: Public Class
Created: 6/27/2005 11:37:14 AM
Modified: 3/21/2015 12:24:42 AM
Project:
Advanced:
DEFINITION:<br /></p><p>The completed action within the context of a given study or experiment that is not directly related to the overarching hypothesis evaluation or testing, but is nonetheless essential to the efficient and/or effective coordination and execution of the study or experiment.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>assignment to a treatment arm, registration to a study, start of on-study period, end of on-study period, obtain informed consent, verify eligibility criteria, enroll, randomize, complete study visits, exit study, break treatment blind, protocol violation, premature withdrawal, etc.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  varianceTypeCode
Details:
Map:CTRv1.0=PerformedAdministrativeActivity.varianceTypeCode
Map:LSDAM=PerformedAdministrativeActivity.varianceTypeCode
Map:SDTM IGv3.1.1=(New content - variance type needed for RIM mapping)
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of variance.#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;early / late occurrence of an act, higher / lower amount transferred#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 DSET<CD>
  varianceReasonCode
Details:
Map:CTOM=StudyParticipantAssignment.eligibilityWaiverReasonText
Map:CTRv1.0=PerformedAdministrativeActivity.varianceReason
Map:LSDAM=PerformedAdministrativeActivity.varianceReason
Map:SDTM IGv3.1.1=DS.DSTERM
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying why what occurred is different from what was expected.#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;Subject received early treatment because of vacation plans.#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
StudySite
Class   		Name: performedPerformedAdministrativeActivity
  		Name: performingStudySite
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedAdministrativeActivity might be performed at one StudySite.  Each StudySite might perform one or more PerformedAdministrativeActivity.<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:CTRPv3.8 PerformedAdministrativeActivity
Details:
 
Map:CTRv1.0 PerformedAdministrativeActivity
Details:
 
Map:HL7SP RegistrationEvent
Details:
 
Map:LSDAM PerformedAdministrativeActivity
Details:
 
Map:LSDAMv2.2.3Plus PerformedAdministrativeActivity
Details:
 
Constraint Type Status
be performed at actualIndicator Qualifier Invariant Approved
Details:
Only Organization (via StudySite) with actualIndicator = "true" is valid.
Object Type Connection Direction Notes
PerformedSubjectMilestone Class Generalization From DESCRIPTION: Each PerformedSubjectMilestone always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedSubjectMilestone. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedStudyAgentTransfer Class Generalization From DESCRIPTION: Each PerformedStudyAgentTransfer always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedStudyAgentTransfer. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedStudyAdministrativeActivity Class Generalization From DESCRIPTION: Each PerformedStudyAdministrativeActivity always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedStudyAdministrativeActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedNotification Class Generalization From DESCRIPTION: Each PerformedNotification always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedNotification. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedMaterialStorage Class Generalization From DESCRIPTION: Each PerformedMaterialStorage always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedMaterialStorage. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedExperimentalUnitAllocation Class Generalization From DESCRIPTION: Each PerformedExperimentalUnitAllocation always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedExperimentalUnitAllocation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedActivity Class Generalization To DESCRIPTION: Each PerformedAdministrativeActivity always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedAdministrativeActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedSpecimenMove Class Generalization From DESCRIPTION: Each PerformedSpecimenMove always specializes one PerformedAdministrativeActivity. Each PerformedAdminisrativeActivity might be specialized by one PerformedSpecimenMove. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):