Study Conduct Sub-Domain::ScheduledSubstanceAdministration

: Public Class

Created:	10/21/2010 8:06:50 AM
Modified:	8/30/2019 12:34:04 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{9A2AF91F-AA50-4c2e-B428-15F46824F0C0}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct, SDTM IG v3.2, Surveillance, Epidemiology & End Results (SEER)

DEFINITION: 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. EXAMPLE(S): Administration of methotrexate as part of chemotherapy. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values
Constraints
Other Links

Attribute

Public PQ
activeIngredientDose

Details:

Alias:
Initial:
Stereotype:
Ordered:
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:

DEFINITION: The quantity of active ingredient anticipated to be administered. EXAMPLE(S): 5 mg OTHER NAME(S): NOTE(S): This is intended to be a subject-specific quantity. 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.

Public PQ
productDose

Details:

Alias:
Initial:
Stereotype:
Ordered:
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:

DEFINITION: The quantity of a substance or medication to be used in a substance administration. EXAMPLE(S): 5 mg OTHER NAME(S): NOTE(S): 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.

Public ST
productDoseDescription

Details:

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

Map:SDTM IGv3.1.2=EC.ECDOSTXT

Notes:

DEFINITION: The textual representation of dosing amounts or a range of dosing information to be used in a substance administration. EXAMPLE(S): 200-400 OTHER NAME(S): NOTE(S): 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.

Public CD
doseFrequencyCode

Details:

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

Map:SDTM IGv3.1.2=EC.ECDOSFRQ

Notes:

DEFINITION: A coded value specifying how often doses are to be administered. EXAMPLE(S): BID, TID, QID OTHER NAME(S): NOTE(S): 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".

Public PQ
periodProductDoseTotal

Details:

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

Map:SDTM IGv3.1.2=EC.ECDOSTOT

Notes:

DEFINITION: The total of all doses of treatment to be given in a period of time. EXAMPLE(S): OTHER NAME(S): NOTE(S): The given period of time is defined in dosePeriodCode. This attribute, periodProductDoseTotal, is not necessarily derivable since the dose may be provided as a string (in productDoseDescription).

Public CD
dosePeriodCode

Details:

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

Map:SDTM IGv3.1.2=EC.ECDOSTOT

Notes:

DEFINITION: A coded value specifying the period during which the dose total is to be administered. EXAMPLE(S): daily, course OTHER NAME(S): NOTE(S): The dose total is defined in periodProductDoseTotal and/or periodActiveIngredientDoseTotal.

Element	Source Role	Target Role
Product Class	Name: usingScheduledSubstanceAdministration	Name: usedProduct
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/>

Tag	Value
Map:SDTM IGv3.2	EC
Details:

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/>
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/>

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):