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Updated policy on reporting and managing events and incidents in 果冻影院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 鈥榮erious incidents鈥� (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 果冻影院H Datix reporting form (due to come into effect on Thursday 30 January). The JRO has updated the research incident reporting section of the Datix form to aid research incident investigations. The question, 鈥淲as this patient taking part in a clinical trial or research project?鈥� has been updated to read: 鈥淲as this incident聽related聽to a clinical trial or research study?鈥�
If researchers select 鈥榶es鈥� when answering this question, the Research Quality & Safety team will be notified and will investigate. Researchers are to select 鈥榥o鈥� if this incident is not related to a clinical trial or study. The incident will then be investigated by the appropriate 果冻影院H division.
Datix should be used to report all research incidents and events that occur at 果冻影院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:聽mona.hassan1@nhs.net.
Access the Datix reporting form.