Clinical Research and GCP Update

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Hosting Remote Inspections?

• Access arrangements for multiple Inspectors, at multiple times. • Read Only access for Inspectors ̶ they may test this! • Arrange for Audit Trails (of all systems) to be available for Inspection remotely. • Rescind access after Inspection ̶ Again they may test this! ̶

Beware that Inspectors may require access after inspection …̶ discuss with Lead Inspector & how to control.

• Consider if various systems Audit Trails can adequately track Inspectors access to various systems/files.

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

• Ensuring reliable access & support from IT at all times. • Increase personnel resources compared to on-site inspection • Possibility of Inspectors having wide access to systems across all Sponsor/Vendor platforms, including SOP system holding SOP exceptions (waivers) & deviations. ̶ Consider what access your systems allocate & control. • Consider possible Inspection Scope Expansion̶ Inspection of certain (pre-defined) clinical trials may have been requested in the Inspection Plan, but if total access (to all systems) is available, there could be inspection of other trials or other development programs.̶ This may involve more Host resources/support to manage this expansion!

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