: Public Class
Created: 5/3/2012 11:54:17 AM
Modified: 7/9/2012 4:25:21 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A kind of physical entity which is intended to be the primary unit of operational and/or administrative interest in a study.<br /></p><p><br /></p><p>EXAMPLE(S): <br /></p><p>10 Adult males, 20 female 6-month old chickens<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S): <br /></p><p>Some studies may specify multiple kinds of subjects, each with their own quantity.<br /></p>
Attribute
Public URG<INT.POS>
  quantityRange
Details:
Map:FDA HL7 SD SD DSTU2012=personKind.quantity
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer falling within minimum and maximum bounds that specifies how many of a particular type of subject are planned to be included 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;
Element Source Role Target Role
StudyProtocolVersion
Class   		Name: intendedPlannedStudySubject
  		Name: plannedForStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each PlannedStudySubject always participates in one StudyProtocolVersion. Each StudyProtocolVersion always is participated in by one or more PlannedStudySubject.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the types of StudySubjects intended to participate in the StudyProtocolVersion.<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><p>ActualIndicator should be set to 'false' for the Entity that is the subject<br /></p>
DefinedEligibilityCriterionAnswer
Class   		Name: constrainedPlannedStudySubject
  		Name: constrainingDefinedEligibilityCriterion
 
Details:
DESCRIPTION:<br /></p><p>Each PlannedStudySubject might be constrained by one or more DefinedEligibilityCriterionAnswer. Each DefinedEligibilityCriterionAnswer might constrain one or more PlannedStudySubject.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the specific criteria a particular PlannedStudySubject is expected to adhere to.<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:CTRv1.0 PlannedSubject
Details:
 
Constraint Type Status
be a function performed by actualIndicator Qualifier Invariant Approved
Details:
Only BiologicEntity, Material (via Subject) with actualIndicator = "false" is valid.
Object Type Connection Direction Notes
Subject Class Generalization To DESCRIPTION: Each PlannedStudySubject always specializes one Subject. Each Subject might be specialized by one PlannedStudySubject. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):