Latest COVID19 guidance for sponsors, sites and researchers
Date: 17 March 2020
HRA
The HRA has released guidance for sponsors, sites and researchers about COVID-19: www.hra.nhs.uk/coronavirus
The guidance provides details of expedited processes for studies which will investigate COVID-19 (i.e. new studies and/or amendments to existing studies); as well as how to handle any changes to existing studies which are necessary as a result of response to the pandemic (e.g. impact on NHS staffing, restrictions on movement of people, any changes to supply of IMP etc.)
MHRA
The MHRA has issued guidance in their inspectorate blog for the management of clinical trials in relation to COVID19
https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/
Guidance will be continually updated.
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