Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020

On 20 May 2022 the EMA published the annual report of the GCP IWG, which was adopted by the GCP IWG on 30 April 2022.

This Annual Report is set out in line with the format and objectives of the 2020 GCP IWG Work Plan. However, due to the COVID-19 pandemic and imposed restrictions as well as the business continuity plans of the Agency and the Member States, the majority of activities under training and development outlined in the Work Plan for 2020, had to be postponed.

A total of 363 deficiencies, comprising 16 critical (4.4%), 200 major (55.1%) and 147 minor (40.5%) findings were recorded for the 34 CHMP requested inspections conducted in 2020. The main findings cover the following categories: Sponsor Trial Management; General; IMPs; Investigational Site; Computer System; Laboratory/Technical Facilities; Subject Protection; Informed Consent and IEC/IRB.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /