CDISC SHARE: A BRIDG-based
Metadata Repository Environment
Wayne R. Kubick
CDISC
© CDISC 2011
1
The CDISC Standards Guide
© CDISC 2011
2
BRIDG – Part of the SHARE Foundation
• BRIDG Purpose:
A collaborative effort to produce a shared view of the dynamic and
static semantics that collectively define a shared domain-of-interest.
 The semantic foundation for HL7/CDISC-based application and message
development
• Domain-of-interest/scope: Protocol-driven research
 A Unified Modeling Language (UML) Model of the data (using ISO 21090
datatypes), organization, resources, rules, and processes involved in the formal
assessment of the utility, impact, or other pharmacological, physiological, or
psychological effects of a drug, procedure, process, or device on a human,
animal, or other biologic subject or substance plus all associated regulatory
artifacts required for or derived from this effort.
• Stakeholders:
• Governance Process:
Board of Directors prioritizes projects and committee consults with
projects and harmonizes project models into main model with help of
project analysts/SMEs
3
© CDISC 2011
SME View
Canonical View
OWL View HL7 RIM View
© CDISC 2011
BRIDG Model Content (Layer 2)
class UML-Based Comprehensiv e BRIDG Model Diagram
Common Sub-Domain::DocumentRelationship
Legend
+
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.
Adverse Event Sub-Domain
Common Sub-Domain
Protocol Representation Sub-Domain
typeCode: CD
Regulatory Sub-Domain
Common Sub-Domain::
DocumentIdentifier
Study Conduct Sub-Domain
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::Document
{root}
identifier: II
typeCode: CD
primaryIndicator: BL
identifies
{is identified
by}
0..*
1
constraints
{Is Issued By Exclusive Or}
0..*
0..*
is issued by
+
+
+
+
+
+
+
+
+
typeCode: CD
officialTitle: ST
text: ED
keywordCode: DSET<CD>
keywordText: DSET<ST>
revisionReason: ST
revisionNumberText: ST
uniformResourceLocator: URL
bibliographicDesignation: ST
Protocol Representation Sub-Domain::Arm
{root}
{issues}
is issued by
1
{issues}
{leaf}
Documents
Common Sub-Domain::Report
{leaf}
is a function performed by
{functions as}
0..1
Common Sub-Domain::BiologicEntity
{root}
+
+
+
+
+
+
is part of
actualIndicator: BL
administrativeGenderCode: CD
birthCountryCode: CD
birthOrder: INT
birthDate: TS.DATETIME
deathDate: TS.DATETIME
{has}
1
0..*
Common Sub-Domain::
BiologicEntityPart
{functions as}
is a function performed by
Common Sub-Domain::
BiologicEntityGroup 0..1
{functions as}
0..*
identifier: DSET<II>
subgroupCode: CD
statusCode: CD
statusDate: TS.DATETIME
comment: ST
statusCode: CD
statusDate: TS.DATE.FULL
constraints
1..*
Common Sub-Domain::Subj ect
{root}
+
+
+
+
0..1
Common Sub-Domain::DocumentAuthor
{root}
0..*
0..*
0..*
Common Sub-Domain::Activity
constraints
{Is a Function Performed By Qualifier}
{Study Author Performed By Qualifier}
1
+ confidentialityIndicator: BL
+ paymentMethodCode: CD
+ statusCode: CD
+ statusDate: TS.DATETIME
::Subject
+ state: ST
Common Sub-Domain::Animal
{leaf}
identifies
+ speciesCode: CD
+ breedCode: CD
+ strain: ST
+ reproductiveOrgansPresentIndicator: BL
+ description: ED
::BiologicEntity
+ actualIndicator: BL
+ administrativeGenderCode: CD
+ birthCountryCode: CD
+ birthOrder: INT
+ birthDate: TS.DATETIME
+ deathDate: TS.DATETIME
0..*
+
+
+
identifier: II
typeCode: CD
effectiveDateRange: IVL<TS.DATETIME>
{root}
+
+
+
+
1 {is identified 0..* +
by}
+
1..*
Protocol Representation
Sub-Domain::StudyObj ectiv e
+
+
Protocol Representation Sub-Domain::Study
primaryIndicator: BL
description: ST
identifier: II
typeCode: CD
effectiveDateRange: IVL<TS.DATETIME>
{root}
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
1..*
measures
0..*
{is measured by}
1..*
Protocol Representation
Sub-Domain::
StudyOutcomeMeasure
Study Conduct Sub-Domain::Assessor
+
+
+
+
+
actualIndicator: BL
constraints
name: ST
typeCode: DSET<CD>
primaryIndicator: BL
timeFrameText: ST
{Is a Function Performed By Exclusive Or}
+
+
0..*
statusCode: CD
statusDate: TS.DATETIME
+
+
+
postalAddress: AD
telecomAddress: BAG<TEL>
effectiveDateRange: IVL<TS.DATETIME> 0..1
+
+
0..* +
+
+
+
is a function performed by
{functions as}
is a function performed by
constraints
{Person-Org Pair Unique}
{functions as}
0..*
Protocol Representation Sub-Domain::
DefinedContingentOnRelationship
Protocol Representation
Sub-Domain::
DefinedCompositionRelationship
+
+
+
+
+
+
+
+
+
roleCode: CD
primaryIndicator: BL
postalAddress: AD
telecomAddress: BAG<TEL>
statusCode: CD
statusDate: TS.DATETIME
+prerequisite
+
+
+
constraints
1 {mulitInstitutionalIndicator Qualifier}
{is described by}
People and
their Roles
0..1
Common Sub-Domain::
Administrativ eMemberPI
0..1 +repeated
Common Sub-Domain::
MemberInstitution
0..1
0..*
identifier: II
certificateLicenseText: ST
postalAddress: AD
telecomAddress: BAG<TEL>
effectiveDateRange: IVL<TS.DATETIME>
0..* {is associated to a resource by}
1
1
{functions as}
is a member of
{has as a member}
0..*
+
studyFocusIndicator: BL
1
{leaf}
is a function performed by
Common Sub-Domain::
TreatingSite
{functions as}
is a function
performed by
constraints
{Is a Member Of Exclusive Or}
{functions as}
{contains}
1
handles
communications
for
{has communications
handled by}
0..*
+
+
+
+
+
+
Common Sub-Domain::Ov ersightCommittee
{leaf}
1
is used to
group staff for
typeCode: DSET<CD>
title: ST
primaryIndicator: BL
postalAddress: AD
telecomAddress: BAG<TEL>
effectiveDateRange: IVL<TS.DATETIME>
+
+
is credentialed by
{groups staff into}
typeCode: CD
effectiveDateRange: IVL<TS.DATETIME>
is assigned by
1
{assigns}
1
Organizations
and their
Roles
+credentialing
identifier: DSET<II>
name: DSET<ON>
typeCode: CD
actualIndicator: BL
postalAddress: AD
telecomAddress: BAG<TEL>
description: ST
1
1
0..1
is responsible for
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
1
Protocol Representation Sub-Domain::Resource
{root}
is provided by
Common Sub-Domain::ResourceProv ider
{root} 1
+
+
constraints
{Is a Function Performed By Exclusive Or}
0..1
1
+subdivided
1
Protocol Representation
Sub-Domain::Serv ice
{leaf}
::Resource
+ activeIndicator: BL
+ inactiveComment: ST
+ typeCode: CD
::Resource
+ activeIndicator: BL
+ inactiveComment: ST
+
0..* +
Protocol Representation
Sub-Domain::Gov ernmentFunding
{leaf}
name: ST
acronym: ST
+ fundingTypeCode: CD
+ fundingMechanismCode: CD
+ nihInstituteCode: CD
+ serialNumberText: ST
::Resource
+ activeIndicator: BL
+ inactiveComment: ST
constraints
{actualIndicator Qualifier}
Protocol Representation Sub-Domain::DefinedProcedure
{leaf}
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Protocol Representation Sub-Domain::
DefinedStudyAdministrativ eActiv ity
{leaf}
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
telecomAddress: TEL
Protocol Representation
Sub-Domain::
MaterialResource
{leaf}
::Resource
+ activeIndicator: BL
+ inactiveComment: ST
identifier: II
typeCode: CD
effectiveDateRange: IVL<TS.DATETIME>
+
+
+contingent
triggers the cessation of
Study Conduct Sub-Domain::PerformedActiv ity
{leaf}
0..*
{is repeated until}
is repeated until
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
{triggers the
cessation of}
is contingent
upon
+ enhancementRateValue: RTO<PQ, PQ.TIME>
+ enhancementDescription: ST
+ contrastAgentEnhancementIndicator: BL
::DefinedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Protocol Representation Sub-Domain::
DefinedEligibilityCriterion
{leaf}
Protocol Representation Sub-Domain::
DefinedSpecimenCollection
{leaf}
::DefinedProcedure
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
+ requiredResponse: ANY
+ displayOrder: INT
::DefinedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Protocol Representation
Sub-Domain::
PlannedCompositionRelationship
+
+
+
+
{is contingent upon}
sequenceNumber: INT
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
0..*
Study Conduct Sub-Domain::PerformedObserv ationResult
{Is a Function Performed By Qualifier}
{actualIndicator Exclusive Or}
{Instantiates Exclusive Or}
{Occurs in the Context Of Qualifier}
{actualDateRange Qualifier}
0..*
is the parent of
is the component of
Study Conduct Sub-Domain:
:AssessedResult
+
+
+contingent
1
+prerequisite
0..1
0..1
0..1
1
+triggering
1
1
+repeated
1
1..*
1..*
+
{leaf}
+
+
Common Sub-Domain::Manufacturer
1..*
+option
{leaf}
1
is a choice that has as option
{is an option that can satisfy}
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteConditionCode: CD
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Protocol Representation Sub-Domain::
PlannedRandomizationBookAllocation
{leaf}
::PlannedActivity
+ name: ST
+ purpose: ST
+ targetAccrualNumberRange: URG<INT>
+ description: ST
+ blindedDescription: ST
+ plannedDuration: PQ.TIME
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: INT
+ /repeatDuration: PQ.TIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
+choice 0..*
Protocol Representation
Sub-Domain::
PlannedOptionRelationship
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
Adv erse Ev ent Sub-Domain::
Adv erseEv entOutcomeAssessment
{leaf}
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
constraints
{DefinedActivity Qualifier}
{Repeat Not Applicable}
1
is defined by
{defines}
Protocol Representation Sub-Domain::DefinedStratificationCriterionPermissibleResult
{leaf}
Protocol
Representation
Sub-Domain::
StratumGroup
is defined by
1..*
{defines}
1..*
+
1..*
0..*
Protocol Representation Sub-Domain::
RandomizationBookEntry
randomizes
groupNumber: INT
1
{is randomized by}
+
0..* +
positionNumber: INT
positionFilledIndicator: BL
0..*
Study Conduct Sub-Domain::PerformedImaging
{leaf}
constraints
{Is a Function Performed By Qualifier}
Study Conduct Sub-Domain::
PerformedStudyAdministrativ eActiv ity
{leaf}
::PerformedAdministrativeActivity
+ varianceTypeCode: CD
+ varianceReason: ST
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
identifier: II
typeCode: CD
typeCode: CD
+
+
+
Regulatory Sub-Domain::SubmissionUnit
typeCode: CD
receiptDate: TS.DATETIME
effectiveDateRange: IVL<TS.DATETIME>
constraints
{Grouped Into Exclusive Or}
Common
Sub-Domain::
ManufacturingSite
+
+
0..1
identifier: DSET<II>
typeCode: CD
stores
Study Conduct Sub-Domain::BiologicSpecimen 1
{leaf}
0..*
Common Sub-Domain::Material
{root}
+
+
+
+
+
+
provides
{is provided by}
constraints
{Is a Function Performed By Qualifier}
{leaf}
typeCode: CD
delayDuration: PQ.TIME
{leaf}
identifier: DSET<II>
name: TN
typeCode: CD
formCode: CD
lotNumberText: ST
capTypeCode: CD
capacityQuantity: PQ
Common Sub-Domain::
ProductGroup
+
+
+
identifier: II
quantity: INT
actualIndicator: BL
is a function performed by
0..1
{functions as}
1
{has as part}
0..*
Adv erse Ev ent Sub-Domain::
Adv erseEv ent
{leaf}
+ gradeCode: CD
+ severityCode: CD
+ seriousnessCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ occurrencePatternCode: CD
+ endRelativeToReferenceCode: CD
+ unexpectedReasonCode: DSET<CD>
+ expectedIndicator: BL
+ hospitalizationRequiredIndicator: BL
+ highlightedIndicator: BL
1
+ duration: PQ.TIME
+ onsetDate: TS.DATETIME
+ resolutionDate: TS.DATETIME
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
1 + confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
constraints
{Is a Function Performed By Qualifier}
Study Conduct Sub-Domain::
PerformedExclusionCriterion
{leaf}
::PerformedEligibilityCriterion
+ questionCode: CD
+ displayOrder: INT
+ notApplicableIndicator: BL
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
+
+
Adv erse Ev ent Sub-Domain::
PerformedProductProblemDiscov ery
{leaf}
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
strength: RTO<PQ,PQ>
activeIngredientIndicator: BL
Adv erse Ev ent Sub-Domain::
PerformedProductInv estigation
{leaf}
uses
{is used during}
0..*
Study Conduct Sub-Domain::
PerformedStudyAgentTransfer
Protocol Representation Sub-Domain::StudyAgent
+
+
+
functionCode: CD
statusCode: CD
statusDate: TS.DATETIME
Products and Study Agents
Study Conduct Sub-Domain::
ConcomitantAgent
Protocol Representation Sub-Domain::
ExpandedAccessStudy
{leaf}
+ interventionDescription: ST
::Study
+ acronym: ST
+ phaseCode: CD
+ primaryPurposeCode: CD
+ purposeStatement: ST
+ diseaseCode: DSET<CD>
+ targetAnatomicSiteCode: DSET<CD>
+ designConfigurationCode: CD
+ studySchematic: ED
+ populationDescription: ST
+ studySubjectTypeCode: CD
+ plannedStudySubjectExperience: ST
+ targetAccrualNumberRange: URG<INT>
+ periodicTargetAccrualNumber: RTO<INT,PQ>
+ accrualReportingMethodCode: CD
+ responsiblePartyCode: CD
+ participatingOrganizationTypeCode: CD
+ participatingCountryCode: DSET<CD>
+ aeCodingSystem: II
+ multiInstitutionIndicator: BL
Common Sub-Domain::Dev ice
{leaf}
Common Sub-Domain::FoodProduct
{leaf}
+ lotNumberText: ST
::Product
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
Common Sub-Domain::Biologic
{leaf}
+ lotNumberText: ST
::Product
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
+ age: PQ
+ manufactureDate: TS.DATETIME
+ reprocessedDeviceCode: CD
0..1
+ availableForEvaluationIndicator: BL
+ overTheCounterProductIndicator: BL
+ singleUseDeviceIndicator: BL
::Product
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
is a function performed by
{functions as}
Protocol Representation Sub-Domain::
Observ ationalStudy
{leaf}
Common Sub-Domain::Cosmetic
{leaf}
+ lotNumberText: ST
::Product
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
Common Sub-Domain::Drug
{leaf}
+ lotNumberText: ST
::Product
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
© CDISC 2011
+ samplingMethodCode: CD
+ timePerspectiveCode: CD
::Study
+ acronym: ST
+ phaseCode: CD
+ primaryPurposeCode: CD
+ purposeStatement: ST
+ diseaseCode: DSET<CD>
+ targetAnatomicSiteCode: DSET<CD>
+ designConfigurationCode: CD
+ studySchematic: ED
+ populationDescription: ST
+ studySubjectTypeCode: CD
+ plannedStudySubjectExperience: ST
+ targetAccrualNumberRange: URG<INT>
+ periodicTargetAccrualNumber: RTO<INT,PQ>
+ accrualReportingMethodCode: CD
+ responsiblePartyCode: CD
+ participatingOrganizationTypeCode: CD
+ participatingCountryCode: DSET<CD>
+ aeCodingSystem: II
+ multiInstitutionIndicator: BL
Protocol Representation Sub-Domain::
Interv entionalStudy
{leaf}
+ controlTypeCode: CD
+ controlConcurrencyTypeCode: CD
+ allocationCode: CD
+ blindingSchemaCode: CD
+ blindedRoleCode: DSET<CD>
+ interventionGroupQuantity: INT
+ acceptsHealthyVolunteersIndicator: BL
+ interventionDescription: ST
::Study
+ acronym: ST
+ phaseCode: CD
+ primaryPurposeCode: CD
+ purposeStatement: ST
+ diseaseCode: DSET<CD>
+ targetAnatomicSiteCode: DSET<CD>
+ designConfigurationCode: CD
+ studySchematic: ED
+ populationDescription: ST
+ studySubjectTypeCode: CD
+ plannedStudySubjectExperience: ST
+ targetAccrualNumberRange: URG<INT>
+ periodicTargetAccrualNumber: RTO<INT,PQ>
+ accrualReportingMethodCode: CD
+ responsiblePartyCode: CD
+ participatingOrganizationTypeCode: CD
+ participatingCountryCode: DSET<CD>
+ aeCodingSystem: II
+ multiInstitutionIndicator: BL
constraints
{blindedRoleCode Qualifier}
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Specimen Collection
{leaf}
Protocol Representation Sub-Domain::
DefinedExclusionCriterion
{leaf}
::DefinedEligibilityCriterion
+ requiredResponse: ANY
+ displayOrder: INT
::DefinedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Protocol Representation Sub-Domain::
DefinedInclusionCriterion
{leaf}
::DefinedEligibilityCriterion
+ requiredResponse: ANY
+ displayOrder: INT
::DefinedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Study Conduct Sub-Domain::
PerformedSubstanceAdministration
{leaf}
+ dose: PQ
+ doseDescription: ST
+ doseFrequencyCode: CD
+ dailyDoseTotal: PQ
+ changeTypeCode: CD
+ plannedChangeIndicator: BL
+ changeReason: ST
+ routeOfAdministrationCode: CD
+ /startRelativeToReferenceCode: CD
+ /endRelativeToReferenceCode: CD
::PerformedProcedure
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteConditionCode: CD
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
constraints
{Is a Function Performed By Qualifier}
{relativeToReference Qualifier}
