: Public Class
Created: 3/1/2016 11:40:15 AM
Modified: 8/26/2017 2:00:49 AM
Project:
Advanced:
DEFINITION:<br/>An entity with management and reporting responsibilities in the context of a particular study for a set of study sites which may or may not be physically located within the geographic location, state or nation of the entity.<br/><br/>EXAMPLE(S):<br/>United Kingdom - acting as a Study Country for all study sites in the UK and Republic of Ireland for the Phase III Study of Exotocillin in community acquired pneumonia in patients over 65<br/>France - acting  as a Study Country for all study sites in mainland France and its offshore departments, plus two sites in French-speaking Belgium for the Phase II Study of Exotomumab in treatment of rheumatoid arthritis<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A Study Country exists as a business object in the context of planning and management of specific individual studies.<br/>
Attribute
Public CD
  countryCode
Details:
Map:Vendor1v1.0=StudyCountry.countryCode
Notes: DEFINITION:<br/>A coded value specifying the country that is the home base of the study country.<br/><br/>EXAMPLE(S):<br/>FR as the ISO 3166 Country Code for France.<br/>BE as the ISO 3166 Country Code for Belgium.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>ISO 3166 Country codes can be used<br/>
Element Source Role Target Role
Organization
Class  
Name: performedStudyCountry
 
Name: performingOrganization
 
Details:
DESCRIPTION:<br/>Each StudyCountry always is a function performed by one or more Organization.  Each Organization might function as one or more StudyCountry.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
Activity
Class  
Name: hasContextActivity
 
Name: contextForStudyCountry
 
Details:
DESCRIPTION:<br/>Each Activity might have as context one StudyCountry. Each StudyCountry might be the context for one or more Activity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyCountryPersonnel
Class  
Name: performingStudyCountryPersonnel
 
Name: performedStudyCountry
 
Details:
DESCRIPTION:<br/>Each StudyCountryPersonnel might perform a role for one StudyCountry. Each StudyCountry might have a role performed by one or more StudyCountryPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudySite
Class  
Name: managedStudySite
 
Name: managingStudyCountry
 
Details:
DESCRIPTION:<br/>Each StudySite might be managed by one StudyCountry.  Each StudyCountry might manage one or more StudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Study
Class  
Name: participatedStudy
 
Name: participatingStudyCountry
 
Details:
DESCRIPTION:<br/>Each Study might be participated in by one or more StudyCountry.  Each StudyCountry always participates in one Study.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:Vendor1v1.0 StudyCountry
Details: