Clinical trials involving medicinal products fall under the Medicines for Human Use (Clinical Trials) Regulations 2004, that implement the EU Clinical Trials Directive into English law. These regulations help to ensure that the rights, safety and well-being of clinical trial subjects are protected, by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognised principles of Good Clinical Practice (GCP).
The Regulations cover investigations/studies which are undertaken to ascertain the efficacy or safety of a medicine (or investigational medicinal product; IMP) in human subjects. Non-interventional trials (i.e. studies that involve products with a marketing authorisation that are prescribed in the usual manner and used in accordance with the authorisation) are excluded from the Regulations, as are "physiological" studies, where the product is simply being used as an aid or tool in the study.
The Medicines and Health-Care Products Regulatory Agency (MHRA), regulates the EU Directive in the UK. An application to the MHRA for a Clinical Trial Authorisation (CTA) must be made for all studies involving IMPs.
To ascertain if your project is subject to the Clinical Trial Regulations 2004, the MHRA has produced an algorithm which can be found in our research document library.
Read the current guidance and information on the CT Regulations .
Clinical research is governed by various legislation and frameworks. For more information, please go to our research document library which contains a list of useful links.