: Public abstract Class
Created: 3/14/2005 4:52:41 PM
Modified: 11/25/2014 10:55:27 AM
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DEFINITION:<br /></p><p>Any action that can, in the context of a study, experiment or a post-marketing investigation, be defined, planned, scheduled or performed. <br /></p><p> <br /></p><p>EXAMPLE(S):<br /></p><p>Administrative activities such as subject registration or informed consent<br /></p><p>Clinical activities such as surgical procedure, laboratory test, administration of a drug<br /></p><p> <br /></p><p>OTHER NAME(S):<br /></p><p> <br /></p><p>NOTE(S):<br /></p><p>This is similar in idea to HL7 RIM's Act class<br /></p>
Attribute
Public II
  identifier
Details:
Map:CTRPv1.0=PlannedEligibilityCriterion.identifier
Map:CTRPv1.0=PlannedActivity.identifier
Map:CTRPv1.0=SubstanceAdministration.identifier
Map:CTRPv1.0=Activity.identifier
Map:CTRPv1.0=PlannedObservation.identifier
Map:CTRPv3.8=Activity.identifier
Map:CTRRr3=Activity.identifier
Map:CTRv1.0=Activity.identifier
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Act.id
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Encounter.id
Map:FDA HL7 SD SD DSTU2012=StudyProtocol//plannedStudy/precondition/eligibilityCriterion.id
Map:FDA HL7 SD SD DSTU2012=plannedStudy/component4/timePointEventDefinition.id
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Procedure.id
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/SubstanceAdministration.id
Map:FDA HL7 SD SD DSTU2012=PlannedSubjectActivity/Observation.id
Map:ICSRr2=ProductEvent.id (in R_Product)
Map:ICSRr2=AdverseEffectReference.id (in IndividualCaseSafetyReport)
Map:ICSRr2=TransportationEvent.id (in R_Product)
Map:Lab=Activity.identifier
Map:LabViewer2.2=SpecimenCollection.identifier
Map:LabViewer2.2=Activity.identifier
Map:LabViewer2.2=LaboratoryTestIdentifier
Map:LSDAM=Activity.identifier
Map:LSDAMv2.2.3Plus=Activity.identifier
Map:SDTM IGv3.1.2=DS.DSREFID
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes identity of an activity.#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;12345 is the identifier for a substance administration#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>
  reasonCode
Details:
Map:AE=Indication
Map:AE=ProductInvestigation.reasonCode
Map:C3PRv2.9=ScheduledEpoch.eligibilityWaiverReasonText
Map:C3PRv2.9=StudySubject.backDatedReasonCode
Map:C3PRv2.9=ScheduledEpoch.disapprovalReasonText
Map:C3PRv2.9=ScheduledEpoch.offEpochReasonText
Map:C3PRv2.9=ScheduledArm.eligibilityWaiverReasonText
Map:CDASHv1.1=CM.CMINDC
Map:CTOM=FemaleReproductiveCharacteristic.menopauseReasonCode
Map:CTOM=Surgery.reasonCode
Map:CTOM=FemaleReproductiveCharacteristic.menopauseReasonOtherText
Map:CTOM=Activity.reasonCode
Map:CTOM=Radiation.reasonCode
Map:CTOM=SubstanceAdministration.reasonCode
Map:CTOM=Procedure.reasonCode
Map:CTOM=SpecimenAcquisition.reasonCode
Map:CTOM=Imaging.reasonCode
Map:CTRPv1.0=PlannedEligibilityCriterion.reasonCode
Map:CTRPv1.0=Activity.reasonCode
Map:CTRPv1.0=PlannedActivity.reasonCode
Map:CTRPv1.0=PlannedObservation.reasonCode
Map:CTRPv1.0=SubstanceAdministration.reasonCode
Map:CTRPv3.8=PerformedSubjectMilestone.reasonCode
Map:CTRv1.0=Activity.reasonCode
Map:CTRv1.0=PlannedActivity.purpose
Map:HCTv1.0=CDE 2861356:Therapies.Indication for therapy:
Map:HCTv1.0=MD Anderson Specific Content: Product.Specificity #1 of product
Map:HCTv1.0=CDE 2691434:Therapies.What was the indication for the alternative hematopoietic cell transplantation (HCT)?
Map:HCTv1.0=CDE 2957419:Therapies.What was the reason for the current HSCT:
Map:HCTv1.0=CDE 2957528:Therapies.Specify the reason for the current HSCT:
Map:HCTv1.0=CDE 2680962:Therapies.Indication for DCI
Map:HCTv1.0=CDE 2771490:Therapies.What was the indication for the subsequent HSCT?
Map:HCTv1.0=CDE 2861364:Therapies.If code "4" other for indication of therapy, specify:
Map:HCTv1.0=CDE 2775815:Therapies.What was the reason hematopoietic, lymphoid growth factors or cytokines were administered?
Map:HCTv1.0=CDE 2737040:Preparative Regimen.What was the reason for the reduced intensity/ non-myeloablative preparative regimen?
Map:HCTv1.0=CDE 2691344:Therapies.Specify the indication for the other alternative HCT:
Map:HCTv1.0=CDE 2737050:Therapies.Specify the other reason for the non-myeloablative / reduced intensity (NST / RIC) preparative regimen:
Map:HCTv1.0=MD Anderson Specific Content: Product.Specificity #2 of product
Map:HCTv1.0=CDE 2771502:Therapies.Specify the other indication for the subsequent HSCT:
Map:HCTv1.0=CDE 2680966:Therapies.DCI indication other: specify
Map:HCTv1.0=CDE 2775984:Therapies.Specify the other indication type for the supplemental intravenous immunoglobulin therapy:
Map:HCTv1.0=CDE 2775979:Therapies.Specify the indication(s) for the supplemental intravenous immunoglobulin therapy:
Map:HCTv1.0=CDE 2744499:Therapies.Purpose of therapy:
Map:HCTv1.0=CDE 3181140:Therapies.Therapeutic procedure administered begin reason:
Map:ICSRr2=CausalityAssessment.reasonCode (in IndividualCaseSafetyReport)
Map:Lab=Activity.reason
Map:LabViewer2.2=Activity.reason
Map:LabViewer2.2=SpecimenCollection.reason
Map:LSDAM=PlannedActivity.purpose
Map:LSDAM=Activity.reasonCode
Map:LSDAMv2.2.3Plus=Activity.reasonCode
Map:NCI CRF Standard=CDE 2003870v4.0: Concomitant Agent Concomitant Intervention or Procedure Reason
Map:PSC=Occurred.reason
Map:PSC=ScheduledEventState.reason
Map:PSC=Scheduled.reason
Map:SDTM IGv3.1.1=CM.CMINDC
Map:SDTM IGv3.1.1=DS.DSTERM
Map:SDTM IGv3.1.2=CM.CMINDC
Map:TDM=ContactActivityPurpose.purposeType
Map:TDMv2=(New content - DefinedObservationResult.comment)
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the motivation, cause, or rationale of an activity.#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;routine requirement, drug reaction, infectious disease reporting requirement, on patient request#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;#lt;p#gt;The key difference in how this attribute is used across the Activity subclasses is temporal and the attribute has essentially the same meaning wherever it is used. The most likely uses of reasonCode are with PlannedActivities, where it identifies why an activity should be done as part of the study or experiment plan, and with PerformedActivities, where it identifies why an activity was done. While it's possible for a DefinedActivity to have a reason, BRIDG has no use cases for the use of this attribute in a DefinedActivity, though some may come to harmonization in the future. Nor is it likely, based on existing use cases, to be used much, if at all, for ScheduledActivities.#lt;br /#gt;#lt;/p#gt;
Public ST
  comment
Details:
AE:Exclude=True
Map:caAERSv2.2=TreatmentAssignment.comments
Map:caAERSv2.2=CourseAgent.comments
Map:caAERSv2.2=ReportReviewComment
Map:CTRPv1.0=PlannedActivity.comment
Map:CTRPv1.0=Activity.comment
Map:CTRPv1.0=SubstanceAdministration.comment
Map:CTRPv1.0=PlannedEligibilityCriterion.comment
Map:CTRPv1.0=PlannedObservation.comment
Map:CTRv1.0=DefinedObservationResult.commentText
Map:CTRv1.0=Activity.comment
Map:ICSRr2=CausalityAssessment.text (in IndividualCaseSafetyReport)
Map:Lab=Specimen.commentsFromLaboratory
Map:Lab=Specimen.commentsFromInvestigator
Map:Lab=LabTest.comments
Map:LabViewer2.2=LaboratoryTest.comment
Map:LabViewer2.2=Specimen.commentFromLaboratory
Map:LSDAM=DefinedCompositionRelationship.comment
Map:LSDAM=Activity.comment
Map:LSDAMv2.2.3Plus=Activity.comment
Map:PSC=ScheduledEvent.notes
Map:PSCv2.6=ScheduledActivity.notes
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Additional description of the activity.#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;Guidance on how to perform the observation. (for DefinedObservation.comment)#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
ExperimentalUnit
Class   		Name: involvingActivity
  		Name: involvedExperimentalUnit
 
