Created: | 1/5/2005 2:51:42 PM |
Modified: | 3/21/2015 1:46:50 AM |
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Public INT.POS repetitionNumber |
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![]() Map:caAERSv2.2=TreatmentInformation.totalCourses Map:caAERSv2.2=AdverseEventReportingPeriod.cycleNumber Map:CTRv1.0=PerformedActivity.repetitionNumber Map:HCTv1.0=CDE 3060732:Therapies.What is the reason for the number of cycles missing value? Map:HCTv1.0=CDE 3060718:Therapies.What was the number of cycles for the therapeutic procedure? Map:HCTv1.0=CDE 2954036:Therapy Doses.Specify the number of days of radiation therapy Map:HCTv1.0=CDE 2763975:Therapies.What is the number of systemic/intrathecal therapy cycles administered? Map:LSDAM=PerformedActivity.repetitionNumber Map:NCI CRF Standard=CDE 2744948v1.0: Treatment Cycle Number Map:NCI CRF Standard=CDE 2072v4.1: Treatment Current Course Number Map:NCI CRF Standard=CDE 2732184v1.0: Protocol Course Number Count Map:NCI CRF Standard=CDE 62590v3.0: Agent Course Count Map:NCI CRF Standard=CDE 62676v3.0: Prior Chemotherapy Regimen Number Map:PGx v1.0=PF.PFREPNUM
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Public ST nameCodeModifiedText |
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Public IVL<TS.DATETIME> dateRange |
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![]() Map:AE=AdverseEvent.baselineDate Map:AE=Device.dateDeviceReturnedToManufacturer Map:C3PRv2.9=StudyParticipantDiseaseHistory.diagnosisDate Map:C3PRv2.9=ScheduledEpoch.offEpochDate Map:C3PRv2.9=StudySubjectConsentVersion.informedConsentSignedDate Map:C3PRv2.9=ScheduledEpoch.startDate Map:C3PRv2.9=ScheduledArm.startDate Map:C3PRv2.9=ScheduledNotification.dateSent Map:caAERSv2.2=DiseaseHistory.diagnosticDate Map:caAERSv2.2=StudyParticipantPriorTherapy.startDate Map:caAERSv2.2=MedicalDevice.implantedDate Map:caAERSv2.2=StudyParticipantConcomitantMedication.startDate Map:caAERSv2.2=ConcomitantMedication.endDate Map:caAERSv2.2=StudyParticipantConcomitantMedication.endDate Map:caAERSv2.2=RadiationIntervention.lastTreatmentDate Map:caAERSv2.2=Lab.labDate Map:caAERSv2.2=SurgeryIntervention.interventionDate Map:caAERSv2.2=AdverseEventReportingPeriod.endDate Map:caAERSv2.2=CourseDate.date Map:caAERSv2.2=MedicalDevice.explantedDate Map:caAERSv2.2=TreatmentInformation.firstCourseDate Map:caAERSv2.2=CM.CMENTIM Map:caAERSv2.2=AdverseEvent.gradedDate Map:caAERSv2.2=AdverseEventResponseDescription.statusDate Map:caAERSv2.2=LabValue.date Map:caAERSv2.2=StudyParticipantPriorTherapy.endDate Map:caAERSv2.2=StudyParticipantAssignment.firstCourseDate Map:caAERSv2.2=AdverseEventReportingPeriod.startDate Map:caAERSv2.2=AdverseEventResponseDescription.reducedDate Map:caAERSv2.2=ConcomitantMedication.startDate Map:caAERSv2.2=AdverseEventResponseDescription.dateRemovedFromProtocol Map:caAERSv2.2=ReportingPeriodReviewComment Map:caAERSv2.2=AdverseEventResponseDescription.eventTreatmentTime Map:CDASHv1.1=PE.PEDAT Map:CDASHv1.1=CM.CMSTDAT Map:CDASHv1.1=MH.MHDAT Map:CDASHv1.1=DS.DSSTTIM Map:CDASHv1.1=DA.DADAT Map:CDASHv1.1=EX.EXSTTIM Map:CDASHv1.1=LB.LBTIM Map:CDASHv1.1=CM.CMENTIM Map:CDASHv1.1=VS.VSTIM Map:CDASHv1.1=EX.EXSTDAT Map:CDASHv1.1=CM.CMENDAT Map:CDASHv1.1=CM.CMSTTIM Map:CDASHv1.1=LB.LBDAT Map:CDASHv1.1=EG.EGTIM Map:CDASHv1.1=DM.DMDAT Map:CDASHv1.1=DS.DSSTDAT Map:CDASHv1.1=PE.PETIM Map:CDASHv1.1=VS.VSDAT Map:CDASHv1.1=EX.EXENDAT Map:CDASHv1.1=SU.SUSTDAT Map:CDASHv1.1=SU.SUENDAT Map:CDASHv1.1=EX.EXENTIM Map:CDASHv1.1=EG.EGDAT Map:CTGOV=Record Verification Date Map:CTOM=Activity.startDate Map:CTOM=SubstanceAdministration.startDate Map:CTOM=Imaging.startDate Map:CTOM=SpecimenAcquisition.startDate Map:CTOM=Activity.stopDate Map:CTOM=DeathSummary.evaluationDate Map:CTOM=Procedure.startDate Map:CTOM=LesionEvaluation.evaluationDate Map:CTOM=DiseaseResponse.evaluationDate Map:CTOM=Diagnosis.evaluationDate Map:CTOM=FemaleReproductiveCharacteristic.menopauseStartDate Map:CTOM=QualitativeEvaluation.evaluationDate Map:CTOM=StudyParticipantAssignment.enrollmentAge Map:CTOM=SpecimenAcquisition.stopDate Map:CTOM=Procedure.stopDate Map:CTOM=Radiation.stopDate Map:CTOM=Radiation.startDate Map:CTOM=Imaging.stopDate Map:CTOM=Surgery.startDate Map:CTOM=AdverseEventTherapy.treatmentDate Map:CTOM=Assessment.evaluationDate Map:CTOM=SubstanceAdministration.stopDate Map:CTOM=Surgery.stopDate Map:CTRPv1.0=ObservationalStudyProtocol.recordVerificationDate Map:CTRPv1.0=InterventionalStudyProtocol.recordVerificationDate Map:CTRPv1.0=StudyProtocol.recordVerificationDate Map:CTRPv3.8=PerformedActivity.actualDateRange Map:CTRv1.0=PerformedActivity.dateRange Map:HCTv1.0=CDE 2705511:Occurrences.Product infusion begin time: Map:HCTv1.0=CDE 2770388:Lab Results.What was the date of the molecular analysis? Map:HCTv1.0=CDE 2866494:Lab Results.Date of decline in ANC to less than 500/mmE3 for 3 days or more: Map:HCTv1.0=CDE 2875783:Therapies.Preparative regimen begin date: Map:HCTv1.0=CDE 2960313:Therapies.When did the