[The "quality house pediatric oncology" as an instrument for improving the performance of the trial centers].
The project group "Central Trial Support" of the German Competence Network Pediatric Oncology and Haematology supports the members of the Society of Pediatric Oncology and Haematology in their effort to cope with the growing statutory, ethical and administrative requirements for therapy optimization studies (investigator-initiated, non-profit clinical trials). By these quality improvement measures the studies will become more revisable and reliable, but at the same time their processing will become more and more complex. The basic instrument of the project group "Central Trial Support" will be the so-called "Quality House" which has been built up in order to improve the performance of the associated study centres and to help put a systematic quality management system into practice. The "Quality House Pediatric Oncology" comprises detailed descriptions of the activities of all trial center co-workers. Its process map details all operational sequences which constitute an efficiently performing trial center. The so-called value adding processes are explained step by step, and the associated specific tasks are assigned to each respective co-worker. At each process step, the person in charge will have explanatory descriptions at her/his disposal and - if necessary - further problem solving means as well as references to possible optimization measures (e. g. Standard Operating Procedures and other documents). The German Competence Network Pediatric Oncology and Haematology will be implementing this electronic quality management system in trial centers which will convince both sponsors and authorities of the compliance with requirements and standards.
Creutzig
U
U
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Str. 33, 48129 Münster. ursula@creutzig.de
Hannemann
J
J
Krämer
I
I
Zimmermann
M
M
Herold
R
R
Marx
J F
JF
D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards*; D005858:Germany; D006405:Hematology / Q000592:standards*; D006801:Humans; D008495:Medical Oncology / Q000592:standards*; D015337:Multicenter Studies as Topic; D010372:Pediatrics / Q000592:standards*; D012106:Research; D012955:Societies, Medical; D017749:Total Quality Management