: Public Class
Created: 10/21/2010 7:45:30 AM
Modified: 3/16/2015 3:52:26 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A collection of activities that are intended to occur or start for the same study or experiment subject at a specific point in the context of a particular study or experiment.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Clinic visit during which a physical exam, a blood test, and a substance administration occur<br /></p><p><br /></p><p>Telephone contact during which temperature, blood pressure and adverse events are reported<br /></p><p><br /></p><p>Recording multiple observation results in a diary<br /></p><p><br /></p><p>A treatment strategy that consists of drug administrations with rules for modifying doses<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p>visit, time point, study segment, course, treatment strategy, period, cycle<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public INT.NONNEG
  sequenceNumber
Details:
Map:CDASHv1.1=IE.VISITNUM
Map:CDASHv1.1=EG.VISITNUM
Map:CDASHv1.1=VS.VISITNUM
Map:CDASHv1.1=DA.VISITNUM
Map:CDASHv1.1=LB.VISITNUM
Map:CDASHv1.1=PE.VISITNUM
Map:CTRv1.0=PlannedSubjectActivityGroup.sequenceNumber
Map:PGx v1.0=BE.VISITNUM
Map:PGx v1.0=BS.VISITNUM
Map:PGx v1.0=PF.VISITNUM
Map:PGx v1.0=PG.VISITNUM
Map:PGx v1.0=SB.VISITNUM
Map:SDTM IGv3.1.2=LB.VISITNUM
Map:SDTM IGv3.1.2=IE.VISITNUM
Map:SDTM IGv3.1.2=PC.VISITNUM
Map:SDTM IGv3.1.2=MS.VISITNUM
Map:SDTM IGv3.1.2=EG.EGTPTNUM
Map:SDTM IGv3.1.2=MB.MBTPTNUM
Map:SDTM IGv3.1.2=TV.VISITNUM
Map:SDTM IGv3.1.2=PE.VISITNUM
Map:SDTM IGv3.1.2=SV.VISITNUM
Map:SDTM IGv3.1.2=DA.VISITNUM
Map:SDTM IGv3.1.2=MS.MSTPTNUM
Map:SDTM IGv3.1.2=FA.VISITNUM
Map:SDTM IGv3.1.2=PC.PCTPTNUM
Map:SDTM IGv3.1.2=QS.VISITNUM
Map:SDTM IGv3.1.2=EG.VISITNUM
Map:SDTM IGv3.1.2=VS.VISITNUM
Map:SDTM IGv3.1.2=EX.EXTPTNUM
Map:SDTM IGv3.1.2=MB.VISITNUM
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer specifying the order of a visit within a study or experiment.#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;Visit Number#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;#lt;p#gt;Derived from the sequence number that orders this activity group within a larger activity group:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;PlannedSubjectActivityGroup [visit, timepoint or other kind of group] #gt; PlannedCompositionRelationship.sequenceNumber #gt;  PlannedSubjectActivityGroup [set of planned visits for the study or some other larger activity group] #lt;br /#gt;#lt;/p#gt;
Public URG<INT.NONNEG>
  targetAccrualNumberRange
Details:
Map:BRIDGv2.2=PlannedStudyCell.targetAccrualNumber
Map:C3PRv2.9=Arm.targetAccrualNumber
Map:CTRv1.0=PlannedActivity.targetAccrualNumberRange
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer falling within minimum and maximum bounds that specifies how many subjects are to be accrued for the planned subject activity group. #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;
Tag Value
Map:CTRv1.0 PlannedSubjectActivityGroup
Details:
 
Map:SDTM IGv3.1.2 TV.DOMAIN
Details:
 
Map:SDTM IGv3.1.2 TE.DOMAIN
Details:
 
Map:SDTMIGv3.1.3 TV
Details:
 
Constraint Type Status
be participated in by Qualifier Invariant Approved
Details:
Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid.
Object Type Connection Direction Notes
PlannedActivity Class Generalization To DESCRIPTION: Each PlannedSubjectActivityGroup always specializes one PlannedActivity. Each PlannedActivity might be specialized by one PlannedSubjectActivityGroup. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):