Kirsty Wydenbach

Deputy Unit Manager/Senior Medical Assessor, CTU

Advice for Management of Clinical trials in relation to Coronavirus

Gail Francis and Kirsty Wydenbach, 12 March 2020 - Compliance matters, Good clinical practice

MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.

How to manage safety reporting in a blinded trial

Gail Francis and Kirsty Wydenbach, 9 April 2019 - Compliance matters, Good clinical practice

Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs

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

Jennifer Martin and Kirsty Wydenbach, 20 December 2018 - Compliance matters, Good clinical practice

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.

Blog MHRA Inspectorate