17/18 March 2021
The MHRA recently published the 2018 metrics report for GCP serious breaches.
Serious breaches of the clinical study protocol or Good Clinical Practice (GCP) have to be reported to the MHRA within 7 days of awareness. According to the agency, a serious breach is defined as a "breach which is likely to effect to a significant degree:
The sponsor is required to report serious breaches. However, if an investigator or third party organization disagrees with the sponsor assessment of the breach, the MHRA expects that due diligence is exercised by the investigator/ third party organization. In addition, investigators/ third party organizations should retain correspondence demonstrating their due diligence during inspection.
The MHRA received a total of 115 serious breaches, of which
Serious breaches due to data integrity and contracting activities
In most cases patient safety was the reason for reporting serious breaches (49 out of 115), followed by other non-compliances (24 out of 115), like:
In 2018 there were six serious breaches reported which required a subsequent inspection to be performed. For the majority of the serious breach notifications received, the MHRA inspectors received updates from the reporter on the progress of the investigation and the corrective and preventive actions (CAPAs) proposed. Hence, there was no need for a triggered GCP-Inspection.
More information - and examples - can be found in the MHRA Inspectorate blog entitled "GCP Serious Breaches - the 2018 Edition" as well as in the MHRA's "Annual review of good clinical practice referrals".