Adverse event reporting and harms {22}
congenital anomaly/birth defectAny
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
All severe adverse events (SAEs) will be immediately reviewed by the steering committee and reported to the UCSF IRB, Tanzanian IRB, and the NIAMS-appointed safety officer. Serious adverse events consist of any of the following:Results in deathIs life-threateningRequires inpatient hospitalization or prolongation of existing hospitalizationResults in a persistent or significant disability/incapacityResults in congenital anomaly/birth defectAny other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definitionAdverse events (AEs) will be screened for at every follow-up visit using the question “Have you developed any new health problems since the previous visit?”. AEs will be recorded on a separate form documenting the date of onset and recovery, seriousness/severity, and outcome. Each AE will be classified as either expected/unexpected and definitely related/possibly related/definitely not related by the DSMC. AEs will be reviewed every 6 months during standard DSMC meetings.