Protocol Representation Sub-Domain::StudyOutcomeMeasure

: Public Class

Created:	6/3/2008 1:57:50 PM
Modified:	3/19/2019 12:20:44 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{590750F9-AC4E-40cb-BEA2-F2E7D931FAF7}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning, SDTM IG v3.1.3, SDTM IG v3.2, Registering a Trial at ClinicalTrials.gov

DEFINITION: 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. EXAMPLE(S): Time to Local Recurrence (TLR), Disease-free Survival (DFS), Survival. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values
Constraints

Attribute

Public ST
name

Details:

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

Map:CTGOV=Outcome Measure
Map:CTGOV=Secondary Outcome Measure
Map:CTR&Rr2=Secondary end point
Map:CTR&Rr2=Primary end points
Map:CTRPv1.0=StudyOutcomeMeasure.name
Map:CTRPv3.8=StudyOutcomeMeasure.name
Map:CTRPv3.8=StudyObjective.name
Map:CTRR=Outcomes
Map:CTRRr3=StudyOutcomeMeasure.name
Map:CTRv1.0=StudyOutcomeMeasure.name
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OUTMSPRI"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "OUTMSPRI"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OUTMSEXP"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "OUTMSEXP"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "OUTMSSEC"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OUTMSSEC"
Map:SDTM IGv3.2=TS.(OUTMSEXP) TSVAL WHERE TSPARMCD = "OUTMSEXP"
Map:SDTM IGv3.2=TS.(OUTMSPRI) TSVALNF WHERE TSPARMCD = "OUTMSPRI"
Map:SDTM IGv3.2=TS.(OUTMSEXP) TSVALNF WHERE TSPARMCD = "OUTMSEXP"
Map:SDTM IGv3.2=TS.(OUTMSSEC) TSVAL WHERE TSPARMCD = "OUTMSSEC"
Map:SDTM IGv3.2=TS.(OUTMSSEC) TSVALNF WHERE TSPARMCD = "OUTMSSEC"
Map:SDTM IGv3.2=TS.(OUTMSPRI) TSVAL WHERE TSPARMCD = "OUTMSPRI"

Notes:

DEFINITION: A non-unique textual identifier for the study outcome measure. EXAMPLE(S): all-cause mortality OTHER NAME(S): NOTE(S):

Public DSET<CD>
typeCode

Details:

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

Map:CTGOV=Safety Issue?
Map:CTGOV=Study Classification
Map:CTOM=Trial scope Pharmacokinetics
Map:CTR&Rr2=Trial scope Diagnosis
Map:CTR&Rr2=Trial scope Safety
Map:CTR&Rr2=Trial scope Pharmacodynamics
Map:CTR&Rr2=Trial scope Bioequivalence
Map:CTR&Rr2=Trial scope Dose response
Map:CTR&Rr2=Trial scope Efficacy
Map:CTR&Rr2=Trial scope Other specification
Map:CTR&Rr2=Trial scope Other
Map:CTR&Rr2=Trial scope Prophylaxis
Map:CTR&Rr2=Trial scope
Map:CTR&Rr2=Trial scope Therapy
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
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.2=TS.(TTYPE) TSVAL WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.2=TS.(TTYPE) TSVALCD WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.2=TS.(TTYPE) TSVALNF WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.2=TS.(TTYPE) TSVCDVER WHERE TSPARMCD = "TTYPE"
Map:SDTM IGv3.2=TS.(TTYPE) TSVCDREF WHERE TSPARMCD = "TTYPE"

Notes:

DEFINITION: A coded value specifying the kind of study outcome measure. EXAMPLE(S): n/a, safety, efficacy, bio-equivalence, bio-availability, pharmacokinetics, pharmacodynamics OTHER NAME(S): NOTE(S):

Public BL
primaryIndicator

Details:

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

Map:CTGOV=Primary Outcome Measure
Map:CTRPv1.0=StudyOutcomeMeasure.primaryIndicator
Map:CTRPv3.8=StudyOutcomeMeasure.primaryIndicator
Map:CTRR=Primary Outcome Type
Map:CTRR=Outcomes
Map:CTRRr3=StudyOutcomeMeasure.primaryIndicator
Map:CTRv1.0=StudyOutcomeMeasure.primaryIndicator

Notes:

DEFINITION: Specifies whether this is the main or principal study outcome measure. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
exploratoryIndicator

Details:

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

Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OUTMSEXP"
Map:SDTM IGv3.2=TS.(OUTMSEXP) TSVAL WHERE TSPARMCD = "OUTMSEXP"

Notes:

DEFINITION: Specifies whether this study outcome measure is used to evaluate and/or form hypotheses. EXAMPLE(S): A study outcome measure may be marked exploratory if its used to form hypotheses about the intervention outcome(s). OTHER NAME(S): NOTE(S): Adapted from NCI Thesaurus, Exploratory Outcome Measure (Code C98724) 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.

Public ST
description

Details:

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

Map:CTRPv3.8=StudyOutcomeMeasure.descriptionText
Map:CTRRr3=StudyOutcomeMeasure.description

Notes:

DEFINITION: The textual summary of the study outcome measure used to clarify its meaning, method, or purpose. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public ST
timeFrameText

Details:

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

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: Time point(s) at which the study outcome measure is assessed EXAMPLE(S): one year OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudyObjective Class	Name: measuringStudyOutcomeMeasure	Name: measuredStudyObjective
Details: DESCRIPTION:<br/>Each StudyOutcomeMeasure always measures one or more StudyObjective. Each StudyObjective always is measured by one or more StudyOutcomeMeasure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

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.<br/>
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/>Note that all StudyObjectives to which a StudyOutcomeMeasure is associated must be associated with the same StudyProtocolVersion since measures are study-specific.<br/>