: Public Class
DEFINITION:<br /></p><p>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.<br /></p><p><br /></p><p>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.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A study designed to assess the effects of treatments might have 3 epochs.<br /></p><p>A Screening Epoch in which subjects' eligibility is determined and baseline measurements are made.<br /></p><p>A Treatment Epoch during which treatments are given and effects of treatment are assessed.<br /></p><p>A Follow-up Epoch during which post-treatment assessments are conducted. <br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>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.<br /></p>
- Attributes
- Associations To
- Associations From
- Tagged Values
- Constraints
Attribute |
Public ST name
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Details:
Alias: |
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Initial: |
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Stereotype: |
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Ordered: |
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Range: |
Range:0 to 1 |
Transient: |
False |
Derived: |
False |
IsID: |
False |
Map:C3PR=Epoch.name Map:C3PR=PlannedEpoch.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=EX.EPOCH Map:SDTM IGv3.1.2=SE.EPOCH Map:SDTM IGv3.1.2=TA.EPOCH Map:SDTM IGv3.1.2=DS.EPOCH Map:SDTM IGv3.1.2=DV.EPOCH Map:TDM=StudyDesignEpoch.name
Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A non-unique textual identifier for the epoch.#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;first treatment epoch, second treatment epoch, first wash-out epoch, second wash-out epoch#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;When multiple Epochs have the same purpose (e.g., treatment), then the titles will probably include order numbers to distinguish them.#lt;br /#gt;#lt;/p#gt;
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Public CD typeCode
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Details:
Alias: |
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Initial: |
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Stereotype: |
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Ordered: |
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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:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of epoch.#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;screening, treatment, follow-up#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;
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Public INT.NONNEG sequenceNumber
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Details:
Alias: |
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Initial: |
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Stereotype: |
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Ordered: |
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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:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer specifying the relative sequential or temporal ordering of this epoch among other similar epochs in a study.#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;In a Study that has Screening, Treatment and Follow-Up epochs, the sequence number indicates which Epoch precedes the other.#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;
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Public ST description
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Details:
Alias: |
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Initial: |
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Stereotype: |
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Ordered: |
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Range: |
Range:0 to 1 |
Transient: |
False |
Derived: |
False |
IsID: |
False |
Map:C3PR=Epoch.descriptionText Map:C3PR=PlannedEpoch.description 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:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual representation of the epoch.#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 2-week period during which eligibility is determined and baseline measurements are taken".#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;"The first treatment epoch is a one-week period during which a single dose of one of the three investigational treatments is administered".#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;
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Public URG<INT.NONNEG> targetAccrualNumberRange
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Details:
Alias: |
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Initial: |
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Stereotype: |
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Ordered: |
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Range: |
Range:0 to 1 |
Transient: |
False |
Derived: |
True |
IsID: |
False |
Map:C3PRv2.9=Epoch.accrualCeiling Map:CTRv1.0=Epoch.targetAccrualNumberRange
Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer falling within minimum and maximum bounds that specifies how many study subjects to be accrued for the epoch.#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;The Phase II, one-armed study has a target accrual of 60 accruals.#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;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.#lt;br /#gt;#lt;/p#gt;
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Element |
Source Role |
Target Role |
StudyProtocolVersion
Class
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Name: subdividingEpoch
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Name: subdividedStudyProtocolVersion
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 Details:
DESCRIPTION:<br /></p><p>Each Epoch always is a division of one StudyProtocolVersion. Each StudyProtocolVersion might be divided into one or more Epoch.<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>
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Element |
Source Role |
Target Role |
PerformedActivity
Class
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Name: containedPerformedActivity
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Name: containingEpoch
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 Details:
DESCRIPTION:<br /></p><p>Each PerformedActivity might be contained by one Epoch. Each Epoch might contain one or more PerformedActivity.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates that a performed but unplanned activity is categorized as part of a particular Epoch.<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><p>This cannot be derived by looking at the corresponding planned activity because this association is only used for unplanned activities.<br /></p>
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PlannedActivity
Class
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Name: containedPlannedActivity
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Name: containingEpoch
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 Details:
DESCRIPTION:<br /></p><p>Each PlannedActivity might occur in one Epoch. Each Epoch might contain one or more PlannedActivity.<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>
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Tag |
Value |
Map:C3PRv2.9 |
Epoch |
 Details:
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Map:caAERSv2.2 |
Epoch |
 Details:
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Map:CTRPv3.8 |
Epoch |
 Details:
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Map:CTRv1.0 |
Epoch |
 Details:
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Map:PSCv2.6 |
Epoch |
 Details:
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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.
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Mandatory Attribute Qualifier |
Invariant |
Approved |
 Details:
At least one of the following attributes must be mandatory for Epoch: name, typeCode, sequenceNumber.
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