Regulatory oversight/monitoring
ADVERSE EVENTS, RECRUITMENT
All study modifications will be communicated with and regulated by the IRB. Even though the study is expected to pose minimal risk, the Data Safety Monitoring Board (DSMB), in collaboration with the study investigators will closely monitor recruitment, process evaluation, and retention activities. The DSMB will meet yearly with the study investigators and staff, or more often as needed, for oversight of the study. Any adverse events will be reported to the NHLBI and the IRB at the University of Minnesota. This trial is also registered in the OnCore clinical trial management system and is audited by the Medical School at the University of Minnesota.