Transcript Source concept

Proposed BRIDG Changes for
New Imaging Sub-Domain
September, 2016
Wendy Ver Hoef
Ed Helton
Agenda
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Project goal & objectives
Project Team
What are we trying to accomplish?
Imaging use cases under consideration
Iteration 1 – scope and mapping summary
– Overview of new classes
• Iteration 2 – scope and mapping summary
• Changes proposed for existing BRIDG classes
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Project Overview
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Project Goal & Objectives
• Project Goal:
Clinical
Research
Imaging
Genomics
Others
– To provide the semantic foundation for supporting standards-based
interoperability between the imaging, clinical and genomics domains
to enable advances in precision medicine.
• Project Objectives:
– To align the Imaging concepts from various NCI and external
standards initiatives and harmonize or align with the BRIDG model
concepts
• Add Imaging semantics to BRIDG to ensure that BRIDG represents the
imaging concepts needed to support NCI efforts – DICOM, NBIA, AIM,
Micro-AIM, CIP, CTIIP.
• Understand requirements and mechanics for modeling by reference the
Imaging-related concepts that are already well established in another
standard but are required for translational research in BRIDG
NOTE: This does not necessarily mean that all imaging concepts will be in
BRIDG, but that BRIDG is able to implement modeling-by-reference and
point correctly to external standards to enable interoperability.
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Project Team
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Wendy Ver Hoef
David Clunie
Smita Hastak
Ulli Wagner
Ed Helton
What are we trying to accomplish?
• Leverage BRIDG as the framework to support
interoperability between clinical research and imaging
– Do this by using existing standards – DICOM, AIM, HL7
FHIR
– Identify and harmonize the touch points with BRIDG when
overlap exists
– Develop a methodology to point to or navigate to other
standards from a semantic point of view
• We are referring to this as “modeling by reference”, meaning
enough concepts from one model in another to be able to
support interoperability between them
– Develop and implement real world use case(s) to show
how leveraging BRIDG as a framework will enable
interoperability
Imaging Use Cases Under Consideration
1. Identification of entities – person, animal, specimen,
image
2. Image acquisition
3. Image Type (modalities)
4. Annotation & Structured Reporting
5. Pathology (WSI); electron microscopy(J Saltz)
6. Archiving (building a single archive for radiology,
WSI and proteogenomic)
7. Support gene panels
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Iteration 1
DICOM
First draft done
Iteration 2
AIM & DICOM
SR TID 1500,
first draft
done
Iteration 1: Identification of entities, Image
acquisition, and Image Type
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Project Scope for Iteration 1
• Focus of the DICOM to BRIDG mapping was to support the
first 3 use cases of Identification of entities, Image acquisition
and Image Type (modalities)
– Scoped to CT, MR, PET
– Key concepts of Series and Image level of data were
summarized in BRIDG
• Identify the touch points between BRIDG and DICOM to
support an implementable interoperability scenario
– Scoped to interfaces only
– Include enough imaging concepts in BRIDG to find desired data
in a DICOM-based system
• Scope informed by the QIBA (Quantitative Imaging Biomarker
Alliance) CT Tumor Volume Change for Advanced Disease
(CTV-AD) Profile.
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Out-of-Scope in DICOM to BRIDG mapping
• Images and Series themselves are out-of-scope, just key
summary-level metadata about the images are in scope
• Elements from DICOM that were not considered likely
search criteria
• DICOM implementation-specific structures
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Summary of DICOM to BRIDG Mapping
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Initial draft model completed July, 2016
– Worked with David Clunie, DICOM SME
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Scoped to CT, MR and PET modalities
– Plus other concepts re general imaging, equipment, acquisition,
reconstruction, etc.
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Mapping done in 2 sets:
– Spreadsheet 1: Mapped modules, macros or other groups of DICOM
concepts (e.g., Subject, parts of Imaging Study, Series & instance,
equipment, etc.)
• 794 distinct DICOM elements considered in total
– Artifact: Main DICOM spreadsheet
– Spreadsheet 2: Mapped DICOM Supplement 121 (Protocol related
elements)
• 178 distinct DICOM elements considered in total
– Artifact: Supplement 121 mapping spreadsheet
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Detailed mapping spreadsheets require knowledge of BRIDG, but can
be provided if interest exists
Results of the Mapping
• New draft classes and attributes added to the BRIDG
model in the new Imaging Sub-Domain
– 13 new classes (~approx.)
– 58 new attributes
• Existing classes not changed yet, pending approval from
the BRIDG WG
– 8 existing classes, see details in subsequent slides
• ~ 79% of DICOM elements were designated out-ofscope
Key Imaging Concepts Added to BRIDG
• PerformedImagingStudy – subclass of PerformedObservation
• PerformedImagingTimepoint – subclass of PerformedActivity
• ImagingProcessProtocol – subclass of ProcessProtocol
– GenericImagingProcessProtocol – DICOM’s “defined” protocol
– SpecificImagingProcessProtocol – DICOM’s “performed” protocol
• ImagingProcessProtocolElement – subclass of DefinedActivity
– ImagingAcquisitionProtocolElement
– ImagingReconstructionProtocolElement
– Each of these have 3 subclasses: one each for CT, MR, PET
• Radiopharmaceutical – subclass of Drug
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PerformedImagingStudy & PerformedImagingTimepoint
PerformedImagingStudy class
• dicomStudyID
• imagingAccessionIdentifier
• description
• admittingDiagnosisCode
• nonAcquisitionModalitiesInStudyCode
• subjectHistory
• subjectAge
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subjectHeight
subjectWeight
storageSOPClassesInStudy
lossyImageCompressionIndicator
seriesCount
imageCount
PerformedImagingTimepoint class
class PerformedImagingStudy
Common Sub-Domain::Activity
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identifier: II [0..1]
reasonCode: DSET<CD> [0..*]
comment: ST [0..1]
Both classes inherit
attributes from Activity,
PerformedActivity and
PerformedObservation
parent classes
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Study Conduct Sub-Domain::
PerformedActiv ity
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/repetitionNumber: INT.POS [0..1]
nameCodeModifiedText: ST [0..1]
dateRange: IVL<TS.DATETIME> [0..1]
dateRangeValidationCode: CD [0..1]
/studyDayRange: IVL<INT> [0..1]
/duration: PQ.TIME [0..1]
/delayDuration: PQ.TIME [0..1]
negationIndicator: BL [0..1]
negationReason: DSET<SC> [0..*]
/fastingStatusIndicator: BL [0..1]
/medicalHistoryIndicator: BL [0..1]
statusCode: CD [0..1]
statusDate: TS.DATETIME [0..1]
Study Conduct Sub-Domain::
PerformedObserv ation
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methodCode: CD [0..1]
targetAnatomicSiteCode: CD [0..1]
targetAnatomicSiteLateralityCode: CD [0..1]
approachAnatomicSiteCode: CD [0..1]
approachAnatomicSiteLateralityCode: CD [0..1]
bodySystemCode: CD [0..1]
bodyPositionCode: CD [0..1]
/focalDateRange: IVL<TS.DATETIME> [0..1]
/focalDuration: PQ.TIME [0..1]
Imaging Sub-Domain::
PerformedImagingTimepoint
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description: ST [0..1]
Imaging Sub-Domain::PerformedImagingStudy
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dicomStudyID: ST [0..1]
imagingAccessionIdentifier: II [0..1]
description: ST [0..1]
admittingDiagnosisCode: DSET<CD> [0..*]
nonAcquisitionModalitiesInStudyCode: DSET<CD> [0..*]
/subjectHistory: ST [0..1]
/subjectAge: PQ.TIME [0..1]
/subjectHeight: PQ [0..1]
/subjectWeight: PQ [0..1]
storageSOPClassesInStudy: DSET<OID> [0..*]
lossyImageCompressionIndicator: BL [0..1]
seriesCount: INT.NONNEG [0..1]
imageCount: INT.NONNEG [0..1]
ImagingProcessProtocol
• ImagingProcessProtocol has no attributes aside from
inherited ones (e.g. identifier, nameCode, title)
• 2 Subclasses:
– GenericImagingProcessProtocol – template protocol
– SpecificImagingProcessProtocol – template applied to subject
class ImagingProcessProtocol
Common Sub-Domain::Activity
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identifier: II [0..1]
reasonCode: DSET<CD> [0..*]
comment: ST [0..1]
Protocol Representation Sub-Domain::DefinedActiv ity
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nameCode: CD [1...1]
categoryCode: CD [0..1]
subcategoryCode: CD [0..1]
repeatFrequencyCode: CD [0..1]
repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
repeatQuantityRange: URG<INT.NONNEG> [0..1]
/repeatDuration: PQ.TIME [0..1]
description: ST [0..1]
statusCode: CD [0..1]
statusDate: TS.DATETIME [0..1]
Common SubDomain::
ProcessProtocol
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title: ST [0..1]
«Comment_Requested»
Imaging Sub-Domain::
GenericImagingProcessProtocol
0..*
be based on
{be the basis of}
0..*
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Imaging Sub-Domain::
ImagingProcessProtocol
«Comment_Requested»
Imaging Sub-Domain::
SpecificImagingProcessProtocol
lass ImagingProcessProtocolElement
ImagingProcessProtocolElement
Protocol Representation Sub-Domain::DefinedActiv ity
Common Sub-Domain::Activity
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identifier: II [0..1]
reasonCode: DSET<CD> [0..*]
comment: ST [0..1]
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nameCode: CD [1...1]
categoryCode: CD [0..1]
subcategoryCode: CD [0..1]
repeatFrequencyCode: CD [0..1]
repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
repeatQuantityRange: URG<INT.NONNEG> [0..1]
/repeatDuration: PQ.TIME [0..1]
description: ST [0..1]
statusCode: CD [0..1]
statusDate: TS.DATETIME [0..1]
Imaging Sub-Domain::
ImagingProcessProtocolElement
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summary: ST [0..1]
bodyPositionCode: CD [0..1]
primaryAnatomicSiteCode: DSET<CD> [0..*]
Imaging Sub-Domain::
ImagingAcquisitionProtocolElement
Imaging Sub-Domain::
ImagingReconstructionProtocolElement
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acquisitionTypeCode: DSET<CD> [0..1]
specifies a reconstruction of
imageTypeCode: DSET<CD>
cardiacSynchronizationTechniqueCode: CD [0..1] 1..* {be specified for reconstructing} 0..* respiratoryMotionTechniqueCode: CD [0..1]
dataCollectionDiameter: PQ [0..1]
resonantNucleusCode: CD
Imaging Sub-Domain::
Imaging Sub-Domain::
CTImagingAcquisitionProtocolElement
MRImagingAcquisitionProtocolElement
Acquisition
Subclasses
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singleCollimationWidth: IVL<PQ> [0..1]
totalCollimationWidth: IVL<PQ> [0..1]
gantryDetectorTilt: IVL<PQ> [0..1]
tableSpeed: IVL<PQ> [0..1]
spiralPitchFactor: IVL<PQ> [0..1]
ctdiVol: IVL<PQ> [0..1]
ctdiPhantomTypeCode: CD [0..1]
kVp: IVL<PQ> [0..1]
exposureModulationTypeCode: DSET<CD> [0..*]
Imaging Sub-Domain::
PETImagingAcquisitionProtocolElement
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gantryDetectorTilt: IVL<PQ>
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echoPulseSequenceCategoryCode: CD
diffusionBValue: IVL<PQ>
diffusionDirectionalityCode: CD
magneticFieldOfStrength: PQ
acquisitionContrastCode: CD
inversionRecoveryIndicator: BL
pulseSequenceName: ST
multipleSpinEchoIndicator: BL
phaseContrastIndicator: BL
timeOfFlightContrastIndicator: BL
arterialSpinLabelingContrastCode: CG
steadyStatePulseSequenceCode: CD
echoPlanarPulseSequenceIndicator: BL
saturationRecoveryIndicator: BL
spectrallySelectedSuppressionCode: CD
Reconstruction
Subclasses
reconstructionFieldOfViewHeight: IVL<PQ> [0..1]
reconstructionFieldOfViewWidth: IVL<PQ> [0..1]
reconstructionDiameter: IVL<PQ> [0..1]
slideThickness: IVL<PQ> [0..1]
reconstructionInterval: IVL<PQ> [0..1]
bodyPositionCode: CD [0..1]
algorithmCode: CD
typeCode: CD
Imaging Sub-Domain::
CTImagingReconstructionProtocolElement
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convolutionKernal: ST [0..1]
convolutionKernalGroup: DSET<CD> [0..1]
Imaging Sub-Domain::
MRImagingReconstructionProtocolElement
Imaging Sub-Domain::
PETImagingReconstructionProtocolElement
class Radiopharmaceutical
Radiopharmaceutical
• One attribute
– radionuclideCode
Common Sub-Domain::Material
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code: CD [0..1]
formCode: CD [0..1]
description: ST [0..1]
characteristicBehaviorCode: DSET<CD>
actualIndicator: BL [1...1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
Common Sub-Domain::Product
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typeCode: CD [0..1]
classCode: DSET<CD> [0..*]
codeModifiedText: ST [0..1]
lotNumberText: ST.SIMPLE [0..1]
expirationDate: TS.DATE.FULL [0..1]
pre1938Indicator: BL [0..1]
Common Sub-Domain::Drug
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actionModeCode: CD [0..1]
handlingCode: CD [0..1]
riskCode: CD [0..1]
stabilityDuration: IVL<TS.DATETIME> [0..1]
Imaging Sub-Domain::
Radiopharmaceutical
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/radionuclideCode: CD
Iteration 2: Annotations and Structured
Reporting
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Scope for Iteration 2
• Focus of iteration 2 was to support the 4th of the BRIDG Imaging use
cases of Annotations and Structured Reporting
• Identify the touch points between BRIDG and AIM or DICOM to
support an implementable interoperability scenario
– Scoped to interfaces only
– Include enough annotation and structured reporting concepts in
BRIDG to link between a BRIDG-based system and an AIM- or
DICOM-based system
– Scoped to CT, MR, PET regions of interest in a cancer context
– Examined known implementations for use cases (ePAD, AIM
ClearCanvas, QIICR 3DSlicer, etc.)