preparative regimen medication start? Map:HCTv1.0=CDE 2594446:Therapies.Specify the start date of the KGF administration: Map:HCTv1.0=CDE 2770410:Occurrences.What is the documented date of the stable, mixed chimerism? Map:HCTv1.0=CDE 2866433:Occurrences.Specify the date the clinical / hematologic CR was achieved: Map:HCTv1.0=CDE 2750854:Therapy Results.Date of relapse following the therapeutic procedure: Map:HCTv1.0=CDE 2960535:Therapies.When did therapy stop? Map:HCTv1.0=CDE 2866037:Procedures.Date of multiple product infusion Map:HCTv1.0=CDE 2866144:Occurrences.If absolute neutrophil count of 0.5x10^9/L has not been achieved, what was the date of last assessment? Map:HCTv1.0=CDE 3163964:Therapies.Platelet transfusion date: Map:HCTv1.0=CDE 2965140:Procedures.Date of excisional biopsy / surgical procedure performed: Map:HCTv1.0=CDE 2866131:Occurrences.Date the original disease status was determined: Map:HCTv1.0=CDE 3018891:Therapies.Radiation therapy administered begin date: Map:HCTv1.0=CDE 3019234:Therapies.What date did the radiation therapy end? Map:HCTv1.0=CDE 2594448:Therapies.What was the start date for the velafermin administration? Map:HCTv1.0=CDE 2866523:Therapies.Date of DCI: Map:HCTv1.0=CDE 2866490:Occurrences.Thawing process begin date: Map:HCTv1.0=CDE 3057653:Therapies.Specify the date retinoid therapy was started: Map:HCTv1.0=CDE 3124175:Occurrences.Date cytogenetic status established: Map:HCTv1.0=CDE 2775861:Occurrences.What date was an initial platelet count greater than or equal to 50 x 10E9/L achieved? Map:HCTv1.0=CDE 2798743:Diagnosis.Specify the year the diagnosis was made: Map:HCTv1.0=CDE 2979195:Therapies.What was the date of the last chemotherapy cycle? Map:HCTv1.0=CDE 2866035:Therapies.Date of receipt of product at your facility: Map:HCTv1.0=CDE 2953206:Techniques.Date of consent to donate research blood samples: Map:HCTv1.0=CDE 2980873:Therapies.Date of orthopedic surgery Map:HCTv1.0=CDE 3082352:Therapies.What was the last date chemotherapy was administered? Map:HCTv1.0=CDE 2866059:Lab Results.Date of product analysis: Map:HCTv1.0=CDE 2771948:Therapies.Date of last leukapheresis: Map:HCTv1.0=CDE 2931619:Therapies.Date radiation therapy started: Map:HCTv1.0=CDE 2866527:Diagnosis.Date of diagnosis of chronic GVHD Map:HCTv1.0=CDE 2770403:Lab Results.What was the date of the clinical or hematologic evidence? Map:HCTv1.0=CDE 2821465:Disease Response.What was the date of best response? Map:HCTv1.0=CDE 3061478:Therapies.Specify the date other treatment was started: Map:HCTv1.0=CDE 2860472:Therapies.What date did the systemic therapy end? Map:HCTv1.0=CDE 2978753:Occurrences.Date of post therapy disease relapse/progression Map:HCTv1.0=CDE 2931627:Therapies.Date radiation therapy stopped: Map:HCTv1.0=CDE 2866483:Therapies.Specify the date for the first course of each agent administered: Map:HCTv1.0=CDE 2786643:Occurrences.Thawing process begin time: Map:HCTv1.0=CDE 2866078:Occurrences.Date platelets >= 20 x 10^9/L: Map:HCTv1.0=CDE 2770838:Occurrences.What was the date of the subsequent HSCT? Map:HCTv1.0=CDE 2774075:Numbers.How many subsequent days of collection? Map:HCTv1.0=CDE 2866710:Diagnosis.What is the diagnosis date of the new malignancy, lymphoproliferative or myeloproliferative disorder that occurred? Map:HCTv1.0=CDE 2866424:Hematopoietic Stem Cell Transplant (HSCT) : Part 1 of 4.Date of the most recent previous HSCT: Map:HCTv1.0=CDE 3005937:Occurrences.Evaluation Date: Map:HCTv1.0=CDE 2797546:Occurrences.Date first discharged from hospital post-HSCT: Map:HCTv1.0=CDE 2866737:Medical Records and Forms.Clinical Data Form Today's Date Map:HCTv1.0=CDE 2957536:Occurrences.Date of secondary malignancy: Map:HCTv1.0=CDE 2794460:Occurrences.Actual date of follow-up: Map:HCTv1.0=CDE 3061335:Therapies.What date was immunotherapy administered? Map:HCTv1.0=CDE 2953362:Lab Results.Date the histologic transformation occurred: Map:HCTv1.0=CDE 2866766:Therapies.Date of product collection: Map:HCTv1.0=CDE 2953241:Techniques.Date of consent to submit research data: Map:HCTv1.0=CDE 2866947:Occurrences.Date the relapse / progression was first seen by molecular method: Map:HCTv1.0=CDE 2866435:Occurrences.Date the molecular complete remission was determined: Map:HCTv1.0=CDE 2986174:Occurrences.If necessary, please validate the sample collection date response. Map:HCTv1.0=CDE 2771946:Therapies.Date of first leukapheresis: Map:HCTv1.0=CDE 2771864:Therapies.If the apheresis for the DCI source was done at a different time other than for the collection of PBSC used for the allogeneic HSCT, what was the date of apheresis? Map:HCTv1.0=CDE 2964208:Therapies.Specify the date the first chemotherapy cycle began Map:HCTv1.0=CDE 2866133:Occurrences.What date was the relapse/progression detected by a molecular method? Map:HCTv1.0=CDE 2943067:Diagnosis.What was the date of MDS / MPS transformation? Map:HCTv1.0=CDE 2866525:Occurrences.Date of the latest cytogenetic / FISH assessment: Map:HCTv1.0=CDE 