Protocol Representation Sub-Domain::DefinedSubstanceAdministration

: Public Class

Created:	7/24/2009 12:52:12 PM
Modified:	7/3/2019 3:18:30 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{6FA3844B-1D28-4d2d-B5B7-542A8E73A2F1}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View IM: Imaging, Imaging Acquisition, View PR: Protocol Representation, SDTM IG v3.1.3, SDTM Exposure (EX) Domain, SDTM IG v3.2, Oncology & Imaging, Surveillance, Epidemiology & End Results (SEER), Common Data Model Harmonization (CDMH), National Biomedical Imaging Archive (NBIA), National Marrow Donor Program (NMDP)

DEFINITION: An activity defined at a global library level that is an action of applying, introducing or otherwise giving medications or other substances to a subject or experimental unit. EXAMPLE(S): Administration of methotrexate as part of chemotherapy. OTHER NAME(S): NOTE(S):

Attributes
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public PQ
productDose

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:
Transient:	False
Derived:	False
IsID:	False

Map:SDTM IGv3.2=TS.(DOSE) TSVALNF WHERE TSPARMCD = "DOSE"
Map:SDTM IGv3.2=TS.(DOSU) TSVAL WHERE TSPARMCD = "DOSU"
Map:SDTM IGv3.2=TS.(DOSU) TSVALCD WHERE TSPARMCD = "DOSU"
Map:SDTM IGv3.2=TS.(DOSU) TSVCDVER WHERE TSPARMCD = "DOSU"
Map:SDTM IGv3.2=TS.(DOSU) TSVCDREF WHERE TSPARMCD = "DOSU"
Map:SDTM IGv3.2=TS.(DOSU) TSVALNF WHERE TSPARMCD = "DOSU"
Map:SDTM IGv3.2=TS.(DOSE) TSVAL WHERE TSPARMCD = "DOSE"

Notes:

DEFINITION: The quantity of a substance or medication to be administered. EXAMPLE(S): 5 mg 20 mg of drug per kg of subject weight 370MBq 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 EXPR<PQ>
periodProductDoseTotal

Details:

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

Map:CTR&Rr2=Maximum dose per Day or Total
Map:CTR&Rr2=First dose in FIH Dose per Day or Total
Map:CTR&Rr2=First dose in FIH Total Dose Unit
Map:CTRPv1.0=SubstanceAdministration.doseTotal
Map:CTRPv3.8=PlannedSubstanceAdministration.doseTotal
Map:CTRRr3=DefinedSubstanceAdministration.dailyDoseTotal
Map:CTRv1.0=DefinedSubstanceAdministration.periodProductDoseTotal
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.doseCheckQuantity
Map:HCTv1.0=CDE 3040382:Preparative Regimen.What was the planned total dosage of the radiolabeled monoclonal antibody preparative regimen?
Map:HCTv1.0=CDE 2685005:Preparative Regimen.What was the unit of measure for the total prescribed cumulative dose of total nodal or total abdominal irradiation for the preparative regimen (per the protocol)?
Map:HCTv1.0=CDE 2685003:Preparative Regimen.What was the total prescribed cumulative dose of total nodal or total abdominal irradiation for the preparative regimen (per the protocol)?
Map:HCTv1.0=CDE 3040323:Preparative Regimen.What was the total dose of the planned preparative regimen per the protocol?

Notes:

DEFINITION: Total of all doses of this agent in a given period of time. EXAMPLE(S): OTHER NAME(S): NOTE(S): The given period of time is defined in dosePeriodCode. This is needed because the dose may not always be derivable, e.g., if it is a string, and because it is often used as a cross-check on dose to ensure mistakes are not made in dosing subjects.

Public CD
dosePeriodCode

Details:

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

Map:BRIDGSCC=Model Integrity
Map:CTRPv3.8=PlannedSubstanceAdministration.doseDuration
Map:CTRv1.0=DefinedSubstanceAdministration.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):

Public CD
doseFrequencyCode

Details:

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

Map:CTRPv1.0=SubstanceAdministration.doseFrequencyCode
Map:CTRPv3.8=PlannedSubstanceAdministration.doseFrequencyCode
Map:CTRv1.0=DefinedSubstanceAdministration.doseFrequencyCode
Map:HCTv1.0=CDE 2965486:Therapies.What was the fractional schedule of radiation therapy?
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=DOSFRQ
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.2=TS.(DOSFRQ) TSVAL WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.2=TS.(DOSFRQ) TSVALNF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.2=TS.(DOSFRQ) TSVALCD WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.2=TS.(DOSFRQ) TSVCDREF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.2=TS.(DOSFRQ) TSVCDVER WHERE TSPARMCD = "DOSFRQ"

Notes:

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

Public ST
doseRegimen

Details:

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

Map:CTRPv1.0=SubstanceAdministration.doseRegimen
Map:CTRPv3.8=PlannedSubstanceAdministration.doseRegimen
Map:CTRR=Dose regimen
Map:CTRR=Comparator Route of administration - Add dosage/regimen info
Map:CTRRr3=DefinedSubstanceAdministration.doseRegimen
Map:CTRv1.0=DefinedSubstanceAdministration.doseRegimen
Map:NCI CRF Standard=CDE 2871669v1.0: Treatment Regimen Name
Map:SDTM IGv3.1.1=CM.CMDOSRGM
Map:SDTM IGv3.1.2=CM.CMDOSRGM
Map:SDTM IGv3.1.2=EX.EXDOSRGM
Map:SDTM IGv3.1.3=EX.EXDOSRGM
Map:SDTM IGv3.1.3=CM.CMDOSRGM
Map:SDTM IGv3.2=EC.ECDOSRGM
Map:SDTM IGv3.2=PR.PRDOSRGM
Map:SDTM IGv3.2=EX.EXDOSRGM
Map:SDTM IGv3.2=CM.CMDOSRGM

Notes:

DEFINITION: Text description of the intended schedule for administering a substance. EXAMPLE(S): 2 weeks on, 2 weeks off OTHER NAME(S): NOTE(S): This represents the dosing calendar in a text format. This is a non-computational description that may need to be expanded as additional use cases arise.

