Study management
The study is sponsored by the University of Bristol. The sponsor, the chief investigator (GMK) and the colead (RU) will have overall responsibility for the study. A named principal investigator will take clinical responsibility for study activities at each site. The study does not require the formal arrangement of a steering committee because, according to the HRA, it is not a Clinical Trial of an Investigational Medicinal Product. However, to enhance monitoring of the study, a study management group will be established, comprising academic and clinical experts in psychiatry, rheumatology, neuroscience and immunology.