The Leeds Teaching Hospitals NHS Trust is the largest in the UK and includes the largest teaching hospital in Europe. It provides high quality acute hospital services for the population of Leeds and the surrounding area and acts as a regional centre for a number of specialist services such as cancer and cardiac surgery. In total it employs over 14,000 staff across eight sites, treating around a million patients a year with a budget of £730 million. The Trust has already deployed EQMS to manage its Quality systems across its 900 strong Pathology Directorate and in its Non-Surgical Oncology department.  The system will now be extended to support the Trust's Clinical Trials Unit. An EU Directive has been issued with the aim of harmonising the different rules and procedures for clinical trials throughout the EU. The Directive has been transposed into law in this country under the Medicines for Human Use (Clinical Trials) Regulations 2004. The Regulations will 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. The Leeds Teaching Hospitals NHS Trust and University of Leeds have agreed a Quality Control Policy to ensure continuous improvement in clinical trial conduct and patient care and compliance with statutory requirements. EQMS will be used to manage all the documents and processes emanating from this policy.  The system will underpin compliance, standardising processes and reducing the risk of error.