Data and safety monitoring
EVENTS, EVENT, ADVERSE EVENT, RECRUITMENT
The following information will be included in the yearly reports to the Chair of our data and safety monitoring committee: study event updates (e.g., changes in personnel, recruitment strategies, testing procedures), study enrollment (actual vs. expected), baseline data on participants, recruitment and retention flow diagram, participant retention data (loss to follow up, withdrawals), and adverse health event monitoring. An adverse health event is any untoward medical occurrence experienced by a participant during participation in the clinical study. These events can be non-serious or serious. A serious adverse event is any adverse event that results in one or more of the following outcomes:A life-threatening eventInpatient hospitalization or prolongation of existing hospitalizationA persistent or significant disability/incapacityAn important medical event based upon appropriate medical judgmentDeath