: Public Class
Created: 3/24/2010 1:26:15 PM
Modified: 9/18/2013 4:52:59 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A condition that is a focus of the study.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Acute pain syndrome; Advanced Adenocarcinoma of the Colon and Rectum; <br /></p><p>Hot Flashes<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  code
Details:
Map:C3PRv2.9=DiseaseTerm.medraCode
Map:C3PRv2.9=DiseaseTerm.ctepTerm
Map:C3PRv2.9=DiseaseTerm.term
Map:C3PRv2.9=DiseaseTerm
Map:caAERSv2.2=DiseaseTerm.ctepTerm
Map:caAERSv2.2=AbstractMeddraDomain.whoArtCode
Map:caAERSv2.2=AbstractMeddraDomain.jartCode
Map:caAERSv2.2=AbstractMeddraDomain.version_id
Map:caAERSv2.2=AbstractMeddraDomain.meddraCode > MeddraStudyDisease
Map:caAERSv2.2=Condition.name
Map:caAERSv2.2=MeddraVersion.name > MeddraStudyDisease
Map:caAERSv2.2=AbstractMeddraDomain.icd10Code
Map:caAERSv2.2=AbstractMeddraDomain.icd9Code
Map:caAERSv2.2=AbstractMeddraDomain.icd9CmCode
Map:caAERSv2.2=DiseaseTerm.medraCode
Map:caAERSv2.2=AbstractMeddraDomain.costartSymbol
Map:caAERSv2.2=DiseaseTerm.term
Map:caAERSv2.2=AbstractMeddraDomain.meddraTerm
Map:caAERSv2.2=AbstractMeddraDomain.hartsCode
Map:CTOM=Protocol.diseaseCode
Map:CTR&Rr2=MedDRA Level
Map:CTR&Rr2=MedDRA Version
Map:CTR&Rr2=MedDRA Term
Map:CTR&Rr2=MedDRA Code
Map:CTR&Rr2=Medical condition in lay language
Map:CTR&Rr2=MedDRA EUTCT ID
Map:CTR&Rr2=Medical condition
Map:CTRPv1.0=InterventionalStudyProtocol.diseaseCode
Map:CTRPv1.0=StudyProtocol.diseaseCode
Map:CTRPv1.0=ObservationalStudyProtocol.diseaseCode
Map:CTRPv3.8=StudyDisease.diseaseCode
Map:CTRRr3=Study.diseaseCode
Map:CTRv1.0=StudyCondition.code
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=INDIC
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the condition that is the focus of 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;In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.#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:
Map:C3PRv2.9=StudyDisease.leadDisease
Map:caAERSv2.2=AbstractStudyDisease.leadDisease
Map:CTRPv3.8=StudyDisease.leadDiseaseIndicator
Map:CTRv1.0=StudyCondition.leadIndicator
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the primary condition of a 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: investigatedStudyCondition
 
Name: focuses onStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each StudyCondition always is the focus of one StudyProtocolVersion. Each StudyProtocolVersion might focus on one or more StudyCondition.<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:C3PRv2.9 StudyDisease
Details:
 
Map:caAERSv2.2 DiseaseTerm
Details:
 
Map:caAERSv2.2 AbstractStudyDisease
Details:
 
Map:CTRPv1.0 Conditions or Focus of Study
Details:
 
Map:CTRPv3.8 StudyDisease
Details:
 
Map:CTRR Condition
Details:
 
Map:CTRv1.0 StudyCondition
Details:
 
Constraint Type Status
code Unique Qualifier Invariant Approved
Details:
A StudyCondition.code must be unique within the context of the StudyProtocolVersion to which it is associated.