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
- EU Clinical Trials Register (http://www.clinicaltrialsregister.eu), which is linked to the EudraCT register, which is mandatory for all CTIMPs in patients authorised on or after 1 May 2004
- International Standard Randomised Controlled Trials Number (ISRCTN) Register (http://isrctn.org/)
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).