Data and Safety Monitoring Board

1. Data and Safety Monitoring Board Responsibilities • Review routine reports created by ACRIN Biostatistics Center: Mid-Year and Year-End Updates. • Routine reports will include: • Accrual and participant characteristics; • Timeliness and completeness, eligibility and protocol compliance, and outcome data; • All reported AEs. • Trial may be stopped for safety DSMB will review rate of cardiac deaths occurring among randomized participants who had a negative evaluation for CAD. The DSMB will also review all primary endpoint events—MACE and revascularization.

2. Data and Safety Monitoring Board Proposed list of DSMB Members (AHRQ to check for COI) • Ruth C. Carlos, MD – radiologist, U of Michigan, Member of ACRIN DSMB • Jon F. Merz, MBA, JD, PhD – Director of Center for Bioethics, UPenn • Stanley Baum, MD – radiologist, UPenn • Todd Alonso, MD – statistician, has participated on ACRIN PA DSMB • Ray Gibbons, MD – cardiologist, Mayo Clinic, former president of American Heart Association • Others, patient Advocate (?)

3. Institutional Review Board (IRB) • ACRIN – Finalized protocol will go to ACRIN IRB for approval on October 20, 2010. • Local – Each site must obtain approval locally. PROTOCOL 14.5 Sites must obtain initial, full-board, local IRB approval to participate in ACRIN trials. Prior to participant registration, a copy of the IRB approval letter for the protocol and the ICF must be sent to ACRIN, along with a copy of the IRB-approved, site-specific ICF. Any study-related materials for patients must be IRB reviewed and approved prior to distribution; approval notifications and other IRB correspondence should be delivered to ACRIN PDRC. Investigator will provide a copy(ies) of IRB approval letter(s) for any amendment(s), and copy(ies) of annual renewal(s). International sites may use an Ethics Committee instead of an IRB.