ACRIN Fall Meeting 2009 ACRIN Adverse Event Reporting Manual Revisions Presented by: Cornelia Tsikos, BS, MS

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Overview Revisions to the Adverse Event Reporting Manual Introduction of the Regulatory Resources Webpage

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Alphabetized list and addition of... Baseline Adverse Event C3D CAEPR Comprehensive Adverse Events & Potential Risk List Expedited Reporting Routine Reporting Section 1: AE Terminology & Definitions

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Section 2: Adverse Event Reporting Six Categories of ACRIN Studies 1.Diagnostic 2.Screening 3.Interventional 4.Investigational Agents 5.Investigational Device 6.Collaborative

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Section 3: Expedited AE Reporting Reflects current practices Compliance with federal regulatory requirements Protocol-specific AE reporting requirements will supersede the guidelines of the manual.

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Electronic Adverse Event Reporting System (AdEERS) 24 hour electronic reporting instructions Submission through web application System unavailable Training Assistance Section 3: Expedited AE Reporting

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 New Sections in AE Reporting Manual Section 4: Reporting Requirements for Diagnostic Studies Section 5: Reporting Requirements for Screening Studies Section 6: Reporting Requirements for Interventional Studies

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 New Sections in AE Reporting Manual Section 7: Reporting Requirements for Studies Using Investigational Agents Section 8: Reporting Requirements for Studies Using Investigational Devices Section 9: Reporting Requirements for Collaborative Clinical Studies

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Section 10: Additional Resources ACRIN’s Protocol Development & Regulatory Resources –Updated AE Reporting Manual AdEERS Resources National Cancer Institute (NCI) Resources –NCI Cancer Imaging Program (CIP) –NCI Cancer Therapy Evaluation Program (CTEP) AdEERS Reporting U.S. Food and Drug Administration (FDA)

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Section 11: Appendix NCI-CIP AE Reporting Guidance Documents: Appendix 1: Phase 1 through Early Phase 2 CIP-IND Imaging Agent Trials Appendix 2: Late Phase 2 through Phase 3 CIP-IND Imaging Agent Trials Appendix 3: Commercial (Non-IND) Imaging Agent Trials

ACRIN Fall Meeting 2009

January 31, 2008 ACRIN: Principles & Practice of Clinical ResearchACRIN Fall Meeting 2009 Reminder Always Available for Questions ACRIN Adverse Event Coordinator –(215) –Ask for an ACRIN AE Coordinator Assistance Completing AdEERS Report AdEERS MD Line (medical questions) –(301) AdEERS Technical Help –(888)

ACRIN Fall Meeting 2009 Contact Information Cornelia (Lia) Tsikos, BS, MS ACRIN AE Coordinator & ACRIN Research Associate Phone: Fax :