Updated policy on reporting and managing events and incidents in MyAV·¶H research
27 January 2020
The JRO has updated its standard operating procedure (SOP) for reporting and managing events and incidents in research.
The SOP now includes a section on how âserious incidentsâ (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 MyAV·¶H Datix reporting form. The JRO has updated the research incident reporting section of the Datix form to aid research incident investigations. The question, âWas this patient taking part in a clinical trial or research project?â has been updated to read: âWas this incident related to a clinical trial or research study?â
If researchers select âyesâ when answering this question, the Research Quality & Safety team will be notified and will investigate. Researchers are to select ânoâ if this incident is not related to a clinical trial or study. The incident will then be investigated by the appropriate MyAV·¶H division.
Datix should be used to report all research incidents and events that occur at MyAV·¶H. 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.
.