Study Conduct Sub-Domain::PerformedSubstanceAdministration

: Public Class

Created:	12/14/2005 2:21:14 PM
Modified:	3/18/2019 2:10:31 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{CE070FC5-5B80-404b-8E4A-3249008E6F13}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View SC: Study Conduct, SDTM 3.1.3 View, SDTM Exposure (EX) Domain View, SDTM 3.2 View, Oncology & Imaging View, Oncology View, Participant Registration, SEER View, CDMH View, Animal View

DEFINITION: The completed action of applying, introducing or otherwise giving medications or other substances to the subject or experimental unit. EXAMPLE(S): An experimental unit who receives methotrexate as part of chemotherapy, radiation therapy. For a SubstanceAdministration, targetAnatomicSiteCode = coronary artery, approachAnatomicSiteCode = groin, routeOfAdministrationCode = intra-arterial. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public PQ
activeIngredientDose

Details:

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

Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=RadiationIntervention.dosageUnit
Map:caAERSv2.2=AdverseEventResponseDescription.reducedDose
Map:caAERSv2.2=Dose.unit
Map:caAERSv2.2=RadiationIntervention.dosage
Map:CDASHv1.1=EX.EXDOSU
Map:CDASHv1.1=EX.EXDSTXT
Map:CDASHv1.1=CM.CMDOSU
Map:CDASHv1.1=SU.SUDOSU
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevelUnitOfMeasureCode
Map:CTOM=SubstanceAdministration.singleDose
Map:CTOM=SubstanceAdministration.singleDoseUnitOfMeasureCode
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevel
Map:CTRv1.0=PerformedSubstanceAdministration.activeIngredientDose
Map:SDTM IGv3.1.1=EX.EXDOSU
Map:SDTM IGv3.1.1=CM.CMDOSE
Map:SDTM IGv3.1.1=EX.EXDOSE
Map:SDTM IGv3.1.1=CM.CMDOSU
Map:SDTM IGv3.1.1=SU.SUDOSE
Map:SDTM IGv3.1.1=SU.SUDOSU
Map:SDTM IGv3.1.2=SU.SUDOSE
Map:SDTM IGv3.1.2=EX.EXDOSE
Map:SDTM IGv3.1.2=EX.EXDOSU
Map:SDTM IGv3.1.2=CM.CMDOSE
Map:SDTM IGv3.1.2=SU.SUDOSU
Map:SDTM IGv3.1.2=CM.CMDOSU
Map:SDTM IGv3.1.3=EX.EXDOSU
Map:SDTM IGv3.1.3=CM.CMDOSE
Map:SDTM IGv3.1.3=EX.EXDOSE
Map:SDTM IGv3.1.3=SU.SUDOSE
Map:SDTM IGv3.1.3=SU.SUDOSU
Map:SDTM IGv3.1.3=CM.CMDOSU
Map:SDTM IGv3.2=EX.EXDOSE
Map:SDTM IGv3.2=EX.EXDOSU
Map:SDTM IGv3.2=SU.SUDOSE
Map:SDTM IGv3.2=SU.SUDOSU
Map:SDTM IGv3.2=CM.CMDOSE
Map:SDTM IGv3.2=CM.CMDOSU

Notes:

DEFINITION: The quantity of active ingredients used in a substance administration. EXAMPLE(S): 5 mg OTHER NAME(S): NOTE(S): Derived by multiplying the PerformedSubstanceAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true").

Public ST
activeIngredientDoseDescription

Details:

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

Map:CDASHv1.1=SU.SUDSTXT
Map:CDASHv1.1=EX.EXDSTXT
Map:CDASHv1.1=CM.CMDSTXT
Map:CTOM=SubstanceAdministration.descriptionText
Map:CTRv1.0=PerformedSubstanceAdministration.activeIngredientDoseDescription
Map:SDTM IGv3.1.1=SU.SUDOSTXT
Map:SDTM IGv3.1.1=EX.EXDOSTXT
Map:SDTM IGv3.1.1=CM.CMDOSTXT
Map:SDTM IGv3.1.2=SU.SUDOSTXT
Map:SDTM IGv3.1.2=EX.EXDOSTXT
Map:SDTM IGv3.1.2=CM.CMDOSTXT
Map:SDTM IGv3.1.3=SU.SUDOSTXT
Map:SDTM IGv3.1.3=CM.CMDOSTXT
Map:SDTM IGv3.2=CM.CMDOSTXT
Map:SDTM IGv3.2=SU.SUDOSTXT

