Clinical Research and GCP Update

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MHRA: Electronic System, Inspection access - Do’s 10March2020 • DO : Ensure this is all set-up well in advance, • DO : Ensure as a company you know all the systems that make up your TMF and ensure you can give Inspectors direct access . Discuss this with your Lead Inspector up front to ensure access is provided as expected. • DO : Aid electronic system access:- links on desktop; short crib sheet; ensure lock-out times are reasonable; minimise need for numerous passwords where possible; etc.. • DO : Inspectors are happy to have training in electronic systems new to them, however, do make sure the training is efficient and useful in ensuring competence in using the system, for example a system demonstration is much more useful than presenting slides

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Hosting Remote Inspections?

• Need for extensive input from IT & support services for prolonged periods of time both pre, during and post inspection. • Need for several virtual “Inspection Management Rooms” for Sponsor/CRO/Vendor with multiple work parties, (preferably 24/7 availability if Global reach). • Arrange remote training (if requested) for Inspectors on all systems they will access. • Do your SOPs allow for this training? – do the SOPs need amending?

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