Study Conduct Sub-Domain::StudyRecruitmentStatus

: Public Class

Created:	6/12/2008 5:09:23 PM
Modified:	8/26/2017 2:57:22 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{183261AC-3F52-4957-9EA2-2581F9B61819}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct, Registering a Trial at ClinicalTrials.gov

DEFINITION: Status of finding and enrolling appropriate study subjects (those selected on the basis of the protocol's inclusion/exclusion criteria) into a study. EXAMPLE(S): Not Yet Recruiting, Recruiting, etc OTHER NAME(S): NOTE(S): A study must complete all of the requirements to allow subject recruitment - statuses include Not Yet Recruiting, Recruiting, etc. and the status changes are determined by the sponsor. If study XYZ is in Recruiting status, participating sites, after completing the necessary regulatory requirements, may recruit and enroll subjects.

Attributes
Associations To
Tagged Values

Attribute

Public CD
code

Details:

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

Map:CTGOV=Recruitment Status
Map:CTGOV=Overall Recruitment Status
Map:CTRPv1.0=StudyRecruitmentStatus.statusCode
Map:CTRPv3.8=StudyRecruitmentStatus.statusCode
Map:CTRR=Recruitment Status
Map:CTRRr3=StudyRecruitmentStatus.statusCode
Map:CTRv1.0=StudyRecruitmentStatus.code
Map:WHO=Recruitment Status

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of recruitment for the study. EXAMPLE(S): Not yet recruiting; recruiting; enrolling by invitation; active, not recruiting; completed; suspended; terminated; withdrawn. OTHER NAME(S): NOTE(S): The recruitment status of a study may overlap with the study site status and accrual status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study recruitment status codes and adopt the CTRP values for study status code.

Public TS.DATETIME
date

Details:

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

Map:CTRPv1.0=StudyRecruitmentStatus.statusDate
Map:CTRPv3.8=StudyRecruitmentStatus.statusDate
Map:CTRv1.0=StudyRecruitmentStatus.date

Notes:

DEFINITION: The date (and time) on which the recruitment status is assigned. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudyConduct Class	Name: describingStudyRecruitmentStatus	Name: describedStudyConduct
Details: DESCRIPTION:<br/>Each StudyRecruitmentStatus always describes one StudyConduct. Each StudyConduct might be described by one or more StudyRecruitmentStatus.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Tag	Value
Map:CTRPv1.0	StudyRecruitmentStatus
Details:
Map:CTRPv3.8	StudyRecruitmentStatus
Details:
Map:CTRRr3	StudyRecruitmentStatus
Details:
Map:CTRv1.0	StudyRecruitmentStatus
Details:
Map:HL7SP	Study.subjectOf2
Details: