14/15 June 2021
The annual review of MHRA´s GCP referrals has recently been published. In 2019, the MHRA received a total of 112 serious breach notifications, of which patient safety was the main reason for the reporting of serious breaches followed by scientific value and data credibility. This is similar to MHRA´s 2018 report.
The MHRA notes that the initial notification of a serious breach must be submitted within 7 days of first awareness. Thus, the agency expects that details and information may be incomplete at that point. However, follow-up reports should provide complete information, including, for example:
More information can be found on MHRA´s blog "GCP Serious Breaches Update".