This allows trends and best practice to be highlighted and communicated to improve standards across the Trust. During 2025-26 one MHRA (Medicines and Healthcare Products Regulatory Agency) site inspection was supported.
17.15. Safety Reporting. As Sponsor, the OUH is responsible for regulatory assessment of Serious Adverse Events (SAEs). As host organisation, the Trust has a responsibility for ensuring that safety reporting processes are appropriate and compliant. The appropriate level of oversight is established by a risk assessment prior to the granting of Trust Management Approval, for both sponsored and hosted trials. All SAEs reported are reviewed by the OUH/University of Oxford Joint Trials Safety Group (TSG). The aims of this review are to: pick up any trends, such as increases in un/expected events, and take appropriate action; identify whether additional advice or information is required from investigators; evaluate the risk of the trial continuing and take appropriate action where necessary, including requests for specific audits. During 2025-26 OUH has reviewed 95 SAEs which have also been presented at the quarterly Trial Safety Group meetings.
17.16. Organisational Information Document (OID). When specified by the Sponsor, an OID can be used as the contractual agreement for non-commercial studies that are not clinical trials or clinical investigations. Unlike other site agreements with Sponsors, which are managed by the R&D Contracts team, the review; approval and completion of OIDs is managed by the R&D governance team. During 20254-26 106 OIDs were processed.
17.17. Research incident reporting. The Head of NMAHP CRD reports the number of incidents relating to clinical research delivery to the R&D Committee and to the Lead NMAHPs' CRD forum on a quarterly basis, highlighting key themes and any shared learning. 254 incidents were reported in Ulysses in 2025-26, although not all were causally related to research. The breakdown by Division, in Figure 9, shows one Division (SuWON) accounts for nearly two thirds of the total. However, it is likely this is due at least in some part to variation in reporting practice across Divisions. Figure 10 shows a breakdown of reported incidents by actual impact; except for one which was Moderate, all of them were either Minor or No Harm. Figure 11 shows a breakdown of reported incidents by Incident Type, with just under two thirds affecting Patients and just under a quarter affecting Staff.