ACRIN Adverse Event Reporting Manual Revisions Presented by: Cornelia Tsikos, BS, MS

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ACRIN Adverse Event Reporting Manual Revisions Presented by: Cornelia Tsikos, BS, MS. Revisions to the Adverse Event Reporting Manual Introduction of the Regulatory Resources Webpage. Overview. Alphabetized list and addition of . . . Baseline Adverse Event C3D CAEPR
ACRIN Adverse Event Reporting Manual RevisionsPresented by: Cornelia Tsikos, BS, MSRevisions to the Adverse Event Reporting ManualIntroduction of the Regulatory Resources WebpageOverviewAlphabetized list and addition of . . .Baseline Adverse EventC3DCAEPR Comprehensive Adverse Events & Potential Risk ListExpedited ReportingRoutine ReportingSection 1: AE Terminology & DefinitionsSix Categories of ACRIN StudiesDiagnosticScreeningInterventional Investigational AgentsInvestigational DeviceCollaborativeSection 2: Adverse Event Reporting Reflects current practices Compliance with federal regulatory requirements  Protocol-specific AE reporting requirements will supersede the guidelines of the manual.Section 3: Expedited AE ReportingElectronic Adverse Event Reporting System(AdEERS) 24 hour electronic reporting instructionsSubmission through web applicationSystem unavailableTraining Assistance Section 3: Expedited AE Reporting Section 4: Reporting Requirements for Diagnostic StudiesSection 5: Reporting Requirements for Screening StudiesSection 6: Reporting Requirements for Interventional StudiesNew Sections in AE Reporting ManualSection 7: Reporting Requirements for Studies Using Investigational AgentsSection 8: Reporting Requirements for Studies Using Investigational DevicesSection 9: Reporting Requirements for Collaborative Clinical StudiesNew Sections in AE Reporting ManualACRIN’s Protocol Development & Regulatory ResourcesUpdated AE Reporting ManualAdEERS ResourcesNational Cancer Institute (NCI) ResourcesNCI Cancer Imaging Program (CIP)NCI Cancer Therapy Evaluation Program (CTEP)AdEERS ReportingU.S. Food and Drug Administration (FDA)Section 10: Additional ResourcesNCI-CIP AE Reporting Guidance Documents:Appendix 1: Phase 1 through Early Phase 2 CIP-IND Imaging Agent TrialsAppendix 2: Late Phase 2 through Phase 3 CIP-IND Imaging Agent TrialsAppendix 3: Commercial (Non-IND) Imaging Agent TrialsSection 11: AppendixAlways Available for QuestionsACRIN Adverse Event Coordinator(215)574-3150 Ask for an ACRIN AE CoordinatorAssistance Completing AdEERS ReportAdEERS MD Line (medical questions)(301)897-7497 adeersmd@tech-res.comAdEERS Technical Help(888)283-7457ncictephelp@ctep.nci.nih.govReminderCornelia (Lia) Tsikos, BS, MSACRIN AE Coordinator & ACRIN Research Associate ctsikos@acr-arrs.orgPhone: 215-574-3236Fax : 215-940-8819Contact Information
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