Data management {19}
SFTP
ADVERSE EVENTS
A formal Data Sharing Agreement was agreed between NHSBT and the University of Cambridge, prior to the start of the STRIDES trial. On a daily basis, NHSBT staff have forwarded to an authorised data manager at the academic coordinating centre pseudonymised extracts from NHSBT’s database including information on donors: donation history, attendance and deferrals; adverse events; microbiology results; merged donor records; and the right to be forgotten. Reports have been in .csv format (accessible only to authorised staff) and uploaded to the SFTP site. These daily extracts have been imported into a password-protected restricted access SAS database where the provided anonymous ID (GUID) has been replaced by a separate anonymous study ID; the link table between GUID and study ID has been available only to an authorised data manager at the academic coordinating centre.Queries are automatically generated by the STRIDES Data Management systems (written in SAS) by cross-checking/looking for inconsistencies in the data. Resulting queries are resolved by the study helpdesk, by either looking things up in NHSBT systems or contacting the participant directly. Once resolved, any updates/corrections are entered into an Access database by the helpdesk. The Access database is then automatically read into the Data Management systems and updates corrections are automatically implemented. The Data Management Team is responsible to review the data and ensure it is clean prior to analyses.