Clinical Research and GCP Update

17

MHRA inspection findings - critical

The RSI is a hot topic for inspections and care must be taken to ensure that you get this right as it has a potential impact on under reporting of SUSARs, the accuracy of the DSUR and the safety of patients .

17

18

MHRA Blog on RSI (Part III) & CTFG guidance

• Reference Safety Information (RSI) for Clinical Trials- Part III • Posted by Mandy Budwal-Jagait, Gail Francis and Dr Maria Beatrice Panico 5 February 2021 • https://mhrainspectorate.blog.gov.uk /2021/02/05/reference-safety- information-rsi-for-clinical-trials-part- iii/ • Remember applicable law in the UK is SI 2004/1031 • Also relevant: CT-1, CT-3, national legislation in Member States, CTFG Q&A on RSI

18

© Brookwood Global (Canary Ltd) 2021

9