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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.
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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 (?)
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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.
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