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- 1. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK REQUIREMENTS REPORT* *ÌýNOTE:ÌýScoresÌýonÌýthisÌýRequirementsÌýReportÌýreflectÌýquizÌýcompletionsÌýatÌýtheÌýtimeÌýallÌýrequirementsÌýforÌýtheÌýcourseÌýwereÌýmet.ÌýSeeÌýlistÌýbelowÌýforÌýdetails. SeeÌýseparateÌýTranscriptÌýReportÌýforÌýmoreÌýrecentÌýquizÌýscores,ÌýincludingÌýthoseÌýonÌýoptionalÌý(supplemental)ÌýcourseÌýelements. •Ìý Name: StacyÌýFlanneryÌý(ID:Ìý2135756) •Ìý Email: sflannery@carolinaear.us •Ìý InstitutionÌýAffiliation: UniversityÌýofÌýNorthÌýCarolinaÌýatÌýChapelÌýHillÌý(ID:Ìý420) •Ìý InstitutionÌýUnit: Institute •Ìý Phone: 919-850-4327 •Ìý CurriculumÌýGroup: CITIÌýGoodÌýClinicalÌýPractice •Ìý CourseÌýLearnerÌýGroup: GCPÌýforÌýClinicalÌýTrialsÌýwithÌýInvestigationalÌýDrugs,ÌýBiologicsÌýandÌýDevicesÌýCourse •Ìý Stage: StageÌý1Ìý-ÌýBasicÌýCourse •Ìý ReportÌýID: 6349474 •Ìý CompletionÌýDate: 06/25/2014 •Ìý ExpirationÌýDate: 06/25/2017 •Ìý MinimumÌýPassing: 75 •Ìý ReportedÌýScore*: 100 REQUIREDÌýANDÌýELECTIVEÌýMODULESÌýONLY DATEÌýCOMPLETED TheÌýCITIÌýGoodÌýClinicalÌýPracticeÌýCourseÌýforÌýClinicalÌýTrialsÌýInvolvingÌýDrugsÌýandÌýDevicesÌý(ID:Ìý1350)Ìý 07/13/11 OverviewÌýofÌýNewÌýDrugÌýDevelopmentÌý(ID:Ìý1351)Ìý 07/13/11 OverviewÌýofÌýICHÌýGCPÌý(ID:Ìý1352)Ìý 07/13/11 ICHÌý-ÌýComparisonÌýBetweenÌýICHÌýGCPÌýE6ÌýandÌýU.S.ÌýFDAÌýRegulationsÌý(ID:Ìý1354)Ìý 07/13/11 ConductingÌýInvestigator-InitiatedÌýStudiesÌýAccordingÌýtoÌýFDAÌýRegulationsÌýandÌýGCPÌý(ID:Ìý1355)Ìý 06/25/14 InvestigatorÌýObligationsÌýinÌýFDA-RegulatedÌýResearchÌý(ID:Ìý1356)Ìý 06/25/14 ManagingÌýInvestigationalÌýAgentsÌýAccordingÌýtoÌýGCPÌýRequirementsÌý(ID:Ìý1357)Ìý 06/25/14 OverviewÌýofÌýU.S.ÌýFDAÌýRegulationsÌýforÌýMedicalÌýDevicesÌý(ID:Ìý1358)Ìý 06/25/14 InformedÌýConsentÌýinÌýClinicalÌýTrialsÌýofÌýDrugs,ÌýBiologics,ÌýandÌýDevicesÌý(ID:Ìý1359)Ìý 06/25/14 DetectingÌýandÌýEvaluatingÌýAdverseÌýEventsÌý(ID:Ìý1360)Ìý 06/25/14 ReportingÌýSeriousÌýAdverseÌýEventsÌý(ID:Ìý1361)Ìý 06/25/14 AuditsÌýandÌýInspectionsÌýofÌýClinicalÌýTrialsÌý(ID:Ìý1363)Ìý 06/25/14 MonitoringÌýofÌýClinicalÌýTrialsÌýbyÌýIndustryÌýSponsorsÌý(ID:Ìý1362)Ìý 06/25/14 CompletingÌýtheÌýCITIÌýGCPÌýCourseÌý(ID:Ìý1364)Ìý 06/25/14 ForÌýthisÌýReportÌýtoÌýbeÌývalid,ÌýtheÌýlearnerÌýidentifiedÌýaboveÌýmustÌýhaveÌýhadÌýaÌývalidÌýaffiliationÌýwithÌýtheÌýCITIÌýProgramÌýsubscribingÌýinstitution identifiedÌýaboveÌýorÌýhaveÌýbeenÌýaÌýpaidÌýIndependentÌýLearner.Ìý CITIÌýProgram Email:Ìýcitisupport@miami.edu Phone:Ìý305-243-7970 Web:Ìýhttps://www.citiprogram.org