– Size and intensity
– Simple (e.g., RECIST length) and complex (e.g., 3D volume)
– Categorical statements (Q/A; name-value pairs with codes)
– Scope informed by the CDISC Study Data Tabulation Model
(SDTM) Oncology domains (TU, TR) already in BRIDG
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Scope for Iteration 2 (continued)
• Focus of the AIM to BRIDG mapping was particularly
annotation-related concepts:
– Scoped to annotations, basic calculation info, observations,
person ID and equipment used
– Out of scope were most other person info, the studies, series &
images themselves, all Statements,
spatial/dimensional/geometric information, referenced DICOM
info, task context, adjudication info
• Focus of the DICOM SR TID 1500 to BRIDG mapping was
reporting structures:
– Scoped to observation, subject and timepoint contexts, observer
device or person, measurements, measurement groups and
measurement reports
– Out of scope were fetus-related concepts, language, image
library-related concepts, image/spatial/waveform/temporal
coordinates, measurement properties
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AIM Mapping Summary
• 508 concepts in AIM to map
• 511 mappings made – a couple items had more than one
mapping:
– 49 concepts were supported with existing BRIDG classes
– 19 concepts were considered implementation-specific
– 440 concepts are out of scope – too much detail for the
BRIDG use case
– 2 concepts suggest potential BRIDG changes, see
subsequent slides
• No BRIDG changes are done in the model yet as they
are pending BRIDG WG approval
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DICOM SR TID 1500 Mapping Summary
• 296 concepts in DICOM SR TID 1500 (plus associated
macros and other TIDs) to map
• 307 mappings made – a few items had more than one
mapping:
–
–
–
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91 concepts were supported with existing BRIDG classes
1 concept was considered derived
10 concepts were considered implementation-specific
199 concepts are out of scope – too much detail for the BRIDG
use case
– 6 concepts suggest potential BRIDG changes, see subsequent
slides
• No BRIDG changes are done in the model yet as they are
pending BRIDG WG approval
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Conclusion
• First drafts from Iteration 1 and 2 complete
–
–
–
–
Significant reuse of existing semantics, with only 13 new classes
Modest changes to existing BRIDG classes proposed
Sufficient imaging representation in BRIDG for CT, MR and PET
Sufficient image-related annotation information in BRIDG for cancer
CT, MR and PET region of interest measurement and categorical
statement use cases
• Next steps:
– BRIDG WG review proposed changes to existing BRIDG classes
– Stakeholders (e.g., FDA, DICOM experts) review and incorporate
feedback
– Include imaging concepts in the overall BRIDG vocabulary plans
(identification of DICOM value sets in process)
– Tag model with DICOM/AIM mapping tags (in process)
– Include new Imaging Sub-Domain in next BRIDG release and ballot
cycle
– Potentially eventually extend use case representation to whole slide
images
BRIDG Imaging Sub-Domain
class View IM: Imaging
uses
DRAFT
Imaging
Sub-Domain
Name:
View IM: Imaging
Package: Imaging Sub-Domain
Version: 4.1
Author:
wverhoef
Legend
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Protocol Representation SubDomain::
DefinedAdministrativ eActiv ity
Protocol Representation Sub-Domain
Common Sub-Domain
Study Conduct Sub-Domain
Imaging Sub-Domain
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0..*
{be used by}
Protocol Representation Sub-Domain::PlannedActiv ity
be a use of
name: ST [0..1]
0..*
description: ST [0..1]
blindedDescription: ST [0..1]
transitionDescription: ST [0..1]
/studyDayRange: IVL<INT> [0..1]
duration: PQ.TIME [0..1]
repeatFrequencyCode: CD [0..1]
repeatFrequencyRatio: RTO<INT.NONNEG,PQ.TIME> [0..1]
0..1
repeatQuantityRange: URG<INT.NONNEG> [0..1]
/repeatDuration: PQ.TIME [0..1]
agentAdministrationCareSettingTypeCode: CD [0..1]
interruptibleIndicator: BL [0..1]
{be used as}
Protocol Representation SubDomain::StudyActiv ity
0..1 +
Study Conduct Sub-Domain::StudyResource
studyFocusIndicator: BL [0..1]
0..*
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0..*
0..*
instantiate
0..*
{use}
«VNDR»
Study Conduct Sub-Domain:
:Resource
be performed at
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Common SubDomain::
1
Subj ect
Common Sub-Domain::
BiologicEntityClassification
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is classified as
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0..* {classify}
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The Imaging SubDomain diagram
contains more
than just the new
imaging classes.
It also includes all
existing BRIDG
classes to which
DICOM concepts
were mapped.
