Plans for assessment and collection of outcomes {18a}
SFTP
ADVERSE EVENTS, EVENTS
Via a Secure File Transfer Protocol (SFTP), NHSBT staff have shared pseudonymised information about donors’ demographic characteristics and adverse donation events (including VVRs) with authorised staff at the academic coordinating centre. All data shared have been strictly pseudonymised (i.e. stripped of personal identifiers). To enhance collection of information on relevant trial outcomes, NHSBT staff have sent donors SMS text messages immediately after donation visits, asking them to report any adverse events by phoning the NHSBT Customer Care line. All adverse events reported by the donors will be assessed by a nurse at the time of reporting and if considered serious, the coordinating centre is informed, along with the study Sponsor and ethics committee.