Public RTO<PQ,PQ.TIME>
flowRate

Details:

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

Map:DICOM=Enhanced Contrast/Bolus Module - Contrast/Bolus Agent Sequence > Contrast Administration Profile Sequence > Contrast Flow Rate (0018,1046)
Map:DICOM=Contrast/Bolus Module - Contrast/Bolus Flow Rate (0018, 1046)
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.rateQuantity

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 CD
routeOfAdministrationCode

Details:

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

Map:caAERSv2.2=Dose.route
Map:CTR&Rr2=Maximum dose RoA
Map:CTR&Rr2=First dose in FIH RoA
Map:CTR&Rr2=Placebo Route of administration
Map:CTR&Rr2=IMP Routes of Administration
Map:CTRPv1.0=SubstanceAdministration.routeOfAdministrationCode
Map:CTRPv3.8=PlannedSubstanceAdministration.routeOfAdministrationCode
Map:CTRR=Comparator Route of administration - Add dosage/regimen info
Map:CTRR=Route of administration
Map:CTRRr3=DefinedSubstanceAdministration.routeOfAdministrationCode
Map:CTRv1.0=DefinedSubstanceAdministration.routeOfAdministrationCode
Map:DICOM=Contrast/Bolus Module - Contrast/Bolus Administration Route Sequence (0018,0014)
Map:DICOM=Contrast/Bolus Module - Contrast/Bolus Route (0018,1040)
Map:DICOM=Enhanced Contrast/Bolus Module - Contrast/Bolus Agent Sequence > Contrast/Bolus Ingredient Code Sequence (0018,9338)
Map:DICOM=Enhanced PET Isotope Module - Radiopharmaceutical Information Sequence > Administration Route Code Sequence (0054,0302)
Map:DICOM=Enhanced Contrast/Bolus Module - Contrast/Bolus Agent Sequence > Contrast/Bolus Administration Route Sequence (0018,0014)
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.routeCode
Map:HCTv1.0=CDE 2740971:Preparative Regimen.What was the route of administration for the planned preparative regimen medication?
Map:NBIAv6.4=General_Image.source_to_detector_distance
Map:NBIAv6.4=General_Image.contrast_bolus_route
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=ROUTE
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=TS.(ROUTE) TSVALCD WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=TS.(ROUTE) TSVCDREF WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=TS.(ROUTE) TSVCDVER WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=TS.(ROUTE) TSVALNF WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=TS.(ROUTE) TSVAL WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.2=EC.ECROUTE

Notes:

DEFINITION: A coded value specifying the physiological path or method of introducing the substance. EXAMPLE(S): oral, intravenous, nasal, intradermal, intracardial OTHER NAME(S): NOTE(S):

Public CD
targetAnatomicSitePortionCode

Details:

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

Map:SDTM IGv3.1.2=EC.ECPORTOT

Notes:

DEFINITION: A coded value specifying the arrangement or apportionment of the body (or a paired organ) that is a target site for a substance administration. EXAMPLE(S): entire, single, segment, many OTHER NAME(S): NOTE(S):

Public BL
fastingStatusIndicator

Details:

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

Map:SDTM IGv3.1.2=EC.ECFAST

Notes:

DEFINITION: Specifies whether the participant is expected to abstain from eating prior to the substance administration. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
DefinedExpressionVariableRelationship Class	Name: usedDefinedExpressionVariableRelationship	Name: usingDefinedSubstanceAdministration
Details: DESCRIPTION:<br/>Each DefinedExpressionVariableRelationship always is used in one or more DefinedSubstanceAdministration. Each DefinedSubstanceAdministration might use one or more DefinedExpressionVariableRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:CDMHv1.0	DefinedSubstanceAdministration
Details:
Map:CTRPv3.8	PlannedSubstanceAdministration
Details:
Map:CTRRr3	DefinedSubstanceAdministration
Details:
Map:CTRv1.0	DefinedSubstanceAdministration
Details:
Map:DICOM	Enhanced Contrast/Bolus Module - Contrast/Bolus Agent Sequence > Contrast Administration Profile Sequence (0018,9340)
Details:
Map:DICOM	Contrast/Bolus Module
Details:
Map:DICOM	Enhanced Contrast/Bolus Module
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/>
Dose Qualifier	Invariant	Approved
Details: productDose, periodProductDoseTotal must only be used when the DefinedSubstanceAdministration is associated to a single Product. Otherwise, it would be ambiguous to which Product the amounts indicated in these attributes apply.<br/>
Dose Expression Qualifier	Invariant	Approved
Details: If a dose expression uses parameters, each parameter must be defined as a DefinedExpressionVariableRelationship.localVariableName.<br/>

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