Protocol Representation Sub-Domain::Arm

: Public Class

Created:	3/12/2008 12:11:14 PM
Modified:	8/26/2017 2:39:19 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{3A2BE812-FD20-4597-A4E0-336DC4ACE897}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, SDTM 3.1.3 View, ClinicalTrials.gov

DEFINITION: A path through the study which describes what activities the study subject or experimental unit will be involved in as they pass through the study. EXAMPLE(S): A study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment, then Oral treatment. OTHER NAME(S): Group [CTRR Observational Studies] NOTE(S): An Arm is typically equivalent to a treatment group in a parallel design study. Generally, each subject is assigned to an arm, and the design of the study is reflected in the number and composition of the individual arms. This intended path through which the subject progresses in a study is composed of time point events (study cell) for each epoch of the study. Each time point event, in turn, has a pattern of child time points through which the subject would pass. This planned path thus describes how subjects assigned to the arm will be treated.

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public SC
name

Details:

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

Map:C3PR=ScheduledArm.name
Map:C3PR=Arm.name
Map:C3PR=PlannedArm.name
Map:caAERSv2.2=RadiationIntervention.treatmentArm
Map:CTGOV=Group/Cohort Number or Label
Map:CTGOV=Arms/Groups
Map:CTGOV=Arm Number or Label
Map:CTOM=StudyParticipantAssignment.armIdentifier
Map:CTRPv1.0=Arm.name
Map:CTRPv3.8=Arm.name
Map:CTRRr3=Arm.name
Map:CTRv1.0=Arm.name
Map:FDA HL7 SD SD DSTU2012=plannedStudy/component2/arm.title
Map:HL7SD=Arm.title
Map:NCI CRF Standard=CDE 2454528v1.0: Protocol Arm Assignment Text
Map:SDTM IGv3.1.1=DM.ARMCD
Map:SDTM IGv3.1.1=TV.ARMCD
Map:SDTM IGv3.1.1=TA.ARMCD
Map:SDTM IGv3.1.2=TV.ARMCD
Map:SDTM IGv3.1.2=TA.ARMCD
Map:SDTM IGv3.1.2=DM.ARMCD
Map:SDTM IGv3.1.3=TV.ARM
Map:SDTM IGv3.1.3=TA.ARMCD
Map:SDTM IGv3.1.3=TA.ARM
Map:SDTM IGv3.1.3=DM.ARMCD
Map:SDTM IGv3.1.3=DM.ARM
Map:SDTM IGv3.1.3=DM.ACTARMCD
Map:SDTM IGv3.1.3=DM.ACTARM
Map:SDTM IGv3.1.3=TV.ARMCD
Map:TDM=StudyDesignArm.name

Notes:

DEFINITION: The text and/or code that identifies the arm. EXAMPLE(S): “Treatment A” with an optional code “A” OTHER NAME(S): NOTE(S): This value is at minimum a string with an optional code attached. The codes are likely to be local to the study rather than a standard of any kind.

Public CD
typeCode

Details:

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

Map:CTGOV=Arm Type
Map:CTR&Rr2=Number Treatment Arms
Map:CTRPv1.0=Arm.typeCode
Map:CTRPv3.8=Arm.typeCode
Map:CTRRr3=Arm.typeCode
Map:CTRv1.0=Arm.typeCode

Notes:

DEFINITION: A coded value specifying the kind of arm. EXAMPLE(S): Experimental, Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other OTHER NAME(S): NOTE(S):

Public ST
description

Details:

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

Map:C3PR=PlannedArm.description
Map:C3PR=ScheduledArm.description
Map:C3PR=Arm.descriptionText
Map:CTGOV=Arm Description
Map:CTRPv1.0=Arm.description
Map:CTRPv3.8=Arm.description
Map:CTRRr3=Arm.description
Map:CTRv1.0=Arm.description
Map:SDTM IGv3.1.1=TA.ARM
Map:SDTM IGv3.1.1=DM.ARM
Map:SDTM IGv3.1.1=TV.ARM
Map:SDTM IGv3.1.2=TV.ARM
Map:SDTM IGv3.1.2=DM.ARM
Map:SDTM IGv3.1.2=TA.ARM
Map:TDM=StudyDesignArm.description

Notes:

DEFINITION: The textual representation of the arm. This is a description of the pathway followed by all subjects, study subjects, or experimental units in a particular treatment regimen. EXAMPLE(S): Study subjects receive Drug X Experimental units receive Placebo Study subjects receive drug A IV in the first phase, drug B Oral in the second phase OTHER NAME(S): NOTE(S): This description should point out what is different between the Arms, if there is more than one Arm.

