Clinical Research and GCP Update

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MHRA inspection metrics (2018)

• Commercial sponsors = 8 • Contract Research Organisations (CROs) = 11 • Investigator sites = 19 • Phase 1 unit inspections = 7 • Non-commercial organisations = 12 • GCP inspections of UK labs conducting clinical trial sample analysis = 17 (up from 13 previous period)

Findings are summarised into one of 42 categories and graded as critical, major or other

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