Poll on serious breaches suggests under-reporting

A poll running on the ClinDev website since mid-May suggests that up to a quarter of serious breaches of GCP are not reported in accordance with MHRA requirements. While this precise notification requirement is specific to UK regulation, it does include provision for breaches occurring at sites outside the UK, if their likely impact is significant for safety or study integrity within the UK.

Of the 27 poll respondents who had encountered one or more serious breaches in the past 12 months, only two-thirds (18 of 27) confirmed that they had all been reported to the MHRA correctly. In contrast, 10% (3 of 27) said that none of the serious breaches they were aware of had been reported. Over 30% (13 of 40) of professionals who have taken part in the poll so far said that they had not encountered a serious breach in the past year.

The poll is still in progress, and needs more participation to make these findings robust. Please share your experience with reporting serious breaches and encourage your colleagues to do the same.