| Created: | 8/27/2009 4:58:42 PM |
| Modified: | 8/26/2017 2:39:33 AM |
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DEFINITION:<br/>An activity that is intended to occur at some point in the context of a particular study and that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur) based on a randomization book.<br/><br/>EXAMPLE(S):<br/>A study has two treatment arms, A and B, to which study subjects will be evenly distributed. The first study subject to be randomized received treatment Arm A and that was documented as part of the Randomization Book, the next study subject to be randomized will receive the next open treatment, which is Arm B.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A randomization book is a predefined set of assignments to portions of a study based on criteria, such as stratum group for example, that ensures a desired distribution of experimental units across those portions of the study. For example, the book entries indicate which arm a given experimental unit, Joe, is assigned to based on the fact that he's the 5th person in stratum group #2.<br/>
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| Element | Source Role | Target Role |
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RandomizationBookEntry Class |
Name: definedRandomizationBookEntry |
Name: definingPlannedRandomizationBookAllocation |
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DESCRIPTION:<br/>Each RandomizationBookEntry always is defined by one PlannedRandomizationBookAllocation. Each PlannedRandomizationBookAllocation always defines one or more RandomizationBookEntry.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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| Tag | Value |
| Map:C3PR | BookRandomization |
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| Map:C3PRv2.9 | BookRandomization |
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| Map:CTRRr3 | PlannedRandomizationBookAllocation |
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| Constraint | Type | Status |
| DefinedActivity Qualifier | Invariant | Approved |
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A PlannedRandomizationBookAllocation can only reference a StudyActivity that points to DefinedExperimentalUnitAllocation, not any other DefinedActivity subclass.<br/>
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| Repeat Not Applicable | Invariant | Approved |
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The Repeat attributes should not be used for a PlannedRandomizationBookAllocation.<br/>
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| be participated in by Qualifier | Invariant | Approved |
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Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid.<br/>
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| Object | Type | Connection | Direction | Notes |
| PlannedExperimentalUnitAllocation | Class | Generalization | To | DESCRIPTION: Each PlannedRandomizationBookAllocation always specializes one PlannedExperimentalUnitAllocation. Each PlannedExperimentalUnitAllocation might be specialized by one PlannedRandomizationBookAllocation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |