REGULATORY QUALIFICATION • Recognition, approval for a given context of use

34

© CDISC 2012

C-Path: How

Act as trusted neutral third party

Convene industry, academia, and government for pre-competitive collaboration

6 Global consortia

41 Companies, 1000+ scientists

The best science

Shared risk and costs

Iteratively involve FDA in the development process

Regulatory participation, guidance

Official recognition of standards through “qualification”

35

© CDISC 2012

C-Path: What We Do

DEVELOP INTERNATIONAL STANDARDS

•Data standards

o CDISC clinical data standards for therapeutic areas

o Alzheimer’s disease, tuberculosis, others

•MEET REGULATORY NEEDS•58 disease areas in 5 years

•FDA deadline for required data submission using CDISC standards in 2017

•EXPANSION OF DATA STANDARDS MISSION THROUGH CFAST

37

© CDISC 2012

Baseline Content for Initial Release

•Essential core data elements with definitions, data types (simple and ISO 21090), BRIDG and SDTM mappings

•Mindmap/model of Disease Area concepts

•Standard CDASH CRFs with SDTM annotations

•User/Implementation Guide with permissions statement

•Minimum value sets (code lists) with definitions

•SDTM domains and examples

Potential Additional Content

•Domain Analysis Model

•Representative ADaM Models

•Added content (concepts, domains, terms, CDASH)

•Sample SDM-XML study designs

•Examples of SEND non-clinical data

Therapeutic Area Standards Content

39

© CDISC 2012

C

CFAST TA Standards Governance Model

CFAST Program

Manager(s)

CFAST Steering Committee

TA Project Core TeamsProject Manager Terminology Lead Clinical Lead BRIDG ModelerData Standards Lead Data AnalystStatistics Consultant Technical Writer

CDISC FoundationalStandards

Teams

CDISC Leadership

Community and Process

CFAST Support:•IT•Admin•Communications

40

CFAST Scientific Advisory Comm.

FDA

CDISC

C-Path

TransCelerateBioPharma