: Public Class
Created: 3/11/2009 10:41:00 AM
Modified: 11/18/2014 5:09:45 PM
Project:
Advanced:
DEFINITION:<br /></p><p>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.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>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<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  methodCode
Details:
Map:AE=CausalAssessment.methodCode
Map:AE=PerformedProductInvestigation.evaluationMethodCode
Map:CTOM=ClinicalResult.labTechniqueCode
Map:CTOM=ClinicalResult.meansVitalStatusObtainedCode
Map:CTOM=ClinicalResult.assayMethodCode
Map:CTOM=LesionDescription.methodCode
Map:CTRv1.0=DefinedObservation.methodCode
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Observation.methodCode
Map:LSDAM=DefinedObservation.methodCode
Map:LSDAMv2.2.3Plus=DefinedObservation.methodCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the technique that is used for the observation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Arterial puncture, sphygmomanometry (for blood pressure measurement)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Global introspection, algorithm, bayesian (for Adverse Event causality)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Estrogen Receptor Assay, Progesterone Receptor Assay, p53 Assay (for clinical result assay)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  bodyPositionCode
Details:
AE:Exclude=True
Map:CTOM=ClinicalResult.bodyPositionCode
Map:CTRv1.0=DefinedObservation.bodyPositionCode
Map:LSDAM=DefinedObservation.bodyPositionCode
Map:LSDAMv2.2.3Plus=DefinedObservation.bodyPositionCode
Map:PSC=VS.VSPOS
Map:SDTM IGv3.1.1=EG.EGPOS
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the 3-dimensional spatial orientation of a subject during a particular observation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;supine, trendelenburg, standing#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  targetAnatomicSiteCode
Details:
Map:AE=AdverseEvent.bodyLocation
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:LSDAM=DefinedObservation.targetAnatomicSiteCode
Map:LSDAMv2.2.3Plus=DefinedObservation.targetAnatomicSiteCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the anatomic location that is the focus of the observation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;lung, leg#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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).#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public CD
  targetAnatomicSiteLateralityCode
Details:
Map:AE=AdverseEvent.bodyLocation
Map:CTOM=Diagnosis.primaryAnatomicSiteLateralityCode
Map:CTRv1.0=DefinedObservation.targetAnatomicSiteLateralityCode
Map:LSDAM=DefinedObservation.targetAnatomicSiteLateralityCode
Map:LSDAMv2.2.3Plus=DefinedObservation.targetAnatomicSiteLateralityCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the side of the body (or a paired organ) that is a target site for an observation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;bilateral, left, right#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public CD
  approachAnatomicSiteCode
Details:
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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the anatomic location or access point for an observation.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Anus for a colonoscopy observation#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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#lt;br /#gt;#lt;/p#gt;#lt;p#gt;structure or as multiple code repetitions.#lt;br /#gt;#lt;/p#gt;
Public PQ.TIME
  focalDuration
Details:
AE:Exclude=True
Map:CTOM=DiseaseResponse.progressionPeriodUnitOfMeasureCode
Map:CTOM=DiseaseResponse.progressionPeriod
Map:CTRv1.0=DefinedObservation.focalDuration
Map:LSDAM=DefinedObservation.focalDuration
Map:LSDAMv2.2.3Plus=DefinedObservation.focalDuration
Map:SDTM IGv3.1.1=QS.QSEVLINT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A quantity of time in which the observation result is held to be true.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;2 months is the focalDuration for the question, "Have you smoked in the last 2 months?"#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The focalDuration can be derived from the expression captured in the focalDateRange.IVL#lt;EXPR#lt;TS.DATETIME#gt;#gt;.#lt;br /#gt;#lt;/p#gt;
Public IVL<EXPR<TS.DATETIME>>
  focalDateRange
Details:
AE:Exclude=True
Map:CTOM=DiseaseResponse.evaluationDate
Map:CTOM=Histopathology.reportingDate
Map:CTOM=DiseaseResponse.progressionDate
Map:CTOM=Diagnosis.confirmationDate
Map:CTRv1.0=DefinedObservation.focalDateRange
Map:LSDAM=DefinedObservation.focalDateRange
