In the case of any unexpected serious events that might impact participant safety or data integrity (for example any breaches of protocol), please contact the Research Governance Team via researchgovernance@contacts.bham.ac.uk as soon as possible. The Team will need the details of the event that occurred and the corrective / preventative actions that have been taken or will be put into place. The Team will assist with reporting needs.
Please see the UoB Deviations & Serious Breach Reporting SOP (UoB-DSB-SOP-001) (Word - 74 KB) for more information.
For UoB CTU-managed trials, please refer to internal CTU procedures.