: Public Class
Created: 6/3/2008 1:57:50 PM
Modified: 9/18/2013 4:53:33 PM
Project:
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DEFINITION:<br /></p><p>Specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the subjects in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. The specific measure that receives the most emphasis in assessment that would most specifically answer the hypothesis proposed by the study design.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Time to Local Recurrence (TLR), Disease-free Survival (DFS), Survival.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public ST
  name
Details:
Map:CTGOV=Secondary Outcome Measure
Map:CTGOV=Outcome Measure
Map:CTR&Rr2=Secondary end point
Map:CTR&Rr2=Primary end points
Map:CTRPv1.0=StudyOutcomeMeasure.name
Map:CTRPv3.8=StudyObjective.name
Map:CTRPv3.8=StudyOutcomeMeasure.name
Map:CTRR=Outcomes
Map:CTRRr3=StudyOutcomeMeasure.name
Map:CTRv1.0=StudyOutcomeMeasure.name
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A non-unique textual identifier for the study outcome measure.#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;all-cause mortality#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 DSET<CD>
  typeCode
Details:
Map:CTGOV=Safety Issue?
Map:CTGOV=Study Classification
Map:CTOM=Trial scope Pharmacokinetics
Map:CTR&Rr2=Trial scope Dose response
Map:CTR&Rr2=Trial scope
Map:CTR&Rr2=Trial scope Other specification
Map:CTR&Rr2=Trial scope Safety
Map:CTR&Rr2=Trial scope Pharmacodynamics
Map:CTR&Rr2=Trial scope Bioequivalence
Map:CTR&Rr2=Trial scope Efficacy
Map:CTR&Rr2=Trial scope Therapy
Map:CTR&Rr2=Trial scope Other
Map:CTR&Rr2=Trial scope Diagnosis
Map:CTR&Rr2=Trial scope Prophylaxis
Map:CTR&Rr2=Trial scope Pharmacogenetic
Map:CTRPv1.0=StudyOutcomeMeasure.typeCode
Map:CTRPv3.8=InterventionalStudyProtocol.studyClassificationCode
Map:CTRR=Primary Outcome Type
Map:CTRRr3=StudyOutcomeMeasure.typeCode
Map:CTRv1.0=StudyOutcomeMeasure.typeCode
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TTYPE
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of study outcome measure.#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;n/a, safety, efficacy, bio-equivalence, bio-availability, pharmacokinetics, pharmacodynamics#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 BL
  primaryIndicator
Details:
Map:CTGOV=Primary Outcome Measure
Map:CTRPv1.0=StudyOutcomeMeasure.primaryIndicator
Map:CTRPv3.8=StudyOutcomeMeasure.primaryIndicator
Map:CTRR=Outcomes
Map:CTRR=Primary Outcome Type
Map:CTRRr3=StudyOutcomeMeasure.primaryIndicator
Map:CTRv1.0=StudyOutcomeMeasure.primaryIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the main or principal study outcome measure.#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;#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 BL
  exploratoryIndicator
Details:
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this study outcome measure is used to evaluate and/or form hypotheses.#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;A study outcome measure may be marked exploratory if its used to form hypotheses about the intervention outcome(s).#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;Adapted from NCI Thesaurus, Exploratory Outcome Measure (Code C98724)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;As per CDISC, study objective can be exploratory (supported by StudyObjective.typeCode) and an outcome measure can also be exploratory independent of the study objective hence this attribute.#lt;br /#gt;#lt;/p#gt;
Public ST
  description
Details:
Map:CTRPv3.8=StudyOutcomeMeasure.descriptionText
Map:CTRRr3=StudyOutcomeMeasure.description
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual summary of the study outcome measure used to clarify its meaning, method, or purpose.#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;#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 ST
  timeFrameText
Details:
Map:CTGOV=Time Frame
Map:CTR&Rr2=Secondary end point timepoint
Map:CTR&Rr2=Primary end point timepoint
Map:CTRPv1.0=StudyOutcomeMeasure.timeframe
Map:CTRPv3.8=StudyOutcomeMeasure.timeFrame
Map:CTRR=Outcomes
Map:CTRRr3=StudyOutcomeMeasure.timeFrameText
Map:CTRv1.0=StudyOutcomeMeasure.timeFrameText
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Time point(s) at which the study outcome measure is assessed#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;one year#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;
Element Source Role Target Role
StudyObjective
Class   		Name: measuringStudyOutcomeMeasure
  		Name: measuredStudyObjective
 
Details:
DESCRIPTION:<br /></p><p>Each StudyOutcomeMeasure always measures one or more StudyObjective.  Each StudyObjective always is measured by one or more StudyOutcomeMeasure.<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:CTRPv1.0 StudyOutcomeMeasure
Details:
 
Map:CTRPv3.8 StudyOutcomeMeasure
Details:
 
Map:CTRRr3 StudyOutcomeMeasure
Details:
 
Map:CTRv1.0 StudyOutcomeMeasure
Details:
 
Constraint Type Status
Mandatory Attribute Qualifier Invariant Approved
Details:
At least one of the following must be mandatory for StudyOutcomeMeasure: name, typeCode.
name Unique Qualifier Invariant Approved
Details:
A StudyOutcomeMeasure.name must be unique within the context of the StudyProtocolVersion to which it is associated via StudyObjective.<br /></p><p>Note that all StudyObjectives to which a StudyOutcomeMeasure is associated must be associated with the same StudyProtocolVersion since measures are study-specific.<br /></p>