Notes:

DEFINITION: The textual representation of active ingredients in the dosing amounts or a range of dosing information 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
approachAnatomicSiteDirectionalityCode

Details:

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

Map:SDTM IGv3.1.2=EX.EXDIR

Notes:

DEFINITION: A coded value specifying the directional portion of the anatomic site that is an approach site for a substance administration EXAMPLE(S): ANTERIOR, LOWER, PROXIMAL, UPPER OTHER NAME(S): NOTE(S): This attribute complements the approach anatomic site code and approach anatomic site laterality code.

Public ST
changeReason

Details:

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

Map:CDASHv1.1=EX.EXADJ
Map:CDMHv1.0=PerformedSubstanceAdministration.changeReason
Map:CTRv1.0=PerformedSubstanceAdministration.changeReason
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.changeReason
Map:SDTM IGv3.1.1=EX.EXADJ
Map:SDTM IGv3.1.2=EX.EXADJ
Map:SDTM IGv3.1.3=EX.EXADJ
Map:SDTM IGv3.2=EC.ECADJ
Map:SDTM IGv3.2=EX.EXADJ

Notes:

DEFINITION: The rationale for changing the substance administration in relation to the previous substance administration. EXAMPLE(S): Dose reduced due to hematologic toxicity OTHER NAME(S): NOTE(S):

Public CD
changeTypeCode

Details:

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

Map:caAERSv2.2=CourseAgent.agentAdjustment
Map:CTOM=SubstanceAdministration.doseChangeCode
Map:CTRv1.0=PerformedSubstanceAdministration.changeTypeCode
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.changeTypeCode

Notes:

DEFINITION: A coded value specifying the modification of the substance administration in relation to the previous substance administration. EXAMPLE(S): Agent Added, Agent Dose Decreased, Agent Dose Increased OTHER NAME(S): NOTE(S):

Public INT.POS
distinctProductCount

Details:

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

Map:HCTv1.0=CDE 2693395:Procedures.Were multiple products infused?
Map:HCTv1.0=CDE 3010760:DONOR'.What is the number of hematopoietic stem cell products that resulted from different collection methods or episodes and or mobilization techniques?

Notes:

DEFINITION: The number of products (resulting from different collections) used for this substance administration. EXAMPLE(S): If blood is taken from 2 people (two donations from one of them), this would be counted as 3 different collections. OTHER NAME(S): NOTE(S): This is a count of distinct donations, typically used for stem cell transplants.

Public CD
doseFrequencyCode

Details:

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

Map:caAERSv2.2=CourseAgent.durationAndSchedule
Map:CDASHv1.1=SU.SUDOSFRQ
Map:CDASHv1.1=EX.EXDOSFRQ
Map:CDASHv1.1=CM.CMDOSFRQ
Map:CDMHv1.0=PerformedSubstanceAdministration.doseFrequencyCode
Map:CTOM=SubstanceAdministration.doseFrequencyCode
Map:CTOM=SubstanceAdministration.doseFrequencyText
Map:CTRv1.0=PerformedSubstanceAdministration.doseFrequencyCode
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.doseFrequencyCode
Map:NCI CRF Standard=CDE 2003322v4.0: Administration Schedule Term Name
Map:SDTM IGv3.1.1=SU.SUDOSFRQ
Map:SDTM IGv3.1.1=EX.EXDOSFRQ
Map:SDTM IGv3.1.1=CM.CMDOSFRQ
Map:SDTM IGv3.1.2=EX.EXDOSFRQ
Map:SDTM IGv3.1.2=CM.CMDOSFRQ
Map:SDTM IGv3.1.2=SU.SUDOSFRQ
Map:SDTM IGv3.1.3=SU.SUDOSFRQ
Map:SDTM IGv3.1.3=CM.CMDOSFRQ
Map:SDTM IGv3.1.3=EX.EXDOSFRQ
Map:SDTM IGv3.2=EC.ECDOSFRQ
Map:SDTM IGv3.2=EX.EXDOSFRQ
Map:SDTM IGv3.2=PR.PRDOSFRQ
Map:SDTM IGv3.2=SU.SUDOSFRQ
Map:SDTM IGv3.2=CM.CMDOSFRQ

Notes:

DEFINITION: A coded value specifying how often doses are 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 took med X 3 times a day for 10 days starting on June 9th".

