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© 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
1
CDISC Standards Update
© CDISC 2012
Programme de la réunion du GUF CDISC du 17/12/2012
© 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 2012 10
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>
Study Conduct Sub-Domain::
PerformingLaboratory
Study Conduct Sub-Domain::
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
constraints{Is a Function Performed By Exclusive Or}
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>
constraints{Is a Function Performed By Exclusive Or}
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>
constraints{Is a Function Performed By Exclusive Or}
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
constraints{Is a Function Performed By Qualifier}
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
constraints{Is a Function Performed By Qualifier}
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
constraints{Is a Function Performed By Qualifier}
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
constraints{Is a Function Performed By Qualifier}
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}
+ 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::FoodProduct{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::Cosmetic{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>
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
constraints{Is a Function Performed By Qualifier}
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
constraints{Is a Function Performed By Exclusive Or}
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
+ effectiveDateRange: IVL<TS.DATETIME>
Common Sub-Domain::HealthcareProv iderGroupMember
+ effectiveDateRange: IVL<TS.DATETIME>
Protocol Representation Sub-Domain::RandomizationBookEntry
+ positionNumber: INT+ positionFil ledIndicator: BL
Protocol Representation
Sub-Domain::StratumGroup
+ groupNumber: INT
Common Sub-Domain::BiologicEntityIdentifier
+ identifier: II+ typeCode: CD+ effectiveDateRange: IVL<TS.DATETIME>
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
constraints{Is a Function Performed By Exclusive Or}
Protocol Representation Sub-Domain::
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}
Protocol Representation Sub-Domain::
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
constraints{Is a Function Performed By Exclusive Or}
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>
constraints{Is a Function Performed By Exclusive Or}
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}
::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 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}
::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::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}
::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}
Protocol Representation Sub-Domain::DefinedStudyAdministrativ 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
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}
::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{actualIndicator Qualifier}
Protocol Representation Sub-Domain::DefinedStudyAgentTransfer
{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
constraints{Is a Function Performed By Qualifier}
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
constraints{actualIndicator Qualifier}
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
constraints{Is a Function Performed By Qualifier}
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
Protocol Representation Sub-Domain::
DefinedCompositionRelationship
+ sequenceNumber: INT+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST
Protocol Representation Sub-Domain::
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
+ sequenceNumber: INT+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST
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}
Protocol Representation Sub-Domain::
PlannedCompositionRelationship
+ sequenceNumber: INT+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST
Protocol Representation Sub-Domain::
PlannedContingentOnRelationship
+ pauseQuantity: PQ.TIME+ evaluableExpression: ED+ comment: ST
constraints{Is Contingent Upon Exclusive Or}
Protocol Representation Sub-Domain::PlannedCriterionGroup
Protocol Representation Sub-Domain::PlannedCriterionGroupCompositionRelationship
+ sequenceNumber: INT+ priorityNumber: INT+ pauseQuantity: PQ.TIME+ comment: ST
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}
Protocol Representation Sub-Domain::
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}
Protocol Representation Sub-Domain::
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
+ identifier: II+ typeCode: CD+ effectiveDateRange: IVL<TS.DATETIME>
Protocol Representation Sub-Domain::
RegistrationCenter{leaf}
+ telecomAddress: TEL
Study Conduct Sub-Domain::Assessor
+ actualIndicator: BL
constraints{Is a Function Performed By Exclusive Or}
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..*
is a function performed by
{functions as}0..1
0..*
is credentialed by
{credentials}
1
0..*
is a function performed by
{functions as}
1
0..*
describes
{is described by} 1
0..*
is a functionperformed by
{functions as}
0..1
0..*
is a function performed by
{functions as}1
0..*
is a function performed by
{functions as}0..1
0..1
is a function performed by
{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..*
is a function performed by
{functions as}0..1
0..*
is triggered by
{triggers} 1
0..1
is a function performed by
{functions as}0..*
0..*
triggers
{is triggered by}
1
0..*
is part of
{has}1
0..*
performs
{is performed by} 1..*
0..*
is a function performed by
{functions as}0..1
0..*
is a function performed by
{functions as}0..1
0..*
is a functionperformed by
{functions as}
0..1
0..*
provides
{is provided by}
1..*
0..*
is a functionperformed by
{functions as}
0..1
0..*
randomizes
{is randomized by}1
0..*
is assigned to
{contains}
1
1..*
belongs to
{contains}
1
0..*
is a function performed by
{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
is a functionperformed by
{functions as}
+performing 1
0..*
identifies
{is identifiedby}
1
0..1
is a functionperformed by
{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..*
is a functionperformed by
{functions as}
1
0..1
is a functionperformed by
{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..*
is a function performed by
{functions as}0..1
0..*
is responsible for
{is the responsibil i ty of}
1
0..*
is a function performed by
{functions as}0..1
0..1
is a functionperformed by
{functions as}
0..1
1..*
is defined by{defines}
1
0..*
is a function performed by
{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
{is the component of}
+component 0..1
0..*
is the parent of
{is the component of}
0..1
0..*
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{is tested during}0..*
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{aims to achieve} 1
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{functions as}
0..1
1..*
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{groups} 0..*
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manufactures for
{manufactures at}
1..*
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{functions as}
1
0..*
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{is produced by}
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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
Controlled Terminology
Definitions
Controlled Terminology
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.
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© CDISC 2012
ControlledTerminology
CDISC Alliances / Partners / Collaborations
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© 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
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© 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:Who We’ve Convened
36
Partners
© 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 38
© 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
© CDISC 2012
A New Process
41
© CDISC 2012 42
© CDISC 2012 43
© CDISC 2012
Strength through collaboration.
44