Poll on reporting serious breaches

Earlier this year, the MHRA updated its guidance on notification of serious breaches of GCP or the trial protocol. 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. The principle is also rooted in section 5.20 of ICH E6 (ICH GCP), so the general concept is appropriate worldwide.

At ClinDev, we thought it might be useful to explore this issue a little further, and ask readers to tell us how good (or bad) their organisation has been at spotting and reporting any serious breaches. Depending on how the results come out, we might move on to some more detailed research…

In the past 12 months, what proportion of any Serious Breaches of GCP that you have been aware of were reported in accordance with requirements?

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  1. Pingback: Poll on serious breaches suggests under-reporting | ClinDev

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