2866764:Occurrences.What assessment date determined that CR has not been achieved from the HSCT? Map:HCTv1.0=CDE 3163960:Therapies.Erythrocyte transfusion date: Map:HCTv1.0=CDE 2866508:Occurrences.Date the current disease status was established: Map:HCTv1.0=CDE 2866380:Occurrences.If initial platelets have not recovered to >20 x 10^9/L since HSCT, what was the date of last assessment? Map:HCTv1.0=CDE 2744513:Therapies.Specify date systemic/intrathecal therapy started: Map:HCTv1.0=CDE 2760949:Disease, Disorder or Finding.Date of the disease status evaluation: Map:HCTv1.0=CDE 2932795:Diagnosis.Date of diagnosis: Map:HCTv1.0=CDE 2866443:Occurrences.Date the cytogenetic complete remission was determined via conventional cytogenetics: Map:HCTv1.0=CDE 2866949:Occurrences.Date the relapse / progression was first seen by clinical / hematological method: Map:HCTv1.0=CDE 2866139:Occurrences.What date was the relapse/progression detected by a clinical/hematological method? Map:HCTv1.0=CDE 2866135:Occurrences.What date was the relapse/progression detected by a cytogenetic/FISH method? Map:HCTv1.0=CDE 2866504:Occurrences.Date of current clinical / hematologic assessment used to assess the disease status Map:HCTv1.0=CDE 2866437:Occurrences.Date the cytogenetic complete remission was determined via FISH: Map:HCTv1.0=CDE 2947021:Occurrences.Date of relapse: Map:HCTv1.0=CDE 2951782:Diagnosis.What was the date of the PET assessment? Map:HCTv1.0=CDE 2954767:Therapies.What date was the surgical procedure performed? Map:HCTv1.0=CDE 2866951:Occurrences.First date seen that detected the relapse / progression by cytogenetic / FISH method: Map:HCTv1.0=CDE 2866938:Hematopoietic Stem Cell Transplant (HSCT) : Part 1 of 4.Date of hematopoietic stem cell transplantation (HSCT) for which this form is being completed: Map:HCTv1.0=CDE 2744515:Therapies.Specify date systemic/intrathecal therapy ended: Map:HCTv1.0=CDE 2782523:Lab Results.What was the date of the cytogenetic analysis? Map:HCTv1.0=CDE 2866487:Activity.Date storage started: Map:HCTv1.0=CDE 2866485:Lab Results.Date of ANC recovery: Map:HCTv1.0=CDE 2786663:Occurrences.Thawing process end time: Map:HCTv1.0=CDE 2866414:Occurrences.First date of 3 consecutive labs initial ANC recovery >= to 0.5 x 10^9 was achieved: Map:HCTv1.0=CDE 3115646:Therapies.Date of previous HSCT: Map:HCTv1.0=CDE 2750705:Therapy Results.Date response to line of therapy established: Map:HCTv1.0=CDE 2861238:Occurrences.When was the disease assessment type used to assess the disease? Map:HCTv1.0=CDE 2860466:Therapies.What date did the systemic therapy begin? Map:HCTv1.0=CDE 2866534:Diagnosis.If the MDS sub type is AML, date of MDS diagnosis: Map:HCTv1.0=CDE 2866759:Occurrences.Survival status:latest follow-up date Map:HCTv1.0=MD Anderson Specific Content: Product.Number of days cell product was in culture Map:HCTv1.0=CDE 2960533:Therapies.When did the therapy start? Map:HCTv1.0=CDE 2866746:Diagnosis.What was the date of diagnosis of the primary disease for which the hematopoietic stem cell transplantation was performed? Map:HCTv1.0=CDE 2794409:Therapies.What was the end date the immunosuppressive agents were administered to treat or prevent GVHD? Map:HCTv1.0=CDE 2970253:Occurrences.If necessary, please validate the recurrent/progressive disease status date response. Map:HCTv1.0=CDE 2936618:Occurrences.Date the disease status was established: Map:HCTv1.0=CDE 2944110:Occurrences.What date did the disease relapse or progress? Map:HCTv1.0=MD Anderson Specific Content: Transplant.Day of infusion. Map:HCTv1.0=CDE 2947020:Involvement and Extent of Disease.Date of progression: Map:HCTv1.0=CDE 2707802:Occurrences.Product infusion end time: Map:HCTv1.0=CDE 2866462:Occurrences.Date of the current molecular assessment used to assess the disease status. Map:HCTv1.0=CDE 2774708:Therapies.Time of receipt of product: Map:HCTv1.0=CDE 3006893:Occurrences.Sample (specimen) collection date. Map:HCTv1.0=CDE 2936575:Disease Response.Specify the date complete remission was achieved: Map:ICSRr2=SpecimenCollectionProcess.effectiveTime (in R_Specimen universal) Map:ICSRr2=ProductEvent.effectiveTime (in R_Product) Map:ICSRr2=TransportationEvent.effectiveTime (in R_Product) Map:ICSRr2=RelatedInvestigation.effectiveTime (in IndividualCaseSafetyReport) Map:ICSRr2=InvestigativeEvent.effectiveTime (in IndividualCaseSafetyReport) Map:Lab=LabResult.testPerformedDateTime Map:Lab=Activity.actualStartDateTime Map:Lab=Activity.actualEndDateTime Map:LabViewer2.2=SpecimenCollection.actualStartDateTime Map:LabViewer2.2=SpecimenCollection.actualEndDateTime Map:LabViewer2.2=Activity.actualEndDateTime Map:LabViewer2.2=LaboratoryResult.testPerformedDateTime Map:LabViewer2.2=Activity.actualStartDateTime Map:LSDAM=PerformedActivity.actualDateRange Map:NCI CRF Standard=CDE 62739v3.0: Current Stage Complete Assessment Date Map:NCI CRF Standard=CDE 3008897v1.0: Case Report Form Review Date Map:NCI CRF Standard=CDE 2004170v3.0: Evaluation Date Map:NCI CRF Standard=CDE 