Please also refer to the Research & Development Directorate - Home  

All clinical trials involving medicines must adhere to The Medicines for Human Use (clinical trials) Regulations 2003.  

Medicines used in research must be manufactured to GMP standards.  

Clinical trial supplies must be stored in the Pharmacy department or other pharmacy-approved environment. 

Commercial Clinical Trials

The department currently manages more than 60 clinical trials for the Trust and about 6 trials for Manchester Mental Healthcare Partnership NHS Trust.

If you are embarking on a commercial clinical trial please ask the sponsor company to contact us early, we can help design prescriptions to minimise errors.

We will archive our documentation with the Investigator files

Non-commercial Clinical Trials

We have the expertise to provide help at any stage of your project. The approval process is quite complicated. We can help you complete your CTA application to the MHRA , from helping you obtain your EudraCT number to submission, further information can be found  www.mhra.gov.uk – link to MHRA website here.

We will only use medicines that have marketing authorisations or made in licensed manufacturing units to GMP and released by a Qualified Person.

Any commercially available medicines that require additional labelling will be labelled according to strict SOPs.   

Before embarking on research you must have been trained in ICHGCP www.gcptraining.org.uk – link If you are designing you own research project please come and see us early so we can advise you on protocol development, re-sourcing IMP, randomisation schedules, documentation  and design of SOPs and patient information.