+ quantity: PQ
+ originalQuantity: PQ
::PerformedAdministrativeActivity
+ varianceTypeCode: CD
+ varianceReason: ST
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
+ toxicityTermCode: CD
+ toxicityGradeCode: CD
+ severityCode: CD
+ clinicallySignificantIndicator: BL
+ abnormalIndicator: BL
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
+
+
+
+
typeCode: CD
result: ANY
targetAnatomicSiteCode: CD
comment: ST
Study Conduct Sub-Domain::
PerformedClinicalResult
{leaf}
+ /normalRangeComparisonCode: CD
+ reportedResultStatusCode: CD
+ biomarkerIndicator: BL
+ asCollectedIndicator: BL
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
Study Conduct Sub-Domain::
PerformedMedicalHistoryResult
{leaf}
+ endRelativeToReferenceCode: CD
+ occurrenceDateRange: IVL<TS.DATETIME>
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
constraints
{relativeToReference Qualifier}
Common Sub-Domain::
ProductPart
0..*
is part of
1
Study Conduct Sub-Domain::
PerformedProtocolDev iation
{leaf}
{functions as}
is a function performed by
1
{triggers}
{triggers}
+ differentiationGradeCode: DSET<CD>
+ cellTypeCode: DSET<CD>
+ involvedSurgicalMarginIndicator: BL
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
+ questionCode: CD
+ displayOrder: INT
+ notApplicableIndicator: BL
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Study Conduct Sub-Domain::
PerformedInclusionCriterion
0..1
is triggered by
0..*
is triggered by
0..*
probability: REAL
uncertaintyCode: CD
{leaf}
+ categoryCode: CD
+ dateRange: IVL<TS.DATETIME>
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
{leaf}
Common Sub-Domain::Product
constraints
{leaf}
+ informedConsentDate: TS.DATETIME
+ registrationDate: TS.DATETIME
+ offStudyDate: TS.DATETIME
+ offStudyReasonCode: CD
+ studyReferenceDateRange: IVL<TS.DATETIME>
::PerformedAdministrativeActivity
+ varianceTypeCode: CD
+ varianceReason: ST
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
::PerformedEligibilityCriterion
+ questionCode: CD
+ displayOrder: INT
+ notApplicableIndicator: BL
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Common Sub-Domain::
Package
+
+
+
+
+
+
+
1..*
{Distributor Qualifier}
{Manufacturer Qualifier}
{ManufacturingSite Qualifier}
Study Conduct Sub-Domain::
PerformedEligibilityCriterion
constraints
{Is a Function Performed By Qualifier}
{Date Exclusive Or}
results in
{is a result of}
1
constraints
{actualIndicator Qualifier}
identifier: DSET<II>
name: DSET<TN>
formCode: CD
actualIndicator: BL
description: ST
effectiveDateRange: IVL<TS.DATETIME>
+ nameCode: CD
+ nameModifiedText: ST
+ typeCode: CD
+ classCode: DSET<CD>
+ pre1938Indicator: BL
+ treatmentVehicleCode: CD
+ treatmentVehicleVolume: PQ
+ expirationDate: TS.DATE.FULL
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
{is stored during}
Specimens
+ accessionNumberText: ST
+ conditionCode: CD
::Material
+ identifier: DSET<II>
+ name: DSET<TN>
+ formCode: CD
+ actualIndicator: BL
+ description: ST
+ effectiveDateRange: IVL<TS.DATETIME>
0..*
Common Sub-Domain::
Distributor
+
+
Adv erse Ev ent Sub-Domain::
Ev aluatedResultRelationship
+
+
Study Conduct Sub-Domain::
PerformedClinicalInterpretation
{leaf}
Study Conduct Sub-Domain::
PerformedHistopathology
Study Activities,
Observations and
Results
Study Conduct Sub-Domain::
PerformedStudySubj ectMilestone
Common Sub-Domain::Place
{has as an outlet}
+ imageIdentifier: II
+ enhancementRateValue: RTO<PQ, PQ.TIME>
+ enhancementDescription: ST
+ contrastAgentEnhancementIndicator: BL
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
+ varianceTypeCode: CD
+ varianceReason: ST
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
{leaf}
constraints
Regulatory
Sub-Domain::
Rev iew ableUnit
{triggers}
Adv erse Ev ent Sub-Domain::
Adv erseEv entActionTaken
Study Conduct Sub-Domain::
PerformedSpecimenCollection
typeCode: CD
/receiptDate: TS.DATETIME
statusCode: CD
statusDate: TS.DATETIME
+
is triggered by
0..*
{Association Cardinality Qualifier}
+ fastingStatusIndicator: BL
::PerformedProcedure
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteConditionCode: CD
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Adv erse Ev ent Sub-Domain::
Adv erseEv entOutcomeResult
{leaf}
Adverse
Events
constraints
{Is a Function Performed By Qualifier}
triggers
{is triggered by}
+ diseaseStatusCode: CD
+ recurrenceIndicator: BL
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
+ appearanceTypeCode: CD
+ contactAnatomicSiteCode: CD
+ lesionNumber: INT
+ measurableIndicator: BL
+ xDimension: PQ
+ yDimension: PQ
+ zDimension: PQ
+ /dimensionProduct: PQ
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
{leaf}
::PerformedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Study Conduct Sub-Domain::
PerformedDiagnosis
{leaf}
Study Conduct Sub-Domain::
PerformedLesionDescription
{leaf}
+ defectTypeCode: CD
+ deviceMalfunctionCode: CD
+ evaluationConclusionCode: CD
+ conclusion: ST
::PerformedObservationResult
+ identifier: II
+ typeCode: CD
+ result: ANY
+ resultCodeModifiedText: ST
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ uncertaintyCode: CD
+ reportedDate: TS.DATETIME
+ comment: ST
Adv erse Ev ent Sub-Domain::
CausalAssessment
constraints
{Is a Function Performed By Qualifier}
{Groups Exclusive Or}
functions as
an outlet for
0..1
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ /focalDateRange: IVL<TS.DATETIME>
