Adverse event reporting should be undertaken in accordance with the Trust Policy on reporting of adverse events, which can be found on the Trust intranet. All adverse events should be reported to the Clinical Risk Department using a Trust incident report form. However, researchers are responsible for ensuring that Clinical Risk, R&D and Ethics and other regulatory bodies, are informed of any adverse events, which occur during research-related activity.
The Clinical Risk team in collaboration with R&D undertakes a full investigation and review. Information on adverse events is submitted regularly to directorates, the site-based Clinical Audit, Risk and Effectiveness committees, to the Clinical Governance Core Group and the Trust Board.
REGULATORY REPORTING OF ADVERSE EVENTS
There is a legal requirement to report all adverse events associated with the use of a Medicinal Product or a Medical Device undergoing clinical investigation to the Medicines and Healthcare products Regulatory Agency.
The investigator has a specific duty to report adverse events to the sponsor who then must report to the MHRA and REC.
Investigators should be aware of those responsibilities delegated to them at the beginning of a trial and should be familiar with the Trust's Research SOP on Recording, Managing and Reporting Adverse Events.
Investigations of Medicinal Products
In clinical investigations of medicinal products there are specific timelines that are mandatory for reporting. A Suspected Unexpected Serious Adverse Event (SUSAR) that is fatal or life threatening must be reported immediately to the sponsor who then has 7 days to report to the MHRA and REC. Non-Fatal or non-life threatening SUSARS must be reported to the MHRA and REC as soon as possible but within 15 days of the sponsor first becoming aware of the event.
Investigations of Medical Devices
In clinical investigations of medical devices adverse events should be reported as soon as possible to the sponsor who is responsible for reporting to the MHRA and the REC.
Detailed records should be kept of all adverse events by the investigator and the sponsor. The sponsor is required to notify all investigators. Annual reports of adverse events must also be provided.
Information about adverse event reporting can be found on the MHRA website www.mhra.gov.uk
Please contact Ira Jakupovic for further information.