Clinical studies support
The Clinical studies support office provides a centralised management function to the many clinical and laboratory studies in the unit that require GCP and GCLP support.
While some externally funded multi-Centre studies have mechanisms in place for trial management, trial coordination and trial monitoring; for MRC funded core work, each programme or project previously supported their own studies. In order to maximize available resources, this office was created with an independent clinical research coordinator responsible for coordinating study approvals, compliance with GCP and GCLP as well as trial monitoring across the unit.
For studies with sponsor funded external monitoring, the coordinator of these activities is made aware of these plans for documentation on behalf of the Unit.