All clinical research sponsored by the University must be in compliance with the following requirements:
Registration
All interventional clinical trials must be registered on a publicly accessible database before recruitment of the first participant. More information on suitable registries is available here.
Registration is a condition of Research Ethics Committee favourable opinion and must also be in compliance with any requirements of the funder of the research.
Reporting
There is a legal requirement for results from all Clinical Trials of Investigational Products (CTIMPs) to be uploaded to the European Clinical Trials (EudraCT) Database within 1 year of the end of trial declaration (6 months for paediatric trials). For all studies (including CTIMPs), the relevant Research Ethics Committee should be updated with annual progress reports and provided with a summary of results within 12 months of the end of the study. Information on registries should also be updated during and at the end of the study.
> Managing your approval
Government focus on clinical research registration and reporting
30 November 2018