: Public Class
Created: 6/29/2009 1:48:02 PM
Modified: 1/12/2018 9:33:36 AM
Project:
Advanced:
DEFINITION:<br/>The intention to use a defined activity in the design of a study.<br/><br/>EXAMPLE(S):<br/>If a study's design includes the activity of taking blood pressure, the DefinedActivity for blood pressure is linked to the study via this class.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The number of times this activity occurs during the study and the relative timing for those occurrences is represented by PlannedActivity.<br/>
Attribute
Public BL
  studyFocusIndicator
Details:
Map:CTRPv1.0=PlannedEligibilityCriterion.name
Map:CTRR=Comparator(s) product name(s)
Map:CTRR=Intervention Name
Map:CTRv1.0=StudyActivity.studyFocusIndicator
Notes: DEFINITION:<br/>Specifies whether the activity is a key investigational activity for a study.<br/><br/>EXAMPLE(S):<br/>A study focused on investigating the effectiveness of a drug will flag the substance administration of the drug or a study focused on determining the average blood pressure of a certain population will flag the blood pressure observation.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>If a study has study agents, one or more of the study activities will presumably use the agent and have this indicator set to true.<br/>
Element Source Role Target Role
StudyProtocolVersion
Class  
Name: usedStudyActivity
 
Name: usingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyActivity might be used by one StudyProtocolVersion.  Each StudyProtocolVersion might use one or more StudyActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
DefinedActivity
Class  
Name: usingStudyActivity
 
Name: usedDefinedActivity
 
Details:
DESCRIPTION:<br/>Each StudyActivity always uses one DefinedActivity.  Each DefinedActivity might be used by one or more StudyActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
PlannedActivity
Class  
Name: usingPlannedActivity
 
Name: usedStudyActivity
 
Details:
DESCRIPTION:<br/>Each PlannedActivity might be a use of one StudyActivity. Each StudyActivity might be used as one or more PlannedActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:caAERSv2.2 StudyTherapy
Details:
 
Map:CTRv1.0 StudyActivity
Details:
 
Map:HL7SD PlannedStudy.Component2
Details:
 
Map:LSDAMv2.2.3Plus ActivityCollection.(Protocol)
Details:
 
Map:SDTM IGv3.1.3 TE
Details: