Urgent Safety Measures (USMs) to trials that continue to follow-up must be reported in the usual way and CIs and PIs need to report any USM to sponsor immediately. Please refer to NJRO-GEN-SOP-002 ‘Protocol Deviations, Violations, Waivers and USMs in studies sponsored and hosted by NuTH FT’ available via https://newcastlejro.com/
To note: Regulation 3 amends the Medicines for Human Use (Clinical Trials) Regulations 2004 to allow for notice of USMs to be given as soon as possible to the licensing authority and an ethics committee. Prospective protocol waivers are unacceptable and should not be used to change a trial due to the pandemic (for example eligibility, patient safety and/or difficulties in assessments). CIs should discuss with R&D and consider use of USM, temporary halts or patient discontinuation.