Public URG<INT.NONNEG>
targetAccrualNumberRange

Details:

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

Map:C3PR=Arm.targetAccrualNumber
Map:C3PR=PlannedArm.targetAccrual
Map:CTGOV=Number of Subjects per Treatment Arm
Map:CTRR=Number of subjects per treatment arm
Map:CTRv1.0=Arm.targetAccrualNumberRange
Map:TDM=StudyDesignArm.plannedArmAccrual

Notes:

DEFINITION: An integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the arm. EXAMPLE(S): For a 2-arm study with non-weighted randomization needing 500 subjects to provide the appropriate statistical power to answer the study question, each Arm should have a target accrual of 250 subjects. OTHER NAME(S): NOTE(S): This may represent the minimum number of study subjects needed to support data analysis and/or the maximum number of study subjects that may be accrued to this arm.

Public RTO<INT.NONNEG,INT.POS>
randomizationWeight

Details:

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

Map:CTRv1.0=Arm.randomizationWeight
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=RANDRAT
Map:TDM=StudyDesignArm.randomizationWeightForArm

Notes:

DEFINITION: The relative proportion of study subjects to be randomized to the arm. EXAMPLE(S): If 1/3 of study subjects are to be randomized to Arm A and 2/3 to Arm B, then the values of randomizationWeight for Arms A and B, respectively, could be expressed as 1 and 2 or as 1/3 and 2/3. OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
PlannedActivity Class	Name: containingArm	Name: containedPlannedActivity
Details: DESCRIPTION:<br/>Each Arm always contains one or more PlannedActivity. Each PlannedActivity might occur in one or more Arm. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyProtocolVersion Class	Name: subdividingArm	Name: subdividedStudyProtocolVersion
Details: DESCRIPTION:<br/>Each Arm always is a division of one StudyProtocolVersion. Each StudyProtocolVersion might be divided into one or more Arm.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
ExperimentalUnit Class	Name: performingExperimentalUnit	Name: performedArm
Details: DESCRIPTION:<br/>Each ExperimentalUnit might have performed one Arm. Each Arm might have been performed by one ExperimentalUnit.<br/><br/>DEFINITION:<br/>Indicates that an ExperimentalUnit was, at the end of their participation in a study, assigned to a particular arm based on their actual path through the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>This is derivable if the set of performed activities the ExperimentalUnit participated in are available.<br/>
PerformedExperimentalUnitAllocation Class	Name: assigningPerformedExperimentalUnitAllocation	Name: assignedArm
Details: DESCRIPTION:<br/>Each PerformedExperimentalUnitAllocation might assign an experimental unit to one Arm. Each Arm might be assigned an experimental unit by one or more PerformedExperimentalUnitAllocation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
ExperimentalUnit Class	Name: experiencingExperimentalUnit	Name: experiencedArm
Details: DESCRIPTION: <br/>Each ExperimentalUnit might actually have experienced one Arm. Each Arm might actually have been experienced by one or more ExperimentalUnit.<br/><br/>DEFINITION: <br/>The association between a ExperimentalUnit and an Arm that identifies the treatment plan actually received by the experimental unit as determined retrospectively regardless of what treatment plan was in fact assigned to the experimental unit.<br/><br/>EXAMPLE(S): <br/>For an A/B cross-over study the arms may be “A-B” and “B-A”; if John Doe was assigned Arm “A-B”, but actually experienced Arm “B-A”, this association would link his role of ExperimentalUnit to the Arm he really participated in.<br/><br/>OTHER NAME(S): <br/>Actual Arm<br/><br/>NOTE(S): In most trials one would expect that the Arm linked to the ExperimentalUnit will be the same as the Arm.name that was assigned in the PerformedExperimentalUnitAllocation for that ExperimentalUnit. However, if what actually happened is different than what was assigned but is actually a valid arm in the trial arms table, i.e. the experimental unit was assigned A-B but actually received B-A, this association shows the connection to the treatment plan that actually was followed. Or alternatively, if CDISC’s SDTM DM.ACTARMCD = "UNPLAN” (meaning "Unplanned Treatment"), then the treatment that occurred doesn’t match any arm in trial arms table and this association would not be used. Rather the ExperimentalUnit.unplannedTreatmentIndicator would be “true”. <br/>Note that this association has a retrospective nature – i.e. you might not know what treatment an experimental unit was actually on until after all treatments have been completed and the blind, if any, has been broken. This is typically the case for studies in which there may be more than one randomization.<br/>

Tag	Value
Map:CTRPv1.0	Arm
Details:
Map:CTRPv3.8	Arm
Details:
Map:CTRRr3	Arm
Details:
Map:CTRv1.0	Arm
Details:
Map:HL7SD	Arm
Details:
Map:SDTM IGv3.1.2	TA.DOMAIN
Details:
Map:SDTM IGv3.1.3	TA
Details:

Constraint	Type	Status
name Unique Qualifier	Invariant	Approved
Details: An Arm name must be unique within the context of the StudyProtocolVersion to which it is associated.<br/>
Mandatory Attribute Qualifier	Invariant	Approved
Details: At least one of the following attributes must be mandatory for Arm: name, typeCode.<br/>
armType Qualifier	Invariant	Approved
Details: armType is only valid for InterventionalStudyProtocolVersion.<br/>