Clinical Research and GCP Update

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SUSAR reporting through UK national portals

• The MHRA has issued guidance on submitting SUSARs and DSURs. • The MHRA guidance on submitting clinical trial safety reports notes that SUSARs in Great Britain and Northern Ireland must be submitted to the MHRA through one of the following routes:̶

ICSR Submissions̶ the MHRA Gateway̶ the eSUSAR website.

• For trials ongoing in both the UK and the EU, dual reporting is needed and SUSARs should be reported to both the MHRA and the relevant Member States, as well as to the EMA’s EudraVigilance Clinical Trial Module.

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UK and GDPR – Data Protection

• The Data Protection Act 2018 is the UK’s implementation of the General Data Protection Regulation (GDPR). • “Today’s draft decisions follow months of discussions and pave the way for continued free flow of data between the EU and the UK”

https://www.gov.uk/government/news/uk-government-welcomes-the-european- commissions-draft-data-adequacy-decisions

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© Brookwood Global (Canary Ltd) 2021

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