All SAEs will be reported internally to the University Hospitals of Leicester (UHL) NHS Trust Research & Development (R&D) and the sponsor (University of Leicester) using appropriate reporting forms, within 24 hours of the study team becoming aware of the event. The principal investigator is responsible for the review and submission of any SAE, or in their absence, another member of the team (in order to avoid a delay). The investigator site file will contain documentation for SAE reports and evidence of timely submissions.