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identifier: II [1...1]
typeCode: CD [0..1]
identifies
missingIdentifierReasonCode: CD [0..1]
{be
effectiveDateRange: IVL<TS.DATETIME> [0..1] 0..* identified
by}
0..*
Common Sub-Domain::Animal
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breedCode: CD [0..1]
description: ED [0..1]
reproductiveOrgansPresentIndicator: BL [0..1]
«DEPRECATED»
speciesCode: CD [0..1]
Common Sub-Domain::BiologicEntity
1 +
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{scope}
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1..* +
Common Sub-Domain::ResearchStaff
is a function
performed by
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0..* +
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{function as}
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[0..1]
/repeatDuration: PQ.TIME [0..1]
description: ST [0..1]
statusCode: CD [0..1]
statusDate: TS.DATETIME [0..1]
0..1
0..*
be assigned by
{assign}
0..*
{function as}
0..*
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0..*
Study Conduct Sub-Domain:
:Assessor
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evaluatorAlias: ST [0..1]
be a function
performed by
description: ST [0..1]
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be a function
performed by
{function as}
0..*
0..*
Common SubDomain::
Ov ersightAuthority
0..1
{function as}
0..1
0..1
0..1
ImagingProcessProtocolElement
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methodCode: CD [0..1]
bodyPositionCode: CD [0..1]
targetAnatomicSiteCode: CD [0..1]
targetAnatomicSiteLateralityCode: CD [0..1]
approachAnatomicSiteCode: CD [0..1]
/focalDuration: PQ.TIME [0..1]
focalDateRange: IVL<EXPR<TS.DATETIME>> [0..1]
1
identifies
-
0..1
0..*
1
1
1
0..1
{play}
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identifier: II [1...1]
typeCode: CD [0..1]
primaryIndicator: BL [0..1]
identifier: II [1...1]
typeCode: CD [0..1]
identifies
{be the source for}
{be the target for}
Common Sub-Domain::
1..* {is named by} 1
MaterialName
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0..*
Common Sub-Domain::OrganizationRelationship
typeCode: CD [0..1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
name: TN [0..1]
typeCode: CD [0..1]
{function as}
produces
is produced by
1
{produces}
1..*
Common SubDomain::
ProcessedProduct
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0..* {be
produced
by}
identifier: II [0..1]
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typeCode: CD [0..1]
classCode: DSET<CD> [0..*]
codeModifiedText: ST [0..1]
lotNumberText: ST.SIMPLE
[0..1]
expirationDate:
TS.DATE.FULL [0..1]
pre1938Indicator: BL [0..1]
1
/radionuclideCode: CD
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acquisitionTypeCode: DSET<CD> [0..1]
imageTypeCode: DSET<CD>
cardiacSynchronizationTechniqueCode: CD [0..1]
respiratoryMotionTechniqueCode: CD [0..1]
dataCollectionDiameter: PQ [0..1]
actionModeCode: CD [0..1]
handlingCode: CD [0..1]
riskCode: CD [0..1]
stabilityDuration: IVL<TS.DATETIME> [0..1]
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has as source
has as target
{be the target for}
handlingCode: CD [0..1]
riskCode: CD [0..1]
reprocessedDeviceCode: CD [0..1]
/age: PQ.TIME [0..1]
manufactureDate: TS.DATETIME [0..1]
returnedToReprocessorDate: TS.DATETIME
[0..1]
singleUseDeviceIndicator: BL [0..1]
availableForEvaluationIndicator: BL [0..1]
overTheCounterProductIndicator: BL [0..1]
ceMarkIndicator: BL [0..1]
be assigned by
{assign}
specify the use of
{be specified by}
0..*
0..*
0..*
identifier: II [0..1]
typeCode: CD [0..1]
quantity: RTO<PQ,PQ> [0..1]
confidentialityCode: DSET<CD> [0..*]
activeIngredientIndicator: BL [0..1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
-
singleCollimationWidth: IVL<PQ> [0..1]
totalCollimationWidth: IVL<PQ> [0..1]
gantryDetectorTilt: IVL<PQ> [0..1]
tableSpeed: IVL<PQ> [0..1]
spiralPitchFactor: IVL<PQ> [0..1]
ctdiVol: IVL<PQ> [0..1]
ctdiPhantomTypeCode: CD [0..1]
kVp: IVL<PQ> [0..1]
exposureModulationTypeCode: DSET<CD> [0..*]
Protocol Representation Sub-Domain::
DefinedProcedure
0..*
Common Sub-Domain::ProductRelationship
CTImagingAcquisitionProtocolElement
{function as}
Common Sub-Domain::Dev ice
use
{be used during}
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1
lesionNumber: INT.NONNEG [0..1]
appearanceTypeCode: CD [0..1]
contactAnatomicSiteCode: CD [0..1]
measurableIndicator: BL [0..1]
xDimension: PQ [0..1]
yDimension: PQ [0..1]
zDimension: PQ [0..1]
/dimensionProduct: PQ [0..1]
acceptedIndicator: BL [0..1]
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0..* +
0..1
nameCodeModifiedText: ST [0..1]
methodCode: CD [0..1]
targetAnatomicSiteCode: CD [0..1]
targetAnatomicSiteLateralityCode: CD [0..1]
approachAnatomicSiteCode: CD [0..1]
approachAnatomicSiteLateralityCode: CD [0..1]
versionNumberText: ST [0..1]
licenseKey: ST [0..1]
licenseTypeCode: CD [0..1]
licenseEffectiveDateRange: IVL<TS.DATE> [0..1]
buildNumberText: ST [0..1]
content: ED [0..1]
«VNDR»
Protocol Representation Sub-Domain::
StudyProtocolDocumentVersionPublicTitle
Protocol Representation SubDomain::
StudyProtocolDocumentVersion
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publicDescription: ST [0..1]
scientificDescription: ST [0..1]
names
«VNDR» {is named by} 0..*
1
-
contain
{be the contents for}
-
dicomStudyID: ST [0..1]
imagingAccessionIdentifier: II [0..1]
description: ST [0..1]
admittingDiagnosisCode: DSET<CD> [0..*]
nonAcquisitionModalitiesInStudyCode:
DSET<CD> [0..*]
/subjectHistory: ST [0..1]
/subjectAge: PQ.TIME [0..1]
/subjectHeight: PQ [0..1]
/subjectWeight: PQ [0..1]
storageSOPClassesInStudy: DSET<OID> [0..*]
lossyImageCompressionIndicator: BL [0..1]
seriesCount: INT.NONNEG [0..1]
imageCount: INT.NONNEG [0..1]
is responsible for
{be the responsibility of}
0..*
Common Sub-Domain::DocumentVersion
+
+
+
+
+
+
+
+
0..1 +
+
numberText: ST.SIMPLE [0..1]
officialTitle: ST [0..1]
languageCode: CD [0..1]
date: TS.DATETIME [0..1]
keywordCode: DSET<CD> [0..*]
keywordText: DSET<ST> [0..*]
/uniformResourceLocator: TEL.URL [0..1]
bibliographicDesignation: ED [0..1]
revisionReasonCode: DSET<CD> [0..*]
confidentialityCode: CD [0..1]
0..*
PETImagingAcquisitionProtocolElement
-
is a version of
gantryDetectorTilt: IVL<PQ>
CTImagingReconstructionProtocolElement
-
{have as a version}
convolutionKernal: ST [0..1]
convolutionKernalGroup: DSET<CD> [0..1]
1
MRImagingAcquisitionProtocolElement
-
echoPulseSequenceCategoryCode: CD
diffusionBValue: IVL<PQ>
diffusionDirectionalityCode: CD
magneticFieldStrength: PQ
resonantNucleusCode: CD
acquisitionContrastCode: CD
inversionRecoveryIndicator: BL
pulseSequenceName: ST
multipleSpinEchoIndicator: BL
phaseContrastIndicator: BL
timeOfFlightContrastIndicator: BL
arterialSpinLabelingContrastCode: CD
steadyStatePulseSequenceCode: CD
echoPlanarPulseSequenceIndicator: BL
saturationRecoveryIndicator: BL
spectrallySelectedSuppressionCode: CD
Common Sub-Domain::
Document
+
typeCode: CD [0..1]
MRImagingReconstructionProtocolElement
-
1
complexImageComponentCode: CD [0..1]
identifies
PETImagingReconstructionProtocolElement
{be identified by}
0..*
Common Sub-Domain::
DocumentIdentifier
Common Sub-Domain::Softw are
1
{be the source for}
0..*
Common Sub-Domain::Drug
Radiopharmaceutical
-
0..1
be a function performed by
Common Sub-Domain::Product
Common Sub-Domain:
:Processor
-
ImagingProcessProtocol
title: ST [0..1]
0..1 0..1
0..*
code: CD [0..1]
formCode: CD [0..1]
description: ST [0..1]
characteristicBehaviorCode: DSET<CD>
actualIndicator: BL [1...1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
is a function
performed by
0..*
Common Sub-Domain::
Manufacturer
ImagingAcquisitionProtocolElement
wondering if we should keep this in support of LSDAM imaging - should
we consider reviewing those concepts and figure out where they fit?
Common Sub-Domain::Material
+
+
+
+
+
+
0..*{be identified by}1
names
has as target
«placeholder»
ImagingCenter
{result in recording}
0..*
be located at
{be the location for}
Common Sub-Domain::
MaterialIdentifier
0..*
0..1
0..1
Study Conduct Sub-Domain::
PerformedLesionDescription
contains
PerformedImagingStudy
contain
0..*
0..*
has as source
+
+
0..1
+convertedPerformedLesionDescription 0..
+
+
+
+
+
+
+
+
+
0..1
be recorded as a result of
{result in}
1
0..*
methodCode: CD [0..1]
targetAnatomicSiteCode: CD [0..1]
targetAnatomicSiteLateralityCode: CD [0..1]
approachAnatomicSiteCode: CD [0..1]
approachAnatomicSiteLateralityCode: CD [0..1]
bodySystemCode: CD [0..1]
bodyPositionCode: CD [0..1]
/focalDateRange: IVL<TS.DATETIME> [0..1]
/focalDuration: PQ.TIME [0..1]
-
1..*
{be the contents of}
be assigned by
{assign}
1
{be converted into} be converted from
+originalPerformedLesionDescription 0..1
specifies a reconstruction of
be based on
{be specified for reconstructing}
Common Sub-Domain::
ProcessProtocol
+
+
+
+
+
+
+
+
+
+
0..* {be the basis of}
is played by
Common Sub-Domain::
OrganizationIdentifier
+
+
+
0..*
0..1
{assign}
reconstructionFieldOfViewHeight: IVL<PQ> [0..1]
reconstructionFieldOfViewWidth: IVL<PQ> [0..1]
reconstructionDiameter: IVL<PQ> [0..1]
sliceThickness: IVL<PQ> [0..1]
reconstructionInterval: IVL<PQ> [0..1]
bodyPositionCode: CD [0..1]
algorithmCode: CD
typeCode: CD
«Comment_Requested»
SpecificImagingProcessProtocol
0..*
Protocol Representation Sub-Domain::StudyProtocolVersion
0..*
duration: PQ.TIME [0..1]
follow
{be followed by}
0..*
be assigned by
{be identified by}
+
Study Conduct SubDomain::Laboratory
be a function performed by
+ identifier: II [0..1]
{function as}
0..1
0..1
name: DSET<ON> [0..*]
typeCode: CD [0..1]
description: ST [0..1]
postalAddress: AD [0..1]
telecomAddress: BAG<TEL> [0..*]
actualIndicator: BL [1...1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
Protocol Representation SubDomain::
DefinedSubj ectActiv ityGroup
0..1
acronym: ST [0..1]
mandatoryIndicator: BL [0..1]
amendmentGracePeriod: PQ.TIME [0..1]
phaseCode: CD [0..1]
primaryPurposeTypeCode: CD [0..1]
purposeStatement: ST [0..1]
targetAnatomicSiteCode: DSET<CD> [0..*]
studySchematic: ED [0..1]
designConfigurationCode: CD [0..1]
adaptiveDesignIndicator: BL [0..1]
companionCode: CD [0..1]
therapeuticAreaCode: CD [0..1]
studySubjectTypeCode: CD [0..1]
populationDescription: ST [0..1]
plannedStudySubjectExperience: ST [0..1]
plannedSiteNumberRange: URG<INT.POS> [0..1]
plannedDuration: PQ.TIME [0..1]
plannedInvestigationalExposureQuotient: REAL [0..1]
targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
periodicTargetAccrualNumber: RTO<INT.NONNEG,PQ.TIME> [0..1]
accrualReportingMethodCode: CD [0..1]
responsiblePartyCode: CD [0..1]
multiInstitutionIndicator: BL [0..1]
participatingOrganizationTypeCode: CD [0..1]
participatingLocationCode: DSET<CD> [0..*]
aeCodingSystem: OID [0..1]
conditionCodingSystem: OID [0..1]
delayedRegistryPostingIndicator: BL [0..1]
dataCutoffDate: TS.DATETIME [0..1]
Study Conduct Sub-Domain::
PerformedObserv ation
ImagingReconstructionProtocolElement
summary: ST [0..1]
bodyPositionCode: CD [0..1]
primaryAnatomicSiteCode: DSET<CD> [0..*]
«Comment_Requested»
GenericImagingProcessProtocol
{function as}
0..1
Common Sub-Domain::Organization
+
+
+
+
+
+
+
be a function
performed by
0..1
0..1
{be the contents of}
0..*
be a function
performed by
is a function performed by
0..1
0..1
0..*
belong to a department at
{function as}
1
0..1
0..*
is a result of
Protocol Representation Sub-Domain::
DefinedObserv ation
0..*
{be the department for}
1
+
+
+
+
+
+
+
+
+
+
+
+
+
execute under
+
{be executed by}
0..1 +
+
{infer} be inferred from
+
+
+
+inferredPerformedObservationResult 0..*
+
+infersPerformedObservationResult 0..1
+
Study Conduct Sub-Domain::
+
PerformedObserv ationResult
+
+ identifier: II [0..1]
+
have start evaluated in relation to
+ typeCode: CD [0..1]
+
+
{be the timepoint for evaluating start of} 0..* + value: ANY [1...1]
+ valueCodeModifiedText: ST [0..1]
+
+ valueNullFlavorReason: ST [0..1]
+
have end evaluated in relation to
+ confidentialityCode: CD [0..1]
+
{be the timpoint for evaluating end of} 0..*
+ uncertaintyCode: CD [0..1]
be commenting on
+ baselineIndicator: BL [0..1]
+ createdDate: TS.DATETIME [0..1]
{be commented on by}
+ reportedDate: TS.DATETIME [0..1]
+ comment: ST [0..1]
0..*
{report}
0..*
0..1
0..*
typeCode: CD [0..1]
effectiveDateRange: IVL<TS.DATETIME> [0..1] 0..1
0..*
0..1
0..1
{function as}
Common Sub-Domain::Ov ersightCommittee
0..1
be reported by
be a function performed by
identifier: II [0..1]
postalAddress: AD [0..1]
0..1
telecomAddress: BAG<TEL> [0..*]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
+
+
-
{function as}
Common Sub-Domain::HealthcareProv ider
+
+
0..1
+
+
0..*
0..*
be a function
performed by
is a function performed by
{function as}
{assign}
{function as}
identifier: II [0..1]
typeCode: CD [0..1]
postalAddress: AD [0..1]
telecomAddress: BAG<TEL> [0..*]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
1
be assigned by
be a function performed by
Common Sub-Domain::Performer
be a function
performed by +
+
0..1
0..* +
{function as}
+
+
{be executed at}
1
Study Conduct Sub-Domain::StudySite
identifier: II [0..1]
reasonCode: DSET<CD> [0..*]
comment: ST [0..1]
Study Conduct SubDomain::Serv ice
0..*
executes
{execute}
0..*
is the parent of
Study Conduct Sub-Domain::PerformedActiv ity
Study Conduct Sub-Domain::
0..1 {be the component of} 1
+ /repetitionNumber: INT.POS [0..1]
PerformedCompositionRelationship
+ nameCodeModifiedText: ST [0..1]
is the component of
+ dateRange: IVL<TS.DATETIME> [0..1]
0..* {be the parent of}
1 + dateRangeValidationCode: CD [0..1]
+ /studyDayRange: IVL<INT> [0..1]
1
0..1
+ /duration: PQ.TIME [0..1]
+ /delayDuration: PQ.TIME [0..1]
Protocol Representation Sub-Domain::
+ negationIndicator: BL [0..1]
DefinedActiv ity
+ negationReason: DSET<SC> [0..*]
instantiate
+ /fastingStatusIndicator: BL [0..1]
nameCode: CD [1...1]
+ /medicalHistoryIndicator: BL [0..1]
categoryCode: CD [0..1]
{be instantiated by }
0..1
0..*
+ statusCode: CD [0..1]
subcategoryCode: CD [0..1]
+ statusDate: TS.DATETIME [0..1]
repeatFrequencyCode: CD [0..1]
repeatFrequencyRatio:
RTO<INT.NONNEG,PQ.TIME> [0..1]
PerformedImagingTimepoint
repeatQuantityRange: URG<INT.NONNEG>
performs
{be performed by}
identifier: II [0..1]
jobTitle: ST [0..1]
postalAddress: AD [0..1]
telecomAddress: BAG<TEL> [0..*]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
0..*
is executed at
+ identifier: II [0..1]
+ leadIndicator: BL [0..1]
+ targetAccrualNumberRange: URG<INT.NONNEG> [0..1]
+ plannedDuration: PQ.TIME [0..1]
+contextForStudySite
+ dateRange: IVL<TS.DATETIME> [0..1]
oversee
has as context
+hasContextActivity
0..1 + statusCode: CD [0..1]
{be overseen
by}
«VNDR» {is the context
for}
+ statusDate: TS.DATETIME [0..1]
0..*
«DEPRECATED»
0..*
+ accrualStatusCode: CD [0..1]
be a function performed
by
+ accrualStatusDate:
TS.DATETIME [0..1]
{function as}
0..*
{assign}
be participated in by
{participate in}
0..*
0..1
effectiveDateRange: IVL<TS.DATETIME> [0..1]
{be described by}
reviewBoardApprovalNumberText: ST.SIMPLE [0..1]
0..*
reviewBoardProcessCode: CD [0..1]
reviewBoardProcessDate: TS.DATETIME [0..1]
be assigned by
0..1
+
describes
specializes
+
0..* +
+
0..*
Study Conduct Sub-Domain::
StudySiteProtocolVersionRelationship
is assigned to
effectiveDateRange: IVL<TS.DATETIME> [0..1] 0..* {be the assigned version for}1
+
1
Common Sub-Domain::Activity
0..*
Study Conduct Sub-Domain::
StudySubj ectProtocolVersionRelationship
0..*
{be
assigned
to}
Study Conduct Sub-Domain::StudySiteOv
ersightStatus
{be specialized by}
be a function
performed by
{function as}
paymentMethodCode: CD [0..1] 1
confidentialityIndicator: BL [0..1]
statusCode: CD [0..1]
statusDate: TS.DATETIME [0..1]
{be used by}
name: DSET<EN> [0..*]
administrativeGenderCode: CD [0..1]
sexGenotypeCode: CD [0..1]
be a function performed by
birthCountryCode: CD [0..1]
birthOrder: INT.POS [0..1]
{function as}
0..1
birthDate: TS.DATETIME [0..1]
deathDate: TS.DATETIME [0..1]
is a function performed by
Common Sub-Domain::
deathDateEstimatedIndicator: BL [0..1]
{function as}
AssociatedBiologicEntity
1
0..*
deathIndicator: BL [0..1]
actualIndicator: BL [1...1]
+ typeCode: DSET<CD> [0..*]
is scoped by
1
initials: ST [0..1]
postalAddress: AD [0..1]
telecomAddress: BAG<TEL> [0..*]
raceCode: DSET<CD> [0..*]
ethnicGroupCode: DSET<CD> [0..*]
maritalStatusCode: CD [0..1]
educationLevelCode: CD [0..1]
1
primaryOccupationCode: CD [0..1]
occupationDateRange: IVL<TS.DATE> [0..1]
Common Sub-Domain::
StudySubj ect
+
+
+
+
be a use of
Common Sub-Domain::Person
+
+
+
+
+
+
+
+
+
1
24
commonName: TN [0..1]
scientificNameCode: CD [0..1]
taxonomyIdentifierCode: CD [0..1]
taxonomyRankCode: CD [0..1]
synonymCode: DSET<CD> [0..*]
strain: ST [0..1]
nonHostIndicator: BL [0..1]
-
{use}
is the
assigned
version for
activeIndicator: BL [0..1]
«VNDR»
typeCode: CD [0..1]
identifier: II [0..1]
name: ST
be used for
{be identified by}
identifier: II [1...1]
typeCode: CD [0..1]
primaryIndicator: BL [0..1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
{be used for}
1
{perform}
identifies
+
+
+
+
0..*
uses
be used by
varianceTypeCode: CD [0..1]
varianceReasonCode: DSET<CD> [0..*]
{be instantiated by}
«DEPRECATED»
purpose: ST [0..1]
Common Sub-Domain::Subj ectIdentifier
0..*
primaryIndicator: BL [0..1]
inactiveComment: ST [0..1]
effectiveDateRange: IVL<TS.DATETIME> [0..1]
Study Conduct Sub-Domain::
PerformedAdministrativ eActiv ity
0..*
Common Sub-Domain::BiologicEntityIdentifier
+
+
+
0..*
+
+
+
identifier: II [0..1]
typeCode: CD [0..1]
primaryIndicator: BL [0..1]
Protocol Representation Sub-Domain::
DefinedSubstanceAdministration
be a function performed by
{function as}
+
+
+
+
+
+
+
productDose: EXPR<PQ> [0..1]
periodProductDoseTotal: EXPR<PQ> [0..1]
dosePeriodCode: CD [0..1]
doseFrequencyCode: CD [0..1]
doseRegimen: ST [0..1]
flowRate: RTO<PQ,PQ.TIME> [0..1]
routeOfAdministrationCode: CD [0..1]
0..*
Protocol Representation SubDomain::StudyLegalSponsor
0..*
+
0..*
primaryIndicator: BL [0..1]
«VNDR»
name: ST [0..1]
typeCode: CD [0..1]
Changes Proposed to Existing BRIDG Classes
25
APPROVED
Device.locatingOrganization(Organization)
• Source concept: DICOM General Equipment Module - Institution
Name (0008,0080): Institution where the equipment that produced
the composite instances is located.
• Add association on Device: Device [locatedDevice] (0..*) be
located at / be the location for (0..1) [locatingOrganization]
Organization
DESCRIPTION:
Each Device might be located at one Organization. Each
Organization might be the location for one or more Device.
DEFINITION:
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
26
APPROVED
Animal.breedCode => BiologicEntityClassification
• Source concept: DICOM Patient Module - Patient Breed
Description (0010,2292): "The breed of the patient. … Required if
the patient is an animal and if Patient Breed Code Sequence
(0010,2293) is empty. May be present otherwise.“
• Move breedCode from Animal to BiologicEntityClassification
DEFINITION:
A coded value specifying a group of animals presumably related by
descent from common ancestors and are visibly similar in most
characteristics.
EXAMPLE(S):
Holstein, Angora, Himalayan cat, Labrador Retriever
OTHER NAME(S):
NOTE(S):
27
APPROVED
BiologicEntityClassification.strain(ST) => strainCode(CD)
•
Source concept: Patient Module - Strain Description (0010,0212): “The strain of the patient.”; and
Strain Code Sequence (0010,0219): “A coded identification of the strain of the patient. … One or more
Items are permitted in this sequence. If more than one item is present, each item represents the same
information but encoded using a different coding scheme (rather than post-coordinated modifiers).”
•
Change data type and attribute name on strain(ST) to strainCode(CD)
DEFINITION:
A coded value specifying a group of presumed common ancestry with clear-cut physiological but usually
not morphological distinctions.WENDY to update definition per convention for SC
EXAMPLE(S):
Minnesota5 (swine strain), DXL (poultry strain)
For DICOM'sStrain Code Sequence (0010,0219): Code Value = "3028467“, Coding Scheme Designator
= "MGI => MGI_2013“, Code Meaning = "C57BL/6J“ <=use this as the string
OTHER NAME(S):
NOTE(S):
The specific genotypic or phenotypic variant of an animal, microorganism, fungus, or pathogen.
DICOM defines this to be a group of animals that are genetically uniform.
•
28
CHANGE: strain(SC) not CD
APPROVED
BiologicEntityClassification.strainNomenclatureIdentifier
•
Source concept: DICOM Patient Module - Strain Nomenclature (0010,0213):
The nomenclature used for Strain Description (0010,0212)
– This is like a syntax or parsing scheme for what can go in the code.
•
Add BiologicEntityClassification.strainNomenclatureIdentifier(II)
DEFINITION:
A unique symbol that establishes the identity of the conventions used to
construct the value in the original text of strain code.
EXAMPLE(S):
II.extension = MGI_2013
II.root = <oid for DICOM assigned terms for strain nomenclature>
OTHER NAME(S):
NOTE(S):
This should be the codeSystem of the SC.code on the previous slide, so this
concept is not needed – tag should be added to strain(SC)
29
APPROVED
BiologicEntityClassification.strainComment
• Source concept: DICOM Patient Module - Strain Additional
Information (0010,0216): “Additional information about the
strain of the patient that is not encoded in the formal
nomenclature used in Strain Description (0010,0212).”
• Add BiologicEntityClassification.strainComment(ST)
DEFINITION:
Additional information about the strain.
EXAMPLE(S):
"Athymic nude" mouse which is not described by the
nomenclature of "NCr-nu/nu“
OTHER NAME(S):
Strain Additional Information
NOTE(S):
30
APPROVED
BiologicEntityClassification.strainStockIdentifier
•
Source concept: DICOM Patient Module - Strain Stock Sequence >
Strain Stock Number (0010,0214): “The stock number of the strain of
the patient issued by the organization identified by Strain Source
(0010,0217).”; and
Strain Stock Sequence > Strain Source (0010,0217): “Identification of
the organization that is the source of the animal, issued by the registry
identified by Strain Source Registry Code Sequence (0010,0215).”
•
Add BiologicEntityClassification.strainStockIdentifier
DEFINITION:
A unique symbol that establishes the identity of the sub-population of
the strain as obtained from a particular source.
EXAMPLE(S):
II.extension = 000664
II.root = <oid for Jrep>
OTHER NAME(S):
Strain Stock Sequence
NOTE(S):
31
APPROVED
BiologicEntity.responsibleOrganization(Organization)
•
Source concept: DICOM Patient Module - Responsible Organization (0010,2299): "Name
of organization with medical decision making authority for the patient. Required if patient is
an animal. May be present otherwise.“
•
Add association on BiologicEntity: BiologicEntity [caredForBiologicEntity] (0..*) have
decisions made by / have medical decision making authority on behalf of (0..1)
[responsibleOrganization] Organization
DESCRIPTION:
Each BiologicEntity might have decisions made by one Organization. Each Organization
might have decision making authority on behalf of one or more BiologicEntity.
DEFINITION:
i
The link between a person or animal and the organ zation who has decision making
authority for them.
EXAMPLE(S):
In non-human primate research, such as at UC Davis Primate Center, the Center is
responsible for the health and well-being of the primates, irrespective of the research.
<NEED EXAMPLES FROM DAVID>
OTHER NAME(S):
NOTE(S):
32
APPROVED
DefinedSubstanceAdministration.productDose
•
Source concept: Enhanced PET Isotope Module - Radiopharmaceutical Information
Sequence > Radionuclide Total Dose (0018,1074): “The radiopharmaceutical dose
administered to the patient measured in MegaBecquerels (MBq) at the
Radiopharmaceutical Start DateTime (0018,1078).”
•
Add example to attribute definition - Units are units of radioactivity - MilliCuries or
MegaBecquerels, e.g. 370MBq
DEFINITION:
The quantity of a substance or medication to be administered.
EXAMPLE(S):
5 mg
20 mg of drug per kg of subject weight
370MBq
OTHER NAME(S):
NOTE(S):
DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or
relative terms (e.g., mg or mg/kg).
ScheduledSubstanceAdministration.activeIngredientDose and
PerformedSubstanceAdministration.productDose must contain a dose expressed in
absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was
expressed in relative terms (e.g., mg/kg), then the absolute dose must have been
calculated using one or more observed factors as identified by the
DefinedExpressionVariableRelationship.
33
APPROVED
Material.code
•
Source concept: Enhanced PET Isotope Module - Radiopharmaceutical
Information Sequence > Radiopharmaceutical Code Sequence (0054,0304):
“Sequence that identifies the radiopharmaceutical. Only a single Item shall be
included in this Sequence.”
•
Add example to attribute definition - to cover the new Drug subclass:
Fluorodeoxyglucose F^18^
DEFINITION:
A coded value specifying the non-unique textual identifier for the material.
EXAMPLE(S):aspirin, tobacco, caffeine, tongue depressors, x-ray machine,
olive oil, oats, lipstick, skin moisturizer, blisterpack, test tube, specimen slide,
urine, blood, plasma, platelet rich plasma, serum, DNA, gDNA, RNA, gRNA,
mRNA, Fluorodeoxyglucose F^18^
OTHER NAME(S):
NOTE(S):The granularity of the code may vary depending on the specificity of
the material. For example, acetaminophen, Tylenol, Tylenol 250 mg gel cap.
34
APPROVED
StudySiteOversightStatus.effectiveDateRange
• Source concept: DICOM Clinical Trial Context Module - Ethics
Committee Approval Effectiveness Start Date and End Date (no
definition provided)
– The existing review board process date (in BRIDG) is not
necessarily the same date as the effective date - boards can
backdate approval for instance - so this maps to a new attribute in
BRIDG
• Add StudySiteOversightStatus.effectiveDateRange
DEFINITION:
The date and time span specifying when the review board's
oversight status (process code) begins and ends.
EXAMPLE(S):
OTHER NAME(S):
Ethics Committee Approval Effectiveness Start and End Date
NOTE(S):
35
APPROVED
PerformedLesionDescription.lesionNumber
•
Source concept: AIM AnnotationEntity.name: “Human readable colloquial name of the annotation not guaranteed
to be unique”;
DICOM TID 1410 PlanarROIMeasurements - Measurement Group > Tracking Identifier: “DCM - A text label used for
tracking a finding or feature,potentially across multiple reporting objects, over time.This label shall be unique within
the domain in which itis used. Corresponds to Tracking ID (0062,0020).”;
DICOM TID 1411 VolumetricROIMeasurements - Measurement Group > Tracking Identifier: “DCM - A text label
used for tracking a finding or feature,potentially across multiple reporting objects, over time.This label shall be
unique within the domain in which itis used. Corresponds to Tracking ID (0062,0020).”
DICOM TID 1501 MeasurementGroup - Measurement Group > Tracking Identifier: “DCM - A text label used for
tracking a finding or feature,potentially across multiple reporting objects, over time.This label shall be unique within
the domain in which itis used. Corresponds to Tracking ID (0062,0020).”
•
Change data type and attribute name on PerformedLesionDescription.lesionNumber(INT.NONNEG) to
PerformedLesionDescription.lesionIdentifierText(ST)
DEFINITION:
A human-readable text label used for tracking a finding or feature, potentially across multiple observations, over
time, where this label is unique among other findings or features for the same subject. [Adapted from DICOM
Tracking ID (0062,0020)]
EXAMPLE(S):
T01, NT02, T04.2, T02/T03, NEW01 [Adopted from CDISC SDTM's TU.TULNKID examples]
OTHER NAME(S):
Lesion NumberTracking IdentifierLink ID (TU.TULNKID)
NOTE(S):
Once a lesion identifier text is designated for a specific lesion that identifier text may not change or be re-used to
denote a different lesion for the same subject. Note there is no expectation that lesion identifier texts are unique
across all subjects.
WG Decision: keep lesionNumber(INT.NONNEG) as is and ADD lesionIdentifier(ST) as defined above
•
36
APPROVED
Performer.evaluatorAlias
• Source concept: AIM User. numberWithinRoleOfClinicalTrial: "An
identifier assigned to the author by the clinical trial, for example, role
might be ‘reader’, and NumberWithinRole might be ’42’, or
numberWithinRoleOfCLinicalTrial might be ‘A12345’.”
• Add Performer.evaluatorAlias – dependent on a current BRIDG
WG discussion topic re consolidation of Performer & Assessor
DEFINITION:
A non-unique textual identifier for the performer.
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
When multiple performers perform the same activity or result, the
value of Performer.evaluatorAlias will attribute an evaluation to a
particular performer.
37
APPROVED
HealthcareProvider.roleCode
• Source concept: DICOM TID 1003
PersonObserverIdentifyingAttributes - Person Observer's Role
in the Organization: (no definition provided)
• Add HealthcareProvider.roleCode
DEFINITION:
A coded value specifying the function) of the person in the
context of this organization.
EXAMPLE(S):
physician, nurse, radiographer
OTHER NAME(S):
occupation
NOTE(S):
38
APPROVED
PerformedObservation.derivationMethodCode
•
Source concept: DICOM TID 1419 ROIMeasurements - $Measurement
parameter > Derivation: “DCM - Method of deriving or calculating a measured
value. E.g.,mean, or maximum of set.”;
DICOM TID 300 Measurement - $Measurement parameter > Derivation: “DCM
- Method of deriving or calculating a measured value. E.g.,mean, or maximum of
set.”
– Note that this is different from the Measurement Method in that it is a mathematical
rather than physical aspect of the observation and supplements the methodCode,
meaning that you can have both, and it's NOT a case where you can derive the value
from other places in the model - they don't send all the raw data which is used in the
derivation to arrive at the sent data. This is a mapping for what people need rather
than a mapping reflecting the most normalized representation of the concepts.
•
Add PerformedObservation.derivationMethodCode
DEFINITION:
A coded value specifying the technique used to calculate a measured value.
EXAMPLE(S):
<ASK DAVID FOR A DICOM EXAMPLE FOR THIS>
OTHER NAME(S):
NOTE(S):
39
Block vote on proposed changes as marked up
• 0 Abst
• 0 Neg
• Unanimously approved as documented in this slide deck
(9 positive votes)
40
For Reference
41
Acquisition Subclass Attributes
•
ImagingAcquisitionProtocolElement •
Class:
–
–
–
–
–
–
•
acquisitionTypeCode
imageTypeCode
cardiacSynchronizationTechniqueCode
respiratoryMotionTechniqueCode
dataCollectionDiameter
resonantNucleusCode
CTImagingAcquisitionProtocolElement
Class:
–
–
–
–
–
–
–
–
–
singleCollimationWidth
totalCollimationWidth
gantryDetectorTilt
tableSpeed
spiralPitchFactor
ctdiVol
ctdiPhantomTypeCode
kVp
exposureModulationTypeCode
•
MRImagingAcquisitionProtocolElement
Class:
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
echoPulseSequenceCategoryCode
diffusionBValue
DiffusionDirectionalityCode
magneticFieldOfStrength
acquisitionContrastCode
inversionRecoveryIndicator
pulseSequenceName
multipleSpinEchoIndicator
phaseContrastIndicator
timeOfFlightContrastIndicator
arterialSpinLabelingContrastCode
steadyStatePulseSequenceCode
echoPlanarPulseSequenceIndicator
saturationRecoveryIndicator
spectrallySelectedSuppressionCode
PETImagingAcquisitionProtocolElement
Class:
– gantryDetectorTilt
42
Reconstruction Subclass Attributes
•
ImagingReconstructionProtocolElement Class:
–
–
–
–
–
–
–
–
•
reconstructionFieldOfViewHeight
reconstructionFieldOfViewWidth
reconstructionDiameter
slideThickness
reconstructionInterval
bodyPositionCode
algorithmCode
typeCode
CTImagingReconstructionProtocolElement Class:
– convolutionKernal
– convolutionKernalGroup
•
MRImagingReconstructionProtocolElement Class:
– (none)
•
PETImagingReconstructionProtocolElement Class:
– (none)
43