The UK is due to leave the EU on the 31 October 2019. Regardless of whether there is a deal or no-deal Brexit, the following actions are needed:
Urgent actions before 31 October
Planning for any disruption to the supply of equipment, samples or drugs to research studies should have been sent to PIs and CIs by the trial sponsor.
PIs and CIs who have yet to receive an adequate assurance of the above should make immediate contact with the research sponsor. This is particularly the case for studies reliant on IMP (Investigational Medicinal Products) or other drugs, specialist equipment or products which are supplied outside of the UK. The PI or CI should also have been provided with instructions or guidance specific to their research study.
Several sponsors have provided general assurances to UCLH (either to UCLH Pharmacy or UCLH R&D); a list of these sponsors is available upon request from UCLH R&D.
Actions after 31 October
If Brexit results in any unforeseen issues (i.e., outside of sponsor contingency plans) that impacts the delivery of the trial at UCLH, the UCLH CI or PI must immediately contact the research sponsor and in the case of IMP, UCLH Pharmacy.
Any queries should be sent to jro.communications@nhs.net
The JRO has separately put together a position statement in relation to clinical trials sponsored by UCL in the event of a ‘no deal’ Brexit.
