SpecimenCollectionProtocol

: Public Class

Created:	5/29/2009 11:40:11 AM
Modified:	3/26/2015 11:41:33 PM

Project:
Author:	lschick
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{402BD8FA-64B7-4210-9564-702FEDA0D927}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View CM: Common, BRIDG BackBone

DEFINITION: A set of procedures that govern the collection of biospecimens. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Linked Document
Attributes
Associations From
Tagged Values
Other Links

Attribute

Public ST
irbApprovalNumber

Details:

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

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An identifier indicating that an Institutional Review Board (IRB) has reviewed the protocol and determined it is acceptable for use within the constraints set forth by the IRB and other institutional and federal requirements. [adapted from NCIt, Institutional Review Board Approval (Code C70800), http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=14.10d&code=C70800&ns=NCI_Thesaurus&key=878592761&b=1&n=null]#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;Question for SMEs: Is the IRB approval site and version specific for specimen collection protocols?#lt;br /#gt;#lt;/p#gt;

Public ST
shortTitle

Details:

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

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Abbreviated textual designation by which the specimen collection protocol is known.#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 URG<INT.NONNEG>
targetAccrualNumberRange

Details:

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

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer falling within minimum and maximum bounds that specifies how many subjects are to be accrued for the protocol.#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 IVL<TS.DATE.FULL>
activeDateRange

Details:

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

Map:LSDAM=SpecimenCollectionProtocol.activeDateRange

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) span within which the protocol is active (i.e., from activation through close).#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 BL
aliquotInSameContainerIndicator

Details:

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

Map:LSDAM=SpecimenCollectionProtocol.aliquotInSameContainer

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether all aliquots in specimens which belong to that collection protocol are in the same container.#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 BL
consentsWaivedIndicator

Details:

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

Map:LSDAM=SpecimenCollectionProtocol.consentsWaived

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether consent may be waived.#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
SpecimenCollectionProtocolSubject Class	Name: havingSpecimenCollectionProtocolSubject	Name: assignedSpecimenCollectionProtocol
Details: DESCRIPTION:<br /></p><p>Each SpecimenCollectionProtocolSubject always has been assigned one SpecimenCollectionProtocol. Each SpecimenCollectionProtocol might be assigned to one or more SpecimenCollectionProtocolSubject.<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:LSDAM	SpecimenCollectionProtocol
Details:
Map:LSDAMv2.2.3Plus	SpecimenCollectionProtocol
Details:

Object	Type	Connection	Direction	Notes
«Comment_Requested» Protocol	Class	Generalization	To	DESCRIPTION: Each SpecimenCollectionProtocol always specializes one Protocol. Each Protocol might be specialized by one SpecimenCollectionProtocol. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):