| General increase in quality in the consortium
The network works together on a project basis —such as with multicentre trials —and also on a subject basis in specialised work groups and task forces. Binding standards for a general increases in the quality of clinical research in Germany are being developed as one means of harmonising the scientific services of the network. The following work groups are currently active: quality management work group: The worldwide harmonisation process in the performance of clinical trials leads to continuous re-adjustments to the legal requirements. The quality management work group ensures that trials at the individual KKS sites comply with national and international laws and standards at all times and satisfy uniformly high quality criteria, i.e. are ICH-GCP conform, and are in agreement with the respective laws and regulations (e.g. AMG, MPG, BDSG, X-ray and radiation protection directive, Declaration of Helsinki). The quality management work group maintains unified standard operating procedures (SOP’s) and thus allows unobstructed cooperation of the KKS in jointly run trials. It also carries out regular workshops for KKS employees. These provide extensive information about various aspects of quality management, as well as current developments concerning laws, guidelines and regulations which are relevant for performing clinical trials. Contact: Dr. Ursula Paulus (Head of methodical devision, ZKS Köln) ursula.paulus@zks-koeln.de Data management/biometry work group: The work group serves to exchange experience and to further the harmonisation of processes in the area of data management/biometry. The scope of the work group lies, amongst other things, in the harmonisation of quality management by preparing standardised instructions for activities (SOP’s) in the field of biometry. Furthermore, it is intended to build up a structure for standardised reports and to promote the exchange of practical experience, for example, regarding the use of SAS MACRO. In the data management area the work group is dealing with, amongst other things, the process analysis of data management/ monitoring using remote data entry systems. A uniform standard throughout the network is also strived for in data management via the harmonisation of quality management (SOP’s). Contact: Dr. Michael Wittenberg (Deputy head of KKS Marburg) michael.wittenberg@kks.uni-marburg.de Training and continuing education work group: Well-trained trial physicians and trial assistants are a fundamental requirement for a high quality standard when performing clinical trials. One of the central tasks performed by the KKS Network is thus the propagation of know-how and skills in connection with clinical trials in medicine and health care. In this respect the KKS is in an excellent position through its close involvement with medical faculties and regional connections to the state medical councils and the highly motivated teaching staff who are available. The KKS Network has developed standardised curricula for various functions involved in performing clinical trials. The course content is checked regularly to ensure it is up-to-date. Uniform evaluation procedures have been agreed for all courses (see Continuing Education/ Events). Courses whose curriculum and evaluation meet the requirements of the KKS Network receive a respective certificate. The KKS thus assigns a quality seal to study assistants and trial physicians. Further course curricula for advancement to principal investigator and monitor are in preparation. Great importance is attached to the exchange of qualified speakers between individual KKS when organising the available courses. Furthermore, the KKS Network offers seminars in the paediatric field and advanced training in speciality areas and for medical and scientific professional associations, for example, “Women in clinical trials”, “Insurance in clinical trials”, “From the idea to the publication”. Contact: Rainer Bredenkamp (Head of ZKS Freiburg) rainer.bredenkamp@uniklinik-freiburg.de |
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