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4th August 2020
The annual metrics report for GCP referrals has now been published for 2019.
In 2019, MHRA received a total of 112 serious breach notifications, of which:
Patient safety was the main reason for reporting of serious breaches in 2019 (56/112), with the sponsor being the primary reporter of breaches (83/112); 57% of breaches were on commercial trials; 43% on non-commercial.
Only 1 serious breach of the 112 prompted a triggered inspection, with the majority (66%) requiring in-house follow-up with the organisation.
2018 saw a total of 115 serious breaches, with a similar breakdown of numbers: https://mhrainspectorate.blog.gov.uk/2019/05/24/gcp-serious-breaches-the-2018-edition/