[Collaboration with clinical research organizations : Introduction of a questionnaire for clinical study centers]

Clinical trials with pharmaceuticals or medical devices make complex demands on sponsors and participating centers. During the past two decades, sponsors have increasingly delegated regulatory and organizational tasks to clinical research organizations (CRO). As a rule, these companies are the main interface for the collaboration with the participating study centers. The main purpose of the participation is the support of the study centers for achieving an optimal study quality. The study centers involved in the DOG working group on clinical study centers perceived varying experiences in the collaboration with CROs. In the future these experiences will be systematically assessed at the participating study centers and analyzed by the coordinating investigator. Reflecting these experiences to the respective CROs and the delegating sponsors will contribute to the quality of support by CROs and herewith to the quality of clinical trials. This paper presents which areas of collaboration will be assessed and analyzed.