Map:LSDAMv2.2.3Plus=DefinedObservation.focalDateRange
Map:SDTM IGv3.1.2=QS.QSEVLINT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The time period in which the observation result is held to be true, expressed #lt;br /#gt;#lt;/p#gt;#lt;p#gt;either as a simple date range or as an evaluable expression that references a #lt;br /#gt;#lt;/p#gt;#lt;p#gt;study-defined date or milestone.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For a survey question, "Have you traveled to Europe between 1990 and 1999?", the #lt;br /#gt;#lt;/p#gt;#lt;p#gt;focalDateRange would be "January 1, 1990 to December 31, 1999".#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;For the question, "Have you smoked in the last 2 months", the focalDateRange would #lt;br /#gt;#lt;/p#gt;#lt;p#gt;be an expression referencing a variable that represents the #lt;br /#gt;#lt;/p#gt;#lt;p#gt;PerformedObservation.actualDateRange (a value yet to be defined) and a formula for #lt;br /#gt;#lt;/p#gt;#lt;p#gt;the date range between when the question is asked #lt;br /#gt;#lt;/p#gt;#lt;p#gt;(PerformedObservation.actualDateRange.low) and 2 months prior #lt;br /#gt;#lt;/p#gt;#lt;p#gt;(PerformedObservation.actualDateRange.low - 2 months).#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;As an attribute with data type IVL#lt;EXPR#lt;TS.DATETIME#gt;#gt;, focalDateRange can be used #lt;br /#gt;#lt;/p#gt;#lt;p#gt;to express a simple date range such as "January 1, 1990 to December 31, 1999" or a #lt;br /#gt;#lt;/p#gt;#lt;p#gt;relative time expression that includes a variable that represents another date in #lt;br /#gt;#lt;/p#gt;#lt;p#gt;the model that is a study-defined anchor point. The other date may or may not be #lt;br /#gt;#lt;/p#gt;#lt;p#gt;known at the time the DefinedObservation is created, but will be known by the time #lt;br /#gt;#lt;/p#gt;#lt;p#gt;the PerformedObservation is created.#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
DefinedObservationResult
Class   		Name: focusedDefinedObservation
  		Name: focusingDefinedObservationResult
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedObservation might have as focal context one DefinedObservationResult. Each DefinedObservationResult might be the focal context for one or more DefinedObservation.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DefinedCriterionGroup
Class   		Name: focusedDefinedObservation
  		Name: focusingDefinedCriterionGroup
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedObservation might have as focal context one DefinedCriterionGroup. Each DefinedCriterionGroup might be the focal context for one or more DefinedObservation.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Was there a liver chemistry event for the lab samples collected at this visit?<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DefinedActivity
Class   		Name: focusedDefinedObservation
  		Name: focusingDefinedActivity
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedObservation might have as focal context one DefinedActivity. Each DefinedActivity might be the focal context for one or more DefinedObservation.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Element Source Role Target Role
DefinedObservationResult
Class   		Name: producedDefinedObservationResult
  		Name: producingDefinedObservation
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedObservationResult always is a result of one DefinedObservation.  Each DefinedObservation might result in one or more DefinedObservationResult.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DefinedExpressionVariableRelationship
Class   		Name: referencingDefinedExpressionVariableRelationship
  		Name: referencedDefinedObservation
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedExpressionVariableRelationship always is a reference to one DefinedObservation. Each DefinedObservation might be referenced by one or more DefinedExpressionVariableRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:CTRPv3.8 PlannedObservation
Details:
 
Map:CTRRr3 DefinedObservation
Details:
 
Map:CTRv1.0 DefinedObservation
Details:
 
Map:LSDAM DefinedObservation
Details:
 
Map:LSDAM DefinedSpecimenQualityReview
Details:
 
Map:LSDAMv2.2.3Plus DefinedSpecimenQuantityReview
Details:
 
Map:LSDAMv2.2.3Plus DefinedObservation
Details:
 
Object Type Connection Direction Notes
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):
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):
DefinedImaging Class Generalization From DESCRIPTION: Each DefinedImaging always specializes one DefinedObservation. Each DefinedObservation might be specialized by one DefinedImaging. 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):