Details:
DESCRIPTION:<br /></p><p>Each Activity might be participated in by one ExperimentalUnit. Each ExperimentalUnit might participate in one or more Activity.<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>
Subject
Class   		Name: involvingActivity
  		Name: involvedSubject
 
Details:
DESCRIPTION:<br /></p><p>Each Activity might be participated in by one Subject. Each Subject might participate in one or more Activity.<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>
NonResearchProject
Class   		Name: usedActivity
  		Name: usingNonResearchProject
 
Details:
DESCRIPTION:<br /></p><p>Each Activity might be used by one NonResearchProject.  Each NonResearchProject might use one or more Activity.<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>
Experiment
Class   		Name: usedActivity
  		Name: usingExperiment
 
Details:
DESCRIPTION:<br /></p><p>Each Activity might be used by one Experiment.  Each Experiment might use one or more Activity.<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>
Element Source Role Target Role
Performer
Class   		Name: performingPerformer
  		Name: performedActivity
 
Details:
DESCRIPTION:<br /></p><p>Each Performer always performs one or more Activity.  Each Activity might be performed by one or more Performer.<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>
ExperimentalActivityItem
Class   		Name: usedExperimentalActivityItem
  		Name: usingActivity
 
Details:
DESCRIPTION:<br /></p><p>Each ExperimentalActivityItem always is used in one Activity.  Each Activity might use one or more ExperimentalActivityItem.<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>NOTES:<br /></p><p>The documented use cases from life sciences are limited to procedure and observations.  Use cases for other kinds of activities in life sciences are needed to support this relationship at Activity level. In the next release, this relationship will have to be re-assessed. <br /></p>
Tag Value
Map:AE Activity
Details:
 
Map:CTRPv1.0 Activity
Details:
 
Map:CTRPv3.8 Activity
Details:
 
Map:CTRRr3 Activity
Details:
 
Map:CTRv1.0 Activity
Details:
 
Map:LSDAM Activity
Details:
 
Map:LSDAMv2.2.3Plus Activity
Details:
 
Constraint Type Status
be participated in by Declaration Invariant Approved
Details:
Unless constrained at any subclass level, all associations from Subject (including StudySubject) and ExperimentalUnit are valid for all activities.
Object Type Connection Direction Notes
ScheduledActivity Class Generalization From DESCRIPTION: Each ScheduledActivity always specializes one Activity. Each Activity might be specialized by one ScheduledActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedActivity Class Generalization From DESCRIPTION: Each PerformedActivity always specializes one Activity. Each Activity might be specialized by one PerformedActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PlannedActivity Class Generalization From DESCRIPTION: Each PlannedActivity always specializes one Activity. Each Activity might be specialized by one PlannedActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
DefinedActivity Class Generalization From DESCRIPTION: Each DefinedActivity always specializes one Activity. Each Activity might be specialized by one DefinedActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):