Public CD
dosePeriodCode

Details:

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

Map:caAERSv2.2=CourseAgent>totalDoseAdministeredThisCourse>Dose
Map:CTRv1.0=PerformedSubstanceAdministration.dosePeriodCode
Map:HCTv1.0=CDE 2635420:Therapy Doses.Was the radiation therapy fractionated
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.dosePeriodCode

Notes:

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

Public CD
endRelativeToReferenceCode

Details:

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

Map:CTRv1.0=PerformedSubstanceAdministration.endRelativeToReferenceCode
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.endRelativeToReferenceCode
Map:SDTM IGv3.1.1=SU.SUENRF
Map:SDTM IGv3.1.1=CM.CMENRF
Map:SDTM IGv3.1.3=CM.CMENRF
Map:SDTM IGv3.1.3=SU.SUENRF
Map:SDTM IGv3.2=SU.SUENRF
Map:SDTM IGv3.2=CM.CMENRF

Notes:

DEFINITION: A coded value specifying when this event ended with respect to the sponsor-defined reference period. EXAMPLE(S): before, during, during/after, after OTHER NAME(S): NOTE(S): Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME#gt;).high and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected.

Public RTO<PQ,PQ.TIME>
flowRate

Details:

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

Map:CDASHv1.1=EX.EXFLRTU
Map:CDASHv1.1=EX.EXFLRT
Map:CTRv1.0=PerformedSubstanceAdministration.flowRate
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.rateQuantity
Map:NCI CRF Standard=CDE 2475888v1.0: Infusion Flow Rate Number

Notes:

DEFINITION: A ratio specifying the speed with which the substance is introduced into the subject. EXAMPLE(S): 100 mL/h 1 g/d 40 mmol/h OTHER NAME(S): NOTE(S):

Public PQ.TIME
interruptionDuration

Details:

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

Map:CDASHv1.1=EX.EXINTRPU
Map:CDASHv1.1=EX.EXINTRP
Map:CTRv1.0=PerformedSubstanceAdministration.interruptionDuration

Notes:

DEFINITION: The period of time during which a substance administration is interrupted. EXAMPLE(S): An infusion started at 12:15pm and ended at 2:37pm, but there was an interruption of 17 minutes. OTHER NAME(S): NOTE(S):

Public PQ
periodActiveIngredientDoseTotal

Details:

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

Map:caAERSv2.2=RadiationIntervention.fractionNumber
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=Dose.units
Map:CDASHv1.1=CM.CMDOSTOT
Map:CTOM=SubstanceAdministration.totalDose
Map:CTOM=SubstanceAdministration.totalDoseUnitOfMeasureCode
Map:CTRv1.0=PerformedSubstanceAdministration.periodActiveIngredientDoseTotal
Map:SDTM IGv3.1.1=EX.EXDOSTOT
Map:SDTM IGv3.1.1=CM.CMDOSTOT
Map:SDTM IGv3.1.1=SU.SUDOSTOT
Map:SDTM IGv3.1.2=SU.SUDOSTOT
Map:SDTM IGv3.1.2=EX.EXDOSTOT
Map:SDTM IGv3.1.2=CM.CMDOSTOT
Map:SDTM IGv3.1.3=SU.SUDOSTOT
Map:SDTM IGv3.1.3=CM.CMDOSTOT
Map:SDTM IGv3.1.3=EX.EXDOSTOT
Map:SDTM IGv3.1.3=EX.EXDOSTXT
Map:SDTM IGv3.1.3=EX.EXDOSU
Map:SDTM IGv3.2=CM.CMDOSTOT
Map:SDTM IGv3.2=SU.SUDOSTOT
Map:SDTM IGv3.2=EX.EXDOSU
Map:SDTM IGv3.2=EX.EXDOSTXT

Notes:

DEFINITION: The total amount of active ingredient in all doses of treatment in a given period of time. EXAMPLE(S): OTHER NAME(S): NOTE(S): The given period of time is defined in dosePeriodCode. Derived by multiplying PerformedSubstanceAdministration.periodProductDoseTotal (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true").

