Material

: Public Class

Created:	1/5/2005 2:49:47 PM
Modified:	3/16/2015 3:22:42 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{37536741-5B4E-4801-88DE-15BF55C88510}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View EX: Experiment, View MB: Molecular Biology, View AE: Adverse Event, View CM: Common, View PR: Protocol Representation, View RG: Regulatory, View SC: Study Conduct

DEFINITION: A physical substance or system. EXAMPLE(S): drugs such as aspirin devices such as pacemakers or freezers systems such as software programs biologics such as blood food products such as broccoli cosmetics such as lipstick containers such as a blister pack or a test tube OTHER NAME(S): NOTE(S): Materials may be naturally occurring or may be made by natural or engineered processes.

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
code

Details:

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

Map:caAERSv2.2=SAEReportPreExistingCondition > PriorTherapy.text
Map:caAERSv2.2=StudyParticipantPreExistingCondition > PriorTherapy.meddraTerm
Map:caAERSv2.2=SAEReportPreExistingCondition > PriorTherapy.meddraTerm
Map:caAERSv2.2=StudyParticipantPreExistingCondition > PriorTherapy.text
Map:caAERSv2.2=SAEReportPreExistingCondition > PriorTherapy.meddraCode
Map:caAERSv2.2=StudyParticipantPreExistingCondition > PriorTherapy.meddraCode
Map:caAERSv2.2=StudyParticipantPriorTherapy.other
Map:caAERSv2.2=StudyAgent.otherAgent
Map:caAERSv2.2=ChemoAgent.name
Map:caAERSv2.2=SAEReportPriorTherapy.other
Map:CDASHv1.1=CM.CMINGRD
Map:CTR&Rr2=Other comparator
Map:CTR&Rr2=Comparator a placebo
Map:CTR&Rr2=AS current sponsor code
Map:CTR&Rr2=EV Identifiable Product Code
Map:CTR&Rr2=EV (EudraVigilance) Substance Code
Map:CTR&Rr2=Tissue Engineered type stem
Map:CTR&Rr2=Placebo major ingredients
Map:CTR&Rr2=Tissue Engineered type differentiated
Map:CTR&Rr2=Comparator another MP
Map:CTR&Rr2=Tissue Engineered Other
Map:CTRPv1.0=SubstanceAdministration.treatmentVehicleCode
Map:CTRPv1.0=Drug.nameCode
Map:CTRR=Intervention Name
Map:CTRR=StudyAgent
Map:CTRR=Comparator(s) product name(s)
Map:CTRRr3=Product.nameCode
Map:CTRv1.0=Material.code
Map:FDA HL7 SD SD DSTU2012=manufacturedMaterial.code
Map:HCTv1.0=CDE 2739625:Preparative Regimen.What was the type of preparative regimen medication?
Map:ICSRr2=MaterialKind.code (in R_Product)
Map:ICSRr2=Natural.code (in R_Specimen universal)
Map:ICSRr2=ManufacturedMaterial.code (in R_Specimen universal)
Map:LabViewer2.2=SpecimenMaterialType.code
Map:LabViewer2.2=SpecimenMaterialType.codeSystemName
Map:LabViewer2.2=SpecimenMaterialType.codeSystem
Map:LabViewer2.2=SpecimenMaterialType.codeSystemVersion
Map:LabViewer2.2=SpecimenMaterialType.displayName
Map:LSDAM=Material.nameCode
Map:NCI CRF Standard=CDE 2867247v1.0: Agent NCI Enterprise Vocabulary Services Code
Map:PGx v1.0=PF.PFSPEC
Map:PGx v1.0=PG.PGSPEC
Map:PGx v1.0=BS.BSSPEC
Map:PGx v1.0=RELSPEC.SPEC
Map:SDTM IGv3.1.1=EX.EXTRTV
Map:SDTM IGv3.1.1=CM.CMTRT
Map:SDTM IGv3.1.2=SU.SUDECOD
Map:SDTM IGv3.1.2=LB.LBSPEC
Map:SDTM IGv3.1.2=CM.CMDECOD
Map:SDTM IGv3.1.2=PP.PPSPEC
Map:SDTM IGv3.1.2=PC.PCSPEC
Map:SDTM IGv3.1.2=MB.MBSPEC
Map:SDTM IGv3.1.2=EX.EXTRTV

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the non-unique textual identifier for the material.#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;aspirin, tobacco, caffeine, tongue depressors, x-ray machine, olive oil, oats, lipstick, skin moisturizer, blisterpack, test tube, specimen slide, urine, blood, plasma, platelet rich plasma, serum, DNA, gDNA, RNA, gRNA, mRNA #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 granularity of the code may vary depending on the specificity of the material. For example, acetaminophen, Tylenol, Tylenol 250 mg gel cap.#lt;br /#gt;#lt;/p#gt;

