Protocol Representation Sub-Domain::Epoch

: Public Class

Created:	3/12/2008 12:16:10 PM
Modified:	8/26/2017 2:39:29 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{9D868856-E45C-48ee-AC34-73078CACE788}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, SDTM 3.1.3 View, SDTM Disease Response (RS) Domain View, SDTM Exposure (EX) Domain View, Participant Registration

DEFINITION: One of a set of ordered partitions of a subject's participation in a study. An Epoch represents a state within a study such that subjects in separate arms within that state are comparable. Each epoch serves a purpose in the study as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Activities and activity results control the subject's movement from one epoch to another. EXAMPLE(S): A study designed to assess the effects of treatments might have 3 epochs. A Screening Epoch in which subjects' eligibility is determined and baseline measurements are made. A Treatment Epoch during which treatments are given and effects of treatment are assessed. A Follow-up Epoch during which post-treatment assessments are conducted. OTHER NAME(S): NOTE(S): A subject moves from one epoch to another and can only be in one epoch at a time. The subject can only move to an epoch with a greater sequenceNumber. Activities in the same epoch but a different arm need not be similar in time and pattern. Subjects in different arms will not necessarily pass through the same epochs.

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public ST
name

Details:

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

Map:C3PR=PlannedEpoch.name
Map:C3PR=Epoch.name
Map:C3PRv2.9=Epoch.name
Map:caAERSv2.2=Epoch.name
Map:CDASHv1.1=DS.DSNEXT
Map:CDASHv1.1=DS.EPOCH
Map:CTOM=StudyTimePoint.epochName
Map:CTRPv3.8=Epoch.name
Map:CTRv1.0=Epoch.name
Map:FDA HL7 SD SD DSTU2012=plannedStudy/component1/epoch.title
Map:HL7SD=Epoch.title
Map:PSC=Period.name
Map:PSC=Epoch.name
Map:PSCv2.6=Epoch.name
Map:SDTM IGv3.1.1=DS.EPOCH
Map:SDTM IGv3.1.1=TA.EPOCH
Map:SDTM IGv3.1.2=TA.EPOCH
Map:SDTM IGv3.1.2=DV.EPOCH
Map:SDTM IGv3.1.2=DS.EPOCH
Map:SDTM IGv3.1.2=SE.EPOCH
Map:SDTM IGv3.1.2=EX.EPOCH
Map:SDTM IGv3.1.3=TR.EPOCH
Map:SDTM IGv3.1.3=TA.EPOCH
Map:SDTM IGv3.1.3=SE.EPOCH
Map:SDTM IGv3.1.3=RS.EPOCH
Map:SDTM IGv3.1.3=EX.EPOCH
Map:SDTM IGv3.1.3=TU.EPOCH
Map:SDTM IGv3.1.3=DV.EPOCH
Map:SDTM IGv3.1.3=DS.EPOCH
Map:TDM=StudyDesignEpoch.name

Notes:

DEFINITION: A non-unique textual identifier for the epoch. EXAMPLE(S): first treatment epoch, second treatment epoch, first wash-out epoch, second wash-out epoch OTHER NAME(S): NOTE(S): When multiple Epochs have the same purpose (e.g., treatment), then the titles will probably include order numbers to distinguish them.

Public CD
typeCode

Details:

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

Map:C3PR=PlannedEpoch.type
Map:C3PRv2.9=Epoch.treatmentIndicator
Map:CTRPv3.8=Epoch.typeCode
Map:CTRv1.0=Epoch.typeCode

Notes:

DEFINITION: A coded value specifying the kind of epoch. EXAMPLE(S): screening, treatment, follow-up OTHER NAME(S): NOTE(S):

Public INT.NONNEG
sequenceNumber

Details:

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

Map:C3PR=PlannedEpoch.firstEpochIndicator
Map:C3PR=Epoch.epochOrder
Map:C3PRv2.9=Epoch.epchOrder
Map:caAERSv2.2=Epoch.order
Map:CTRv1.0=Epoch.sequenceNumber
Map:FDA HL7 SD SD DSTU2012=plannedStudy/component1.sequenceNumber
Map:HL7SD=Component2.sequenceNumber
Map:TDM=StudyDesignEpoch.epochSequenceNumber

Notes:

DEFINITION: An integer specifying the relative sequential or temporal ordering of this epoch among other similar epochs in a study. EXAMPLE(S): In a Study that has Screening, Treatment and Follow-Up epochs, the sequence number indicates which Epoch precedes the 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=PlannedEpoch.description
Map:C3PR=Epoch.descriptionText
Map:C3PRv2.9=Epoch.descriptionText
Map:caAERSv2.2=Epoch.description
Map:CTRv1.0=Epoch.description
Map:FDA HL7 SD SD DSTU2012=plannedStudy/component1/epoch.text
Map:HL7SD=Epoch.text
Map:TDM=StudyDesignEpoch.description

Notes:

DEFINITION: The textual representation of the epoch. EXAMPLE(S): "A 2-week period during which eligibility is determined and baseline measurements are taken". "The first treatment epoch is a one-week period during which a single dose of one of the three investigational treatments is administered". OTHER NAME(S): NOTE(S):

Public URG<INT.NONNEG>
targetAccrualNumberRange

Details:

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

Map:C3PRv2.9=Epoch.accrualCeiling
Map:CTRv1.0=Epoch.targetAccrualNumberRange

Notes:

DEFINITION: An integer falling within minimum and maximum bounds that specifies how many study subjects to be accrued for the epoch. EXAMPLE(S): The Phase II, one-armed study has a target accrual of 60 accruals. OTHER NAME(S): NOTE(S): Derived from the summary of all arm accruals in that Epoch. This will be the same as the study level target accrual unless this study has parallel Epochs, in which case the summary will only count the accruals for arms in this Epoch.

Element	Source Role	Target Role
StudyProtocolVersion Class	Name: subdividingEpoch	Name: subdividedStudyProtocolVersion
Details: DESCRIPTION:<br/>Each Epoch always is a division of one StudyProtocolVersion. Each StudyProtocolVersion might be divided into one or more Epoch.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
PerformedActivity Class	Name: containedPerformedActivity	Name: containingEpoch
Details: DESCRIPTION:<br/>Each PerformedActivity might be contained by one Epoch. Each Epoch might contain one or more PerformedActivity.<br/><br/>DEFINITION:<br/>Indicates that a performed but unplanned activity is categorized as part of a particular Epoch.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>This cannot be derived by looking at the corresponding planned activity because this association is only used for unplanned activities.<br/>
PlannedActivity Class	Name: containedPlannedActivity	Name: containingEpoch
Details: DESCRIPTION:<br/>Each PlannedActivity might occur in one Epoch. Each Epoch might contain one or more PlannedActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:C3PRv2.9	Epoch
Details:
Map:caAERSv2.2	Epoch
Details:
Map:CTRPv3.8	Epoch
Details:
Map:CTRv1.0	Epoch
Details:
Map:PSCv2.6	Epoch
Details:

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