This is one of the most important aspects of a clinical trial protocol, and is also required for interventional clinical research studies.
It is possible to adopt risk-adapted approaches to safety reporting. Consider whether the burden of reporting can be reduced without compromising safety:
- If your research uses a licensed medicine, do you need to gather data on non-serious adverse events?
- If there are foreseeable serious adverse events (eg due to disease progression) can these be documented in the protocol to avoid the need for immediate reporting?
In both cases they must be clearly stated in the protocol approved by the MHRA (clinical trials only) and REC.
The safety section in protocol templates provide guidance on this, and the Research Governance, Ethics & Assurance Team will advise in the course of the sponsorship review process.
The regulations require that all serious adverse events (SAEs), unless excluded in the protocol, are reviewed by an appropriate safety monitoring committee.
If there is no trial-specific or department-specific safety monitoring committee, the Research Governance, Ethics & Assurance Team may be able to make arrangements for your SAEs to be reviewed by the Oxford University Hospitals NHS Trust/University Trial Safety Group.