Serious adverse reactions (SARs)/serious adverse events (SAEs)
EVENT, EVENTS
The site principal investigator (PI) or medical delegate must report AEs and ARs that fulfil the serious criteria to the LSHTM CTU Global Health Trials Group within 24 h of becoming aware of the event using the AE reporting form. The site PI or medical delegate will complete the form with as much detail as is available. A follow-up report will be submitted promptly should any additional information arise (but no later than five working days of becoming aware of the event). The site PI or medical delegate will record an assessment of seriousness, causality, and expectedness. Events relating to a pre-existing condition or any planned hospitalisations for elective treatment of a pre-existing condition will not be reported as SAEs.