Public CD
formCode

Details:

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

Map:AE=Package.formCode
Map:AE=Component.formCode
Map:AE=Product.formCode
Map:caAERSv2.2=CourseAgent.formulation
Map:CDASHv1.1=CM.CMDOSFRM
Map:CDASHv1.1=EX.EXDOSFRM
Map:CTOM=AgentOccurrence.formCode
Map:CTR&Rr2=Placebo Pharmaceutical form
Map:CTR&Rr2=IMP Pharmaceutical Form
Map:CTRPv1.0=Cosmetic.formCode
Map:CTRPv1.0=Product.formCode
Map:CTRPv1.0=Material.formCode
Map:CTRPv1.0=FoodProduct.formCode
Map:CTRPv1.0=Device.formCode
Map:CTRPv1.0=Drug.formCode
Map:CTRPv1.0=Biologic.formCode
Map:CTRPv3.8=PlannedSubstanceAdministration.doseFormCode
Map:CTRRr3=Material.formCode
Map:CTRv1.0=Material.formCode
Map:FDA HL7 SD SD DSTU2012=manufacturedMaterial.formCode
Map:HL7SD=Product.formCode
Map:ICSRr2=Product.formCode (in R_Product)
Map:ICSRr2=Container.formCode (in R_Product)
Map:ICSRr2=PackagedProduct.formCode (in R_Product)
Map:LSDAM=Material.formCode
Map:NCI CRF Standard=CDE 2179618v1.0: Agent Formulation Descriptive Text
Map:SDTM IGv3.1.1=LB.LBSPEC
Map:SDTM IGv3.1.1=CM.CMDOSFRM
Map:SDTM IGv3.1.1=SU.SUDOSFRM
Map:SDTM IGv3.1.1=EX.EXDOSFRM
Map:SDTM IGv3.1.2=EX.EXDOSFRM
Map:SDTM IGv3.1.2=SU.SUDOSFRM
Map:SDTM IGv3.1.2=CM.CMDOSFRM

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the state and nature of the material.#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;solid, liquid, gas, tablet, ointment, gel#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
description

Details:

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

Map:caAERSv2.2=Agent.descriptionText
Map:CTGOV=Biospecimen Description
Map:CTOM=Agent.descriptionText
Map:CTR&Rr2=Tissue Engineered differentiated specification
Map:CTR&Rr2=Device Other specification
Map:CTR&Rr2=AS description
Map:CTR&Rr2=Device description
Map:CTR&Rr2=Tissue Engineered Other specification
Map:CTR&Rr2=Other comparator specification
Map:CTRPv1.0=Drug.description
Map:CTRPv1.0=Biologic.description
Map:CTRPv1.0=Material.description
Map:CTRPv1.0=ObservationalStudyProtocol.biospecimenDescription
Map:CTRPv1.0=Product.description
Map:CTRPv1.0=Device.description
Map:CTRPv1.0=Cosmetic.description
Map:CTRPv1.0=FoodProduct.description
Map:CTRRr3=Material.description
Map:CTRv1.0=Material.description
Map:ICSRr2=Product.desc (in R_Product)
Map:ICSRr2=Substance.desc (in R_Product)
Map:ICSRr2=Container.desc (in R_Product)
Map:ICSRr2=PackagedProduct.desc (in R_Product)
Map:ICSRr2=ProductInstance.desc (in R_Product)
Map:ICSRr2=DeviceInstance.desc (in R_Product)
Map:LSDAM=Material.description
Map:LSDAM=Container.description
Map:LSDAMv2.2.3Plus=Container.description

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual representation of the material.#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;

Public DSET<CD>
characteristicBehaviorCode

Details:

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

AttributeNotes=added through work with nano sub-domain
CADSR_Description=The characteristic behavior of a nanoparticle that results from the chemical and physical composition and properties of the entity. For example, diagnostic imaging, or targeting.
PropertyConceptCode=C25162
PropertyQualifierConceptCode1=C25284
PropertyQualifierConceptCode2=C25518

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the essential traits of the material that result from the chemical and physical composition and properties of the entity. #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;kinase, RNAse #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;properties of gold might include: good conductor, unaffected by air or moisture, almost insoluble, etc. #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 BL
actualIndicator

Details:

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

Map:CTRv1.0=Material.actualIndicator
Map:HL7SD=ExperimentalUnit>ExperimentalUnit2(choice box).determinerCode
Map:HL7SD=R_AssignedEntity(Universal)
Map:ICSRr2=MaterialKind.determinerCode (in R_Product)
Map:ICSRr2=Product.determinerCode (in R_Product)
Map:LSDAM=Material.actualIndicator

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the material is a particular instance (actual) vs. universal kind.#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;To indicate a particular Material, actualIndicator = "true". To indicate a kind of Material, actualIndicator = "false".#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 IVL<TS.DATETIME>
effectiveDateRange

Details:

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

Map:CTOM=Agent.statusCode
Map:CTRPv1.0=FoodProduct.statusDateRange
Map:CTRPv1.0=TherapeuticAgent.StatusCode
Map:CTRPv1.0=Product.statusCode
Map:CTRPv1.0=Drug.statusCode
Map:CTRPv1.0=Product.statusDateRange
Map:CTRPv1.0=Cosmetic.statusDateRange
Map:CTRPv1.0=Material.statusCode
Map:CTRPv1.0=Biologic.statusDateRange
Map:CTRPv1.0=Cosmetic.statusCode
Map:CTRPv1.0=Drug.statusDateRange
Map:CTRPv1.0=Device.statusCode
Map:CTRPv1.0=Material.statusDateRange
Map:CTRPv1.0=TherapeuticProduct.statusDateRange
Map:CTRPv1.0=FoodProduct.statusCode
Map:CTRPv1.0=Biologic.statusCode
Map:CTRPv1.0=Device.statusDateRange
Map:CTRv1.0=Material.effectiveDateRange
Map:ICSRr2=ProductInstance.existenceTime (in R_Product)
Map:ICSRr2=DeviceInstance.existenceTime (in R_Product)
Map:LSDAM=Software.effectiveDateRange
Map:LSDAM=Material.effectiveDateRange

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) span for when the material is active.#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;

Element	Source Role	Target Role
PerformedMaterialProcessStep Class	Name: producedMaterial	Name: producingPerformedMaterialProcessStep
Details: DESCRIPTION:<br /></p><p>Each Material might have been produced by one PerformedMaterialProcessStep. Each PerformedMaterialProcessStep might have produced one or more Material.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates that material was produced by a process step.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A blood product has anticoagulants added to it to preserve the product<br /></p><p>A blood product has growth factor added to it to induce cell growth<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S): <br /></p>
DefinedMaterialProcessStep Class	Name: producedMaterial	Name: producingDefinedMaterialProcessStep
Details: DESCRIPTION:<br /></p><p>Each Material might have been produced by one DefinedMaterialProcessStep. Each DefinedMaterialProcessStep might have produced one or more Material.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates that material is produced by a process step.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A blood product has anticoagulants added to it to preserve the product<br /></p><p>A blood product has growth factor added to it to induce cell growth<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S): <br /></p>

Element	Source Role	Target Role
MaterialIdentifier Class	Name: identifyingMaterialIdentifier	Name: identifiedMaterial
Details: DESCRIPTION:<br /></p><p>Each MaterialIdentifier always identifies one Material. Each Material might be identified by one or more MaterialIdentifier.<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>
MaterialName Class	Name: namingMaterialName	Name: namedMaterial
Details: DESCRIPTION:<br /></p><p>Each MaterialName always names one Material. Each Material always is named by one or more MaterialName.<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>
PointOfContact Class	Name: supportingPointOfContact	Name: supportedMaterial
Details: DESCRIPTION:<br /></p><p>Each PointOfContact might support one or more Material. Each Material might be supported by one or more PointOfContact.<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>
Protein Class	Name: characterizingProtein	Name: characterizedMaterial
Details: DESCRIPTION:<br /></p><p>Each Protein might characterize one or more Material. Each Material might be characterized by one or more Protein.<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>
MolecularSequence Class	Name: characterizingMolecularSequence	Name: characterizedMaterial
Details: DESCRIPTION:<br /></p><p>Each MolecularSequence might characterize one or more Material. Each Material might be characterized by one or more MolecularSequence.<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>
MessengerRNA Class	Name: characterizingMessengerRNA	Name: characterizedMaterial
Details: DESCRIPTION:<br /></p><p>Each MessengerRNA might characterize one or more Material. Each Material might be characterized by one or more MessengerRNA.<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>
ExperimentalActivityItem Class	Name: playedExperimentalActivityItem	Name: playingMaterial
Details: DESCRIPTION:<br /></p><p>Each ExperimentalActivityItem might be played by one Material. Each Material might play one or more ExperimentalActivityItem. <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>
Specimen Class	Name: performedSpecimen	Name: performingMaterial
Details: DESCRIPTION:<br /></p><p>Each Specimen always is a function performed by one Material. Each Material might function as one Specimen.<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:CTRPv1.0	Material
Details:
Map:CTRRr3	Material
Details:
Map:CTRv1.0	Material
Details:
Map:ICSRr2	ManufacturedMaterial (in R_Specimen universal)
Details:
Map:ICSRr2	Natural (in R_Specimen universal)
Details:
Map:LSDAM	Material
Details:
Map:LSDAMv2.2.3Plus	Material
Details:

Constraint	Type	Status
Attribute Set actualIndicator Qualifier	Invariant	Approved
Details: effectiveDateRange is valid only when actualIndicator = "true".

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