- 2. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) COURSEWORK TRANSCRIPT REPORT** **ÌýNOTE:ÌýScoresÌýonÌýthisÌýTranscriptÌýReportÌýreflectÌýtheÌýmostÌýcurrentÌýquizÌýcompletions,ÌýincludingÌýquizzesÌýonÌýoptionalÌý(supplemental)ÌýelementsÌýofÌýthe course.ÌýSeeÌýlistÌýbelowÌýforÌýdetails.ÌýSeeÌýseparateÌýRequirementsÌýReportÌýforÌýtheÌýreportedÌýscoresÌýatÌýtheÌýtimeÌýallÌýrequirementsÌýforÌýtheÌýcourseÌýwereÌýmet.Ìý •Ìý Name: StacyÌýFlanneryÌý(ID:Ìý2135756) •Ìý Email: sflannery@carolinaear.us •Ìý InstitutionÌýAffiliation: UniversityÌýofÌýNorthÌýCarolinaÌýatÌýChapelÌýHillÌý(ID:Ìý420) •Ìý InstitutionÌýUnit: Institute •Ìý Phone: 919-850-4327 •Ìý CurriculumÌýGroup: CITIÌýGoodÌýClinicalÌýPractice •Ìý CourseÌýLearnerÌýGroup: GCPÌýforÌýClinicalÌýTrialsÌýwithÌýInvestigationalÌýDrugs,ÌýBiologicsÌýandÌýDevicesÌýCourse •Ìý Stage: StageÌý1Ìý-ÌýBasicÌýCourse •Ìý ReportÌýID: 6349474 •Ìý ReportÌýDate: 06/02/2016 •Ìý CurrentÌýScore**: 100 REQUIRED,ÌýELECTIVE,ÌýANDÌýSUPPLEMENTALÌýMODULESÌý MOSTÌýRECENT TheÌýCITIÌýGoodÌýClinicalÌýPracticeÌýCourseÌýforÌýClinicalÌýTrialsÌýInvolvingÌýDrugsÌýandÌýDevicesÌý(ID:Ìý1350) 06/25/14Ìý OverviewÌýofÌýNewÌýDrugÌýDevelopmentÌý(ID:Ìý1351) 06/25/14Ìý OverviewÌýofÌýICHÌýGCPÌý(ID:Ìý1352) 06/25/14Ìý ICHÌý-ÌýComparisonÌýBetweenÌýICHÌýGCPÌýE6ÌýandÌýU.S.ÌýFDAÌýRegulationsÌý(ID:Ìý1354) 06/25/14Ìý ConductingÌýInvestigator-InitiatedÌýStudiesÌýAccordingÌýtoÌýFDAÌýRegulationsÌýandÌýGCPÌý(ID:Ìý1355) 06/25/14Ìý InvestigatorÌýObligationsÌýinÌýFDA-RegulatedÌýResearchÌý(ID:Ìý1356) 06/25/14Ìý ManagingÌýInvestigationalÌýAgentsÌýAccordingÌýtoÌýGCPÌýRequirementsÌý(ID:Ìý1357) 06/25/14Ìý OverviewÌýofÌýU.S.ÌýFDAÌýRegulationsÌýforÌýMedicalÌýDevicesÌý(ID:Ìý1358) 06/25/14Ìý InformedÌýConsentÌýinÌýClinicalÌýTrialsÌýofÌýDrugs,ÌýBiologics,ÌýandÌýDevicesÌý(ID:Ìý1359) 06/25/14Ìý DetectingÌýandÌýEvaluatingÌýAdverseÌýEventsÌý(ID:Ìý1360) 06/25/14Ìý ReportingÌýSeriousÌýAdverseÌýEventsÌý(ID:Ìý1361) 06/25/14Ìý AuditsÌýandÌýInspectionsÌýofÌýClinicalÌýTrialsÌý(ID:Ìý1363) 06/25/14Ìý MonitoringÌýofÌýClinicalÌýTrialsÌýbyÌýIndustryÌýSponsorsÌý(ID:Ìý1362) 06/25/14Ìý CompletingÌýtheÌýCITIÌýGCPÌýCourseÌý(ID:Ìý1364) 06/25/14Ìý ForÌýthisÌýReportÌýtoÌýbeÌývalid,ÌýtheÌýlearnerÌýidentifiedÌýaboveÌýmustÌýhaveÌýhadÌýaÌývalidÌýaffiliationÌýwithÌýtheÌýCITIÌýProgramÌýsubscribingÌýinstitution identifiedÌýaboveÌýorÌýhaveÌýbeenÌýaÌýpaidÌýIndependentÌýLearner.Ìý CITIÌýProgram Email:Ìýcitisupport@miami.edu Phone:Ìý305-243-7970 Web:Ìýhttps://www.citiprogram.org