Clinical Research and GCP Update

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Potential Issues for Inspection Hosts:- Direct Access to all Sponsor systems during Remote Inspections

• Difficult to be adequately forewarned of current areas of interest of the Inspectors – everything is in play at all times. ̶ A live systems audit trail tracking of inspectors’ access, might be helpful. • Challenge of assisting Inspectors with timely & appropriate information & resource̶

compared to an on-site inspection, where Host will know what is being reviewed by Inspectors and questions they are asking (i.e. their areas of interest).

• Consider risk of possible Regulatory Spread – other sections of the Inspectorate (GXPs) or other related Agencies (e.g. data protection) could possibly become informed.

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Some Features of a recent UK Remote GCP Inspection, during COVID-19 emergency

• Inspection lasted about one month, rather than about 1 week. • Inspectee had 5 days notice to provide pre-inspection requested e-Documents. • 4 GCP Inspectors, each inspector separately inspects remotely for 5 days, sequentially. • Trial specific & safety (e.g. RSI) focus ̶ Not traditional full systems inspection. • CAPAs from previous systems inspections in-scope.

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© Brookwood Global (Canary Ltd) 2021

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