Clinical Research and GCP Update

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https://mhrainspectorate.blog.gov.uk/2020/08/03/gcp-serious-breaches- update • Notification of a Serious Breach form and associated guidance have been updated, with the aim of improving the completeness and quality of 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? – 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? MHRA Serious Breaches form & guidance update Jul20

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MHRA SB Referrals 2019, posted 2020

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