1. RESCUE 4701 Adverse Event Reporting October 16, 2010 Maria Oh, Director Protocol Development & Regulatory Compliance

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

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

4. MACE Adjudication Committee Primary endpoint Medical records Revascularizations

5. 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

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

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

8. ACRIN http://www.acrin.org FDA Information Sheet http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsa ndNotices/ucm113709.htm http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinical ICH E6 http://ctep.cancer.gov/branches/ctmb/clinicalTrials/do cs/good_clinical_practices.pdfttp://ctep.cancer.gov/branches/ctmb/clinicalTrials/do cs/good_clinical FDA Code of Federal Regulations http://www.fda.gov/ Resources

9. Thank You Questions?