2179659v2.0: Patient Relevant Medical History Date Map:NCI CRF Standard=CDE 2004139v3.0: Stop Time Map:NCI CRF Standard=CDE 2993v4.0: Treatment Reporting Period Begin Dat Map:NCI CRF Standard=CDE 65167v3.0: Last Treatment Date Map:NCI CRF Standard=CDE 2003745v5.0: Form Completion Date Map:NCI CRF Standard=CDE 3028746v1.0: Intervention Occurrence End Date Map:NCI CRF Standard=CDE 2992v4.0: Treatment Reporting Period End Date Map:NCI CRF Standard=CDE 2004095v3.0: Start Time Map:NCI CRF Standard=CDE 2171v4.0: Patient Registration Date Map:NCI CRF Standard=CDE 2004004v3.0: Sample Collection Date Map:NCI CRF Standard=CDE 64166v3.0: Form Amended Complete Date Map:NCI CRF Standard=CDE 3028744v1.0: Intervention Occurrence Begin Date Map:NCI CRF Standard=CDE 2003745v5.0: Form Completion Date Map:NCI CRF Standard=CDE 2746541v1.0: Participant Enrollment Date Map:NCI CRF Standard=CDE 2003580v3.0: Lab Collection Time Map:PGx v1.0=PF.PFDTC Map:PGx v1.0=PF.PFRFTDTC Map:PGx v1.0=BE.BEDUR Map:PGx v1.0=BE.BEENDTC Map:PGx v1.0=SB.SBDTC Map:PGx v1.0=BS.BSDTC Map:PGx v1.0=PG.PGDTC Map:PGx v1.0=BE.BEDTC Map:PGx v1.0=BE.BESTDTC Map:PSC=VitalSign.measureTime Map:PSC=ScheduledEventState.occured Map:PSC=StudyParticipantAssignment.startDate Map:PSC=Occurred.date Map:PSCv2.6=AdverseEvent.detectionDate Map:SDTM IGv3.1.1=QS.QSDTC Map:SDTM IGv3.1.1=CO.CODTC Map:SDTM IGv3.1.1=SU.SUENDTC Map:SDTM IGv3.1.1=SC.SCDTC Map:SDTM IGv3.1.1=PE.PEDTC Map:SDTM IGv3.1.1=MH.MHDTC Map:SDTM IGv3.1.1=DS.DSDTC Map:SDTM IGv3.1.1=DS.DSSTDTC Map:SDTM IGv3.1.1=CM.CMSTDTC Map:SDTM IGv3.1.1=LB.LBDTC Map:SDTM IGv3.1.1=SV.SVSTDTC Map:SDTM IGv3.1.1=SE.SEENDTC Map:SDTM IGv3.1.1=DM.DMDTC Map:SDTM IGv3.1.1=SV.SVENDTC Map:SDTM IGv3.1.1=SE.SESTDTC Map:SDTM IGv3.1.1=LB.LBENDTC Map:SDTM IGv3.1.1=EX.EXENDTC Map:SDTM IGv3.1.1=IE.IEDTC Map:SDTM IGv3.1.1=EG.EGDTC Map:SDTM IGv3.1.1=SU.SUSTDTC Map:SDTM IGv3.1.1=CM.CMENDTC Map:SDTM IGv3.1.1=DA.DADTC Map:SDTM IGv3.1.1=VS.VSDTC Map:SDTM IGv3.1.1=EX.EXSTDTC Map:SDTM IGv3.1.2=CE.CESTRTPT Map:SDTM IGv3.1.2=IE.IEDTC Map:SDTM IGv3.1.2=SU.SUENRF Map:SDTM IGv3.1.2=SU.SUSENDTC Map:SDTM IGv3.1.2=SE.SEENDTC Map:SDTM IGv3.1.2=PP.PPDTC Map:SDTM IGv3.1.2=VS.VSDTC Map:SDTM IGv3.1.2=EG.EGRFTDTC Map:SDTM IGv3.1.2=SV.SVSTDTC Map:SDTM IGv3.1.2=SU.SUSTRF Map:SDTM IGv3.1.2=PC.PCDTC Map:SDTM IGv3.1.2=CM.CMSTRTPT Map:SDTM IGv3.1.2=MB.MBDTC Map:SDTM IGv3.1.2=MB.MBRFTDTC Map:SDTM IGv3.1.2=DM.DMDTC Map:SDTM IGv3.1.2=DS.DSSTDTC Map:SDTM IGv3.1.2=PC.PCRFTDTC Map:SDTM IGv3.1.2=LB.LBDTC Map:SDTM IGv3.1.2=CE.CEENRTPT Map:SDTM IGv3.1.2=CM.CMENRF Map:SDTM IGv3.1.2=QS.QSDTC Map:SDTM IGv3.1.2=SV.SVENDTC Map:SDTM IGv3.1.2=CE.CESTTPT Map:SDTM IGv3.1.2=CM.CMENDTC Map:SDTM IGv3.1.2=FA.FADTC Map:SDTM IGv3.1.2=SU.SUENTPT Map:SDTM IGv3.1.2=PE.PEDTC Map:SDTM IGv3.1.2=CM.CMSTRF Map:SDTM IGv3.1.2=SU.SUSTDTC Map:SDTM IGv3.1.2=SE.SESTDTC Map:SDTM IGv3.1.2=CE.CESTRF Map:SDTM IGv3.1.2=PP.PPRFTDTC Map:SDTM IGv3.1.2=CE.CEDTC Map:SDTM IGv3.1.2=LB.LBRFTDTC Map:SDTM IGv3.1.2=QS.QSRFTDTC Map:SDTM IGv3.1.2=SC.SCDTC Map:SDTM IGv3.1.2=VS.VSRFTDTC Map:SDTM IGv3.1.2=EX.EXENDTC Map:SDTM IGv3.1.2=DA.DADTC Map:SDTM IGv3.1.2=EG.EGDTC Map:SDTM IGv3.1.2=EX.EXSTDTC Map:SDTM IGv3.1.2=MS.MSDTC Map:SDTM IGv3.1.2=CE.CEENRF Map:SDTM IGv3.1.2=SU.SUSTRTPT Map:SDTM IGv3.1.2=PC.PCENDTC Map:SDTM IGv3.1.2=CO.CODTC Map:SDTM IGv3.1.2=CM.CMENRTPT Map:SDTM IGv3.1.2=CM.CMENTPT Map:SDTM IGv3.1.2=SU.SUSTTPT Map:SDTM IGv3.1.2=CM.CMSTTPT Map:SDTM IGv3.1.2=SU.SUENRTPT Map:SDTM IGv3.1.2=MH.MHDTC Map:SDTM IGv3.1.2=LB.LBENDTC Map:SDTM IGv3.1.2=CM.CMSTDTC Map:SDTM IGv3.1.2=CE.CEENTPT Map:WHO=Date of Registration in Primary Registry Map:WHO=Date of First Enrollment
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Public CD dateRangeValidationCode |
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![]() Map:HCTv1.0=CDE 2794432:Therapies.If necessary, please validate the final date of immunosuppressant administration response. Map:HCTv1.0=CDE 2978136:Therapies.If necessary, please validate the chemotherapy administered date response. Map:HCTv1.0=CDE 2946356:Occurrences.If necessary, please validate the disease status date response. Map:HCTv1.0=CDE 2775863:Occurrences.If necessary, please validate the date of platelets greater than or equal to 50 x 10E9/L response. Map:HCTv1.0=CDE 2980833:Therapies.If necessary, please validate the orthopedic surgery date response. Map:HCTv1.0=CDE 3133870:Diagnosis.If necessary, please validate the diagnosis date response. Map:HCTv1.0=CDE 3071475:Quality of Life.If necessary, please validate the vineland adaptive behavior date response. Map:HCTv1.0=CDE 3162397:Occurrences.If necessary, please validate the last contact date response Map:HCTv1.0=CDE 2775854:Occurrences.If necessary, please validate the date of platelets greater than or equal to 20 x 10E9/L response. Map:HCTv1.0=CDE 2821467:Disease Response.If necessary, please validate the best response date value. Map:HCTv1.0=CDE 2979213:Therapies.If necessary, please validate the last chemotherapy cycle date response.
