This course focuses on the legislation governing clinical trials in the UK and the approvals framework specific to UK trials.
We cover all the Statutory Instruments but concentrate on the two key documents, 2004; 1036 and 2006; 1928. The training summarises the requirements of the legislation and the differences from other countries.
We also talk about the Ethical and Health Service R&D approval (HRA approval) and the Clinical Trials Authorisation (MHRA approval).
Please contact me for more information and to organise your course.