Clinical Research and GCP Update

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Some changes will continue post-pandemic

• ‘Day 1’ of the inspection involved remote data review and accessing electronic systems - most of our inspections were on site̶ This happened beforehand. • The changing ways of working will continue post-pandemic, including ̶ desk-top assessments for low risk organisations̶ amending the way MHRA operate their Inspection Action Group for critical findings to ensure that inspectors are not in a cycle of re-inspecting sites that are not yet in compliance.

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Methods

• Within the first month of lockdown, remote inspections were taking place in all areas. • A variety of file-share platforms have been used, including those already established in the companies inspected, as well as FileShare and, more recently, Teams Channels. • Teams channels can now be set up for every inspection and allows sharing of large data files, as well as providing a space for inspectors to discuss inspections with the companies, replicating the inspection team being ‘in the room’ together as far as possible.

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© Brookwood Global (Canary Ltd) 2021

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