Public PQ
periodProductDoseTotal

Details:

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

Map:caAERSv2.2=Dose.units
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=RadiationIntervention.fractionNumber
Map:CTOM=SubstanceAdministration.totalDoseUnitOfMeasureCode
Map:CTOM=SubstanceAdministration.totalDose
Map:CTRv1.0=PerformedSubstanceAdministration.periodProductDoseTotal
Map:HCTv1.0=CDE 2980940:Therapies.What was the radiation total dose?
Map:HCTv1.0=CDE 3086792:Therapies.Specify total dose:
Map:HCTv1.0=CDE 2960770:Therapies.Specify the total radiation dose administered to another site:
Map:HCTv1.0=CDE 2960298:Therapies.What was the preparative regimen total milligram dose?
Map:HCTv1.0=CDE 2962200:Therapies.Specify interstitial irradiation/brachytherapy total dose:
Map:HCTv1.0=CDE 2979333:Therapies.Local-regional radiation therapy total dose:
Map:HCTv1.0=CDE 2964435:Therapies.Radiation therapy field radioactive instillation total dose
Map:HCTv1.0=CDE 2960635:Therapies.Specify local cranial radiation total dose:
Map:HCTv1.0=CDE 2721441:Therapies.Total Dose
Map:HCTv1.0=CDE 2960618:Therapies.Specify whole brain radiation total dose:
Map:HCTv1.0=CDE 3181110:Therapies.Therapeutic procedure administered milligram daily dose:
Map:HCTv1.0=CDE 2953815:Therapies.Total dose unit of measure:
Map:HCTv1.0=CDE 2960649:Therapies.Specify gamma knife and/or radiosurgery radiation total dose:
Map:HCTv1.0=CDE 2960768:Therapies.Specify local spinal radiation total dose:
Map:HCTv1.0=CDE 2960642:Therapies.Specify craniospinal radiation total dose:
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.periodDoseTotal
Map:SDTM IGv3.2=EC.ECDOSTOT

Notes:

DEFINITION: The total of all doses of treatment in a given 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 BL
plannedChangeIndicator

Details:

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

Map:CTOM=SubstanceAdministration.doseChangeIndicatorCode
Map:CTOM=DiseaseResponse.doseChangeIndicatorCode
Map:CTRv1.0=PerformedSubstanceAdministration.plannedChangeIndicator
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.plannedChangeIndicator

Notes:

DEFINITION: Specifies whether a change in the substance administration in relation to the previous substance administration is planned or not. EXAMPLE(S): True = planned, False = unplanned OTHER NAME(S): NOTE(S):

Public PQ
productDose

Details:

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

Map:caAERSv2.2=AdverseEventResponseDescription.reducedDose
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=RadiationIntervention.dosageUnit
Map:caAERSv2.2=Dose.unit
Map:caAERSv2.2=RadiationIntervention.dosage
Map:CDASHv1.1=EX.EXVOLT
Map:CDASHv1.1=EX.EXVOLTU
Map:CDMHv1.0=PerformedSubstanceAdministration.productDose
Map:CTOM=SubstanceAdministration.singleDose
Map:CTOM=Radiation.dose
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevelUnitOfMeasureCode
Map:CTOM=SubstanceAdministration.singleDoseUnitOfMeasureCode
Map:CTOM=Radiation.doseUnitOfMeasureCode
Map:CTOM=StudyParticipantAssignment.studyAgentDoseLevel
Map:CTRv1.0=PerformedSubstanceAdministration.productDose
Map:HCTv1.0=CDE 2729000:Therapies.For the autologous blood transfusion, specify the number of units:
Map:HCTv1.0=CDE 2954034:Therapy Doses.Dose per fraction unit of measure:
Map:HCTv1.0=CDE 2729014:Therapies.For the allogeneic blood transfusion, specify the number of units:
Map:HCTv1.0=CDE 2738560:Therapy Doses.Total volume of product plus additives infused:
Map:HCTv1.0=CDE 2180757:Therapies.RT Dose per Fraction
Map:HCTv1.0=CDE 3108427:Therapies.What is the dose value of the preparative regimen medication?
Map:HCTv1.0=CDE 2954032:Therapy Doses.Dose per fraction:
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.dose
Map:NCI CRF Standard=CDE 2182728v2.0: Agent Dose
Map:NCI CRF Standard=CDE 3028750v1.0: Intervention Potency Unit of Measure for Unified Code for Units of Measure Code
Map:SDTM IGv3.2=PR.PRDOSU
Map:SDTM IGv3.2=EC.ECDOSE
Map:SDTM IGv3.2=EC.ECDOSU
Map:SDTM IGv3.2=PR.PRDOSE

Notes:

DEFINITION: The quantity of a substance or medication 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 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:CDMHv1.0=PerformedSubstanceAdministration.productDoseDescription
Map:CTOM=SubstanceAdministration.descriptionText
Map:CTRv1.0=PerformedSubstanceAdministration.productDoseDescription
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.doseDescription
Map:SDTM IGv3.2=EC.ECDOSTXT
Map:SDTM IGv3.2=PR.PRDOSTXT

Notes:

DEFINITION: The textual representation of dosing amounts or a range of dosing information 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
routeOfAdministrationCode

Details:

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

Map:caAERSv2.2=Dose.route
Map:CDASHv1.1=EX.EXROUTE
Map:CDASHv1.1=CM.CMROUTE
Map:CDMHv1.0=PerformedSubstanceAdministration.routeOfAdministrationCode
Map:CTOM=SubstanceAdministration.routeCode
Map:CTRv1.0=PerformedSubstanceAdministration.routeOfAdministrationCode
Map:HCTv1.0=CDE 2780200:Therapy Doses.Specify route of infusion:
Map:HCTv1.0=MD Anderson Specific Content: Transplant.Intravenous administration
Map:HCTv1.0=CDE 2698088:Therapy Doses.Specify the route of product infusion:
Map:HCTv1.0=CDE 2960396:Therapies.What was the route of administration for the preparative regimen drugs?
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.routeOfAdministrationCode
Map:NCI CRF Standard=CDE 2003586v6.0: Access Route of Administration Text Code
Map:SDTM IGv3.1.1=SU.SUROUTE
Map:SDTM IGv3.1.1=EX.EXROUTE
Map:SDTM IGv3.1.1=CM.CMROUTE
Map:SDTM IGv3.1.2=SU.SUROUTE
Map:SDTM IGv3.1.2=EX.EXROUTE
Map:SDTM IGv3.1.2=CM.CMROUTE
Map:SDTM IGv3.1.3=CM.CMROUTE
Map:SDTM IGv3.1.3=EX.EXROUTE
Map:SDTM IGv3.1.3=SU.SUROUTE
Map:SDTM IGv3.2=CM.CMROUTE
Map:SDTM IGv3.2=EC.ECROUTE
Map:SDTM IGv3.2=PR.PRROUTE
Map:SDTM IGv3.2=SU.SUROUTE
Map:SDTM IGv3.2=EX.EXROUTE

Notes:

DEFINITION: A coded value specifying the physiological path or method of introducing the substance into or onto the subject. EXAMPLE(S): oral, intravenous, swallow, oral rinse, oral topical application, chew, oral dissolve, oral inhalation OTHER NAME(S): NOTE(S): Route is more than just approach site. It deals with how the body will actually absorb/receive the drug. The approach site might be "mouth", but from a route code perspective, this could include: swallow, oral rinse, oral topical application, chew, oral dissolve, oral inhalation (via intermittent flow or rebreather mask). The effect of the drug could vary depending on the route even if the body site happens to be the same.

Public BL
standardTimeIndicator

Details:

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

Map:HCTv1.0=CDE 2713223:Occurrences.Is it the standard time or daylight savings time?
Map:HCTv1.0=CDE 2713225:Occurrences.Is it the standard time or daylight savings time?

Notes:

DEFINITION: Specifies whether the time of the substance administration is specified using standard (as opposed to daylight savings) time. EXAMPLE(S): OTHER NAME(S): NOTE(S): If the location and date are known, this data is derivable.

Public CD
startRelativeToReferenceCode

Details:

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

Map:CTRv1.0=PerformedSubstanceAdministration.startRelativeToReferenceCode
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.startRelativeToReferenceCode
Map:SDTM IGv3.1.1=CM.CMSTRF
Map:SDTM IGv3.1.1=SU.SUSTRF
Map:SDTM IGv3.1.3=CM.CMSTRF
Map:SDTM IGv3.1.3=SU.SUSTRF
Map:SDTM IGv3.2=CM.CMSTRF
Map:SDTM IGv3.2=SU.SUSTRF

Notes:

DEFINITION: A coded value specifying when this event started with respect to the sponsor-defined reference period. EXAMPLE(S): Medications that are ongoing at the end of the reference period should have a value of "during/after" for this variable. Before, during, during/after, after OTHER NAME(S): NOTE(S): Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME).low and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected.

Public BL
substanceUnknownIndicator

Details:

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

Map:HCTv1.0=CDE 2974124:Therapies.What is the reason for the drug induced drug missing value?

Notes:

DEFINITION: Specifies whether the substance administered was not known. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public PQ
treatmentVehicleQuantity

Details:

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

Map:CTRPv1.0=SubstanceAdministration.treatmentVehicleVolume
Map:LSDAMv2.2.3Plus=PerformedSubstanceAdministration.treatmentVehicleVolume
Map:NCI CRF Standard=CDE 2871633v1.0: Agent Administration Drug Vehicle Total Volume Number
Map:SDTM IGv3.1.2=EX.EXVAMT
Map:SDTM IGv3.1.2=EX.EXVAMTU
Map:SDTM IGv3.1.3=EX.EXVAMT
Map:SDTM IGv3.1.3=EX.EXVAMTU

Notes:

DEFINITION: The quantity and units of treatment vehicle used. EXAMPLE(S): 10 milligrams, 2 milliliters OTHER NAME(S): NOTE(S): Derived by multiplying the PerformedSubstancedAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "false").

Element	Source Role	Target Role
PerformedMedicalConditionResult Class	Name: addressingPerformedSubstanceAdministration	Name: addressedPerformedMedicalConditionResult
Details: DESCRIPTION:<br/>Each PerformedSubstanceAdministration might address one or more PerformedMedicalConditionResult. Each PerformedMedicalConditionResult might be addressed by one or more PerformedSubstanceAdministration.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
SubstanceExtractionAdministrationRelationship Class	Name: producedSubstanceExtractionAdministrationRelationship	Name: usingPerformedSubstanceAdministration
Details: DESCRIPTION:<br/>Each SubstanceExtractionAdministrationRelationship might be producing a substance later used in one PerformedSubstanceAdministration. Each PerformedSubstanceAdministration might be using a substance produced by one or more SubstanceExtractionAdministrationRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	Intervention
Details:
Map:caAERSv2.2	StudyParticipantConcomitantMedication
Details:
Map:caAERSv2.2	StudyParticipantPriorTherapy
Details:
Map:CDMHv1.0	PerformedSubstanceAdministration
Details:
Map:CTRv1.0	PerformedSubstanceAdministration
Details:
Map:HCTv1.0	CDE 3040303:Therapies.Was another radioisotope administered?
Details:
Map:HCTv1.0	CDE 2934704:Therapies.Were tyrosine kinase inhibitors administered?
Details:
Map:LSDAMv2.2.3Plus	PerformedSubstanceAdministration
Details:
Map:SDTM IGv3.1.2	CM.DOMAIN
Details:
Map:SDTM IGv3.1.2	EX.DOMAIN
Details:
Map:SDTM IGv3.1.2	SU.DOMAIN
Details:
Map:SDTM IGv3.1.3	EX
Details:
Map:SDTM IGv3.1.3	SU
Details:
Map:SDTM IGv3.1.3	CM
Details:
Map:SDTM IGv3.2	SU
Details:
Map:SDTM IGv3.2	EC
Details:
Map:SDTM IGv3.2	EC.ECMOOD
Details:
Map:SDTM IGv3.2	EX
Details:
Map:SDTM IGv3.2	PR
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/>
relativeToReference Qualifier	Invariant	Approved
Details: endRelativeToReference must not logically precede the startRelativeToReference. For example, if startRelativeToReference is "during", endRelativeToReference must not be "before".<br/>
Active Ingredient Qualifier	Invariant	Approved
Details: activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. Otherwise, it would be ambiguous to which active ingredient the amounts indicated in these attributes apply.<br/>
Dose Qualifier	Invariant	Approved
Details: productDose, periodProductDoseTotal, treatmentVehicleAmount, activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a single StudyAgent. Otherwise, it would be ambiguous to which agent the amounts indicated in these attributes apply.<br/>
substanceUnknownIndicator Qualifier	Invariant	Approved
Details: PerformedSubstanceAdministration.substanceUnknownIndicator must = "false" if an association from this procedure to a product exists.<br/>

Object	Type	Connection	Direction	Notes
PerformedProcedure	Class	Generalization	To	DESCRIPTION: Each PerformedSubstanceAdministration always specializes one PerformedProcedure. Each PerformedProcedure might be specialized by one PerformedSubstanceAdministration. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):