PharmaSUG Single Day Event: A CDISC Grab Bag
CDISC: Interoperability and Beyond….
C. David Butler, PharmD, MBA
Senior Business Consultant II, Healthcare
2 © 2016 Teradata
Agenda
• The CDISC Roadmap and the data explosion
• Tools and Techniques for Any Data, ALL Data
• How to Integrate CDISC Across the Enterprise to: “Reduce Costs and Speed the Development of Therapies for Patients”
• Discussion
3
The CDISC Roadmap and the Data Explosion
4 © 2016 Teradata
The CDISC Roadmap
CDISC Healthcare Link initiative will support
a future where the clinical researcher will
take full advantage of data from the EHR,
devices, wearables and registries; data will
be created "research-ready" …
Such processes include, but are not limited to registry
population (disclosure); generation and population of
eCRFs, clinical trial management systems and databases;
production of tables and analysis datasets for reporting
and/or eSubmissions; and facilitation of all types of
research, including outcomes, public health and nutrition.
5
Tools and Techniques for Any Data, ALL Data
6 © 2016 Teradata
Teradata Reference Information Architecture
Operational Metadata
Acquisition1..n Integrated Data Access1..n
Regional and Departmental
Views
ADS
Applications& Engines
OperationalAnalytics & Hot Views
Data Marts
Archive
EAIBus
Common Summary
and Derived Values
WWW
OLAP
Reporting
Ad hoc
Dashboard
Applications
External
Intracore
Data Mining
Downstream
Results Loop
Discovery &
Investigation
EAIBus
Tables
Master Data
Reference Data
Transaction Data
Independent
Dependent
Data LabCountry
1..nBU1..n
ExportFiles
User External
Files
Big Data Environment
Txn Txn
AppData
Full Dump Full
CDC Delta
Active Load Stream
RelationalData
StructuredBig Data
WWW
TIER 2 TIER 3TIER 1
DeliveryStructuredSources
DiversifiedSources
BigData
LogsText
Ad
ds C
on
text
Conformed Dimensions
ExportFiles
Audit & Lineage
7 © 2016 Teradata
Business
Focused
Data
Driven
TERADATA UNIFIED DATA ARCHITECTURE
Cost Optimization View
Security, Workload Management
Marketing
Executives
Operational
Systems
Frontline
Workers
Customers
Partners
Engineers
Data
Scientists
Business
AnalystsMath
and Stats
Data
Mining
Business
Intelligence
Applications
Languages
Marketing
USERS
Search
INTEGRATED DATA
WAREHOUSE
ANY-DATA
PLATFORM
INTEGRATED
DISCOVERY
Security, Workload ManagementREAL TIME PROCESSING
GREATER INSIGHTS
HIGHER VALUE
LOWERCOSTS
↓ STORAGE COSTS
↓ SOFTWARE COSTS
↓ INGESTION COSTS
↓ DEVELOPMENT COSTS
↓ SUPPORT & MAINTENANCE COSTS
↓ USAGE COSTS
↓ PEOPLE COSTS
TAILOR ED SECURITY/PRIVACY
HIGHEST INTEGRITY
↓ ANALYTICAL DEVELOPMENT COSTS
↓ PEOPLE COSTS
FAST COMPLEXQUERIESRESEARCH
GENOME
DOCUMENTS
IMAGES
Audio
and Video
Machine
Logs
Text
Web and
Social
SOURCES
Marketing
Executives
Operational
Systems
Frontline
Workers
Customers
Partners
Engineers
Data
Scientists
Business
Analysts
USERS
Executives
Operational
Systems
Knowledge
Workers
Customers
Partners
Lab
Technicians
Scientists
Business
Analysts
USERSANALYTIC
TOOLS & APPS
8 © 2016 Teradata
Life Sciences Logical Data Model (LS-LDM)A Complete Package
• LS-LDM Product:
> Normalized Logical Data Model in CA
ERwin modeling tool
– Entity & Attribute definitions
– Relationship verbs
– Establishes enterprise data integration
> Comprehensive Reference Guides
– PDF and hardcopy
Foundation Core LDM Modules
e.g., Party, Product, Event
Geography, Account, Channel. . .
HCLDMForecasting
/ ScoringTransportation
Financial
Management
LS-LDMBasic Research
LS-LDMClinical Trials
LS-LDMManufacturing
LS-LDMEMR
• Supports:
> Granular object and event data
> Granular traceability
> Industry Standards
(BRIDG, HL7, CDISC, OMOP)
> Easily extended
> Data reuse
9 © 2016 Teradata
Financial ManagementConsolidated GL, Fixed Asset, Project Management, AR, AP
Order FulfillmentSales, Adjustments, Funnel, Acknowledgement, POS/3rd Party Sale
Supply Chain LogisticsCarrier Rate, Logistics, Planning, Notification, Trip Detl., Transport Goal
ManufacturingForecast, Mfg/Work Ord., Production Actual/Standard, Warr./Recall
PurchasingProcurement, Goods Receipt, Invoice, Freight Bill Reconcilliation
Web/ClickstreamWeb Ops./Site, Clickstream
Marketing/AdvertisementCampaign, Promotion, Multimedia, Ads, Item Plans, Demographics
EventRFID Track and Trace
MeasurementTesting, Metrics, Evaluations, Inspections, Experiments, QA
CentralizedBid, Plan, Status, Term, Claim
New Product Design/Material ManagementInventory, Product, Service, Equipment, Vendor, Returns
Geo-location/Geo-politicalGeography, Geospatial, Location, Site, Bldg, Address, Econ. Measure
People and OrganizationsParty, Privacy, Contract, Associate, Internal Organization, Contacts
LEGAL CASE MANAGEMENT
TRADE FUND MANAGEMENT
ACTIVITY-BASED COSTING
PARTY PREFERENCES
ACCOUNT BUDGETS
PLANOGRAM
UNSTRUCTURED DATA CAPTURE
New in LS-LDM
LS-LDM Content At-a-Glance
10 © 2016 Teradata© 2014 Teradata
LS-LDM Example Conceptual View
11 © 2016 Teradata
BRIDG Model
• BRIDG stands for the Biomedical Research Integrated Domain Group
• BRIDG is a collaborative effort among the following four organizations:
– CDISC (Clinical Data Interchange Standards Consortium)
– HL7 Regulated Clinical Research Information Management Work Group (HL7 RCRIM WG)
– National Cancer Institute (NCI), including the Cancer Biomedical Informatics Grid (caBIG®) project
– Food and Drug Administration (FDA)
• The goal of the BRIDG Project is to produce a shared view of protocol-driven research and regulatory information
• This includes a shared understanding of the clinical study, its conduct, events and results
12 © 2016 Teradata
BRIDG Model
• The BRIDG model is a comprehensive model for clinical study information
• Important domains in the BRIDG model include:
– Study Conduct
– Protocol Representation
– Regulatory
– Adverse Event
• A Statistical Analysis domain exists in the BRIDG model for the planning of these analyses and that is represented in the LSDM 3.0 in the PLAN and DOCUMENT subject areas
• The BRIDG model is an object model intended to be directly implemented as data structures and program code (classes) in an object oriented programming language
• LSDM 3.0 modeling includes drug, device, biologic, food, cosmetic and any other materials research, development, experiments, studies and manufacturing
All are represented in detail in the LS-LDM 3.0, 2.0 and 1.0
13 © 2016 Teradata
BRIDG Model – High-Level Illustration
class UML-Based Comprehensiv e BRIDG Model Diagram
Common Sub-Domain::Organization
+ actualIndicator: BL [1...1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ name: DSET<ON> [0..*]
+ postalAddress: AD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
+ typeCode: CD [0..1]
constraints
{Attribute Set actualIndicator Qualifier}
Common Sub-Domain::Person
+ educationLevelCode: CD [0..1]
+ ethnicGroupCode: DSET<CD> [0..*]
+ initials: ST [0..1]
+ maritalStatusCode: CD [0..1]
+ occupationDateRange: IVL<TS.DATE> [0..1]
+ postalAddress: AD [0..1]
+ primaryOccupationCode: CD [0..1]
+ raceCode: DSET<CD> [0..*]
+ telecomAddress: BAG<TEL> [0..*]
::BiologicEntity
+ actualIndicator: BL [1...1]
+ administrativeGenderCode: CD [0..1]
+ birthCountryCode: CD [0..1]
+ birthDate: TS.DATETIME [0..1]
+ birthOrder: INT.POS [0..1]
+ deathDate: TS.DATETIME [0..1]
+ deathDateEstimatedIndicator: BL [0..1]
+ deathIndicator: BL [0..1]
+ name: DSET<EN> [0..*]
constraints
{Attribute Set actualIndicator Qualifier}
::BiologicEntity
{ Attribute Set actualIndicator Qualifier }
{ functions as StudySubject Qualifier }
{ functions as PlannedStudySubject Qualifier }
Common Sub-Domain::HealthcareProv ider
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
+ postalAddress: AD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
Study Conduct
Sub-Domain::
Laboratory
+ identifier: II
[0..1]
Common Sub-Domain::HealthcareFacility
+ effectiveDateRange: IVL<TS.DATETIME>
[0..1]
+ identifier: II [0..1]
+ postalAddress: AD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
Study Conduct
Sub-Domain::
PerformingLaboratory
Study Conduct
Sub-Domain::
CollectingLaboratory
Study Conduct Sub-Domain::StudySite
+ dateRange: IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
+ leadIndicator: BL [0..1]
+ plannedDuration: PQ.TIME [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ targetAccrualNumberRange:
URG<INT.NONNEG> [0..1]
«DEPRECATED»
+ accrualStatusCode: CD [0..1]
+ accrualStatusDate: TS.DATETIME [0..1]
constraints
{be a function performed by Exclusive Or}
{execute Mandatory Qualifier}
{be overseen by actualIndicator Qualifier}
{be a function performed by actualIndicator
Qualifier}
Study Conduct Sub-Domain::
StudyInv estigator
+ identifier: II [0..1]
+ signatureText: ST [0..1]
::StudyPersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
{be a function performed by Qualifier}
::StudyPersonnel
{ be a function performed by Exclusive Or
}
Protocol Representation Sub-Domain::StudyProtocolVersion
+ accrualReportingMethodCode: CD [0..1]
+ acronym: ST [0..1]
+ adaptiveDesignIndicator: BL [0..1]
+ aeCodingSystem: OID [0..1]
+ amendmentGracePeriod: PQ.TIME [0..1]
+ companionCode: CD [0..1]
+ conditionCodingSystem: OID [0..1]
+ delayedRegistryPostingIndicator: BL [0..1]
+ designConfigurationCode: CD [0..1]
+ mandatoryIndicator: BL [0..1]
+ multiInstitutionIndicator: BL [0..1]
+ participatingLocationCode: DSET<CD> [0..*]
+ participatingOrganizationTypeCode: CD [0..1]
+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ phaseCode: CD [0..1]
+ plannedDuration: PQ.TIME [0..1]
+ plannedSiteNumberRange: URG<INT.POS> [0..1]
+ plannedStudySubjectExperience: ST [0..1]
+ populationDescription: ST [0..1]
+ primaryPurposeTypeCode: CD [0..1]
+ purposeStatement: ST [0..1]
+ responsiblePartyCode: CD [0..1]
+ studySchematic: ED [0..1]
+ studySubjectTypeCode: CD [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ targetAnatomicSiteCode: DSET<CD> [0..*]
+ therapeuticAreaCode: CD [0..1]
constraints
{be the responsibil ity of actualIndicator Qualifier}
Common Sub-Domain::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Declaration}
Study Conduct Sub-Domain::ScheduledActiv ity
+ dateRange: IVL<TS.DATETIME> [1...1]
+ idealDateRange: IVL<TS.DATETIME> [0..1]
+ repetitionNumber: INT.POS [0..1]
+ statusChangeReasonCode: CD [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by actualIndicator Qualifier}
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::PerformedActiv ity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by actualIndicator Qualifier}
{instantiates Exclusive Or}
{occurs in the context of Qualifier}
{be performed by actualIndicator Qualifier}
{dateRange Qualifier}
{containingEpoch Qualifier}
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedClinicalResult
+ asCollectedIndicator: BL [0..1]
+ biomarkerIndicator: BL [0..1]
+ /infectiousAgent: ST [0..1]
+ /normalRangeComparisonCode: CD [0..1]
+ statusCode: CD [0..1]
+ targetBiomarkerCode: CD [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{reference Qualifier}
Common Sub-Domain::Subject
constraints
{be a function performed by
Exclusive Or}
Common Sub-Domain::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
{Attribute Set actualIndicator Qualifier}
Common Sub-Domain::
ResourceProv ider
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
constraints
{be a function performed by
Exclusive Or}
«DEPRECATED»
Study Conduct Sub-Domain::
ConcomitantAgent
Study Conduct Sub-Domain::Specimen
+ accessionNumberText: ST.SIMPLE [0..1]
+ /conditionCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
Regulatory Sub-Domain::
RegulatoryApplicationSponsor
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
constraints
{be a function performed by Exclusive Or}
{be a function performed by actualIndicator
Qualifier}
Protocol Representation Sub-Domain::StudyAgent
+ blindedName: ST [0..1]
+ characteristicModifiedIndicator: BL [0..1]
+ expandedAccessIndicator: BL [0..1]
+ firstInHumanIndicator: BL [0..1]
+ firstInHumanRiskFactorCode: DSET<CD> [0..*]
+ functionCode: CD [0..1]
+ pediatricFormulationIndicator: BL [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ substitutionAllowedIndicator: BL [0..1]
Study Conduct Sub-Domain::PerformedAdministrativ eActiv ity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be performed at actualIndicator Qualifier}
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedSpecimenCollection
::PerformedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nonReasonCode: DSET<CD> [0..*]
+ targetAnatomicSiteCode: CD [0..1]
+ targetAnatomicSiteConditionCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedProcedure
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{results in actualIndicator Qualifier}
{be performed by (lab) actualIndicator Qualifier}
::PerformedProcedure
{ uses actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedSubstanceAdministration
+ /activeIngredientDose: PQ [0..1]
+ activeIngredientDoseDescription: ST [0..1]
+ changeReason: ST [0..1]
+ changeTypeCode: CD [0..1]
+ distinctProductCount: INT.POS [0..1]
+ doseFrequencyCode: CD [0..1]
+ dosePeriodCode: CD [0..1]
+ /endRelativeToReferenceCode: CD [0..1]
+ flowRate: RTO<PQ,PQ.TIME> [0..1]
+ interruptionDuration: PQ.TIME [0..1]
+ /periodActiveIngredientDoseTotal: PQ [0..1]
+ periodProductDoseTotal: PQ [0..1]
+ plannedChangeIndicator: BL [0..1]
+ productDose: PQ [0..1]
+ productDoseDescription: ST [0..1]
+ routeOfAdministrationCode: CD [0..1]
+ standardTimeIndicator: BL [0..1]
+ /startRelativeToReferenceCode: CD [0..1]
+ substanceUnknownIndicator: BL [0..1]
+ /treatmentVehicleQuantity: PQ [0..1]
::PerformedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nonReasonCode: DSET<CD> [0..*]
+ targetAnatomicSiteCode: CD [0..1]
+ targetAnatomicSiteConditionCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedProcedure
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
{relativeToReference Qualifier}
{Active Ingredient Qualifier}
{Dose Qualifier}
{substanceUnknownIndicator Qualifier}
::PerformedProcedure
{ uses actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Common Sub-Domain::StudySubject
+ confidentialityIndicator: BL [0..1]
+ paymentMethodCode: CD [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
constraints
{be a function performed by Not Applicable}
::Subject
{ be a function performed by Exclusive Or }
Common Sub-Domain::
Document
+ typeCode: CD [0..1]
Regulatory Sub-Domain::
SubmissionUnit
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ receiptDate: TS.DATETIME
[0..1]
+ typeCode: CD [1...1]
constraints
{be grouped into Exclusive Or}
Regulatory Sub-Domain::
RegulatoryApplication
+ identifier: II [0..1]
+ typeCode: CD [0..1]
Regulatory Sub-Domain::Submission
+ /receiptDate: TS.DATETIME [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ typeCode: CD [1...1]
constraints
{groups Exclusive Or}
{has as subject actualIndicator Qualifier}
Common Sub-Domain::
DocumentVersionRelationship
+ priorityNumber: REAL [0..1]
+ typeCode: CD [0..1]
Regulatory Sub-Domain::
Rev iewableUnit
+ typeCode: CD [1...1]
Study Conduct Sub-Domain::PerformedObserv ationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
+ targetAnatomicSiteLateralityCode: CD [0..1]
Common Sub-Domain::
Ov ersightCommittee
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ typeCode: CD [0..1]
Common Sub-Domain::
AssociatedBiologicEntity
+ typeCode: DSET<CD> [0..*]
constraints
{Performer Scoper Type Unique}
Study Conduct Sub-Domain::
PerformedClinicalInterpretation
+ /abnormalIndicator: BL [0..1]
+ /clinicallySignificantIndicator: BL
[0..1]
+ /severityCode: CD [0..1]
+ /toxicityGradeCode: CD [0..1]
+ toxicityTermCode: CD [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD>
[0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD
[0..1]
constraints
{Derived Attribute Exclusive Or}
Study Conduct Sub-Domain::PerformedStudyAgentTransfer
+ /originalQuantity: PQ [0..1]
+ quantity: PQ [0..1]
::PerformedAdministrativeActivity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{is a transfer of Qualifier}
{is a transfer of actualIndicator Qualifier}
{be authorized by actualIndicator Qualifier}
::PerformedAdministrativeActivity
{ be performed at actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
StudyResearchCoordinator
::StudyPersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
::StudyPersonnel
{ be a function performed by Exclusive
Or }
Study Conduct Sub-Domain::
PerformedProtocolDev iation
+ categoryCode: CD [0..1]
+ occurrenceDateRange: IVL<TS.DATETIME> [0..1]
+ severityCode: CD [0..1]
+ subcategoryCode: CD [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be authorized by actualIndicator Qualifier}
{be managed by actualIndicator Qualifier}
{be addressed by actualIndicator Qualifier}
Study Conduct Sub-Domain::
PerformedMedicalConditionResult
+ /clinicallySignificantIndicator: BL [0..1]
+ endRelativeToReferenceCode: CD [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ occurrenceDateRange: IVL<TS.DATETIME> [0..1]
+ occurrenceDateRangeValidationCode: CD [0..1]
+ severityCode: CD [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Protocol Representation
Sub-Domain::StudyObjectiv e
+ description: ST [0..1]
+ typeCode: CD [0..1]
Study Conduct Sub-Domain::PerformedObserv ation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be reported by actualIndicator Qualifier}
{be reported by Qualifier}
{be performed by (lab) actualIndicator Qualifier}
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::DefinedActiv ity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by actualIndicator Qualifier}
{Repeat Frequency Exclusive Or}
{Repeat Duration or Quantity Exclusive Or}
::Activity
{ be participated in by Declaration }
Common Sub-Domain::ResearchStaff
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
+ jobTitle: ST [0..1]
+ postalAddress: AD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
{Person-ResearchOrganization Pair Unique}
Common Sub-Domain::DocumentAuthor
constraints
{be a function performed by Qualifier}
{Study Author performed by Qualifier}
{be a function performed by Exclusive Or}
{Performer Document Pair Unique}
Study Conduct Sub-Domain::
PerformedStudySubjectMilestone
+ /informedConsentDate: TS.DATETIME [0..1]
+ /informedConsentIndicator: BL [0..1]
+ /offStudyDate: TS.DATETIME [0..1]
+ /offStudyReasonCode: DSET<CD> [0..*]
+ /registrationDate: TS.DATETIME [0..1]
+ /studyReferenceDateRange:
IVL<TS.DATETIME> [0..1]
::PerformedAdministrativeActivity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{Date Exclusive Or}
::PerformedAdministrativeActivity
{ be performed at actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedStudyAdministrativ eActiv ity
::PerformedAdministrativeActivity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Not Applicable}
::PerformedAdministrativeActivity
{ be performed at actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::PerformedDiagnosis
+ bodySystemCode: CD [0..1]
+ diseaseStatusCode: CD [0..1]
+ diseaseStatusMissingReasonCode: CD [0..1]
+ recurrenceIndicator: BL [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Study Conduct Sub-Domain::
PerformedLesionDescription
+ appearanceTypeCode: CD [0..1]
+ contactAnatomicSiteCode: CD [0..1]
+ /dimensionProduct: PQ [0..1]
+ lesionNumber: INT.NONNEG [0..1]
+ measurableIndicator: BL [0..1]
+ xDimension: PQ [0..1]
+ yDimension: PQ [0..1]
+ zDimension: PQ [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Study Conduct Sub-Domain::
PerformedHistopathology
+ differentiationGradeCode: DSET<CD> [0..*]
+ involvedSurgicalMarginIndicator: BL [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Common Sub-Domain::BiologicEntity
+ actualIndicator: BL [1...1]
+ administrativeGenderCode: CD [0..1]
+ birthCountryCode: CD [0..1]
+ birthDate: TS.DATETIME [0..1]
+ birthOrder: INT.POS [0..1]
+ deathDate: TS.DATETIME [0..1]
+ deathDateEstimatedIndicator: BL [0..1]
+ deathIndicator: BL [0..1]
+ name: DSET<EN> [0..*]
constraints
{Attribute Set actualIndicator Qualifier}
{functions as StudySubject Qualifier}
{functions as PlannedStudySubject
Qualifier}
Common Sub-Domain::BiologicEntityGroup
+ actualIndicator: BL [1...1]
+ name: TN [0..1]
+ quantity: INT.NONNEG [0..1]
+ typeCode: CD [0..1]
constraints
{Attribute Set actualIndicator Qualifier}
{contain actualIndicator Qualifier}
Common Sub-Domain::Animal
+ breedCode: CD [0..1]
+ description: ED [0..1]
+ reproductiveOrgansPresentIndicator: BL [0..1]
+ speciesCode: CD [0..1]
+ strain: ST [0..1]
::BiologicEntity
+ actualIndicator: BL [1...1]
+ administrativeGenderCode: CD [0..1]
+ birthCountryCode: CD [0..1]
+ birthDate: TS.DATETIME [0..1]
+ birthOrder: INT.POS [0..1]
+ deathDate: TS.DATETIME [0..1]
+ deathDateEstimatedIndicator: BL [0..1]
+ deathIndicator: BL [0..1]
+ name: DSET<EN> [0..*]
constraints
::BiologicEntity
{ Attribute Set actualIndicator Qualifier }
{ functions as StudySubject Qualifier }
{ functions as PlannedStudySubject Qualifier }
Study Conduct Sub-Domain::PerformedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nonReasonCode: DSET<CD> [0..*]
+ targetAnatomicSiteCode: CD [0..1]
+ targetAnatomicSiteConditionCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{uses actualIndicator Qualifier}
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Common Sub-Domain::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
{Distributor Qualifier}
{Processor Qualifier}
{ProcessingSite Qualifier}
{Attribute Set actualIndicator Qualifier}
::Material
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::Package
+ capacityQuantity: PQ [0..1]
+ capTypeCode: CD [0..1]
+ handlingCode: CD [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::Dev ice
+ /age: PQ.TIME [0..1]
+ availableForEvaluationIndicator: BL [0..1]
+ ceMarkIndicator: BL [0..1]
+ handlingCode: CD [0..1]
+ manufactureDate: TS.DATETIME [0..1]
+ overTheCounterProductIndicator: BL [0..1]
+ reprocessedDeviceCode: CD [0..1]
+ returnedToReprocessorDate: TS.DATETIME [0..1]
+ riskCode: CD [0..1]
+ singleUseDeviceIndicator: BL [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
{Attribute Set actualIndicator Qualifier}
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::Drug
+ actionModeCode: CD [0..1]
+ handlingCode: CD [0..1]
+ riskCode: CD [0..1]
+ stabilityDuration: IVL<TS.DATETIME> [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::Biologic
+ handlingCode: CD [0..1]
+ riskCode: CD [0..1]
+ stabilityDuration: IVL<TS.DATETIME> [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ formCode: CD [0..1]
constraints
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::FoodProduct
+ stabilityDuration: IVL<TS.DATETIME> [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME>
[0..1]
+ formCode: CD [0..1]
constraints
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Common Sub-Domain::Cosmetic
+ stabilityDuration: IVL<TS.DATETIME> [0..1]
::Product
+ classCode: DSET<CD> [0..*]
+ codeModifiedText: ST [0..1]
+ expirationDate: TS.DATE.FULL [0..1]
+ lotNumberText: ST.SIMPLE [0..1]
+ pre1938Indicator: BL [0..1]
+ typeCode: CD [0..1]
::Material
+ actualIndicator: BL [1...1]
+ code: CD [0..1]
+ description: ST [0..1]
+ effectiveDateRange: IVL<TS.DATETIME>
[0..1]
+ formCode: CD [0..1]
constraints
::Product
{ Distributor Qualifier }
{ Processor Qualifier }
{ ProcessingSite Qualifier }
{ Attribute Set actualIndicator Qualifier }
Regulatory Sub-Domain::RegulatoryAssessment
+ completionDate: TS.DATETIME [0..1]
+ expectedResubmissionDate: TS.DATETIME [0..1]
+ identifier: DSET<II> [0..*]
+ reasonCode: CD [0..1]
+ resultCode: CD [1...1]
+ statusCode: CD [0..1]
+ typeCode: CD [0..1]
constraints
{is a function performed by actualIndicator Qualifier}
Common Sub-Domain::Processor
Common Sub-Domain::
ProcessingSite
Regulatory Sub-Domain::RegulatoryAuthority
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ jurisdictionAuthorityCode: CD [0..1]
Adv erse Ev ent Sub-Domain::
PerformedProductInv estigation
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
{is triggered by Exclusive Or}
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Adv erse Ev ent Sub-Domain::
PerformedProductProblemDiscov ery
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Study Conduct Sub-Domain::PerformedEligibilityCriterion
+ notApplicableIndicator: BL [0..1]
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ displayOrder: INT.NONNEG [0..1]
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedInclusionCriterion
::PerformedEligibil ityCriterion
+ notApplicableIndicator: BL [0..1]
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedEligibil ityCriterion
+ displayOrder: INT.NONNEG [0..1]
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
::PerformedEligibil ityCriterion
{ be participated in by Qualifier }
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedExclusionCriterion
::PerformedEligibil ityCriterion
+ notApplicableIndicator: BL [0..1]
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedEligibil ityCriterion
+ displayOrder: INT.NONNEG [0..1]
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
::PerformedEligibil ityCriterion
{ be participated in by Qualifier }
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Adv erse Ev ent Sub-Domain::Adv erseEv ent
+ categoryCode: CD [0..1]
+ /endRelativeToReferenceCode: CD [0..1]
+ expectedIndicator: BL [0..1]
+ /gradeCode: CD [0..1]
+ highlightedIndicator: BL [0..1]
+ hospitalizationRequiredIndicator: BL [0..1]
+ locationDescription: ST [0..1]
+ occurrenceDateRange: IVL<TS.DATETIME> [0..1]
+ occurrencePatternCode: CD [0..1]
+ postReportUpdateDate: TS.DATETIME [0..1]
+ /severityCode: CD [0..1]
+ subcategoryCode: CD [0..1]
+ summary: ST [0..1]
+ treatmentEmergentIndicator: BL [0..1]
+ unexpectedReasonCode: DSET<CD> [0..*]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Adv erse Ev ent Sub-Domain::
Ev aluatedResultRelationship
+ probabilityCode: CD [0..1]
+ probabilityPercent: REAL [0..1]
+ uncertaintyCode: CD [0..1]
Adv erse Ev ent Sub-Domain::
Ev aluatedActiv ityRelationship
+ probabilityCode: CD [0..1]
+ probabilityPercent: REAL [0..1]
+ uncertaintyCode: CD [0..1]
Study Conduct Sub-Domain::
AssessedResultRelationship
+ typeCode: CD [0..1]
Adv erse Ev ent Sub-Domain::
PerformedProductInv estigationResult
+ conclusion: ST [0..1]
+ defectTypeCode: CD [0..1]
+ deviceMalfunctionCode: CD [0..1]
+ evaluationConclusionCode: CD [0..1]
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Common Sub-Domain::ReportReceiv er
+ receivedDate: TS.DATETIME [0..1]
+ receivedIndicator: BL [0..1]
constraints
{be a function performed by Exclusive Or}
Adverse Event Sub-Domain
Common Sub-Domain
Protocol Representation Sub-Domain
Regulatory Sub-Domain
Statistical Analysis Sub-Domain
Study Conduct Sub-Domain
Legend
Common Sub-Domain::ReportVersion
+ communicationModeCode: CD [0..1]
+ dueDate: TS.DATETIME [0..1]
+ physicianSignOffIndicator: BL [0..1]
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
::DocumentVersion
{ language Qualifier }
Adv erse Ev ent Sub-Domain::
SafetyReportVersion
+ nullificationIndicator: BL [0..1]
+ nullificationReasonCode: CD [0..1]
+ subtypeCode: CD [0..1]
::ReportVersion
+ communicationModeCode: CD [0..1]
+ dueDate: TS.DATETIME [0..1]
+ physicianSignOffIndicator: BL [0..1]
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
{describes Exclusive Or}
::DocumentVersion
{ language Qualifier }
Protocol Representation Sub-Domain::Arm
+ description: ST [0..1]
+ name: ST [0..1]
+ randomizationWeight:
RTO<INT.NONNEG,INT.POS> [0..1]
+ targetAccrualNumberRange:
URG<INT.NONNEG> [0..1]
+ typeCode: CD [0..1]
constraints
{name Unique}
{Mandatory Attribute Qualifier}
{armType Qualifier}
Protocol Representation Sub-Domain::Epoch
+ description: ST [0..1]
+ name: ST [0..1]
+ sequenceNumber: INT.NONNEG [0..1]
+ /targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ typeCode: CD [0..1]
constraints
{name Unique}
{Mandatory Attribute Qualifier}
Common Sub-Domain::Place
+ identifier: DSET<II> [0..*]
+ identifierCode: CD [0..1]
+ name: TN [0..1]
+ physicalAddress: AD [0..1]
+ typeCode: CD [0..1]
constraints
{physicalAddress Qualifier}
Common Sub-Domain::
OrganizationalContact
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: BAG<AD> [0..*]
+ primaryIndicator: BL [0..1]
+ telecomAddress: BAG<TEL> [0..*]
+ title: ST [0..1]
+ typeCode: DSET<CD> [0..*]
constraints
{be a function performed by
actualIndicator Qualifier}
{handles communication for
actualIndicator Qualifier}
Common Sub-Domain::
Administrativ eMemberCRA
Common Sub-Domain::
Administrativ eMemberPI
Common Sub-Domain::
Cooperativ eGroup
Common Sub-Domain::
Cooperativ eGroupMember
Common Sub-Domain::
ResearchOrganization
+ effectiveDateRange:
IVL<TS.DATETIME>
[0..1]
+ typeCode: CD [0..1]
Common Sub-Domain::TreatingSite
constraints
{be a member of Exclusive Or}
Common Sub-Domain::
DistributorCommon Sub-Domain::OrganizationRelationship
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
+ typeCode: CD [0..1]
Common Sub-Domain::
HealthcareProv iderGroup
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
Common Sub-Domain::
HealthcareProv iderGroupMember
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
Protocol Representation Sub-Domain::
RandomizationBookEntry
+ positionFilledIndicator: BL [0..1]
+ positionNumber: INT.NONNEG [1...1]
Protocol Representation Sub-Domain::
StratumGroup
+ description: ST [0..1]
+ groupNumber: INT.NONNEG [0..1]
Common Sub-Domain::
BiologicEntityIdentifier
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ identifier: II [1...1]
+ missingIdentifierReasonCode: CD [0..1]
+ typeCode: CD [0..1]
constraints
{identifies actualIndicator Qualifier}
{is assigned by actualIndicator Qualifier}
Common Sub-Domain::DocumentIdentifier
+ identifier: II [1...1]
+ primaryIndicator: BL [0..1]
+ typeCode: CD [0..1]
constraints
{be assigned by Exclusive Or}
{be assigned by actualIndicator Qualifier}
View Description:
This View shows the complete BRIDG Model (current Release)
and specifically shows, for each class where it's applicable, the
complete set of attributes for the class, partitioning the
attributes as to whether they are "local" to the class or inherited
from the class' super-type hierarchy.
Study Conduct Sub-Domain::
StudyOv erallStatus
+ anticipatedIndicator: BL [0..1]
+ code: CD [0..1]
+ comment: ST [0..1]
+ date: TS.DATETIME [0..1]
+ studyStoppedReasonCode: CD [0..1]
Study Conduct Sub-Domain::
StudyRecruitmentStatus
+ code: CD [0..1]
+ date: TS.DATETIME [0..1]
Common Sub-Domain::
DocumentVersionWorkflowStatus
+ code: CD [0..1]
+ comment: ST [0..1]
+ date: TS.DATE.FULL [0..1]
Protocol Representation Sub-Domain:
:StudyOutcomeMeasure
+ description: ST [0..1]
+ name: ST [0..1]
+ primaryIndicator: BL [0..1]
+ timeFrameText: ST [0..1]
+ typeCode: DSET<CD> [0..*]
constraints
{Mandatory Attribute Qualifier}
Common Sub-Domain::
StudyRegistry
+ acronym: ST [0..1]
+ name: ST [0..1]
Protocol Representation Sub-Domain::
StudyReference
+ citationDescription: ST [0..1]
+ linkPageDescription: ST [0..1]
+ publicationIdentifier: II [0..1]
+ publicationName: ST [0..1]
+ uniformResourceLocator: TEL.URL [0..1]
constraints
{Mandatory Attribute Qualifier}
Study Conduct Sub-Domain::Resource
+ activeIndicator: BL [0..1]
Study Conduct Sub-Domain::
Gov ernmentFunding
+ fundingCategoryCode: CD [0..1]
+ fundingMechanismCode: CD [0..1]
+ nciProgramCode: CD [0..1]
+ nihInstituteCode: CD [0..1]
+ serialNumberText: ST.SIMPLE [0..1]
+ typeCode: CD [0..1]
::Resource
+ activeIndicator: BL [0..1]
Protocol Representation
Sub-Domain::StudyLegalSponsor
+ primaryIndicator: BL [0..1]
constraints
{be a function performed by
Exclusive Or}
Study Conduct Sub-Domain::
MaterialResource
::Resource
+ activeIndicator: BL [0..1]
Study Conduct Sub-Domain::
StudyPersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
{be a function performed by Exclusive Or}
Study Conduct Sub-Domain::
StudySitePersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
{be a function performed by Exclusive
Or}
Study Conduct Sub-Domain::
StudySiteInv estigator
+ identifier: II [0..1]
::StudySitePersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
{be a function performed by Qualifier}
::StudySitePersonnel
{ be a function performed by Exclusive
Or }
Protocol Representation Sub-Domain::
Interv entionalStudyProtocolVersion
+ acceptsHealthyVolunteersIndicator: BL [0..1]
+ allocationCode: CD [0..1]
+ blindedRoleCode: DSET<CD> [0..*]
+ blindingSchemaCode: CD [0..1]
+ controlConcurrencyTypeCode: CD [0..1]
+ controlTypeCode: CD [0..1]
+ /dataMonitoringCommitteeIndicator: BL [0..1]
+ interventionDescription: ST [0..1]
+ interventionGroupQuantity: INT.NONNEG [0..1]
+ interventionTypeCode: CD [0..1]
+ studyAgentRandomizationFraction: REAL [0..1]
::StudyProtocolVersion
+ accrualReportingMethodCode: CD [0..1]
+ acronym: ST [0..1]
+ adaptiveDesignIndicator: BL [0..1]
+ aeCodingSystem: OID [0..1]
+ amendmentGracePeriod: PQ.TIME [0..1]
+ companionCode: CD [0..1]
+ conditionCodingSystem: OID [0..1]
+ delayedRegistryPostingIndicator: BL [0..1]
+ designConfigurationCode: CD [0..1]
+ mandatoryIndicator: BL [0..1]
+ multiInstitutionIndicator: BL [0..1]
+ participatingLocationCode: DSET<CD> [0..*]
+ participatingOrganizationTypeCode: CD [0..1]
+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME>
[0..1]
+ phaseCode: CD [0..1]
+ plannedDuration: PQ.TIME [0..1]
+ plannedSiteNumberRange: URG<INT.POS> [0..1]
+ plannedStudySubjectExperience: ST [0..1]
+ populationDescription: ST [0..1]
+ primaryPurposeTypeCode: CD [0..1]
+ purposeStatement: ST [0..1]
+ responsiblePartyCode: CD [0..1]
+ studySchematic: ED [0..1]
+ studySubjectTypeCode: CD [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ targetAnatomicSiteCode: DSET<CD> [0..*]
+ therapeuticAreaCode: CD [0..1]
constraints
{blindedRoleCode Qualifier}
{dataMonitoringCommitteeIndicator Qualifier}
::StudyProtocolVersion
{ be the responsibil ity of actualIndicator Qualifier }
Protocol Representation Sub-Domain::Observ ationalStudyProtocolVersion
+ samplingMethodCode: CD [0..1]
+ specimenAvailableForDNAExtractionIndicator: BL [0..1]
+ specimenRetentionIndicator: BL [0..1]
+ timePerspectiveCode: CD [0..1]
::StudyProtocolVersion
+ accrualReportingMethodCode: CD [0..1]
+ acronym: ST [0..1]
+ adaptiveDesignIndicator: BL [0..1]
+ aeCodingSystem: OID [0..1]
+ amendmentGracePeriod: PQ.TIME [0..1]
+ companionCode: CD [0..1]
+ conditionCodingSystem: OID [0..1]
+ delayedRegistryPostingIndicator: BL [0..1]
+ designConfigurationCode: CD [0..1]
+ mandatoryIndicator: BL [0..1]
+ multiInstitutionIndicator: BL [0..1]
+ participatingLocationCode: DSET<CD> [0..*]
+ participatingOrganizationTypeCode: CD [0..1]
+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ phaseCode: CD [0..1]
+ plannedDuration: PQ.TIME [0..1]
+ plannedSiteNumberRange: URG<INT.POS> [0..1]
+ plannedStudySubjectExperience: ST [0..1]
+ populationDescription: ST [0..1]
+ primaryPurposeTypeCode: CD [0..1]
+ purposeStatement: ST [0..1]
+ responsiblePartyCode: CD [0..1]
+ studySchematic: ED [0..1]
+ studySubjectTypeCode: CD [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ targetAnatomicSiteCode: DSET<CD> [0..*]
+ therapeuticAreaCode: CD [0..1]
constraints
::StudyProtocolVersion
{ be the responsibil ity of actualIndicator Qualifier }
«DEPRECATED»
Protocol Representation Sub-Domain::ExpandedAccessStudyProtocolVersion
::StudyProtocolVersion
+ accrualReportingMethodCode: CD [0..1]
+ acronym: ST [0..1]
+ adaptiveDesignIndicator: BL [0..1]
+ aeCodingSystem: OID [0..1]
+ amendmentGracePeriod: PQ.TIME [0..1]
+ companionCode: CD [0..1]
+ conditionCodingSystem: OID [0..1]
+ delayedRegistryPostingIndicator: BL [0..1]
+ designConfigurationCode: CD [0..1]
+ mandatoryIndicator: BL [0..1]
+ multiInstitutionIndicator: BL [0..1]
+ participatingLocationCode: DSET<CD> [0..*]
+ participatingOrganizationTypeCode: CD [0..1]
+ periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ phaseCode: CD [0..1]
+ plannedDuration: PQ.TIME [0..1]
+ plannedSiteNumberRange: URG<INT.POS> [0..1]
+ plannedStudySubjectExperience: ST [0..1]
+ populationDescription: ST [0..1]
+ primaryPurposeTypeCode: CD [0..1]
+ purposeStatement: ST [0..1]
+ responsiblePartyCode: CD [0..1]
+ studySchematic: ED [0..1]
+ studySubjectTypeCode: CD [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ targetAnatomicSiteCode: DSET<CD> [0..*]
+ therapeuticAreaCode: CD [0..1]
«DEPRECATED»
+ interventionDescription: ST [0..1]
constraints
::StudyProtocolVersion
{ be the responsibil ity of actualIndicator Qualifier }
NOTE: Until further clarification, the
BRIDG SCC believes the IND/IDE
regulatory application serial number is the
number assigned by the applicant/sponsor
to a document that is either a supplement
or an amendment to the original
submission unit and is represented using
DocumentIdentifier.identifer.
Common Sub-Domain::Ov ersightAuthority
Study Conduct Sub-Domain::
StudyOv ersightAuthority
constraints
{oversee Mandatory Qualifier}
Study Conduct Sub-Domain::StudySiteOv ersightStatus
+ reviewBoardApprovalNumberText: ST.SIMPLE
[0..1]
+ reviewBoardProcessCode: CD [0..1]
+ reviewBoardProcessDate: TS.DATETIME [0..1]
constraints
{be assigned by actualIndicator Qualifier}
Common Sub-Domain::
QualifiedPerson
+ certificateLicenseText:
ST [0..1]
+ effectiveDateRange:
IVL<TS.DATETIME>
[0..1]
+ identifier: II [0..1]
+ typeCode: CD [0..1]
constraints
{Mandatory Attribute
Qualifier}
Common Sub-Domain::ExperimentalUnit
+ identifier: DSET<II> [0..*]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subgroupCode: CD [0..1]
constraints
{be a function performed by Exclusive Or}
Common Sub-Domain::ProductGroup
+ actualIndicator: BL [1...1]
+ identifier: II [0..1]
+ quantity: INT.NONNEG [0..1]
constraints
{Attribute Set actualIndicator Qualifier}
Common Sub-Domain::
Performer
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
+ postalAddress: AD [0..1]
+ telecomAddress:
BAG<TEL> [0..*]
+ typeCode: CD [0..1]
constraints
{be a function performed by
Exclusive Or}
Protocol Representation Sub-Domain::DefinedObserv ation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Common Sub-Domain::BiologicEntityPart
+ anatomicSiteCode: CD [0..1]
+ quantityRange: URG<INT.POS> [0..1]
«DEPRECATED»
+ anatomicSiteLateralityCode: CD [0..1]
constraints
{quantity actualIndicator Qualifier}
Study Conduct Sub-Domain::
ReferenceResult
+ comment: ST [0..1]
+ fastingStatusIndicator: BL [0..1]
+ populationScopeCode: CD [0..1]
+ referenceTypeCode: CD [1...1]
+ targetAnatomicSiteCode: CD [0..1]
+ value: ANY [1...1]
+ valueTypeCode: CD [0..1]
«DEPRECATED»
+ targetAnatomicSiteLateralityCode:
CD [0..1]
constraints
{apply to results produced by
actualIndicator Qualifier}
Adv erse Ev ent Sub-Domain::CausalAssessment
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Adv erse Ev ent Sub-Domain::
Adv erseEv entOutcomeResult
::PerformedObservationResult
+ baselineIndicator: BL [0..1]
+ comment: ST [0..1]
+ confidentialityCode: CD [0..1]
+ identifier: II [0..1]
+ reportedDate: TS.DATETIME [0..1]
+ resultClassificationCode: DSET<CD> [0..*]
+ typeCode: CD [0..1]
+ uncertaintyCode: CD [0..1]
+ value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+ valueNullFlavorReason: ST [0..1]
«DEPRECATED»
::PerformedObservationResult
+ targetAnatomicSiteLateralityCode: CD [0..1]
Study Conduct Sub-Domain::StudyResource
+ effectiveDateRange: IVL<TS.DATETIME>
[0..1]
+ inactiveComment: ST [0..1]
+ primaryIndicator: BL [0..1]
Study Conduct Sub-Domain::
Funding
::Resource
+ activeIndicator: BL [0..1]
Study Conduct Sub-Domain::
Serv ice
+ typeCode: CD [0..1]
::Resource
+ activeIndicator: BL [0..1]
Adv erse Ev ent Sub-Domain::Adv erseEv entOutcomeAssessment
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedAdministrativ eActiv ity
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::PerformedImaging
+ contrastAgentEnhancementIndicator: BL [0..1]
+ enhancementDescription: ST [0..1]
+ enhancementRate: RTO<PQ,PQ.TIME> [0..1]
::PerformedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ bodySystemCode: CD [0..1]
+ /focalDateRange: IVL<TS.DATETIME> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedObservation
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::PerformedObservation
{ be reported by Qualifier }
{ be reported by actualIndicator Qualifier }
{ be performed by (lab) actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
StudyActiv ity
+ studyFocusIndicator: BL [0..1]
Protocol Representation Sub-Domain::DefinedObserv ationResult
+ confidentialityCode: CD [0..1]
+ derivationExpression: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
+ targetCodingSystem: OID [0..1]
+ typeCode: CD [0..1]
+ value: ANY [0..1]
+ valueNegationIndicator: BL [0..1]
«DEPRECATED»
+ comment: ST [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
Protocol Representation Sub-Domain::
DefinedStudySubjectMilestone
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedStudyAdministrativ eActiv ity
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Not Applicable}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedExperimentalUnitAllocation
+ methodCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange:
URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{Repeat Not Applicable}
::DefinedActivity
{ be participated in by actualIndicator
Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or
}
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedMaterialStorage
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedStudyAgentTransfer
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{is a transfer of actualIndicator Qualifier}
{is a transfer of Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::DefinedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nameCodeModifiedText: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{use actualIndicator Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::DefinedSubstanceAdministration
+ doseFrequencyCode: CD [0..1]
+ dosePeriodCode: CD [0..1]
+ doseRegimen: ST [0..1]
+ flowRate: RTO<PQ,PQ.TIME> [0..1]
+ periodProductDoseTotal: EXPR<PQ> [0..1]
+ productDose: EXPR<PQ> [0..1]
+ routeOfAdministrationCode: CD [0..1]
::DefinedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nameCodeModifiedText: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedProcedure
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
{Dose Qualifier}
{Dose Expression Qualifier}
::DefinedProcedure
{ use actualIndicator Qualifier }
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedSpecimenCollection
::DefinedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nameCodeModifiedText: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedProcedure
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{results in actualIndicator Qualifier}
::DefinedProcedure
{ use actualIndicator Qualifier }
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::DefinedEligibilityCriterion
::DefinedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ requiredResponse: ANY [0..1]
::DefinedObservation
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedStratificationCriterion
::DefinedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME>
[0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedObservation
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
{Permissible Result Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::DefinedImaging
+ contrastAgentEnhancementIndicator: BL [0..1]
+ enhancementDescription: ST [0..1]
+ enhancementRate: RTO<PQ,PQ.TIME> [0..1]
::DefinedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>>
[0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedObservation
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{be participated in by Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedExclusionCriterion
::DefinedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedEligibil ityCriterion
+ requiredResponse: ANY [0..1]
::DefinedObservation
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
::DefinedEligibil ityCriterion
{ be participated in by Qualifier }
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedInclusionCriterion
::DefinedObservation
+ approachAnatomicSiteCode: CD [0..1]
+ bodyPositionCode: CD [0..1]
+ focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
+ /focalDuration: PQ.TIME [0..1]
+ methodCode: CD [0..1]
+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME>
[0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedEligibil ityCriterion
+ requiredResponse: ANY [0..1]
::DefinedObservation
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
::DefinedEligibil ityCriterion
{ be participated in by Qualifier }
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedCompositionRelationship
+ joinCode: CD [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ sequenceNumber: INT.NONNEG [0..1]
Protocol Representation Sub-Domain::
DefinedOptionRelationship
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
Protocol Representation Sub-Domain::
DefinedContingentOnRelationship
+ checkpointCode: CD [0..1]
+ completionRequiredBeforeStartingIndicator: BL [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
constraints
{completionRequiredIndicator Qualifier}
{be contingent upon Exclusive Or}
Protocol Representation Sub-Domain::
DefinedRepeatActiv ityUntilRule
+ cessationPauseQuantityRange:
URG<PQ.TIME> [0..1]
+ checkpointCode: CD [0..1]
+ priorityNumber: REAL [0..1]
constraints
{be repeated until Exclusive Or}
Protocol Representation Sub-Domain::DefinedCriterionGroup
Protocol Representation Sub-Domain::
DefinedCriterionGroupCompositionRelationship
+ joinCode: CD [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ sequenceNumber: INT.NONNEG [0..1]
constraints
{is the component of Exclusive Or}
Protocol Representation Sub-Domain::
DefinedCriterionGroupOptionRelationship
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
constraints
{be the choice that has as option Exclusive Or}
Protocol Representation Sub-Domain::PlannedActiv ity
+ agentAdministrationCareSettingTypeCode: CD [0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
+ purpose: ST [0..1]
constraints
{Repeat Frequency Exclusive Or}
{Repeat Duration or Quantity Exclusive Or}
{be participated in by actualIndicator Qualifier}
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
PlannedCompositionRelationship
+ joinCode: CD [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ sequenceNumber: INT.NONNEG [0..1]
Protocol Representation Sub-Domain::
PlannedContingentOnRelationship
+ checkpointCode: CD [0..1]
+ completionRequiredBeforeStartingIndicator: BL [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
constraints
{be contingent upon Exclusive Or}
{completionRequiredIndicator Qualifier}
Protocol Representation Sub-Domain::PlannedCriterionGroup
Protocol Representation Sub-Domain::
PlannedCriterionGroupCompositionRelationship
+ joinCode: CD [0..1]
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ sequenceNumber: INT.NONNEG [0..1]
constraints
{be the parent of Exclusive Or}
Protocol Representation Sub-Domain::
PlannedCriterionGroupOptionRelationship
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
constraints
{is a choice that has as option Exclusive Or}
Protocol Representation Sub-Domain::
PlannedOptionRelationship
+ pauseQuantityRange: URG<PQ.TIME> [0..1]
+ priorityNumber: REAL [0..1]
Protocol Representation Sub-Domain::
