Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021

21 November 2022 – EMA published the annual report of the GCP IWG 2021.

In total, 27 triggered GCP inspections were requested by CHMP and carried out by the inspectorates of the EU/EEA Member States (MSs) in 2021. A total of 286 deficiencies, comprising 24 critical (8,4%), 152 major (53,1%) and 110 minor (38,5%) findings were recorded for the 27 CHMP requested inspections conducted in 2021. This represents an average of 10-11 findings per site inspected. The three top categories of the findings were General, Trial Management and Computer System.

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