: Public Class
DEFINITION:<br/>An activity of applying, introducing or otherwise giving medications or other substances to a subject or experimental unit that is anticipated to occur at some time in the future.<br/><br/>EXAMPLE(S):<br/>Administration of methotrexate as part of chemotherapy.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
- Attributes
- Associations To
- Tagged Values
- Constraints
- Other Links
Attribute |
Public PQ activeIngredientDose
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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:CDASHv1.1=EX.EXPDOSEU Map:CDASHv1.1=EX.EXPDOSE Map:CTRPv3.8=PlannedSubstanceAdministration.dose
Notes:
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DEFINITION:<br/>The quantity of active ingredient anticipated to be administered.<br/><br/>EXAMPLE(S):<br/>5 mg<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This is intended to be a subject-specific quantity.<br/><br/>DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedDoseExpressionVariableRelationship. <br/>
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Public PQ productDose
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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:SDTM IGv3.1.2=EC.ECDOSU Map:SDTM IGv3.1.2=EC.ECDOSE
Notes:
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DEFINITION:<br/>The quantity of a substance or medication to be used in a substance administration.<br/><br/>EXAMPLE(S):<br/>5 mg<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose ScheduledSubstanceAdministration.productDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedExpressionVariableRelationship.<br/>
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Public ST productDoseDescription
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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:SDTM IGv3.1.2=EC.ECDOSTXT
Notes:
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DEFINITION:<br/>The textual representation of dosing amounts or a range of dosing information to be used in a substance administration.<br/><br/>EXAMPLE(S):<br/>200-400<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This is used for more complex dosages such as scaling and tapering doses, uncertain dosage ranges, differing morning and evening doses and other instructions that can't be expressed with a simple PQ.<br/>
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Public CD doseFrequencyCode
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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:SDTM IGv3.1.2=EC.ECDOSFRQ
Notes:
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DEFINITION:<br/>A coded value specifying how often doses are to be administered. <br/><br/>EXAMPLE(S):<br/>BID, TID, QID<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This attribute is needed in order to capture multiple substance administrations in one act, rather than each time a patient swallows a pill, for example "The patient is to take med X 3 times a day for 10 days starting on June 9th". <br/>
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Public PQ periodProductDoseTotal
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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:SDTM IGv3.1.2=EC.ECDOSTOT
Notes:
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DEFINITION:<br/>The total of all doses of treatment to be given in a period of time.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The given period of time is defined in dosePeriodCode.<br/><br/>This attribute, periodProductDoseTotal, is not necessarily derivable since the dose may be provided as a string (in productDoseDescription).<br/>
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Public CD dosePeriodCode
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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:SDTM IGv3.1.2=EC.ECDOSTOT
Notes:
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DEFINITION: <br/>A coded value specifying the period during which the dose total is to be administered. <br/><br/>EXAMPLE(S):<br/>daily, course<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The dose total is defined in periodProductDoseTotal and/or periodActiveIngredientDoseTotal.<br/>
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Element |
Source Role |
Target Role |
Product
Class
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Name: usingScheduledSubstanceAdministration
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Name: usedProduct
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 Details:
DESCRIPTION:<br/>Each ScheduledSubstanceAdministration might use one or more Product. Each Product might be used during one or more ScheduledSubstanceAdministration.<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:SDTM IGv3.2 |
EC |
 Details:
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Constraint |
Type |
Status |
be participated in by Qualifier |
Invariant |
Approved |
 Details:
Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. <br/>
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activeIngredientDose Qualifier |
Invariant |
Approved |
 Details:
activeIngredientDose must only be used when the ScheduledSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. <br/>
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Object |
Type |
Connection |
Direction |
Notes |
ScheduledActivity |
Class |
Generalization |
To |
DESCRIPTION:
Each ScheduledSubstanceAdministration always specializes one ScheduledActivity. Each ScheduledActivity might be specialized by one ScheduledSubstanceAdministration.
DEFINITION:
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
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