Internship in the Coordination Centre of Clinical Studies in Düsseldorf

On 19 March 2013 we took part in the one-day internship in the Coordination Centre of Clinical Studies (Koordinierungszentrum für Klinische Studien – KKS) in the German Düsseldorf.

Coordination Centre of Clinical Studies in Düsseldorf


19 March 2013 we took part in the one-day internship in the Coordination Centre of Clinical Studies (Koordinierungszentrum für Klinische Studien – KKS) in the German Düsseldorf.

This workplace is the integral part of the Faculty of Medicine of Heinrich Heine University and grants the complete service for academic clinical studies.

KKS in Düsseldorf was established in 1999 as the integral part of nowadays 17 coordination centres for clinical studies, included in the ECRIN network and managed by the Federal Ministry of Education and Research. It is created by 25 specialists and headed by prof. Dr. Christian Ohmann. KKS is focused on academic clinical studies in the fields of oncology, psychiatry, gastroenterology and surgery. When realizing these clinical studies, KKS in the majority of cases plays the role of the sponsor of the clinical study. 80 % of activities are created by the clinical studies initiated by the investigator and 20% - by the pivot clinical studies. The workplace coordinates ca 30 clinical studies annually.

From the organizational point of view the workplace is broken down into the following sections: data management, monitoring, pharmacovigilance, IT, biostatistics, study management, department of quality and education. The elaborated schedule includes 10 hours of free consultations with the investigators (investigating physicians) regarding feasibility of the clinical study; KKS then ensures funding of the study and all administrative matters (documentation for permission of the clinical study) prior to starting the study. KKS also performs the complete data management (5 data managers, in-house software – OMNICOM for electronic data collection) and monitoring, ensures randomization and statistic processing of study outcomes (results).

The local Ethics Committee asks the investigators to pass the training course of the Good Clinical Practice every two years. KKS organizes annually the 2-day, 3-day and4-week training courses named the “Advanced Training for Clinical Trials” which are mandatory for all investigating physicians and other members of the team.

KKS works in conformity with the uniform and regularly updated SOP.

http://www.uniklinik-duesseldorf.de/kks
http://www.kks-netzwerk.de/en/network/members/kks-duesseldorf.html

Mgr. Michaela Hanáková
MVDr. Renata Horová
Bc. Marianna Brabencová