Common Sub-Domain::ExperimentalUnit

: Public Class

Created:	1/28/2009 11:14:37 AM
Modified:	8/26/2017 2:00:36 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{1138A65E-9307-4f90-98D8-C1EC36985765}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View CM: Common, View PR: Protocol Representation, View SC: Study Conduct, Subject and ExperimentalUnit Comparison, Oncology & Imaging View, Oncology View, SDTM 3.1.3 View

DEFINITION: A physical entity which is the primary unit of interest in a specific research objective. EXAMPLE(S): If all pigs in a pen receive the same intervention in their feed, and the primary observations and analyses of interest are associated with the entire pen (e.g. total feed consumed, total weight of all pigs combined), then the pen of pigs rather than the individual animal is the experimental unit. [example from the CDISC/HL7 Study Participation message] A human may have 10 patches of skin each considered an experimental unit. A product may have 10 bearings in it, each considered an experimental unit. Alternatively, the whole human or product may be an experimental unit. OTHER NAME(S): NOTE(S): Depending on the research objectives, a single study may have multiple levels of experimental units, such as whole people and patches of skin. In an interventional study, the experimental unit is assigned to an intervention. The experimental unit is also the unit of primary statistical analysis. Commonly the individual study subject (animal, person or product) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions.

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public DSET<ID>
identifier

Details:

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

Map:CTRv1.0=ExperimentalUnit.identifier
Map:HL7SP=ExperimentalUnit.id

Notes:

DEFINITION: A unique symbol that establishes identity of the experimental unit. EXAMPLE(S): patient number 7 on a study OTHER NAME(S): NOTE(S):

Public CD
subgroupCode

Details:

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

Map:C3PR=StudySubject.subgroup
Map:CTOM=StudyParticipantAssignment.subgroupCode
Map:CTRv1.0=ExperimentalUnit.subgroupCode
Map:NCI CRF Standard=CDE 1925v2.31: Patient Subgroup Code

Notes:

DEFINITION: A coded value specifying the identification of uniform groups of experimental units for separate analysis or treatment. EXAMPLE(S): Clinical Data Update System (CDUS) Reporting (for the National Cancer Institute (NCI) OTHER NAME(S): NOTE(S):

Public CD
statusCode

Details:

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

Map:CTRv1.0=ExperimentalUnit.statusCode
Map:HL7SP=ExperimentalUnit.statusCode

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the experimental unit. EXAMPLE(S): active, cancelled, pending, suspended, terminated, nullified OTHER NAME(S): NOTE(S): Please refer to the HL7 Role Status state transition diagram for further details.

Public TS.DATETIME
statusDate

Details:

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

Map:CTRv1.0=ExperimentalUnit.statusDate
Map:HL7SP=ExperimentalUnit.effectiveTime

Notes:

DEFINITION: The date (and time) on which the status is assigned to the experimental unit. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
unplannedTreatmentIndicator

Details:

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

Map:SDTM IGv3.1.3=DM.ACTACRMCD
Map:SDTM IGv3.1.3=DM.ACTARM

Notes:

DEFINITION: Specifies whether the treatment plan actually received by the experimental unit, as determined retrospectively, was not only NOT what was assigned, but was not even defined as a valid treatment plan. EXAMPLE(S): If an A/B cross-over study only has arms “A-B” and “B-A” and a given experimental unit has a treatment that is effectively “A-A”, then unplannedTreatmentIndicator = “true”. In SDTM, if DM.ACTARM = “Unplanned Treatment” or DM.ACTARMCD = “UNPLAN”, then unplannedTreatmentIndicator = “true”. OTHER NAME(S): NOTE(S): If the treatment plan received by an experimental unit actually is a valid treatment plan, whether or not it was what was assigned in the experimental unit allocation activity, this is represented as an association from the ExperimentalUnit to the Arm, with unplannedTreatmentIndicator = “false”. Note that this attribute 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.

Element	Source Role	Target Role
BiologicEntityPart Class	Name: performedExperimentalUnit	Name: performingBiologicEntityPart
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one BiologicEntityPart. Each BiologicEntityPart might function as one or more ExperimentalUnit. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
BiologicEntityGroup Class	Name: performedExperimentalUnit	Name: performingBiologicEntityGroup
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one BiologicEntityGroup. Each BiologicEntityGroup might function as one or more ExperimentalUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
BiologicEntity Class	Name: performedExperimentalUnit	Name: performingBiologicEntity
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one BiologicEntity. Each BiologicEntity might function as one or more ExperimentalUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Arm 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/>
Product Class	Name: performedExperimentalUnit	Name: performingProduct
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one Product. Each Product might function as one or more ExperimentalUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Arm 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/>
Specimen Class	Name: performedExperimentalUnit	Name: performingSpecimen
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one Specimen. Each Specimen might function as one or more ExperimentalUnit. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ProductGroup Class	Name: performedExperimentalUnit	Name: performingProductGroup
Details: DESCRIPTION:<br/>Each ExperimentalUnit might be a function performed by one ProductGroup. Each ProductGroup might function as one or more ExperimentalUnit.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
Activity Class	Name: involvingActivity	Name: involvedExperimentalUnit
Details: DESCRIPTION:<br/>Each Activity might be participated in by one ExperimentalUnit. Each ExperimentalUnit might participate in one or more Activity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:CTRRr3	ExperimentalUnit
Details:
Map:CTRv1.0	ExperimentalUnit
Details:
Map:HL7SP	ExperimentalUnit
Details:

Constraint	Type	Status
be a function performed by Exclusive Or	Invariant	Approved
Details: An ExperimentalUnit may be a function performed by one and only one of the following: BiologicEntityPart, BiologicEntity, BiologicEntityGroup, Product, ProductGroup, Specimen.<br/>