Protocol Representation Sub-Domain::StudyActivity

: Public Class

Created:	6/29/2009 1:48:02 PM
Modified:	8/30/2019 8:13:24 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{49F6CBF5-443A-49fd-8602-D270E4F15469}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, BRIDG BackBone, View IM: Imaging, View PR: Protocol Representation, Study Versioning, SDTM IG v3.1.3, SDTM Vital Signs (VS), SDTM Disease Response (RS) Domain, SDTM Exposure (EX) Domain, CDISC Lab Data Model v1.0.1, SDTM IG v3.2, Activities, Oncology & Imaging, Lab-Related Classes, Study Management, Structured Protocol - Core Protocol Concepts, Structured Protocol - Schedule of Activities, Structured Protocol - Backbone, Structured Protocol - Operational Mode

DEFINITION: The intention to use a defined activity in the design of a study. EXAMPLE(S): 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. OTHER NAME(S): NOTE(S): The number of times this activity occurs during the study and the relative timing for those occurrences is represented by PlannedActivity.

Attributes
Associations To
Associations From
Tagged Values

Attribute

Public BL
studyFocusIndicator

Details:

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

Map:CTRPv1.0=PlannedEligibilityCriterion.name
Map:CTRR=Comparator(s) product name(s)
Map:CTRR=Intervention Name
Map:CTRv1.0=StudyActivity.studyFocusIndicator

Notes:

DEFINITION: Specifies whether the activity is a key investigational activity for a study. EXAMPLE(S): 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. OTHER NAME(S): NOTE(S): 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.

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:
Map:SDTM IGv3.2	TS.(INDIC) TSVAL WHERE TSPARMCD = "INDIC"
Details:
Map:SDTM IGv3.2	TS.(INDIC) TSVALNF WHERE TSPARMCD = "INDIC"
Details:
Map:SDTM IGv3.2	TE
Details:
Map:SDTM IGv3.2	TS.(INDIC) TSVALCD WHERE TSPARMCD = "INDIC"
Details:
Map:SDTM IGv3.2	TS.(INDIC) TSVCDREF WHERE TSPARMCD = "INDIC"
Details:
Map:SDTM IGv3.2	TS.(INDIC) TSVCDVER WHERE TSPARMCD = "INDIC"
Details: