Our task (KKS)
Our task (KKS)
Evidence-based clinical research is subject to both national and international regulatory requirements, such as the German Medicinal Products Act, the Medical Devices Implementation Act and EU regulations. Against this background, the KKS service centre offers comprehensive advice and services for doctors and scientists at the university, cooperating hospitals and affiliated institutes.
Important goals of the KKS are the development of service structures and the creation of regulatory framework conditions in the field of clinical studies in order to support doctors and scientists at hospitals and departments in the planning, organisation and implementation of clinical studies.
The KKS would like to contribute to the university-wide networking of cooperating hospitals in the field of clinical trials as a platform. The focus of the KKS is on supporting the planning and implementation of investigator initiated trials (IITs).
In the area of planning, consultancy services are offered with regard to the feasibility of clinical study projects, also against the background of the regulatory requirements mentioned.
In addition to support with conceptual development, this can also include cost calculation, application and, if necessary, the procurement of external service providers. In this way, even complex projects can be set up competitively through consulting and, if necessary, external co-operation during the funding application process.
You can find the services provided by the Service Centre in the Services section. In the FAQ section and in the glossary you will find general explanations and tips on dealing with clinical trials. Under Dates you will find current information on further training opportunities and information on the fields of work covered by our service centre.
Mission statement
The Coordination Centre for Clinical Studies (KKS) supports patient-oriented clinical research projects at a high level and thus serves medical and scientific progress. P.p. of the University of Oldenburg, science-initiated studies and clinical research in an academic environment are funded with the aim of improving medical treatment on the basis of the knowledge gained.
As part of the School V - School of Medicine and Health Sciences, the KKS contributes to strengthening Oldenburg as a centre of research. Expertise in the context of science-initiated clinical studies is bundled in the KKS Oldenburg, research projects are supported in methodological and administrative issues and university clinical research is networked.
Our quality standard is Good Clinical Practice (GCP). We work in accordance with national laws, European regulations and international guidelines for clinical trials. Physicians and scientists are supported in all aspects of patient-centred research and clinical trials at the University of Oldenburg, and patient safety and data validity are ensured through quality assurance measures.
Regulatory principles
Clinical research is subject to extensive regulations at national and international level.
Harmonisation of the regulatory requirements for clinical trials is necessary, as clinical trials are often multicentre and organised internationally.
The KKS Oldenburg works in accordance with the international guideline on Good Clinical Practice (ICH GCP) and the European regulations (EU regulations: CTR 536/2014; MDR 2017/745) as well as applicable national law (AMG; MPDG).
Below you will find some sources on these regulations (not exhaustive):