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Good clinical practice

Short format Development Safety Update Report (DSUR) for Type A trials

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice
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Not all trials are the same in terms of risk. To support UK sponsors of clinical trials, a substantially simpler and shorter form may be submitted in lieu of a full DSUR, giving a significant time saving.

MHRA Laboratories Symposium 2019 ... plus GXP mailbox update

A previous MHRA GLP and GCP Laboratories Symposium, with Martin Reed (GLP and GMPQC Inspector) presenting.

The MHRA Laboratories Symposium will be held on 13 March 2019 at the Novotel in London. Also ... we have recently changed the contact email address for the laboratories inspection group from glp@mhra.gov.uk to gxplabs@mhra.gov.uk

Is it really a First in Human trial? Categorising and assessing the risks correctly

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice
an arrangement of scrabble tiles spelling out the word 'ASSESS'

All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.