Data and safety monitoring
muscle soreness, NIA
ADVERSE EVENTS, EVENT
This study will be monitored by an external Safety Officer (SO), which will act in an advisory capacity to the National Institute on Aging (NIA) and the primary investigators (PIs) to monitor participant safety, data quality, and the progress of the study. The SO will meet with the contact PI (STF) on a quarterly basis and will complete a safety monitoring report to the NIA twice yearly.We expect adverse events (AEs) associated with this intervention to be minimal and consistent with risks associated with normal daily activities and an active lifestyle (e.g., muscle soreness from physical activity). AEs will be tracked in the study database. We will employ multiple approaches to ensure complete and accurate collection of information about AEs. All participants will be prompted to report AEs and serious adverse events (SAEs) at their outcome assessment visits (approximately 6, 12, and 18 months). Participants may also spontaneously report AEs/SAEs during their intervention meetings. All AEs/SAEs will be reviewed within 24 hours by the study clinician/medical monitor to determine seriousness, whether the event was unexpected and related to the intervention. AEs that are serious, unexpected, and related to the intervention will be reported immediately to the project PIs and to the Institutional Review Board (IRB), SO, and NIA.