RESCUE 4701 Adverse Event Reporting October 16, 2010

RESCUE 4701Adverse Event ReportingOctober 16, 2010 Maria Oh, Director Protocol Development & Regulatory Compliance

Adverse Events • AE reporting requirements • Major Adverse Cardiac Event (MACE) • Primary endpoint • Study-related procedures to CCTA • Safety monitoring

Reporting • Major Adverse Cardiac Events • Myocardial infarction (MI) • Cardiac-related deaths • Study-specific procedures • Iodinated contrast agent • IV need placement • CCTA

MACE • Adjudication Committee • Primary endpoint • Medical records • Revascularizations

Protocol AEs • Study procedure-related AEs • Possibly, probably, and definitely related • Grades 3, 4, and 5 • Serious and non-serious • Expected and unexpected • Assignment of grades and attribution by the Site Principal Investigator. • Reporting requirements • Routine reporting • Expedited reporting

Requirements • Code of Federal Regulations – Titles 21 & 45 • ICH E6 – Good Clinical Practice • RESCUE Protocol Sections 6.3.3 & 10.0 • Adverse Event Reporting Manual

AE Monitoring • RESCUE Adjudication Committee • RESCUE Data and Safety Monitoring Committee • Medical Monitor • ACRIN QA Committee • ACR Institutional Review Board • PDRC - Monitors and Auditors

Resources • ACRIN http://www.acrin.org • FDA Information Sheet http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm • ICH E6 http://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/good_clinical_practices.pdf • FDA Code of Federal Regulations http://www.fda.gov/

Thank You Questions?

RESCUE 4701 Adverse Event Reporting October 16, 2010