: Public Class
Created: 7/24/2009 12:52:12 PM
Modified: 3/18/2018 6:51:41 PM
Project:
Advanced:
DEFINITION:<br/>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.<br/><br/>EXAMPLE(S):<br/>Administration of methotrexate as part of chemotherapy.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public PQ
  productDose
Details:
Notes: DEFINITION:<br/>The quantity of a substance or medication to be administered.<br/><br/>EXAMPLE(S):<br/>5 mg<br/>20 mg of drug per kg of subject weight<br/>370MBq<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 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/>
Public EXPR<PQ>
  periodProductDoseTotal
Details:
Map:CTR&Rr2=Maximum dose per Day or Total
Map:CTR&Rr2=First dose in FIH Total Dose Unit
Map:CTR&Rr2=First dose in FIH Dose per Day or Total
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 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?
Map:HCTv1.0=CDE 3040382:Preparative Regimen.What was the planned total dosage of the radiolabeled monoclonal antibody preparative regimen?
Notes: DEFINITION:<br/>Total of all doses of this agent in a given 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 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.<br/>
Public CD
  dosePeriodCode
Details:
Map:BRIDGSCC=Model Integrity
Map:CTRPv3.8=PlannedSubstanceAdministration.doseDuration
Map:CTRv1.0=DefinedSubstanceAdministration.dosePeriodCode
Notes: DEFINITION: <br/>A coded value specifying the period during which the dose total is administered. <br/><br/>EXAMPLE(S):<br/>daily, course<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  doseFrequencyCode
Details:
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.TSVCDREF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "DOSFRQ"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "DOSFRQ"
Notes: DEFINITION:<br/>A coded value specifying how often doses are administered. <br/><br/>EXAMPLE(S):<br/>BID, TID, QID<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  doseRegimen
Details:
Map:CTRPv1.0=SubstanceAdministration.doseRegimen
Map:CTRPv3.8=PlannedSubstanceAdministration.doseRegimen
Map:CTRR=Comparator Route of administration - Add dosage/regimen info
Map:CTRR=Dose regimen
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=EX.EXDOSRGM
Map:SDTM IGv3.1.2=CM.CMDOSRGM
Map:SDTM IGv3.1.3=EX.EXDOSRGM
Map:SDTM IGv3.1.3=CM.CMDOSRGM
Notes: DEFINITION:<br/>Text description of the intended schedule for administering a substance.  <br/><br/>EXAMPLE(S):<br/>2 weeks on, 2 weeks off<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>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.<br/>
Public RTO<PQ,PQ.TIME>
  flowRate
Details:
Map:DICOM=Contrast/Bolus Module - Contrast/Bolus Flow Rate (0018, 1046)
Map:DICOM=Enhanced Contrast/Bolus Module - Contrast/Bolus Agent Sequence > Contrast Administration Profile Sequence > Contrast Flow Rate (0018,1046)
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.rateQuantity
Notes: DEFINITION: <br/>A ratio specifying the speed with which the substance is introduced into the subject.<br/><br/>EXAMPLE(S):<br/>100 mL/h<br/>1 g/d<br/>40 mmol/h<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  routeOfAdministrationCode
Details:
Map:caAERSv2.2=Dose.route
Map:CTR&Rr2=IMP Routes of Administration
Map:CTR&Rr2=First dose in FIH RoA
Map:CTR&Rr2=Placebo Route of administration
Map:CTR&Rr2=Maximum dose RoA
Map:CTRPv1.0=SubstanceAdministration.routeOfAdministrationCode
Map:CTRPv3.8=PlannedSubstanceAdministration.routeOfAdministrationCode
Map:CTRR=Route of administration
Map:CTRR=Comparator Route of administration - Add dosage/regimen info
Map:CTRRr3=DefinedSubstanceAdministration.routeOfAdministrationCode
Map:CTRv1.0=DefinedSubstanceAdministration.routeOfAdministrationCode
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: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: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:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=ROUTE
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "ROUTE"
Map:SDTM IGv3.1.3=TS.TSVCDREF 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"
Notes: DEFINITION:<br/>A coded value specifying the physiological path or method of introducing the substance.<br/><br/>EXAMPLE(S):<br/>oral, intravenous, nasal, intradermal, intracardial<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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 Enhanced Contrast/Bolus Module
Details:
 
Map:DICOM 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):