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Public IVL<INT> studyDayRange |
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![]() Map:PGx v1.0=PF.PFDY Map:PGx v1.0=BS.BSDY Map:PGx v1.0=BE.BESTDY Map:PGx v1.0=BE.BEENDY Map:PGx v1.0=PG.PGDY Map:SDTM IGv3.1.2=AE.AEENDY Map:SDTM IGv3.1.2=DM.DMDY Map:SDTM IGv3.1.2=EX.EXSTDY Map:SDTM IGv3.1.2=AE.AESTDY Map:SDTM IGv3.1.2=MB.MBDY Map:SDTM IGv3.1.2=MS.MSDY Map:SDTM IGv3.1.2=DS.DSSTDY Map:SDTM IGv3.1.2=EG.EGDY Map:SDTM IGv3.1.2=SC.SCDY Map:SDTM IGv3.1.2=VS.VSDY Map:SDTM IGv3.1.2=CM.CMSTDY Map:SDTM IGv3.1.2=SU.SUSTDY Map:SDTM IGv3.1.2=CE.CEDY Map:SDTM IGv3.1.2=LB.LBDY Map:SDTM IGv3.1.2=PE.PEDY Map:SDTM IGv3.1.2=IE.IEDY Map:SDTM IGv3.1.2=FA.FADY Map:SDTM IGv3.1.2=SV.SVENDY Map:SDTM IGv3.1.2=SU.SUENDY Map:SDTM IGv3.1.2=QS.QSDY Map:SDTM IGv3.1.2=EX.EXENDY Map:SDTM IGv3.1.2=PC.PCDY Map:SDTM IGv3.1.2=SV.SVSTDY Map:SDTM IGv3.1.2=CM.CMENDY Map:SDTM IGv3.1.2=MH.MHDY Map:SDTM IGv3.1.2=DA.DADY
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Public PQ.TIME duration |
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![]() Map:caAERSv2.2=CourseAgent.durationAndSchedule Map:CDASHv1.1=SU.SUCDUR Map:CDASHv1.1=SU.SUCDURU Map:CTOM=Imaging.durationUnitOfMeasureCode Map:CTOM=Procedure.durationUnitOfMeasureCode Map:CTOM=Activity.durationValue Map:CTOM=SubstanceAdministration.durationUnitOfMeasureCode Map:CTOM=SubstanceAdministration.durationValue Map:CTOM=Surgery.durationUnitOfMeasureCode Map:CTOM=Imaging.durationValue Map:CTOM=Radiation.durationValue Map:CTOM=SpecimenAcquisition.durationUnitOfMeasureCode Map:CTOM=Activity.durationUnitOfMeasureCode Map:CTOM=Surgery.durationValue Map:CTOM=SpecimenAcquisition.durationValue Map:CTOM=Procedure.durationValue Map:CTOM=Radiation.durationUnitOfMeasureCode Map:CTRPv3.8=PerformedActivity.actualDuration Map:CTRv1.0=PerformedActivity.duration Map:LSDAM=PerformedActivity.actualDuration Map:SDTM IGv3.1.1=SU.SUDUR Map:SDTM IGv3.1.1=EX.EXDUR Map:SDTM IGv3.1.1=CM.CMDUR Map:SDTM IGv3.1.2=CM.CMDUR Map:SDTM IGv3.1.2=SU.SUDUR Map:SDTM IGv3.1.2=EX.EXDUR
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Public PQ.TIME delayDuration |
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![]() Map:caAERSv2.2=CourseAgent.administrationDelayAmount Map:caAERSv2.2=CourseAgent.administrationDelayUnits Map:caAERSv2.2=AdverseEventResponseDescription.daysNotGiven Map:CTRv1.0=PerformedActivity.delayDuration Map:LSDAM=PerformedActivity.delayDuration
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Public BL negationIndicator |
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![]() Map:AE=PerformedObservationResult.negationIndicator Map:CDASHv1.1=VS.VSSTAT Map:CTRv1.0=PerformedActivity.negationIndicator Map:HCTv1.0=CDE 2749870:Lab Results.For the antiphospholipid syndrome, what was the result of the laboratory procedure? Map:HCTv1.0=CDE 2682913:Lab Results.For the systemic lupus erythematosus, what was the test results at diagnosis for the other antibody? Map:HCTv1.0=CDE 3073220:Lab Results.What is the reason for the B alleles missing value? Map:HCTv1.0=CDE 2686188:Lab Results.For the systemic lupus erythematosus, what was the ds DNA test result? Map:HCTv1.0=CDE 2775132:Therapies.Was a particular post hematopoietic stem cell transplant therapy administered? Map:HCTv1.0=CDE 3073218:Lab Results.What is the reason for the A alleles missing value? Map:HCTv1.0=CDE 2760376:Lab Results.Did laboratory procedure test for CD4 + cells? Map:HCTv1.0=CDE 2760277:Lab Results.Did laboratory procedure test for nucleated red blood cells? Map:HCTv1.0=CDE 2689324:Lab Results.For the systemic lupus erythematosus (SLE), what was the C4 test result? Map:HCTv1.0=CDE 2769662:Procedures.Did this donor have a central line placed? Map:HCTv1.0=CDE 2760378:Specimen Characteristics.Was the cell viability tested? Map:HCTv1.0=CDE 2691376:Lab Results.For the polymyositis-dermatomyositis, were the EMG results typical of the disease? Map:HCTv1.0=CDE 2749876:Lab Results.For the wegener granulomatosis, what was the result of the laboratory procedure? Map:HCTv1.0=CDE 3073239:Lab Results.What is the reason for the DQA1 allelles missing value? Map:HCTv1.0=CDE 3098936:Individuals.What is the reason for the missing number of pregnancies? Map:HCTv1.0=CDE 2691374:Lab Results.For the dermatomyositis, was there a rash present that was typical of the disease? Map:HCTv1.0=CDE 2760308:Lab Results.Did laboratory procedure test for CD3 + cells? Map:HCTv1.0=CDE 3073222:Lab Results.What is the reason for the C alleles missing value? Map:HCTv1.0=CDE 2760292:Lab Results.Did the laboratory procedure test for CD34+ cells? Map:HCTv1.0=CDE 2749880:Lab Results.For the polyarteritis nodosa, classical or microscopic, what was the laboratory procedure type? Map:HCTv1.0=CDE 3073235:Lab Results.What is the reason for the DQB1 allelles missing value? Map:HCTv1.0=CDE 2695060:Lab Results.If FDA licensed nucleic acid amplification test (NAT) for human immunodeficiency virus(HIV)-1 performed; specify results Map:HCTv1.0=CDE 3073233:Lab Results.What is the reason for the DRB5 allelles missing value? Map:HCTv1.0=CDE 2760131:Lab Results.Did laboratory procedure test for mononucleated cells? Map:HCTv1.0=CDE 2760264:Lab Results.Did laboratory procedure test for nucleated cells? Map:HCTv1.0=CDE 2748995:Techniques.Was a particular tumor cell detection method used after purging? Map:HCTv1.0=CDE 2681691:Chronic or Associated Diseases and Exposures.What was the recipient's test results for the presence of CMV-antibodies?