Protocol Representation Sub-Domain::DefinedObservation

: Public Class

Created:	3/11/2009 10:41:00 AM
Modified:	3/18/2018 6:51:45 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{6875D0BA-89F5-454a-A99A-4BCEE17FC25C}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View PR: Protocol Representation, View IM: Imaging, Oncology & Imaging View, SDTM 3.1.3 View, Participant Registration, SEER View, Anatomic Pathology Structured Report (APSR)

DEFINITION: An activity defined at a global library level whose intention is to obtain a result by observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a subject's physiologic or psychologic state. EXAMPLE(S): blood chemistry panel, body mass index calculation, blood pressure measurement, obtaining DNA sequence, genotyping a genetic variant, measuring the pH of a solution, specimen quality review OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Other Links

Attribute

Public CD
methodCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=PerformedProductInvestigation.evaluationMethodCode
Map:AE=CausalAssessment.methodCode
Map:AIM v4 rv48=Algorithm.type
Map:AIM v4 rv48=Algorithm.name
Map:CTOM=ClinicalResult.assayMethodCode
Map:CTOM=ClinicalResult.meansVitalStatusObtainedCode
Map:CTOM=ClinicalResult.labTechniqueCode
Map:CTOM=LesionDescription.methodCode
Map:CTRv1.0=DefinedObservation.methodCode
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Observation.methodCode
Map:LSDAMv2.2.3Plus=DefinedObservation.methodCode

Notes:

DEFINITION: A coded value specifying the technique that is used for the observation. EXAMPLE(S): Arterial puncture, sphygmomanometry (for blood pressure measurement) Global introspection, algorithm, bayesian (for Adverse Event causality) Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay) OTHER NAME(S): NOTE(S):

Public CD
bodyPositionCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

AE:Exclude=True
Map:CTOM=ClinicalResult.bodyPositionCode
Map:CTRv1.0=DefinedObservation.bodyPositionCode
Map:LSDAMv2.2.3Plus=DefinedObservation.bodyPositionCode
Map:PSC=VS.VSPOS
Map:SDTM IGv3.1.1=EG.EGPOS

Notes:

DEFINITION: A coded value specifying the 3-dimensional spatial orientation of a subject during a particular observation. EXAMPLE(S): supine, trendelenburg, standing OTHER NAME(S): NOTE(S):

Public CD
targetAnatomicSiteCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=AdverseEvent.bodyLocation
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Problem reported] > hl7:observation > hl7:code > hl7:qualifier > hl7:value > @code
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Problem reported] > hl7:observation > hl7:code > hl7:qualifier > hl7:value
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Problem reported] > hl7:observation > hl7:code > hl7:qualifier > hl7:value > @displayName
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Problem reported] > hl7:observation > hl7:code > hl7:qualifier > hl7:value > @codeSystem
Map:APSRv2.1=[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Problem reported] > hl7:observation > hl7:code > hl7:qualifier > hl7:value > @codeSystemName
Map:CTOM=LesionDescription.anatomicSiteCodeSystem
Map:CTOM=Diagnosis.primaryAnatomicSiteCodeSystem
Map:CTOM=Diagnosis.primaryAnatomicSiteCode
Map:CTOM=LesionDescription.anatomicSiteCode
Map:CTOM=Diagnosis.primaryAnatomicSiteLateralityCode
Map:CTRv1.0=DefinedObservation.targetAnatomicSiteCode
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Observation.TargetSiteCode
Map:LSDAMv2.2.3Plus=DefinedObservation.targetAnatomicSiteCode

Notes:

DEFINITION: A coded value specifying the anatomic location that is the focus of the observation. EXAMPLE(S): lung, leg OTHER NAME(S): NOTE(S): The target site of the observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (e.g. skin) while the target site of the observation result is specific (e.g. skin on chest). Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions.

Public CD
targetAnatomicSiteLateralityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=AdverseEvent.bodyLocation
Map:CTOM=Diagnosis.primaryAnatomicSiteLateralityCode
Map:CTRv1.0=DefinedObservation.targetAnatomicSiteLateralityCode
Map:LSDAMv2.2.3Plus=DefinedObservation.targetAnatomicSiteLateralityCode

Notes:

DEFINITION: A coded value specifying the side of the body (or a paired organ) that is a target site for an observation. EXAMPLE(S): bilateral, left, right OTHER NAME(S): NOTE(S): This attribute was deprecated in BRIDG 3.1 but undeprecated in 4.0 since source use cases for separate laterality include SDTM and CTOM. This change ensures that users of the BRIDG model are not bound to a particular kind of vocabulary, such as pre- or post-coordinated vocabularies. Collapsing laterality into the target site code is an implementation option.

Public CD
approachAnatomicSiteCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDASHv1.1=VS.VSLOC
Map:SDTM IGv3.1.2=EG.EGLOC
Map:SDTM IGv3.1.2=FA.FALOC
Map:SDTM IGv3.1.2=VS.VSLOC

Notes:

DEFINITION: A coded value specifying the anatomic location or access point for an observation. EXAMPLE(S): Anus for a colonoscopy observation OTHER NAME(S): NOTE(S): Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the acces point for the measurement or observation and the target site is what is ultimately being evaluated. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions.

Public PQ.TIME
focalDuration

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	True
IsID:	False

AE:Exclude=True
Map:CTOM=DiseaseResponse.progressionPeriodUnitOfMeasureCode
Map:CTOM=DiseaseResponse.progressionPeriod
Map:CTRv1.0=DefinedObservation.focalDuration
Map:LSDAMv2.2.3Plus=DefinedObservation.focalDuration
Map:SDTM IGv3.1.1=QS.QSEVLINT
Map:SDTM IGv3.1.3=PC.PCEVLINT
Map:SDTM IGv3.1.3=QS.QSEVLINT

Notes:

DEFINITION: A quantity of time in which the observation result is held to be true. EXAMPLE(S): 2 months is the focalDuration for the question, "Have you smoked in the last 2 months?" OTHER NAME(S): NOTE(S): The focalDuration can be derived from the expression captured in the focalDateRange.IVL#lt;EXPR#lt;TS.DATETIME#gt;#gt;.

Public IVL<EXPR<TS.DATETIME>>
focalDateRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

AE:Exclude=True
Map:CTOM=DiseaseResponse.evaluationDate
Map:CTOM=DiseaseResponse.progressionDate
Map:CTOM=Diagnosis.confirmationDate
Map:CTOM=Histopathology.reportingDate
Map:CTRv1.0=DefinedObservation.focalDateRange
Map:LSDAMv2.2.3Plus=DefinedObservation.focalDateRange
Map:SDTM IGv3.1.2=QS.QSEVLINT

Notes:

DEFINITION: The time period in which the observation result is held to be true, expressed either as a simple date range or as an evaluable expression that references a study-defined date or milestone. EXAMPLE(S): For a survey question, "Have you traveled to Europe between 1990 and 1999?", the focalDateRange would be "January 1, 1990 to December 31, 1999". For the question, "Have you smoked in the last 2 months", the focalDateRange would be an expression referencing a variable that represents the PerformedObservation.actualDateRange (a value yet to be defined) and a formula for the date range between when the question is asked (PerformedObservation.actualDateRange.low) and 2 months prior (PerformedObservation.actualDateRange.low - 2 months). OTHER NAME(S): NOTE(S): As an attribute with data type IVL#lt;EXPR#lt;TS.DATETIME#gt;#gt;, focalDateRange can be used to express a simple date range such as "January 1, 1990 to December 31, 1999" or a relative time expression that includes a variable that represents another date in the model that is a study-defined anchor point. The other date may or may not be known at the time the DefinedObservation is created, but will be known by the time the PerformedObservation is created.

Element	Source Role	Target Role
DefinedActivity Class	Name: focusedDefinedObservation	Name: focusingDefinedActivity
Details: DESCRIPTION:<br/>Each DefinedObservation might have as focal context one DefinedActivity. Each DefinedActivity might be the focal context for one or more DefinedObservation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DefinedObservationResult Class	Name: focusedDefinedObservation	Name: focusingDefinedObservationResult
Details: DESCRIPTION:<br/>Each DefinedObservation might have as focal context one DefinedObservationResult. Each DefinedObservationResult might be the focal context for one or more DefinedObservation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DefinedCriterionGroup Class	Name: focusedDefinedObservation	Name: focusingDefinedCriterionGroup
Details: DESCRIPTION:<br/>Each DefinedObservation might have as focal context one DefinedCriterionGroup. Each DefinedCriterionGroup might be the focal context for one or more DefinedObservation.<br/><br/>EXAMPLE(S):<br/>Was there a liver chemistry event for the lab samples collected at this visit?<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
DefinedExpressionVariableRelationship Class	Name: referencingDefinedExpressionVariableRelationship	Name: referencedDefinedObservation
Details: DESCRIPTION:<br/>Each DefinedExpressionVariableRelationship always is a reference to one DefinedObservation. Each DefinedObservation might be referenced by one or more DefinedExpressionVariableRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DefinedObservationResult Class	Name: producedDefinedObservationResult	Name: producingDefinedObservation
Details: DESCRIPTION:<br/>Each DefinedObservationResult always is a result of one DefinedObservation. Each DefinedObservation might result in one or more DefinedObservationResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:CDMHv1.0	DefinedObservation
Details:
Map:CTRPv3.8	PlannedObservation
Details:
Map:CTRRr3	DefinedObservation
Details:
Map:CTRv1.0	DefinedObservation
Details:
Map:LSDAMv2.2.3Plus	DefinedSpecimenQuantityReview
Details:
Map:LSDAMv2.2.3Plus	DefinedObservation
Details:

Object	Type	Connection	Direction	Notes
DefinedActivity	Class	Generalization	To	DESCRIPTION: Each DefinedObservation always specializes one DefinedActivity. Each DefinedActivity might be specialized by one DefinedObservation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
DefinedEligibilityCriterion	Class	Generalization	From	DESCRIPTION: Each DefinedEligibilityCriterion always specializes one DefinedObservation. Each DefinedObservation might be specialized by one DefinedEligibilityCriterion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
DefinedStratificationCriterion	Class	Generalization	From	DESCRIPTION: Each DefinedStratificationCriterion always specializes one DefinedObservation. Each DefinedObservation might be specialized by one DefinedStratificationCriterion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):