Safety and adverse event management
diarrhoea, vomiting
ADVERSE EVENT, ADVERSE EVENT
Where an adverse event was considered serious (SAE) or unexpected (i.e., not listed in the protocol as an expected occurrence), the Principal Investigators at both sites were mandated to report it to the Chief Investigator, who had responsibility for informing the Sponsor’s research and development department within 24 hours and the main Research Ethics Committee (REC) within 15 days using the REC’s standard template. All other Adverse events (AEs) were reported to Barts Health NHS Trust. Measures of adverse safety impacts included daily rates of vomiting (>10mls); number of episodes of diarrhoea (Bristol Stool Score ≥5