(Chronic) Map:HCTv1.0=CDE 2686194:Lab Results.For the systemic lupus erythematosus, what was the C3 test result? Map:HCTv1.0=CDE 2772013:Procedures.Was the donor tested for sickle cell anemia? Map:HCTv1.0=CDE 2682755:Therapies.Was imatinib mesylate given for pre-transplant therapy for the other acute leukemia anytime prior to the start of the preparative regimen? Map:HCTv1.0=CDE 3073226:Lab Results.What is the reason for the DRB3 allelles missing value? Map:HCTv1.0=CDE 3073237:Lab Results.What is the reason for the DPB1 allelles missing value? Map:HCTv1.0=CDE 3073228:Lab Results.What is the reason for the DRB4 alleles missing value? Map:HCTv1.0=CDE 3073224:Lab Results.What is the reason for the DRB1 allelles missing value? Map:HCTv1.0=CDE 2691365:Lab Results.For the polymyositis-dermatomyositis, were the biopsy results typical of the disease? Map:HCTv1.0=CDE 2686182:Lab Results.For the systemic lupus erythematosus, what was the ANA test result? Map:HCTv1.0=CDE 2689329:Lab Results.For systemic lupus, erythematosus, what was the total complement test result? Map:HCTv1.0=CDE 3073243:Lab Results.What is the reason for the DPA1 allelles missing value? Map:LSDAM=PerformedActivity.missedIndicator Map:NCI CRF Standard=CDE 2838523v1.0: Laboratory Specimen Collection Status Indicator Map:NCI CRF Standard=CDE 2179986v1.0: Concomitant Medication Use Ind-3 Map:PGx v1.0=PF.PFSTAT Map:PGx v1.0=BS.BSSTAT Map:PGx v1.0=PG.PGSTAT Map:SDTM IGv3.1.1=SC.SCSTAT Map:SDTM IGv3.1.1=CM.CMSTAT Map:SDTM IGv3.1.1=LB.LBSTAT Map:SDTM IGv3.1.1=PE.PESTAT Map:SDTM IGv3.1.1=EG.EGSTAT Map:SDTM IGv3.1.1=SU.SUSTAT Map:SDTM IGv3.1.1=QS.QSSTAT Map:SDTM IGv3.1.1=VS.VSSTAT Map:SDTM IGv3.1.1=DA.DASTAT Map:SDTM IGv3.1.1=MH.MHSTAT Map:SDTM IGv3.1.2=SC.SCSTAT Map:SDTM IGv3.1.2=MS.MSSTAT Map:SDTM IGv3.1.2=PP.PPSTAT Map:SDTM IGv3.1.2=MB.MBSTAT Map:SDTM IGv3.1.2=SU.SUSTAT Map:SDTM IGv3.1.2=DA.DASTAT Map:SDTM IGv3.1.2=CM.CMSTAT Map:SDTM IGv3.1.2=CE.CESTAT Map:SDTM IGv3.1.2=QS.QSSTAT Map:SDTM IGv3.1.2=PC.PCSTAT Map:SDTM IGv3.1.2=LB.LBSTAT Map:SDTM IGv3.1.2=PE.PESTAT Map:SDTM IGv3.1.2=EG.EGSTAT Map:SDTM IGv3.1.2=MH.MHSTAT Map:SDTM IGv3.1.2=FA.FASTAT Map:SDTM IGv3.1.2=VS.VSSTAT
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Public DSET<SC> negationReason |
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![]() Map:CTRPv3.8=PerformedSubjectMilestone.missedReason Map:CTRv1.0=PerformedActivity.negationReason Map:HCTv1.0=CDE 2963889:Disease, Disorder or Finding.Specify reason status was not assessed: Map:HCTv1.0=CDE 3124485:Disease Response.What is the reason for the missing disease status? Map:HCTv1.0=CDE 2556195:Therapy Results.Specify reason Map:HCTv1.0=CDE 2646256:Treatment/Off-treatment Reasons.Reasons for treatment discontinuation Map:HCTv1.0=CDE 2775548:Therapies.Specify the reason the HSCT was not performed: Map:HCTv1.0=CDE 2764241:Therapies.What is the reason for the systemic/intrathecal number of cycles missing value? Map:HCTv1.0=CDE 2964380:Therapy Doses.What is the reason for the number of chemotherapy cycles missing values? Map:HCTv1.0=CDE 2775605:Therapies.Specify the reason this HSCT was canceled: Map:HCTv1.0=CDE 2949994:Therapies.What is the reason for the systemic therapy cycle administered missing value? Map:LSDAM=PerformedActivity.missedReason Map:PGx v1.0=PF.PFREASND Map:PGx v1.0=BS.BSREASND Map:PGx v1.0=PG.PGREASND Map:PSC=Canceled Map:SDTM IGv3.1.1=DA.DAREASND Map:SDTM IGv3.1.1=VS.VSREASND Map:SDTM IGv3.1.1=CM.CMREASND Map:SDTM IGv3.1.1=EG.EGREASND Map:SDTM IGv3.1.1=PE.PEREASND Map:SDTM IGv3.1.1=SU.SUREASND Map:SDTM IGv3.1.1=QS.QSREASND Map:SDTM IGv3.1.1=LB.LBREASND Map:SDTM IGv3.1.1=MH.MHREASND Map:SDTM IGv3.1.1=SC.SCREASND Map:SDTM IGv3.1.2=CM.CMREASND Map:SDTM IGv3.1.2=MH.MHREASND Map:SDTM IGv3.1.2=DA.DAREASND Map:SDTM IGv3.1.2=SU.SUREASND Map:SDTM IGv3.1.2=CE.CEREASND Map:SDTM IGv3.1.2=SC.SCREASND Map:SDTM IGv3.1.2=PE.PEREASND Map:SDTM IGv3.1.2=MB.MBREASND Map:SDTM IGv3.1.2=PC.PCREASND Map:SDTM IGv3.1.2=VS.VSREASND Map:SDTM IGv3.1.2=QS.QSREASND Map:SDTM IGv3.1.2=EG.EGREASND Map:SDTM IGv3.1.2=MS.MSREASND Map:SDTM IGv3.1.2=FA.FAREASND Map:SDTM IGv3.1.2=PP.PPREASND Map:SDTM IGv3.1.2=LB.LBREASND
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Public BL fastingStatusIndicator |
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![]() Map:CTRv1.0=PerformedActivity.fastingStatusIndicator Map:Lab=SpecimenCollection.fastingStatus Map:LabViewer2.2=SpecimenCollection.fastingStatusIndicator Map:LSDAM=PerformedSpecimenCollection.fastingStatusIndicator Map:SDTM IGv3.1.1=LB.LBFAST Map:SDTM IGv3.1.2=LB.LBFAST Map:SDTM IGv3.1.2=PC.PCFAST
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Public BL medicalHistoryIndicator |
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Public CD statusCode |
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![]() Map:AE=PerformedActivity.ongoingPerformanceIndicator Map:CTOM=Observation.statusCode Map:CTOM=ClinicalResult.statusCode Map:CTOM=Histopathology.statusCode Map:CTRPv1.0=SubstanceAdministration.statusCode Map:CTRPv1.0=Activity.statusCode Map:CTRPv3.8=Activity.statusCode Map:CTRv1.0=PerformedActivity.statusCode Map:HL7SD=EligibilityCriterion.statusCode Map:ICSRr2=RelatedInvestigation.statusCode (in IndividualCaseSafetyReport) Map:ICSRr2=InvestigativeEvent.statusCode (in IndividualCaseSafetyReport) Map:Lab=LabTest.status Map:LabViewer2.2=LaboratoryTest.status Map:LSDAM=PerformedActivity.statusCode
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Public TS.DATETIME statusDate |
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![]() Map:CTRPv1.0=Activity.statusDateRange Map:CTRPv3.8=Activity.statusDateRange Map:CTRv1.0=PerformedActivity.statusDate Map:LabViewer2.2=Study.startDate Map:LSDAM=PerformedActivity.statusDate
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Element | Source Role | Target Role |
ScheduledActivity Class |
Name: instantiatingPerformedActivity |
Name: instantiatedScheduledActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might instantiate one ScheduledActivity. Each ScheduledActivity might be instantiated by one or more PerformedActivity.<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>
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StudyProtocolVersion Class |
Name: executedPerformedActivity |
Name: executingStudyProtocolVersion |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might execute under one StudyProtocolVersion. Each StudyProtocolVersion might be executed by one or more PerformedActivity.<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>
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PlannedActivity Class |
Name: instantiatingPerformedActivity |
Name: instantiatedPlannedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might instantiate one PlannedActivity. Each PlannedActivity might be instantiated by one or more PerformedActivity.<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>
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Epoch Class |
Name: containedPerformedActivity |
Name: containingEpoch |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might be contained by one Epoch. Each Epoch might contain one or more PerformedActivity.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates that a performed but unplanned activity is categorized as part of a particular Epoch.<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><p>This cannot be derived by looking at the corresponding planned activity because this association is only used for unplanned activities.<br /></p>
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DefinedActivity Class |
Name: instantiatingPerformedActivity |
Name: instantiatedDefinedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might instantiate one DefinedActivity. Each DefinedActivity might be instantiated by one or more PerformedActivity.<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>
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Place Class |
Name: locatedPerformedActivity |
Name: locatingPlace |
![]() DESCRIPTION:<br /></p><p>Each PerformedActivity might take place in one Place. Each Place might be the location for one or more PerformedActivity.<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>
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Element | Source Role | Target Role |
PerformedCompositionRelationship Class |
Name: compositePerformedCompositionRelationship |
Name: componentPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedCompositionRelationship always is the parent of one PerformedActivity. Each PerformedActivity might be the component of one PerformedCompositionRelationship.<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>
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PerformedSubstanceAdministration Class |
Name: endEvaluatedPerformedSubstanceAdministration |
Name: endRelatedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedSubstanceAdministration might have end evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timepoint for evaluating the end of one or more PerformedSubstanceAdministration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, CMENTPT indicates a study event that may be a reference event for the end of a concomitant medication (PerformedSubstanceAdministration) or SUENTPT might be the reference event for the end of a substance use event (also a PerformedSubstanceAdministration).<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given substance administration can have its start evaluated in relation to a performed activity. Likewise it can also have its end evaluated in relation to a performed activity. The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeSubstanceAdministration and PerformedActivity for evaluating start and end of the administration.<br /></p>
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PerformedCompositionRelationship Class |
Name: componentPerformedCompositionRelationship |
Name: compositePerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedCompositionRelationship always is the component of one PerformedActivity. Each PerformedActivity might be the parent of one or more PerformedCompositionRelationship.<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>
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«Comment_Requested» PerformedObservationResult Class |
Name: endEvaluatedPerformedObservationResult |
Name: endRelatedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedObservationResult might have end evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timpoint for evaluating end of one or more PerformedObservationResult.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, AEENTPT indicates a study event that may be a reference event for the end of an adverse event, CEENTPT indicates a study event that may be a reference event for the end of a clinical event (PerformedObservationResult) and MHENTPT indicates a study event that may be a reference event for the end of a medical condition (PerformedMedicalConditionResult).<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given observation result can have its start evaluated in relation to a performed activities. Likewise it can also have its end evaluated in relation to a performed activity. The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeObservationResult and PerformedActivity for evaluating start and end of the result.<br /></p>
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PerformedObservation Class |
Name: commentingPerformedObservation |
Name: commentedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedObservation might be commenting on one PerformedActivity. Each PerformedActivity might be commented on by one or more PerformedObservation.<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>
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PerformedSubstanceAdministration Class |
Name: startEvaluatedPerformedSubstanceAdministration |
Name: startRelatedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedSubstanceAdministration might have start evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timepoint for evaluating the start of one or more PerformedSubstanceAdministration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, CMSTTPT indicates a study event that may be a reference event for the start of a concomitant medication (PerformedSubstanceAdministration) or SUENTPT might be the reference event for the start of a substance use event (also a PerformedSubstanceAdministration.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given substance administration can have its start evaluated in relation to a performed activity. Likewise it can also have its end evaluated in relation to a performed activity. The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeSubstanceAdministration and PerformedActivity for evaluating start and end of the administration.<br /></p>
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«Comment_Requested» PerformedObservationResult Class |
Name: startEvaluatedPerformedObservationResult |
Name: startRelatedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each PerformedObservationResult might have start evaluated in relation to one PerformedActivity. Each PerformedActivity might be the timepoint for evaluating start of one or more PerformedObservationResult.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>In CDISC SDTM, CESTTPT indicates a study event that may be a reference event for the start of a clinical event (PerformedObservationResult).<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>As per CDISC, any given observation result can have its start evaluated in relation to a performed activity. Likewise it can also have its end evaluated in relation to a performed activity. The two performed activities need not necessarily be the same in both cases, thus there are two distinct associations between PerformeObservationResult and PerformedActivity for evaluating start and end of the result.<br /></p>
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ObservationResultActionTakenRelationship Class |
Name: triggeringObservationResultActionTakenRelationship |
Name: triggeredPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each ObservationResultActionTakenRelationship always triggers one PerformedActivity. Each PerformedActivity might be triggered by one or more ObservationResultActionTakenRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the PerformedActivity undertaken as a result of an ObservationResult<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>
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AssessedActivityRelationship Class |
Name: assessingAssessedActivityRelationship |
Name: assessedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each AssessedActivityRelationship always has as subject one PerformedActivity. Each PerformedActivity might be the subject of one or more AssessedActivityRelationship.<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>
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EvaluatedActivityRelationship Class |
Name: evaluatingEvaluatedActivityRelationship |
Name: evaluatedPerformedActivity |
![]() DESCRIPTION:<br /></p><p>Each EvaluatedActivityRelationship always evaluates one PerformedActivity. Each PerformedActivity might be evaluated by one or more EvaluatedActivityRelationship.<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>
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Tag | Value |
Map:AE | PerformedActivity |
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Map:C3PRv2.9 | ScheduledArm |
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Map:caAERSv2.2 | CourseDate |
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Map:caAERSv2.2 | AdverseEventReportingPeriod |
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Map:caAERSv2.2 | TreatmentInformation |
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Map:CTRPv3.8 | PerformedActivity |
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Map:CTRv1.0 | PerformedActivity |
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Map:ICSRr2 | productActChoice (in R_Product) |
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Map:ICSRr2 | ProductEvent (in R_Product) |
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Map:LabViewer2.2 | Activity |
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Map:LSDAM | PerformedMedicalHistoryResult |
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Map:LSDAM | PerformedActivity |
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Map:LSDAMv2.2.3Plus | PerformedActivity |
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Map:LSDAMv2.2.3Plus | PerformedMedicalHistoryResult |
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Map:PGx v1.0 | BE |
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Map:PSCv2.6 | Occurred |
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Map:SDTM IGv3.1.2 | SV.DOMAIN |
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Map:SDTM IGv3.1.2 | SE.DOMAIN |
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Map:SDTMIGv3.1.3 | AE.AECONTRT |
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Map:SDTMIGv3.1.3 | MH |
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Map:SDTMIGv3.1.3 | SE |
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Map:SDTMIGv3.1.3 | SV |
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Constraint | Type | Status |
be participated in by actualIndicator Qualifier | Invariant | Approved |
![]() Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = “true” is valid.
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instantiates Exclusive Or | Invariant | Approved |
![]() A PerformedActivity must instantiate one and only one of the following: DefinedActivity, PlannedActivity, ScheduledActivity.
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execute under Qualifier | Invariant | Approved |
![]() A PerformedActivity is only directly related to a StudyProtocolVersion if it is not instantiating a PlannedActivity or ScheduledActivity (i.e., it is instantiating a DefinedActivity).
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be performed by actualIndicator Qualifier | Invariant | Approved |
![]() Only Person, Organization or Device (via Performer) with actualIndicator = "true" is valid.
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dateRange Qualifier | Invariant | Approved |
![]() When PerformedObservation.focalDateRange is present, PerformedObservation.dateRange must be a single date.
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containingEpoch Qualifier | Invariant | Approved |
![]() The containing Epoch association must not be present for PerformedActivities that instantiate PlannedActivities (or ScheduledActivites that instantiate PlannedActivities) with an association to Epoch.
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Object | Type | Connection | Direction | Notes |
PerformedProductTransport | Class | Generalization | From | DESCRIPTION: Each PerformedProductTransport always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedProductTransport. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |
PerformedProcedure | Class | Generalization | From | DESCRIPTION: Each PerformedProcedure always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedProcedure. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |
PerformedObservation | Class | Generalization | From | DESCRIPTION: Each PerformedObservation always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedObservation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |
PerformedAdministrativeActivity | Class | Generalization | From | DESCRIPTION: Each PerformedAdministrativeActivity always specializes one PerformedActivity. Each PerformedActivity might be specialized by one PerformedAdministrativeActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |
Activity | Class | Generalization | To | DESCRIPTION: Each PerformedActivity always specializes one Activity. Each Activity might be specialized by one PerformedActivity. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |