The Danish Medicine Agency on inspection at OPEN
On the 16 and 17 December OPEN was GCP-inspected by the Danish Medicines Agency.
OPEN (Odense Patient data Explorative Network) was visited by the Danish Medicines Agency on December 16 and 17. The inspection was set up in order for the Danish Medicines Agency to oversee whether clinical trials are handled correctly.
OPEN is a research infrastructure aimed to strengthen clinical research at Odense University Hospital & Svendborg Hospital (OUH) and Institute of Clinical Research. OPEN helps scientists to initiate clinical trials making it easier to collect and store biological samples and clinical data. Moreover, OPEN facilitates data-based research on the cohorts. The inspection took place in OPEN's offices on J.B. Winsløws Vej 9a, with attendance from relevant OPEN personal: Data Managers, Project Coordinator (responsible for the qualitysystem), Research Secretary, Head of OPEN and a representative from the GCP-unit in the Region of Southern Denmark.
Among the over 180 projects OPEN currently assists, there are a few drug trials. The Danish Medicines Agency had selected two that were scrutinized further for the researchers and OPENs compliance with Good Clinical Practice (GCP). The inspection processed positively and OPEN looks forward to receiving the Danish Medicines Agency's report in January 2016.