::PerformedActivity
+ /actualDuration: PQ.TIME
+ actualDateRange: IVL<TS.DATETIME>
+ /delayDuration: PQ.TIME
+ missedReason: DSET<SC>
+ missedIndicator: BL
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Study Conduct Sub-Domain::PerformedProcedure
1
is an option that can satisfy
constraints
{Is a Function Performed By Qualifier}
0..*
probability: REAL
uncertaintyCode: CD
Study Conduct Sub-Domain::PerformedObserv ation
+option 0..*
::DefinedObservationResult
+ result: ANY
+ typeCode: CD
+ targetCodingSystem: II
+ targetAnatomicSiteCode: CD
+ confidentialityCode: CD
+ derivationExpression: ST
+ comment: ST
Adv erse Ev ent Sub-Domain::
1 PerformedProductInv estigationResult
{leaf}
{triggers}
Adv erse Ev ent Sub-Domain::
Ev aluatedActiv ityRelationship
{is a choice that has as option}
+
+
+
is triggered by
0..*
+
+
{Repeat Frequency Exclusive Or}
0..* {Repeat Duration or Quantity Exclusive Or}
{actualIndicator Qualifier}
+choice
delayDuration: PQ.TIME
Study Conduct Sub-Domain::PerformedAdministrativ eActiv ity
{leaf}
+
+
+
+
Study Conduct Sub-Domain::
ReferenceResult
Adv erse Ev ent Sub-Domain::
ProductActionTakenRelationship
1
Regulatory Sub-Domain:
:RegulatoryApplication
{functions as}
{is triggered by} 0..*
1
Protocol Representation Sub-Domain::PlannedActivity
+ name: ST
+ purpose: ST
+ targetAccrualNumberRange: URG<INT>
+ description: ST
+ blindedDescription: ST
+ plannedDuration: PQ.TIME
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: INT
+ /repeatDuration: PQ.TIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
constraints
{Is a Function Performed By Qualifier}
{Permissible Result Qualifier}
0..*
identifier: II
typeCode: CD
result: ANY
resultCodeModifiedText: ST
targetAnatomicSiteCode: CD
confidentialityCode: CD
uncertaintyCode: CD
reportedDate: TS.DATETIME
comment: ST
triggers
Protocol Representation Sub-Domain::
DefinedStratificationCriterion
{leaf}
constraints
{actualIndicator Qualifier}
typeCode: CD
comment: ST
{is the component of}
constraints
constraints
{Is a Function Performed By Not Applicable}
+
+
+
+
+
+
+
+
+
constraints
{is the parent of}
::DefinedObservation
+ methodCode: DSET<CD>
+ bodyPositionCode: CD
+ targetAnatomicSiteCode: CD
+ targetAnatomicSiteLateralityCode: CD
+ /focalDuration: PQ.TIME
+ focalDateRange: EXPR<IVL<TS.DATETIME>>
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Study Conduct
Sub-Domain::
CollectingLaboratory
Regulatory
effectiveDateRange: IVL<TS.DATETIME>
constraints
{Is a Function Performed By Exclusive Or}
is a function
performed by
0..*
Study Design
Protocol Representation Sub-Domain::
DefinedSubstanceAdministration
{leaf}
+ dose: PQ
+ doseFrequencyCode: CD
+ doseRegimen: ST
+ dailyDoseTotal: PQ
+ routeOfAdministrationCode: CD
::DefinedProcedure
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Regulatory Sub-Domain::Submission
Regulatory Sub-Domain::
RegulatoryApplicationSponsor
+
jurisdictionCode: CD
effectiveDateRange: IVL<TS.DATETIME>
{is an option that can satisfy}
pauseQuantity: PQ.TIME
evaluableExpression: ED
comment: ST
constraints
{Is Contingent Upon Exclusive Or}
Study Conduct
Sub-Domain::
PerformingLaboratory
{functions as}
identifier: DSET<II>
assessmentCode: CD
assessmentDate: TS.DATETIME
{contains}
identifier: II
Regulatory Sub-Domain::
RegulatoryAssessment
+
+
+
+
+
+
+prerequisite
{is a condition for}
Protocol Representation
Sub-Domain::
0..*
is a function performed by StudyOv ersightAuthority
0..1
is assigned to
1
is a choice that has as option
is a condition for
constraints
{Is a Function Performed By Exclusive Or}
{functions as}
0..* +triggering
0..*
Protocol Representation
Sub-Domain::
PlannedContingentOnRelationship
Protocol Representation Sub-Domain::
DefinedImaging
{leaf}
0..*
Regulatory Sub-Domain::
Ov ersightAuthority
{root} 1
Regulatory Sub-Domain::RegulatoryAuthority
{leaf}
0..*
0..*
primaryIndicator: BL
has as parent
{is the parent for}
+subdividing 0..*
cessationPauseQuantity: PQ.TIME
checkpointCode: CD
conjunctionCode: CD
comment: ST
+repeated
{Uses Qualifier}
Protocol Representation Sub-Domain::
DefinedExperimentalUnitAllocation
{leaf}
+ methodCode: CD
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
0..*
Protocol Representation
Sub-Domain::
RegistrationCenter
{leaf}
+
+
0..* +
+
+
constraints
{Is Repeated Until Exclusive Or}
1
1
is a function performed by
+
+
+
activeIndicator: BL
inactiveComment: ST
Protocol Representation
Sub-Domain::Funding
{leaf}
Common
Sub-Domain::
StudyRegistry
{functions as}
Study Conduct
Sub-Domain::
Laboratory
+
0..*
+
1.. +
{provides}
identifier: II
effectiveDateRange: IVL<TS.DATETIME>
0..1
{functions as}
+
{functions as}
is repeated until
{triggers the cessation of}
0..1
0..1
{is a condition for}
constraints
Protocol Representation Sub-Domain::
DefinedSpecimenStorage
{leaf}
Protocol Representation Sub-Domain::
StudyLegalSponsor
is a function performed by
Common Sub-Domain::OrganizationPart
0..*
Protocol Representation Sub-Domain::
PlannedRepeatActiv ityUntilRule
{is overseen by}
0..1
0..1
is a function
performed by
constraints
{Is a Function Performed By Qualifier}
{is the responsibility of}
describes
reviewBoardApprovalNumberText: ST
0..* {is described by} 1
reviewBoardApprovalStatusCode: CD
reviewBoardApprovalDate: TS.DATETIME
0..1
1
+performed 0..1
Protocol Representation Sub-Domain::
DefinedStudyAgentTransfer
{leaf}
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
{functions as}
is a function performed by
+performing
result: ANY
typeCode: CD
targetCodingSystem: II
targetAnatomicSiteCode: CD
confidentialityCode: CD
derivationExpression: ST
comment: ST
0..*
+ methodCode: CD
+ approachAnatomicSiteCode: CD
+ targetAnatomicSiteCode: CD
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
Common Sub-Domain::Organization
+
+
+
+
+
+
+
is contingent upon
{is a condition for}
oversees
Study Conduct Sub-Domain::
StudySiteOv ersightStatus
+
+
+
0..1
is a function performed by
{functions as}
1
{is an option that can satisfy}
0..1
Protocol Representation Sub-Domain::
DefinedObserv ation
{leaf}
Protocol Representation Sub-Domain::DefinedAdministrativ eActiv ity
{leaf}
constraints
{Is a Function Performed By Qualifier}
constraints
{Is a Function Performed By Exclusive Or}
0..*
effectiveDateRange: IVL<TS.DATETIME>
{credentials}
occurs in
0..1
is the parent of
is a function
performed by
identifier: II
leadIndicator: BL
targetAccrualNumberRange: URG<INT>
accrualStatusCode: CD
accrualStatusDate: TS.DATETIME
dateRange: IVL<TS.DATETIME>
statusCode: CD
statusDate: TS.DATETIME
{credentials}
0..*
1
Common Sub-Domain::
HealthcareProv iderGroup
+
is credentialed by
0..1
is contingent upon
1
+
+
+
+
+
+
+
+
{triggers the cessation of}
0..*
{contains}
0..1
1
Study Conduct Sub-Domain::StudySite
identifier: II
postalAddress: AD
effectiveDateRange: IVL<TS.DATETIME>
Common Sub-Domain::OrganizationalContact
0..*
0..1
is a result of
1
+
+
+
is repeated until
constraints
{Is a Choice that has as Option Exclusive Or}
{is the component of}
+
+
+
+
+
+
+
Common Sub-Domain::HealthcareFacility
identifier: II
typeCode: CD
certificateLicenseText: ST
effectiveDateRange: IVL<TS.DATETIME>
1
is a function
performed by
{functions as}
0..*
+credentialed
is a use of
{is used as}
associates a study to
{is associated to a study by}
constraints
{Is a Function Performed By Qualifier}
{Is a Function Performed By Exclusive Or}
Common Sub-Domain:
:Cooperativ eGroup
belongs to
0..*
Common Sub-Domain::QualifiedPerson
+
+
+
+
{functions as}
0..*
is a member of
0..*
is a function {has as a member}
0..1
performed by
constraints
{actualIndicator Exclusive Or}
is a choice that has as option
{is associated to
a study by}
Protocol Representation Sub-Domain::
DefinedStudySubj ectMilestone
{leaf}
::StudySiteContact
+ roleCode: CD
+ primaryIndicator: BL
+ postalAddress: AD
+ telecomAddress: BAG<TEL>
+ statusCode: CD
+ statusDate: TS.DATETIME
occurs in
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
{is an option that can satisfy}
constraints
Study Conduct Sub-Domain::
StudySiteResearchCoordinator
Study Conduct Sub-Domain::
StudySiteInv estigator
+ dateRange: IVL<TS.DATETIME>
+ /duration: PQ.TIME
+ repeatQuantity: URG<INT>
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
0..1
{contains}
Protocol Representation Sub-Domain::DefinedObserv ationResult
::DefinedActivity
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
0..* ::StudySiteContact
+ roleCode: CD
+ primaryIndicator: BL
+ postalAddress: AD
+ telecomAddress: BAG<TEL>
+ statusCode: CD
+ statusDate: TS.DATETIME
0..1
+choice 0..*
Protocol Representation Sub-Domain::
PlannedCriterionGroupOptionRelationship
+
+
+
{is the
component of}
{triggers the cessation of}
+triggering 1
0..1
{assigns}
{functions as}
+option
is a choice that has as option
{is an option that can satisfy}
+option 0..*
is a choice that has as option
is assigned by
is a function
performed by
1..*
1..*
{leaf}
1
{is a choice that has as option}
{is the component of}
0..1
0..*
Common Sub-Domain::
HealthcareProv iderGroupMember
Study Conduct Sub-Domain::
ScheduledActiv ity
+choice
is an option that can satisfy
{is an option
that can satisfy}
{is the component of}
roleCode: CD
primaryIndicator: BL
postalAddress: AD
telecomAddress: BAG<TEL>
statusCode: CD
statusDate: TS.DATETIME
effectiveDateRange: IVL<TS.DATETIME>
0..*
0..1
Protocol Representation Sub-Domain::PlannedCriterionGroup
0..1
{results in}
Study Conduct Sub-Domain::
StudySiteContact
+
+
+
+
+
+
is a function
performed by
{has as a member}
is a function
performed by
{functions as}
0..*
is the parent of
{is the component of}
1 +component
is a choice
that has as
option
0..1
1
{root}
is a member of
{functions as}
+option
{is the parent of}
is the parent
of
associates a study to
Protocol Representation
0..*
Sub-Domain::StudyActiv ity
0..1
is a function performed by
1
{triggers the cessation of}
1
associates an activity to
{is associated to an activity by}
0..*
0..1
0..1
1
{assigns}
+choice
Protocol Representation Sub-Domain::DefinedCriterionGroup
{actualIndicator Qualifier}
{Repeat Frequency Exclusive Or}
{Repeat Duration or Quantity Exclusive Or}
{categoryCode Qualifier}
1
0..*
{is a choice that
has as option}
0..1
0..* +composite
is the component of
+composite
is the parent of
{has results referenced in} 1
primaryIndicator: BL
effectiveDateRange: IVL<TS.DATETIME>
0..* +component
{is an option that
can satisfy}
is the parent of
{leaf} 0..1
constraints
{Is a Function Performed By Qualifier}
{Is a Function Performed By Exclusive Or}
is assigned by
1
0..1
constraints
+
+
+ identifier: II
+ signatureText: ST
+ effectiveDateRange: IVL<TS.DATETIME>
::StudyContact
+ roleCode: CD
