StudyRegistry

: Public Class

Created:	6/5/2008 1:04:50 PM
Modified:	2/23/2012 4:08:37 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{3F41011B-C51D-4408-B5EA-A0EABA876318}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View RG: Regulatory

DEFINITION: An organization (typically a government agency) that administers the registration of studies. EXAMPLE(S): ClinicalTrials.gov (CT.gov), Netherlands National Trial Register (NTR) OTHER NAME(S): NOTE(S): The study registry should contain basic information about each study sufficient to inform potential subjects (and their healthcare providers) how to enroll in the study.

Attributes
Associations To
Associations From
Tagged Values

Attribute

Public ST
name

Details:

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

Map:CTRR=Registry
Map:CTRRr3=StudyRegistry.name
Map:CTRv1.0=StudyRegistry.name
Map:WHO=Primary Registry

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A non-unique textual identifier for the registry.#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;ClinicalTrials.gov#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
acronym

Details:

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

Map:CTRR=Registry
Map:CTRRr3=StudyRegistry.acronym
Map:CTRv1.0=StudyRegistry.acronym
Map:WHO=Primary Registry

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The non-unique initials or abbreviated name used for identification of the registry.#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;NTR (Netherlands National Trial Register)#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
Organization Class	Name: managedStudyRegistry	Name: managingOrganization
Details: DESCRIPTION:<br /></p><p>Each StudyRegistry might be managed by one Organization. Each Organization might manage one or more StudyRegistry.<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
DocumentIdentifier Class	Name: assignedDocumentIdentifier	Name: assigningStudyRegistry
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier might be assigned by one StudyRegistry. Each StudyRegistry might assign one or more DocumentIdentifier.<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:CTOM	HealthcareSiteParticipantRole.roleCode
Details:
Map:CTRR	Registry Protocol Identifier Source
Details:
Map:CTRRr3	StudyRegistry
Details:
Map:CTRv1.0	StudyRegistry
Details:
Map:HL7SP	Author4 (in IndividualCaseSafetyReport)
Details: