Clinical Research and GCP Update

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MHRA Guidance on Responding to a GLP & GCP Laboratories Inspection Report. 30 Mar 2021 • This format is not mandatory but is the inspectorate’s preferred method for providing responses

• Guidance is presented in the same format as the deficiency annex to a GLP & GCP Laboratories inspection report.

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• TransCellerate addresses the ICH E3 Q & A July 2012 definition of “Important Protocol Deviations”. • Proposes a narrow definition of Protocol Deviations (PD) that are explicitly defined in protocol. • Accounting for other GCP Deviations that are not narrow PDs, is proposed for a separate system (?)

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