Following on from our previous post, further guidance has been published on our MHRA Website in relation to Managing Clinical Trials and Clinical Trial Applications. We address issues such as paperwork for temporary halts, providing IMP by post and remote monitoring. There is also guidance on submitting applications for COVID-19 trials.
We will continue to add to the guidance as the situation develops.
Don’t forget that MHRA is also here to support you, and if you have any questions then do contact the Clinical Trials Unit Helpline (clintrialhelpline@mhra.gov.uk or 020 3080 6456). The Helpline will give inquiries relating to COVID-19 the highest priority, including the possibility for fast-tracking submissions.
HRA (Health Research Authority) also have guidance on research in a public health emergency
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