Clinical Research and GCP Update

MHRA GCP Inspections: Expectations and the dos and don’ts for hosting 10Mar2020

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MHRA: Electronic System Access by Inspectors 10March2020 • Direct access will be required to all systems that make up your TMF and potentially any key clinical trial support systems for example if your SOPs, procedural documents and training records are held in a QMS eSystem, access will be required. • Inspectors should be provided with the means to access and review all of the relevant systems , • Computerised System Validation (CSV) we'll also need access to systems that manage that system, for example, helpdesk systems . • Access to electronic systems should be read-only, but should not be otherwise limited, • Access to audit trails which we will want to see. Audit trails may also be requested to be extracted.

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