Biologic

: Public Class

Created:	2/13/2008 11:03:50 AM
Modified:	3/21/2015 12:24:53 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{3DD0BBA5-1710-4e96-8603-02297B85B5FB}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View CM: Common, View SC: Study Conduct

DEFINITION: A substance made from a living organism or thing it produces. EXAMPLE(S): virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, analogous product OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Other Links

Attribute

Public CD
riskCode

Details:

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

Map:CTRv1.0=Biologic.riskCode
Map:ICSRr2=Product.riskCode (in R_Product)

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the type of hazard or threat associated with the biologic.#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;flammable, explosive#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
handlingCode

Details:

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

Map:CTRv1.0=Biologic.handlingCode
Map:ICSRr2=Product.handlingCode (in R_Product)

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a special handling requirement for the biologic.#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;keep at room temperature, store upright#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>
stabilityDuration

Details:

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

Map:CTRv1.0=Biologic.stabilityDuration
Map:ICSRr2=ProductInstance.stabilityTime (in R_Product)

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The period of time during which the biologic is considered usable after it is activated (opened).#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
BiologicEntityClassification Class	Name: classifiedBiologic	Name: classifyingBiologicEntityClassification
Details: DESCRIPTION:<br /></p><p>Each Biologic might be classified as one BiologicEntityClassification. Each BiologicEntityClassification might classify one or more Biologic.<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>

Element	Source Role	Target Role
PerformedSubstanceExtraction Class	Name: producingPerformedSubstanceExtraction	Name: producedBiologic
Details: DESCRIPTION:<br /></p><p>Each PerformedSubstanceExtraction always produces one Biologic. Each Biologic might be produced by one or more PerformedSubstanceExtraction.<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	Biologic
Details:
Map:CTRRr3	Biologic
Details:
Map:CTRv1.0	Biologic
Details:

Object	Type	Connection	Direction	Notes
HCT: Exatracted Substance	Object	Realization	From
CellCulture	Class	Generalization	From	DESCRIPTION: Each CellCulture always specializes one Biologic. Each Biologic might be specialized by one CellCulture. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Product	Class	Generalization	To	DESCRIPTION: Each Biologic always specializes one Product. Each Product might be specialized by one Biologic. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):