PlannedRandomizationBookAllocation
::PlannedActivity
+ agentAdministrationCareSettingTypeCode: CD [0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
{DefinedActivity Qualifier}
{Repeat Not Applicable}
{be participated in by Qualifier}
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
PlannedRepeatActiv ityUntilRule
+ cessationPauseQuantityRange:
URG<PQ.TIME> [0..1]
+ checkpointCode: CD [0..1]
+ priorityNumber: REAL [0..1]
constraints
{be repeated until Exclusive Or}
Study Conduct Sub-Domain::
ReferenceToStudyResults
+ citationDescription: ST [0..1]
+ linkPageDescription: ST [0..1]
+ publicationIdentifier: II [0..1]
+ publicationName: ST [0..1]
+ uniformResourceLocator:
TEL.URL [0..1]
Protocol Representation
Sub-Domain::
StudyProtocolDocument
::Document
+ typeCode: CD [0..1]
Protocol Representation Sub-Domain::
DefinedStratificationCriterionPermissibleResult
::DefinedObservationResult
+ confidentialityCode: CD [0..1]
+ derivationExpression: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
+ targetCodingSystem: OID [0..1]
+ typeCode: CD [0..1]
+ value: ANY [0..1]
+ valueNegationIndicator: BL [0..1]
«DEPRECATED»
::DefinedObservationResult
+ comment: ST [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{Association Cardinality Qualifier}
Common Sub-Domain::ProductRelationship
+ activeIngredientIndicator: BL [0..1]
+ confidentialityCode: DSET<CD> [0..*]
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ identifier: II [0..1]
+ quantity: RTO<PQ,PQ> [0..1]
+ typeCode: CD [0..1]
constraints
{identifier Qualifier}
Study Conduct Sub-Domain::
StudySiteResearchCoordinator
::StudySitePersonnel
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ postalAddress: AD [0..1]
+ primaryIndicator: BL [0..1]
+ roleCode: CD [0..1]
+ telecomAddress: BAG<TEL> [0..*]
constraints
::StudySitePersonnel
{ be a function performed by
Exclusive Or }
Common Sub-Domain::SubjectIdentifier
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
+ identifier: II [1...1]
+ primaryIndicator: BL [0..1]
+ typeCode: CD [0..1]
constraints
{be assigned by Exclusive Or}
{be assigned by actualIndicator Qualifier}
{identifies actualIndicator Qualifier}
Study Conduct Sub-Domain::
RegistrationCenter
+ telecomAddress: TEL [0..1]
::Service
+ typeCode: CD [0..1]
::Resource
+ activeIndicator: BL [0..1]
Study Conduct Sub-Domain::Assessor
constraints
{be a function performed by Exclusive Or}
Protocol Representation Sub-Domain::
DefinedSubjectActiv ityGroup
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Common Sub-Domain::
OrganizationIdentifier
+ identifier: II [1...1]
+ primaryIndicator: BL [0..1]
+ typeCode: CD [0..1]
constraints
{be assigned by Exclusive Or}
{identifies actualIndicator
Qualifier}
{be assigned by actualIndicator
Qualifier}
Common Sub-Domain::NotificationReceiv er
constraints
{be a function performed by Exclusive Or}
Protocol Representation Sub-Domain::
DefinedNotification
+ deliveryMechanismCode: CD [0..1]
+ message: ST [0..1]
+ messageTitle: ST [0..1]
::DefinedActivity
+ categoryCode: CD [0..1]
+ description: ST [0..1]
+ nameCode: CD [1...1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ subcategoryCode: CD [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{be received by actualIndicator Qualifier}
::DefinedActivity
{ be participated in by actualIndicator Qualifier }
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
PerformedNotification
+ message: ST [0..1]
+ messageTitle: ST [0..1]
::PerformedAdministrativeActivity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{be received by actualIndicator Qualifier}
::PerformedAdministrativeActivity
{ be performed at actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator
Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation
Sub-Domain::StudyCondition
+ code: CD [1...1]
+ leadIndicator: BL [0..1]
Protocol Representation Sub-Domain::
CompanionStudyRelationship
+ registrationRequiredIndicator: BL [0..1]
Protocol Representation Sub-Domain::
PlannedNotification
+ studyAccrualThresholdPercent: INT.POS [0..1]
+ studySiteAccrualThresholdPercent: INT.POS [0..1]
::PlannedActivity
+ agentAdministrationCareSettingTypeCode: CD [0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
{Accrual Threshold Percent Exclusive Or}
{be participated in by Qualifier}
{be received by actualIndicator Qualifier}
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Common Sub-Domain::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
{language Qualifier}
Protocol Representation Sub-Domain::
StudyProtocolDocumentVersion
+ publicDescription: ST [0..1]
+ publicTitle: ST [0..1]
+ scientificDescription: ST [0..1]
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
{is a version of Qualifier}
{DocumentAuthor actualIndicator Qualifier}
::DocumentVersion
{ language Qualifier }
Protocol Representation Sub-Domain::
StudyProtocol
Protocol Representation
Sub-Domain::PlannedStudySite
+ duration: PQ.TIME [0..1]
+ leadIndicator: BL [0..1]
constraints
{be a function planned to be
performed by Exclusive Or}
Study Conduct Sub-Domain::StudyExecution
+ /effectiveDateRange: IVL<TS.DATE.FULL> [0..1]
+ /enrolledStudySubjectNumber: INT.POS [0..1]
constraints
{be overseen by actualIndicator Qualifier}
{use actualIndicator Qualifier}
Study Conduct Sub-Domain::
StudySiteProtocolVersionRelationship
+ effectiveDateRange: IVL<TS.DATETIME> [0..1]
Study Conduct Sub-Domain::
StudySubjectProtocolVersionRelationship
+ effectiveDateRange:
IVL<TS.DATETIME> [0..1]
Protocol Representation Sub-Domain::
AmendmentChangeSummaryVersion
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL
[0..1]
constraints
::DocumentVersion
{ language Qualifier }
Common Sub-Domain::
SystemOfRecord
+ name: ST [1...1]
Common Sub-Domain::
MaterialName
+ name: TN [0..1]
+ typeCode: CD [0..1]
Common Sub-Domain::
Manufacturer
Common Sub-Domain::
Reprocessor
Common Sub-Domain::
MaterialIdentifier
+ identifier: II [1...1]
+ typeCode: CD [0..1]
constraints
{be assigned by
actualIndicator Qualifier}
Adv erse Ev ent Sub-Domain::
Adv erseEv entSeriousness
+ code: CD [0..1]
+ date: TS.DATETIME [0..1]
Common Sub-Domain::
ReportSubmitter
Study Conduct Sub-Domain::
ScheduledNotification
+ message: ST [0..1]
+ messageTitle: ST [0..1]
::ScheduledActivity
+ dateRange: IVL<TS.DATETIME> [1...1]
+ idealDateRange: IVL<TS.DATETIME> [0..1]
+ repetitionNumber: INT.POS [0..1]
+ statusChangeReasonCode: CD [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{be received by actualIndicator Qualifier}
::ScheduledActivity
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
NOTE: BRIDG SCC acknowledges that there are two ways to represent the
relationship between a study protocol and a document that is cited by the
study protocol: 1) use the StudyProtocolVersion to StudyReference
association; 2) use the StudyProtocolVersion >
StudyProtocolDocumentVersion > DocumentVersionRelationship
associations. The first is more direct and uses domain terminology, while
the second is more consistent with other document-to-document
associations. The SCC hopes to clarify this ambiguity in a future release
when a project dealing with publications or a related area comes to
harmonization.
Protocol Representation Sub-Domain::
PlannedSubjectActiv ityGroup
+ /sequenceNumber: INT.NONNEG [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
::PlannedActivity
+ agentAdministrationCareSettingTypeCode: CD [0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
{be participated in by Qualifier}
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
ScheduledSubstanceAdministration
+ activeIngredientDose: PQ [0..1]
::ScheduledActivity
+ dateRange: IVL<TS.DATETIME> [1...1]
+ idealDateRange: IVL<TS.DATETIME> [0..1]
+ repetitionNumber: INT.POS [0..1]
+ statusChangeReasonCode: CD [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{activeIngredientDose Qualifier}
::ScheduledActivity
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedExpressionVariableRelationship
+ localVariableName: ST.SIMPLE
[1...1]
Protocol Representation Sub-Domain::
DefinedAdv erseEv ent
+ categoryCode: CD [0..1]
+ severityCode: CD [0..1]
+ subcategoryCode: CD [0..1]
::DefinedObservationResult
+ confidentialityCode: CD [0..1]
+ derivationExpression: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
+ targetCodingSystem: OID [0..1]
+ typeCode: CD [0..1]
+ value: ANY [0..1]
+ valueNegationIndicator: BL [0..1]
«DEPRECATED»
::DefinedObservationResult
+ comment: ST [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
Common Sub-Domain::
Serv iceDeliv eryLocation
+ code: CD [0..1]
+ postalAddress: BAG<AD> [0..*]
+ telecomAddress: BAG<TEL> [0..*]
Common Sub-Domain::
ProcessedProduct
+ identifier: II [0..1]
Study Conduct Sub-Domain::
PerformedProductTransport
+ methodCode: CD [0..1]
+ standardTimeIndicator: BL [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
{ServiceDeliveryLocation Qualifier}
{originates at actualIndicator Qualifier}
{have destination actualIndicator Qualifier}
::PerformedActivity
{ be participated in by actualIndicator
Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedMedicalConditionResult
::DefinedObservationResult
+ confidentialityCode: CD [0..1]
+ derivationExpression: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
+ targetCodingSystem: OID [0..1]
+ typeCode: CD [0..1]
+ value: ANY [0..1]
+ valueNegationIndicator: BL [0..1]
«DEPRECATED»
::DefinedObservationResult
+ comment: ST [0..1]
+ targetAnatomicSiteLateralityCode: CD
[0..1]
Study Conduct Sub-Domain::PerformedSubstanceExtraction
::PerformedProcedure
+ approachAnatomicSiteCode: CD [0..1]
+ methodCode: CD [0..1]
+ nonReasonCode: DSET<CD> [0..*]
+ targetAnatomicSiteCode: CD [0..1]
+ targetAnatomicSiteConditionCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedProcedure
+ approachAnatomicSiteLateralityCode: CD [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
constraints
{produces actualIndicator Qualifier}
::PerformedProcedure
{ uses actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
SubstanceExtractionAdministrationRelationship
+ donorTypeCode: CD [0..1]
+ relationCode: CD [0..1]
Study Conduct Sub-Domain::
PerformedExperimentalUnitAllocation
::PerformedAdministrativeActivity
+ varianceReasonCode: DSET<CD> [0..*]
+ varianceTypeCode: CD [0..1]
::PerformedActivity
+ dateRange: IVL<TS.DATETIME> [0..1]
+ dateRangeValidationCode: CD [0..1]
+ /delayDuration: PQ.TIME [0..1]
+ /duration: PQ.TIME [0..1]
+ /fastingStatusIndicator: BL [0..1]
+ /medicalHistoryIndicator: BL [0..1]
+ negationIndicator: BL [0..1]
+ negationReason: DSET<SC> [0..*]
