: Public Class
Created: 7/24/2009 12:52:12 PM
Modified: 8/21/2012 11:22:41 AM
Project:
Advanced:
DEFINITION:<br /></p><p>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 /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Administration of methotrexate as part of chemotherapy.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public EXPR<PQ>
  productDose
Details:
Map:caAERSv2.2=Dose.amount
Map:caAERSv2.2=Dose.unit
Map:CTR&Rr2=First dose in FIH (First In Human) dose allowed
Map:CTR&Rr2=Maximum dose Total Dose Unit
Map:CTRPv1.0=SubstanceAdministration.dose
Map:CTRPv3.8=PlannedSubstanceAdministration.dose
Map:CTRRr3=DefinedSubstanceAdministration.dose
Map:CTRv1.0=DefinedSubstanceAdministration.productDose
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.doseQuantity
Map:HCTv1.0=CDE 2741499:Preparative Regimen.What was the unit of measure for the planned dosage of the monoclonal antibody preparative regimen?
Map:HCTv1.0=CDE 2684983:Preparative Regimen.What was the unit of measure for the total prescribed cumulative dose of total body irradiation for the preparative regimen (per the protocol)?
Map:HCTv1.0=CDE 2738649:Preparative Regimen.What was the unit of measure for the planned dosage of the anthracycline preparative regimen?
Map:HCTv1.0=CDE 2684897:Preparative Regimen.What was the total prescribed cumulative dose of total body irradiation for the preparative regimen (per the protocol)?
Map:HCTv1.0=CDE 2740606:Preparative Regimen.What was the unit of measure for the preparative regimen dose per the protocol?
Map:HCTv1.0=CDE 2741600:Preparative Regimen.What was the unit of measure for the planned dosage of the radiolabeled monoclonal antibody preparative regimen?
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=DOSU
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=DOSE
Notes: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The quantity of a substance or medication to be administered.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;5 mg#lt;br /#gt;#lt;/p#gt;#lt;p#gt;20 mg of drug per kg of subject weight#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public EXPR<PQ>
  periodProductDoseTotal
Details:
Map:CTR&Rr2=First dose in FIH Dose per Day or Total
Map:CTR&Rr2=First dose in FIH Total Dose Unit
Map:CTR&Rr2=Maximum 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 3040323:Preparative Regimen.What was the total dose of the planned preparative regimen per the protocol?
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 3040382:Preparative Regimen.What was the planned total dosage of the radiolabeled monoclonal antibody preparative regimen?
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)?
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Total of all doses of this agent in a given period of time.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The given period of time is defined in dosePeriodCode.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public CD
  dosePeriodCode
Details:
Map:BRIDGSCC=Model Integrity
Map:CTRPv3.8=PlannedSubstanceAdministration.doseDuration
Map:CTRv1.0=DefinedSubstanceAdministration.dosePeriodCode
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the period during which the dose total is administered. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;daily, course#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying how often doses are administered. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;BID, TID, QID#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public ST
  doseRegimen
Details:
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=EX.EXDOSRGM
Map:SDTM IGv3.1.2=CM.CMDOSRGM
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Text description of the intended schedule for administering a substance.  #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;2 weeks on, 2 weeks off#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public RTO<PQ,PQ.TIME>
  flowRate
Details:
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.rateQuantity
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;A ratio specifying the speed with which the substance is introduced into the subject.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;100 mL/h#lt;br /#gt;#lt;/p#gt;#lt;p#gt;1 g/d#lt;br /#gt;#lt;/p#gt;#lt;p#gt;40 mmol/h#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
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: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
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the physiological path or method of introducing the substance.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;oral, intravenous, nasal, intradermal, intracardial#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
DefinedExpressionVariableRelationship
Class   		Name: usedDefinedExpressionVariableRelationship
  		Name: usingDefinedSubstanceAdministration
 
Details:
DESCRIPTION:<br /></p><p>Each DefinedExpressionVariableRelationship always is used in one or more DefinedSubstanceAdministration. Each DefinedSubstanceAdministration might use one or more DefinedExpressionVariableRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:CTRPv3.8 PlannedSubstanceAdministration
Details:
 
Map:CTRRr3 DefinedSubstanceAdministration
Details:
 
Map:CTRv1.0 DefinedSubstanceAdministration
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.
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.
Dose Expression Qualifier Invariant Approved
Details:
If a dose expression uses parameters, each parameter must be defined as a DefinedExpressionVariableRelationship.localVariableName.
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):