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

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

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

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

  2. Revisions to the Adverse Event Reporting Manual Introduction of the Regulatory Resources Webpage Overview

  3. 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

  4. Six Categories of ACRIN Studies Diagnostic Screening Interventional Investigational Agents Investigational Device Collaborative Section 2: Adverse Event Reporting

  5. Reflects current practices Compliance with federal regulatory requirements  Protocol-specific AE reporting requirements will supersede the guidelines of the manual. Section 3: Expedited AE Reporting

  6. Electronic Adverse Event Reporting System (AdEERS) 24 hour electronic reporting instructions Submission through web application System unavailable Training Assistance Section 3: Expedited AE Reporting

  7. Section 4: Reporting Requirements for Diagnostic Studies Section 5: Reporting Requirements for Screening Studies Section 6: Reporting Requirements for Interventional Studies New Sections in AE Reporting Manual

  8. 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 New Sections in AE Reporting Manual

  9. 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) Section 10: Additional Resources

  10. 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 Section 11: Appendix

  11. Always Available for Questions ACRIN Adverse Event Coordinator (215)574-3150 Ask for an ACRIN AE Coordinator Assistance Completing AdEERS Report AdEERS MD Line (medical questions) (301)897-7497 adeersmd@tech-res.com AdEERS Technical Help (888)283-7457 ncictephelp@ctep.nci.nih.gov Reminder

  12. Cornelia (Lia) Tsikos, BS, MS ACRIN AE Coordinator & ACRIN Research Associate ctsikos@acr-arrs.org Phone: 215-574-3236 Fax : 215-940-8819 Contact Information

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