+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
constraints
{be participated in by Qualifier}
::PerformedAdministrativeActivity
{ be performed at actualIndicator Qualifier }
::PerformedActivity
{ be participated in by actualIndicator Qualifier }
{ instantiates Exclusive Or }
{ occurs in the context of Qualifier }
{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedEligibilityCriterionAnswer
+ requiredIndicator: BL [0..1]
::DefinedObservationResult
+ confidentialityCode: CD [0..1]
+ derivationExpression: ST [0..1]
+ targetAnatomicSiteCode: CD [0..1]
+ targetCodingSystem: OID [0..1]
+ typeCode: CD [0..1]
+ value: ANY [0..1]
+ valueNegationIndicator: BL [0..1]
«DEPRECATED»
::DefinedObservationResult
+ comment: ST [0..1]
+ targetAnatomicSiteLateralityCode: CD [0..1]
Protocol Representation Sub-Domain::
PlannedEligibilityCriterion
::PlannedActivity
+ agentAdministrationCareSettingTypeCode:
CD [0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange:
URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator
Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
PlannedInclusionCriterion
::PlannedActivity
+ agentAdministrationCareSettingTypeCode: CD
[0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG> [0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
PlannedExclusionCriterion
::PlannedActivity
+ agentAdministrationCareSettingTypeCode: CD
[0..1]
+ blindedDescription: ST [0..1]
+ description: ST [0..1]
+ duration: PQ.TIME [0..1]
+ interruptibleIndicator: BL [0..1]
+ name: ST [0..1]
+ /repeatDuration: PQ.TIME [0..1]
+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
+ repeatQuantityRange: URG<INT.NONNEG>
[0..1]
+ /studyDayRange: IVL<INT> [0..1]
::Activity
+ comment: ST [0..1]
+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PlannedActivity
+ purpose: ST [0..1]
constraints
::PlannedActivity
{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or }
{ be participated in by actualIndicator Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
Observ ationResultActionTakenRelationship
+ delayDuration: PQ.TIME [0..1]
Study Conduct Sub-Domain::
StudySiteRecruitmentStatus
+ code: CD [1...1]
+ date: TS.DATETIME [0..1]
Study Conduct Sub-Domain::
StudySubjectExperienceDocumentVersion
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
{be participated in by actualIndicator
Qualifier}
::DocumentVersion
{ language Qualifier }
Protocol Representation Sub-Domain::
PlannedStudySubject
+ quantityRange: URG<INT.POS> [0..1]
constraints
{be a function performed by actualIndicator Qualifier}
::Subject
{ be a function performed by Exclusive Or }
Regulatory Sub-Domain::
Relev antRegulation
+ applicableIndicator: BL [0..1]
+ code: CD [0..1]
Statistical Analysis Sub-Domain::
DataMonitoringCommitteeCharterVersion
+ description: ST [0..1]
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
::DocumentVersion
{ language Qualifier }
Statistical Analysis Sub-Domain::
StatisticalAnalysisPlanDocumentVersion
::DocumentVersion
+ bibliographicDesignation: ED [0..1]
+ confidentialityCode: CD [0..1]
+ date: TS.DATETIME [0..1]
+ keywordCode: DSET<CD> [0..*]
+ keywordText: DSET<ST> [0..*]
+ languageCode: CD [0..1]
+ numberText: ST.SIMPLE [0..1]
+ officialTitle: ST [0..1]
+ revisionReasonCode: DSET<CD> [0..*]
+ text: ED [0..1]
+ /uniformResourceLocator: TEL.URL [0..1]
constraints
::DocumentVersion
{ language Qualifier }
Statistical Analysis Sub-Domain::StatisticalAnalysisPlanVersion
+ description: ST [0..1]
+ identifier: II [0..1]
+ typeCode: CD [0..1]
constraints
{addresses the needs of Qualifier}
Statistical Analysis
Sub-Domain::
StatisticalAnalysisPlan
Statistical Analysis Sub-Domain::
IntegratedStatisticalAnalysisPlan
Statistical Analysis Sub-Domain::
StudySpecificStatisticalAnalysisPlan
Statistical Analysis Sub-Domain::
StatisticalAnalysisPlanVersionModificationSummary
+ date: TS.DATETIME [0..1]
+ reasonCode: CD [0..1]
+ text: ED [0..1]
+ timingDescription: ST [0..1]
Statistical Analysis Sub-Domain::
StatisticalAnalysisPlanVersionStatus
+ code: CD [0..1]
+ date: TS.DATETIME [0..1]
Statistical Analysis Sub-Domain::
GeneralStatisticalConsideration
+ text: ED [0..1]
+ typeCode: CD [0..1]
Statistical Analysis
Sub-Domain::
SampleSizeConsideration
+ text: ED [0..1]
Statistical Analysis Sub-Domain::
PrincipalStatisticalAnalysisPlanVersion
::StatisticalAnalysisPlanVersion
+ description: ST [0..1]
+ identifier: II [0..1]
+ typeCode: CD [0..1]
constraints
::StatisticalAnalysisPlanVersion
{ addresses the needs of Qualifier }
Statistical Analysis Sub-Domain::
SupplementalStatisticalAnalysisPlanVersion
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::StatisticalAnalysisPlanVersion
+ description: ST [0..1]
+ identifier: II [0..1]
+ typeCode: CD [0..1]
constraints
::StatisticalAnalysisPlanVersion
{ addresses the needs of Qualifier }
Study Conduct
Sub-Domain::
StudySiteResource
Study Conduct Sub-Domain::
PerformedCompositionRelationship
constraints
{Composition Relationship Qualifier}
Study Conduct Sub-Domain::
AssessedActiv ityRelationship
Study Conduct Sub-Domain::
PerformedMaterialProcessStep
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::PerformedProcedure
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::PerformedActivity
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+ /studyDayRange: IVL<INT> [0..1]
::Activity
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+ identifier: II [0..1]
+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::PerformedProcedure
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constraints
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{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Protocol Representation Sub-Domain::
DefinedMaterialProcessStep
::DefinedProcedure
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+ targetAnatomicSiteCode: CD [0..1]
::DefinedActivity
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+ description: ST [0..1]
+ nameCode: CD [1...1]
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+ repeatFrequencyCode: CD [0..1]
+ repeatFrequencyRatio:
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+ repeatQuantityRange:
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+ statusCode: CD [0..1]
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::Activity
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+ reasonCode: DSET<CD> [0..*]
«DEPRECATED»
::DefinedProcedure
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+ targetAnatomicSiteLateralityCode: CD
[0..1]
constraints
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{ use actualIndicator Qualifier }
::DefinedActivity
{ be participated in by actualIndicator
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{ Repeat Frequency Exclusive Or }
{ Repeat Duration or Quantity Exclusive Or
}
::Activity
{ be participated in by Declaration }
Common
Sub-Domain::
DonorRegistry
Study Conduct Sub-Domain::
PerformedMaterialStorage
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+ temperatureRange: URG<PQ> [0..1]
::PerformedAdministrativeActivity
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::PerformedActivity
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+ /repetitionNumber: INT.POS [0..1]
+ statusCode: CD [0..1]
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+ /studyDayRange: IVL<INT> [0..1]
::Activity
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+ reasonCode: DSET<CD> [0..*]
constraints
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}
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{ dateRange Qualifier }
{ be performed by actualIndicator Qualifier }
{ containingEpoch Qualifier }
::Activity
{ be participated in by Declaration }
Study Conduct Sub-Domain::
TargetAnatomicSite
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+ primaryIndicator: BL [0..1]
Study Conduct Sub-Domain::
PerformedDiagnosisProcedureRelationship
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«DEPRECATED»
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0..1
is a function performed by
{function as}
1
«DEPRECATED»
{be specialized by}
0..*
perform a
role for
{have a role
performed by}
0..1
0..*
plan to perform a role for
{have a role planned
to be performed by}0..1
0..*
be a function
performed by
{function as}
0..1
0..*
be a function
performed by
{function as}0..1
0..*
perform a role for
{have a role performed by} 0..1
0..*
perform a role for
{have a role performed by} 0..10..*
be a function
performed by
{function as}0..1
0..*
provides
{be provided by}
1..*
0..*
is a function
performed by
{function as}1
0..*
has as source
{be the source
for}
1
0..*
be a function
performed by{function as}
0..1
0..*
be a function
performed by
{function as}
0..1
0..*
has as subject
{be the subject of} 1
0..*is the subject of
{have as subject}
1
0..*
evaluates
{be evaluated by}1
0..*
is evaluated by
{evaluate}
1
0..*
evaluates
{be evaluated by}
1
0..*
is evaluated by
{evaluate}
1
0..*
describe
{be described by}
0..*
0..*
focuses on
{be the focus of}
1
0..*
is triggered by
{trigger} 1..*
0..*
is triggered by
{trigger}
1
0..*
fabricates
{be fabricated
by}
1..*
0..*
manufactures for
{manufacture at}
1..*
0..*
is a function
performed by
{function as} 1
0..*
is a function performed by
{function as}
1
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is performed by
{perform}
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staffs
{is staffed by}
1
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is a function performed by
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functions as an outlet for
{have as an outlet} 1..*
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is a function
performed by
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be a member
of
{has as a
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{have as a member}
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1
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is a member of
{have as a
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is credentialed by
{credential}
1
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is a function
performed by
{function as}
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receives{be received by}
1
1staffs
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has as target
{be the
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is a function
performed by
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be a function
performed by
{function as}
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handles
communication
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{have
communications
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1
+containedPlace
0..*
{contain} be
contained in
+containingPlace
0..1
0..*
be the location for
{have jurisdiction over}
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is a division of
{be divided
into}1
0..*
is a division of
{be divided
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0..*
contains
{occur in}
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0..*report as prior therapies{be reported as a prior therapy in}
0..*
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describe
{be described by}
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describe
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is a function
performed by{function as}
1
14 © 2016 Teradata
• Teradata LS-LDM statistics
– 235 Subject areas, 4,006 Entities, 15,663 Attributes
• Lines of Business/Areas of Business
– Drug (Materials) Discovery
– Product & Other Materials R&D
– Biologic Entity (animals, plants, bacteria, etc.) Experiments & Studies Management
– Human Clinical Study Management
– Genetics, Proteomics & Pathways
– Legal/Regulatory Compliance
– Product Manufacturing
– Sales & Marketing
– Finance & Performance Management
– Human Capital Management
• Subject Area Examples
> Strategy - Genetics - Shipment/Logistics - Production
> Study - Bioassay - Activity Based Costing - Marketing
> Study Event - Material - Quality Assurance/Metrics - Regulatory
> Adverse Event - Inventory - Human Capital Management
> Protocol - Customs - Biomaterial - Experiment
> Pathways - Forecasts - Observational Medical Outcomes (OMOP)
Life Sciences Data Model 3.0 Overview
INCLUDES:
• Mapping from LSDM to BRIDG
• Quick-Start Physical Model
15 © 2016 Teradata
A Robust Set Of Analytic CapabilitiesDeep internal capability, plus a range of partnerships
• Before: Customer SAS standalone application runtime:
18-20+ Hours
• After: SAS / Teradata In-Database combined runtime:
3 Hours 39 Minutes (approx. 80% improvement)
• Achieved impact in 6 weeks from Teradata hardware delivery to results
• Approximately 97% of SAS Code in application UNMODIFED0
5
10
15
20
Processing Time for 1.67M records(Hours)
16
How to Integrate CDISC Across The Enterprise to: “Reduce Costs and Speed the Development of Therapies for
Patients”
17 © 2016 Teradata
FIPCO FIPNETRisk
Management
Product
Commercializat
ion
Competitive
Intelligence
Data
Integration &
Analysis
Data
Governance,
Privacy,
Security
Business
Continuity
Financial
Reporting &
Analysis
Improvement
Financial
Process
Optimization
Enterprise
Performance
Management
Operational
Analysis &
Reporting
Enhancement
Consistent
Financial
Compliance
Mfg Quality
Optimization
Supply Chain
Visibility &
Lead/Cycle Time
Mgmt
Vendor Mgmt/
Score Carding
Reliability and
Maintenance
Planning
Demand Driven
Supply Network
DSCSA
(Track and
Trace)
Research Data
Profiling,
Integration &
Analysis
Detail Clinical
Data
Integration
(Part 11)
Product
Portfolio
Management
Safety Data
Tracking and
Analysis
Collaborative
Data
Integration
(Translational
Medicine)
Evidence-
based
Outcomes
Analysis
Syndicated
Data Processing
& Integration
360° Customer
View /
Targeting
Event-based
Customer
Messaging
Contract &
Rebate
Management
Channel
Management
Sales & Marketing
Research & Development
Manufacturing
Financial Management
Other
Business Improvement Opportunities Key Business
Processes
Step 1: Identify Business Improvement Opportunities (BIOs)Life Sciences BIO Framework
18 © 2016 Teradata 18
Regulatory MarketingResearch &
DevelopmentFinance
The Superior Business Value of Integrated Analytics (IA)
Step 2: Prioritize BIOs via a Business-Focused, Analytics-Driven Roadmap Incorporating All Applicable Data
Business value
compounds exponentially…
…while IA investment grows incrementally
Valu
e
Finance
Manufacturing
Marketing
Regulatory
ResearchEvolution
to anEnterprise View
Business Value ROI
Integrated Analytics
Investment
Manufacturing
Regulatory
Research Research Research Research
Manufacturing Manufacturing
Marketing
Business-Driven Analytics Gains
MARGIN GAIN
FROM
INTEGRATED
ANALYTICS
Modular growth should be business-focused to speed gains, maximize ROI
Regulatory Regulatory
19 © 2016 Teradata
2855
Tightly Coupled
Loosely Coupled
Non Coupled
Step 3: Appropriately Identify, Value, Utilize and Maximize Gains from ANY and ALL Data
20 © 2016 Teradata
Unified Data Architecture
Disease Management
Manufacturing
Hospitals
Finance
Consumers
Claims
PatientsSales
Physicians
Government
HR/Benefits
Marketing
Contracts
HR
Population Demographics
Products/Services
Call Center/Communication
Disease Mgmt/Wellness
R&D
Finance/GL
HR/Benefits
Sales/Marketing
Drug/Medical
Patient/Consumer
Step 4: Create and Maintain A Unified Data ArchitectureA Single View of the Enterprise Built on an Integrated LDM
Deliver a “single view of data” to a variety of internal and external stakeholders
R&D
21 © 2016 Teradata
The critical step of
operational
deployment is often
overlooked
Step 5: Continually Evolve The Analytics Path to Achieve High Impact Business Outcomes for Everyone in the Enterprise
Frame the Problem
Select & Visualize the Data
Hypothesize the SolutionTest the
Hypothesis (POV)
Implement and Industrialize
Communicate Results
The critical step of
operational deployment
is often overlooked
22 © 2016 Teradata
Q&A Teradata as Analytics Partner
• We coordinate with your business and IT personnel to ensure decisions are:o business-driveno founded on analyticso correctly implemented
• We offer vast experience and brain trust around both retail analytics and the organizational transformation required for success
• We customize analytics to your needs, using ANY and ALL data pertinent to growing business
• We place our services where you want them: in-house, off-site, cloud
• We provide end-to-end support:o strategic planningo organizational assessmento analytics developmento interface usability and testingo operational implementation o ROI assessment
2323
24
Appendix
25 © 2016 Teradata
• Clinical study modeling is now extended to non-human study subjects to accommodate, for example, companies that create drugs/devices/biologics/foods or other materials for animals and plants. Those study subjects can be:
– An Animal
– A Plant
– Groups of Animals
– Groups of Plants
– Animal Parts
– Plant Parts
– Parts can be to the cellular and subcellular level including DNA
• Experiment modeling remains primarily for non-human study subjects although, for example, human cells could be used as study subjects for experiments
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates
26 © 2016 Teradata
• BRIDG focuses on behaviors, functions, structure elements and growth stages as observations to track. Models associate those characteristics with:
– Animals
– Plants
– Groups of Animals
– Groups of Plants
– Animal Parts
– Plant Parts
– Viruses
– Bacteria
– Cells and Parts of Cells
– Nucleic acids (DNA, xRNA)
• These characteristics are associated with BIOLOGIC ENTITYs (as a record of having been seen) and BIOLOGIC ENTITY INSTANCEs (as a record of specific observations of BIOLOGIC ENTITY INSTANCE individuals)
• Any additional observations of any type can be associated with BIOLOGIC ENTITYs and BIOLOGIC ENTITY INSTANCEs using OBSERVATION EVENT:
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates
27 © 2016 Teradata
• Confidentiality indicators for some entities including, for example, INDIVIDUALs participating in STUDYs
• Death indicators and death data such as cause of death associated with INDIVIDUALs and BIOLOGIC ENTITIES (animals, plants, parts of animals and plants, viruses, and bacteria down to the cellular and sub-cellular level)
• Occupation entities with a Primary Indicator in INDIVIDUAL OCCUPATION
• Start and end dates and datetimes in appropriate entities
• Study subject minimum and maximum accrual numbers to studies
• Identifiers assigned by organizations to many entities such as studies, study subjects and drugs
• A status date associated with every entity that can be an experimental unit or a study subject
• Expanded the definition of CONVEYANCE to include helicopters and ambulances because those are specified in BRIDG definitions
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates
28 © 2016 Teradata
• A CONFIDENTIALITY entity and associated it with DOCUMENT and DOCUMENT CONTENT (an extension as BRIDG only associates it with DOCUMENT)
• DOCUMENT SIGNOFF EVENT
• Flow rate for TREATMENT STUDY EVENT and ACTIVITY
• TREATMENT INTERRUPTION EVENT and TREATMENT CHANGE EVENT
• TOXICITY GRADE entity and TOXICITY DAMAGE ABILITY entity, associated with CLINICAL INTERPRETATION EVENT
• A relationship between UNCERTAINTY and EVENT and role named the Uncertainty Cd (FK) to Date Uncertainty
• A Negation Indicator to the TREATMENT STUDY EVENT to indicate a scheduled treatment event that did not occur
• A NEGATION REASON and associated Negation Reason Cd with TREATMENT STUDY EVENT and ACTIVITY. If Negation Reason Cd foreign key is not null, the event or activity did not take place
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates
29 © 2016 Teradata
• Created a REGULATORY ASSESSMENT EVENT as a subtype of EVENT
• Associated REGULATORY ASSESSMENT with REGULATORY ASSESSMENT EVENT
• Added a REGULATORY ASSESSMENT EVENT REASON entity and associated it with REGULATORY ASSESSMENT EVENT
• Added a REGULATORY ASSESSMENT RESULT entity and associated it with REGULATORY ASSESSMENT EVENT
• Added a PRODUCT APPROVAL PROCESS entity to the model and associated it with PRODUCT APPROVAL EVENT
• Added FUNDING CATEGORY entity and related it to STUDY FUNDING EVENT
• Added FUNDING MECHANISM entity and related it to STUDY FUNDING EVENT
• Added a FUNDING MECHANISM IDENTIFIER associated with a FUNDING MECHANISM which is assigned by an ORGANIZATION
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates
30 © 2016 Teradata
• MEASUREMENT STATUS entity associated with LIFE SCIENCES MEASUREMENT
• Life Sciences Measurement Biomarker Indicator for LIFE SCIENCES MEASUREMENT
• Contrast Enhancement Indicator and Enhancement Description for IMAGE
• MATERIAL STORAGE METHOD associated with MATERIAL STORED EVENT
• REGULATION associated to STUDY using STUDY REGULATION. The regulation is associated with the governing and/or enforcement organization, as well as with EXPERIMENT using EXPERIMENT REGULATION
• A Registration Required Indicator for STUDY
LS-LDM and BRIDG Model for Life Sciences CompaniesUpdates