HRA publishes guidance on registration of UK clinical trials

The Health Research Authority (HRA) has published practical guidance to clarify how the registration of all trials, required from 30 September, will work. All applications that receive a favourable ethical opinion from a Research Ethics Committee (REC) will, as a condition of that favourable opinion, be required to be registered in a publicly accessible trial register.

Accepted registers include the

 

The expectation is that all studies are to be registered before the first participant is recruited. However, research awarded a favourable opinion from a REC after 30 September 2013 will not be considered to be in breach of the favourable ethical opinion if the study is registered within 6 weeks of the first participant having been recruited (or, for medical device studies, within the timeline determined by the current registration and publication decision trees).