Background About the CTU The Clinical Trials Unit is an academically based Unit providing expertise and capacity for running several RCTs simultaneously and offering in addition a range of trial-related services. The primary aim of the CTU is to generate convincing evidence on clinically relevant problems in the form of high quality clinical trials. It was suggested at a an informal meeting early in 2005 that a pan-Trent clinical trials support unit could be formed by collaboration between the three nascent clinical trial units at Sheffield, Nottingham and Leicester based on experience with the Trent RDSU (now known as the NIHR Research Design Service for the East Midlands). What a Clinical Trial Unit can offer Facilitation of the approval process Statistical and health economist consultancy for trial design and analysis Sample size estimation Protocol peer review Protocol writing (in full or in part) Design of questionnaires, CRFs (paper or electronic) Literature reviews Patient information sheet writing Completion of ethics committee applications Response to ethical and peer review Trial conduct and management Third party randomisation service Statistical and health economist support for trial design and analysis Data management (design and maintenance of databases) Study monitoring Provision of data monitoring committees (DMC) Data analysis Training/Induction programmes Research ethics, ICH GCP, Research Governance Note: that provision of specialised services such as beds, pathology, other laboratory tests, ECGs, radiology/imaging, pharmacy etc will not be part of the CTUs work. Making the best use of the CTU Come to us early before irrevocable decisions are made - advice and support can then be acted on Allow time for deadlines (calls for grant applications) to be met Background material (publications) on the topic of interest are helpful Have a clear idea of what the trial is to achieve Don't be afraid of constructive criticism - better us than referees Joint projects will be accepted according to the following criteria: Scientific innovation potential Medical relevance Competence of the partners Likely feasibility Available expertise Available and obtainable resources