Kirsty Wydenbach

Deputy Unit Manager/Senior Medical Assessor, CTU

How to manage safety reporting in a blinded trial

Posted by: Gail Francis and Kirsty Wydenbach, Posted on: 9 April 2019 - Categories: 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

Posted by: Jennifer Martin and Kirsty Wydenbach, Posted on: 20 December 2018 - Categories: 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.