Patient Safety Still the Main Reason for Reporting of Serious Breaches

Recommendation

6/7 June 2023

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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.

In addition, the agency updated the notification form (Serious Breach form) and the associated guidance document.

MHRA´s Common Queries

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:

• Impact assessment, methodology and outcome,
• Investigation whether the issue happened at other sites / on other trials,
• Root cause assessments and CAPAs,
• Documentation of the issue in the (electronic) Trial Master Files (eTMFs) and in the Clinical Study Reports.

More information can be found on MHRA´s blog "GCP Serious Breaches Update".