PlannedStudySite

: Public Class

Created:	5/21/2010 2:45:53 PM
Modified:	2/23/2012 4:16:27 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{833F0B7B-817B-41f2-9A0B-586E42A76DB6}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning View

DEFINITION: A facility in which study activities are intended to be conducted. EXAMPLE(S): The site where the study subject encounter is intended to occur, or the site of the Investigator. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints

Attribute

Public PQ.TIME
duration

Details:

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

Map:BRIDGSCC=Model Integrity - Study Versioning
Map:CTRv1.0=PlannedStudySite.duration

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The intended period of time for the planned study site's participation in the study.#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
leadIndicator

Details:

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

Map:C3PR=StudySite.roleCode
Map:CTOM=StudySite.roleCode
Map:CTRv1.0=PlannedStudySite.leadIndicator

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the principal administrative organization intended to be responsible for the study. #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;Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization.#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
StudyProtocolVersion Class	Name: executingPlannedStudySite	Name: executesStudyProtocolVersion
Details: DESCRIPTION:<br /></p><p>Each PlannedStudySite always plans to execute one StudyProtocolVersion. Each StudyProtocolVersion might be planned to be executed at one or more PlannedStudySite.<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>
Organization Class	Name: performedPlannedStudySite	Name: performingOrganization
Details: DESCRIPTION:<br /></p><p>Each PlannedStudySite might be a function planned to be performed by one Organization. Each Organization might plan to function as one or more PlannedStudySite.<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>
HealthcareFacility Class	Name: performedPlannedStudySite	Name: performingHealthcareFacility
Details: DESCRIPTION:<br /></p><p>Each PlannedStudySite might be a function planned to be performed by one HealthcareFacility. Each HealthcareFacility might plan to function as one or more PlannedStudySite.<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
StudySitePersonnel Class	Name: supportsStudySitePersonnel	Name: supportedPlannedStudySite
Details: DESCRIPTION:<br /></p><p>Each StudySitePersonnel might plan to perform a role for one PlannedStudySite. Each PlannedStudySite might have a role planned to be performed by one or more StudySitePersonnel.<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:BRIDGSCC	Model Integrity - Study Versioning
Details:
Map:CTRv1.0	PlannedStudySite
Details:

Constraint	Type	Status
be a function planned to be performed by Exclusive Or	Invariant	Approved
Details: A PlannedStudySite is a function planned to be performed by one and only one of the following: HealthcareFacility, Organization (serving as a PlannedStudySite but is not a HealthcareFacility).