Joint Research Office


Updated policy on reporting and managing events and incidents in UCLH research

27 January 2020

The JRO has updated its standard operating procedure (SOP) for reporting and managing events and incidents in research.

Read the updated SOP.

The SOP now includes a section on how ‘serious incidents’ (which have a specific definition) should be managed and further guidance on reporting and investigation requirements for each type of incident.

The SOP also now reflects a change to the UCLH Datix reporting form. The JRO has updated the research incident reporting section of the Datix form to aid research incident investigations. The question, “Was this patient taking part in a clinical trial or research project?” has been updated to read: “Was this incident related to a clinical trial or research study?”

If researchers select ‘yes’ when answering this question, the Research Quality & Safety team will be notified and will investigate. Researchers are to select ‘no’ if this incident is not related to a clinical trial or study. The incident will then be investigated by the appropriate UCLH division.

Datix should be used to report all research incidents and events that occur at UCLH. Events and incidents are categorised by how serious they are, and SOP defines and provides guidance on each type of event and incident.

For further guidance related to types of research incidents and reporting requirements, contact Mona Hassan, JRO Research Quality & Safety Manager: mona.hassan1@nhs.net.

Read the updated SOP.

Access the Datix reporting form.