Centre for Clinical Trials Kiel
The Centre for Clinical Trials Kiel (ZKS Kiel) was founded in 2008 as an institution primarily to support investigator-initiated research, its headquarters being at the University Medical Cen-ter Schleswig-Holstein (UKSH) Campus Kiel. On September 15, 2020 it was accepted as an associated member of the KKS network.
Service and competence for clinical trials
It is the aim of the ZKS Kiel to provide effective and ongoing support for clinical trials, espe-cially those conducted in an academic environment, in order to ensure a high quality stand-ard in patient-oriented research. For this purpose the ZKS Kiel offers advice and services in the planning and implementation of clinical trials with medicinal products, medical devices and studies according to the “Berufsordnung für Ärzte”. The spectrum of services ranges from project management and biometry over to monitoring and data management.
In order to secure funding for trials the ZKS Kiel participates in the application for third-party funds and therefore gained experience in DFG, BMBF, DKH and EU projects.
Furthermore, the ZKS Kiel provides clinics on the Kiel campus with an experienced study as-sistant either for temporary support in the event of staff shortages or for the induction and establishment of a site.
Qualification
The prerequisite for high-quality clinical research in humans is the knowledge of national and international regulations and ethical principles. For this purpose the ZKS Kiel regularly offers certified courses and further training for doctors, scientists, study assistants and other study personnel according to the current requirements of the German Medical Association (curricular training) among other things.
The aim is to convey well-founded specialist knowledge for the implementation of clinical studies according to the respective regulations (e.g. ICH GCP, Medicines Act, Medical Devices Act). In addition, language courses (English in clinical studies) and courses on shipping dan-gerous goods (IATA) are offered.
Cooperation and networking
Through the affiliation of the ZKS Kiel with the Institute for Medical Informatics and Statistics (IMIS), both institutions benefit from a close and regular exchange as well as an intensive cooperation in various research projects.
Within the UKSH the ZKS Kiel participates in various working groups with the aim to promote investigator-initiated clinical research and to optimise the infrastructure. Together with the ZKS Lübeck it is part of the Clinical Studies Task Force to establish a University Cancer Center at the UKSH.
Furthermore, the ZKS Kiel arranges various fora for clinical staff for the purpose of experi-ence exchange, networking and the establishment of new collaborations with the aim of contributing to a high quality standard of clinical studies at the UKSH.