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GCP Serious Breaches update

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Annual metrics

magnifying glass held up to sheet of paper

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: 

Notification form and guidance documents updated

The Notification of a Serious Breach form and associated guidance have been updated, with the aim of improving the completeness and quality of information being received by us for review and assessment of the breach.

The most common queries we have when reviewing serious breach reports are actually general ones requiring further information and justification of decisions, such as impact assessments and root cause analysis, therefore we have added further details of what we expect to receive.

The initial notification must be submitted within 7 days of first awareness, therefore we appreciate and expect that details and information may be incomplete at that point. However, follow-up reports should strive to provide complete information.

Common questions that come up are, for example:

  • what impact assessment has been done, what methodology was used and what was the outcome?
  • has this issue happened at other sites/on other trials? how do you know this is an issue only at one particular site if you have not checked across sites?
  • what root cause assessments have been undertaken, how was this done, what was found and how does this link to the CAPA provided?
  • how has the issue been documented in the Trial Master File/s (TMF/s) across all organisations involved?
  • have you ensured this incident is transparently reported in the Clinical Study Report/s?

The updated form and guidance aim to address this, however, the quality and completeness of the information also depends on the organisation filling in the form. If you have questions, please do not hesitate to contact the GCP Inspectorate.

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