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

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Presentation transcript:

RESCUE 4701 Adverse Event Reporting October 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

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

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

ACRIN FDA Information Sheet RunningClinicalTrials/GuidancesInformationSheetsa ndNotices/ucm htm RunningClinical ICH E6 cs/good_clinical_practices.pdfttp://ctep.cancer.gov/branches/ctmb/clinicalTrials/do cs/good_clinical FDA Code of Federal Regulations Resources

Thank You Questions?