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MHRA - GCP Serious Breaches update

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:

  • 75 were deemed to be a serious breach
  • 36 deemed not to be a serious breach
  • 1 awaiting further information to enable final determination.

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/ 


Read more here: https://mhrainspectorate.blog.gov.uk/2020/08/03/gcp-serious-breaches-update/

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