General practice-based research networks have become an integral tool to gain medical knowledge from primary care in many countries. For this purpose, a scalable IT-infrastructure is presented considering the limiting peculiarities in the German health system and enabling GPs to participate in clinical studies based on their patient population. The infrastructure consists of a central study management server and local clients for each practice. It adopts to the currently limited digital connectivity of GP practices, data protection regulations for clinical data and the needs of the medical staff to manage a clinical study. The infrastructure is in production at the four university hospitals in the state of Baden-Württemberg. Until now three clinical studies with over 70 GPs and 350 Participants are successfully conducted or have been finished. Further clinical studies are in the planning stages.
Keywords: Clinical studies; digitalization; health services research; primary care.