+ primaryIndicator: BL
+ postalAddress: AD
+ telecomAddress: BAG<TEL>
+ statusCode: CD
+ statusDate: TS.DATETIME
constraints
{Is a Function Performed By Exclusive Or}
0..*
{triggers the cessation of}
{Is the Parent Of Exclusive Or}
Protocol Representation Sub-Domain::DefinedActiv ity
associates a resource to
Protocol Representation Sub-Domain::
StudyResource
Protocol Representation Sub-Domain::
StudyInv estigator
{leaf}
identifier: II
typeCode: CD
actualIndicator: BL
postalAddress: AD
telecomAddress: BAG<TEL>
effectiveDateRange: IVL<TS.DATETIME>
0..*
Common Sub-Domain::HealthcareProv ider
+
+
+
+
+
constraints
{Is a Function Performed By Exclusive Or}
1
{is the
component of}
+component
1
pauseQuantity: PQ.TIME
priorityNumber: INT
comment: ST
constraints
{Is the Choice that has as Option Exclusive Or}
0..*
+option
+choice
0..*
0..* 0..*
0..*
is a choice that
is an option that
has as option
can satisfy
0..*
is repeated until
0..*
0..*
+repeated
is repeated until
{is repeated until}
+prerequisite
+composite
is repeated until
sequenceNumber: INT
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
constraints
+
+
+
+composite
0..*
is the parent
of
{is the parent of}
+ nameCode: CD
+ categoryCode: CD
+ subcategoryCode: CD
+ repeatFrequencyCode: CD
+ repeatFrequencyRatio: RTO<INT,PQ.TIME>
+ repeatQuantity: URG<INT>
+ /repeatDuration: PQ.TIME
+ description: ST
+ statusCode: CD
+ statusDate: TS.DATETIME
::Activity
+ identifier: II
+ reasonCode: DSET<CD>
+ comment: ST
references the results of
publicationIdentifier: II
0..*
publicationName: ST
universalResourceLocator: URL
citationDescription: ST
linkPageDescription: ST
cessationPauseQuantity: PQ.TIME
checkpointCode: CD
conjunctionCode: CD
comment: ST
0..*
+triggering
0..*
triggers the
cessation of
0..*
0..* +
+
+
+
+
+
{functions as}
+
+
is contingent upon +
1
publicationIdentifier: II
publicationName: ST
universalResourceLocator: URL
citationDescription: ST
linkPageDescription: ST
+
+
+
+
+
Protocol Representation Sub-Domain::
DefinedRepeatActiv ityUntilRule
constraints
{Is Repeated Until Exclusive Or}
Protocol Representation
Sub-Domain::
ReferenceToStudyResults
Common Sub-Domain::DocumentReceiv er
Common Sub-Domain::Performer
is a function performed by
is the
component of
1
+
+
+
+
+
0..*
+
+
+
+
Protocol Representation Sub-Domain::
DefinedCriterionGroupOptionRelationship
sequenceNumber: INT
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
constraints
{Is the Component Of Exclusive Or}
+component
{is a condition for}
Studies
handles communications for
::StudyContact
+ roleCode: CD
+ primaryIndicator: BL
+ postalAddress: AD
+ telecomAddress: BAG<TEL>
+ statusCode: CD
+ statusDate: TS.DATETIME
typeCode: CD
effectiveDateRange: IVL<TS.DATETIME>
Protocol Representation Sub-Domain::
DefinedCriterionGroupCompositionRelationship
+
+
+
+
0..*
is a condition f
pauseQuantity: PQ.TIME
priorityNumber: INT
comment: ST
Protocol Representation Sub-Domain::
StudyReference
+
+
0..*
+contingent
+
1..*
is contingent upon
{is a condition for}
0..*
evaluableExpression: ED
pauseQuantity: PQ.TIME
completionRequiredBeforeStartingIndicator: BL
comment: ST
constraints
{completionRequiredIndicator Qualifier}
{Is Contingent Upon Exclusive Or}
Protocol Representation
Sub-Domain::
DefinedOptionRelationship
describes
studyStoppedReasonCode: CD
anticipatedIndicator: BL
comment: ST
statusCode: CD
statusDate: TS.DATETIME
{has communications handled by}
1..*
Study Conduct Sub-Domain::
StudyResearchCoordinator
{leaf}
Common Sub-Domain::ResearchOrganization
Common Sub-Domain::
Administrativ eMemberCRA
0..1
+
+
+
+
+
sequenceNumber: INT
priorityNumber: INT
pauseQuantity: PQ.TIME
comment: ST
Study Conduct Sub-Domain::
StudyOv erallStatus
Protocol Representation Sub-Domain::
StudyContact
{root}
Common Sub-Domain::ResearchStaff
{leaf}
Protocol Representation Sub-Domain::
PlannedCriterionGroupCompositionRelationship
acronym: ST
phaseCode: CD
primaryPurposeCode: CD
purposeStatement: ST
diseaseCode: DSET<CD>
targetAnatomicSiteCode: DSET<CD>
designConfigurationCode: CD
studySchematic: ED
populationDescription: ST
studySubjectTypeCode: CD
plannedStudySubjectExperience: ST
targetAccrualNumberRange: URG<INT>
periodicTargetAccrualNumber: RTO<INT,PQ>
accrualReportingMethodCode: CD
responsiblePartyCode: CD
participatingOrganizationTypeCode: CD
participatingCountryCode: DSET<CD>
aeCodingSystem: II
multiInstitutionIndicator: BL
describes
{is described by}
0..*
Common Sub-Domain::Person
identifier: II
reasonCode: DSET<CD>
comment: ST
performs
{is performed by}
Common Sub-Domain::StudySubj ectIdentifier
identifies
Study Conduct Sub-Domain::
StudyRecruitmentStatus
+ name: PN
+ initials: ST
+ raceCode: DSET<CD>
+ ethnicGroupCode: DSET<CD>
+ postalAddress: AD
+ telecomAddress: BAG<TEL>
+ maritalStatusCode: CD
+ educationLevelCode: CD
+ primaryOccupationCode: CD
+ occupationDateRange: IVL<TS.DATE>
+ deathIndicator: BL
::BiologicEntity
+ actualIndicator: BL
+ administrativeGenderCode: CD
+ birthCountryCode: CD
+ birthOrder: INT
+ birthDate: TS.DATETIME
+ deathDate: TS.DATETIME
name: ST
typeCode: CD
sequenceNumber: INT
description: ST
constraints
{name Unique}
state: ST
Common Sub-Domain::StudySubj ect
{leaf}
{is identified
by}
1
{root}
Adv erse Ev ent Sub-Domain::SafetyReport
{leaf}
typeCode: DSET<CD>
constraints
{Is a Function Performed By Exclusive Or}
Common Sub-Domain::BiologicEntityIdentifier
name: ST
typeCode: CD
targetAccrualNumberRange: URG<INT>
randomizationWeightText: ST
description: ST
{name Unique}
+ subtypeCode: CD
+ nullificationReasonCode: CD
+ nullificationIndicator: BL
::Report
+ communicationModeCode: CD
::Document
+ typeCode: CD
+ officialTitle: ST
+ text: ED
+ keywordCode: DSET<CD>
+ keywordText: DSET<ST>
+ revisionReason: ST
+ revisionNumberText: ST
+ uniformResourceLocator: URL
+ bibliographicDesignation: ST
Common Sub-Domain::
AssociatedBiologicEntity
+
+
+
+
Protocol Representation
Sub-Domain::Epoch
name: TN
typeCode: CD
quantity: INT
actualIndicator: BL
+
Common Sub-Domain::
DocumentWorkflow Status
constraints
{Is a Function Performed By Exclusive Or}
Study
Subjects
+
+
+
+
+ publicTitle: ST
+ publicDescription: ST
+ scientificDescription: ST
::Document
+ typeCode: CD
+ officialTitle: ST
+ text: ED
+ keywordCode: DSET<CD>
+ keywordText: DSET<ST>
+ revisionReason: ST
+ revisionNumberText: ST
+ uniformResourceLocator: URL
+ bibliographicDesignation: ST
0..*
+ communicationModeCode: CD
::Document
+ typeCode: CD
+ officialTitle: ST
+ text: ED
+ keywordCode: DSET<CD>
+ keywordText: DSET<ST>
+ revisionReason: ST
+ revisionNumberText: ST
+ uniformResourceLocator: URL
+ bibliographicDesignation: ST
Common Sub-Domain::ExperimentalUnit
+
+
0..* +
+
is a function performed by
0..1
anatomicSiteCode: CD
anatomicSiteLateralityCode: CD
0..* +
+
+
+
+
+
+
Protocol Representation Sub-Domain::
StudyProtocolDocument
describes
{is described by}
constraints
{Is a Function Performed By Qualifier}
5
CDISC SHARE VISION
A global, accessible electronic metadata library,
which through advanced technology, enables
precise and standardized data element
definitions and richer metadata that can be
used in applications and studies to improve
biomedical research and its link with healthcare.
http://www.cdisc.org/cdisc-share
© CDISC 2011
6
• Single, trusted, authoritative source for
CDISC data standards
• Concepts, metadata, collections,
relationships, value sets across the full
spectrum of CDISC content
• Links research to healthcare concepts to
support interoperability
• Aligned with NCI Semantic Systems
Graphics adapted from Source by Sue Dubman, Sanofi-Aventis
7
© CDISC 2011
7
SHARE Top-Level Functions
SHARE
Functions
1. Manage
Users
•
•
•
•
Manage User
Roles
Manage User
Profiles
Manage
Password
Manage User
Dashboard
3. Using
SHARE
Content
2. Manage
Content
•
•
•
Manage Work
Items
Manage
Standard
Objects
Manage Audit
Trail
•
•
•
•
Search and
Browse
Import
Export
Print
4. Manage
Reporting and
Dissemination
•
•
Send
Notifications
to users re
object
changes
Manage listserv
5. Manage
System
•
•
•
•
© CDISC 2011
Manage
SHARE MDR
Framework
Components
Monitor User
Activity
Maintain
Metrics
Manage
System
Availability
8
CDISC SHARE Library Contents
• Metadata (including BRIDG, SDTM and CDASH)
 Trial Design Metadata
 Definitions
 Datatypes (ISO 21090)
• Links to controlled terminology (CT) dictionaries
via the NCIt (which links to CDISC CT, SNOMED,
ICD9, ICD10, UMLS, etc.)
• Implementation instructions
• Links to analysis concepts.
© CDISC 2011
9
SHARE MDR Framework
Versioned
Standards
Other External Resources
(e.g. value Sets)
Operational
Collections
Research Concepts
Integrated BRIDG /
ISO 21090
Templates
BRIDG
© CDISC 2011
ISO 21090
data
types
A Versioned Standard is comprised of a set of
Operational Collections and associated variables and rules for
a specific use case (e.g., SDTM, CDASH)
An Operational Collection is a grouping of Research Concepts.
There may be additional rules between objects within the
Operational Collection. An Operational Collection may be
analogous with a SDTM Domain, a CRF, an ADaM data set, or a
similar level of operational structure.
Basic elements that are the foundation for the content described
in the SHARE repository. A Research Concept defines one or
more related pieces of clinical data, which is developed using an
Integrated BRIDG / ISO 21090 Template.
Integrated BRIDG / ISO 21090 Templates use BRIDG classes
and relationships to fashion small re-usable patterns that are
commonly needed in clinical research
BRIDG is the foundation model for SHARE that
provides classes, attributes and associations use to
creates core building blocks.
10
SHARE - Describes the Links between
the Metadata
Relationship
Relationship
Relationship
© CDISC 2011
Diagram – Dave Iberson-Hurst
The CDISC SHARE MODEL
CDISC SHARE MODEL
BRIDG Classes
21090 Data types
SDTM Variables
CDASH Variables
Controlled Terminology
© CDISC 2011
12
Content Mapping
© CDISC 2011
SHARE Concept-Based View
VIEWS
Protocol/TDM
CONTROLLED
TERMINOLOGY
BRIDG
DEFINITIONS
21090
DATA TYPES
SHARE
CONCEPTS
CRFs/CDASH
(E.G. BLOOD
PRESSURE)
Analysis/ADa
M
TFLs/SDTM
SHARE FOUNDATION
© CDISC 2011
Define.
XML
14
SHARE Status Update
• RFI issued in August – 24 responses; 10 short-listed
 Software vendors, academics, system integrators
• Draft RFP due to be released in December - targeting a
decision by Q1 2013
• Updated business requirements will soon be posted on
CDISC website
• Currently exploring additional partnership and funding
options.
• Goal is to have a release 1 prototype environment in
initial use by end of 2013.
© CDISC 2011
15
Strength through collaboration.
Wayne R. Kubick
[email protected]
© CDISC 2011
16