title: Quality management for clinical trials within the German Competence Network Paediatric Oncology and Haematology.
abstract: The German 'Competence Network Paediatric Oncology and Haematology' aims at improving the structure of paediatric oncology and haematology as a whole, focussing in particular on the quality of clinical trials and study co-ordinating centres. This comprises the following measures: (1) Employment of research and trial assistants in order to improve the quality of documentation and study management in the participating hospitals. (2) Development of an internet portal to provide medical information for non-professionals, for patients and their families as well as for health professionals. (3) The project group 'Central Trial Support' supports study centres during the process of writing and examining new treatment protocols so that they are in compliance with the Good Clinical Practice criteria, formal criteria, legal requirements and statutory provisions. This group currently produces a structural standardisation of study protocols and case record forms in order to improve their usability. The 'Competence Network Malignant Lymphomas' is a project with similar aims and will be outlined for comparison.
authors.affiliation: Koordinationszentrale KPOH, Hannover und Klinik für Pädiatrie m.S. Hämatologie/Onkologie, Campus Virchow-Klinikum, Charite Universitätsmedizin Berlin, Germany. ursula@creutzig.de
authors.forename: Ursula
authors.initials: U
authors.lastname: Creutzig
authors.forename: Martin
authors.initials: M
authors.lastname: Zimmermann
authors.forename: Julia
authors.initials: J
authors.lastname: Hannemann
authors.forename: Irene
authors.initials: I
authors.lastname: Krämer
authors.forename: Beate
authors.initials: B
authors.lastname: Pfistner
authors.forename: Ralf
authors.initials: R
authors.lastname: Herold
authors.forename: Günter
authors.initials: G
authors.lastname: Henze
mesh_terms: D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D005260:Female; D005858:Germany; D006078:Government Programs / Q000458:organization & administration; D006405:Hematology / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007373:Interinstitutional Relations; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D010372:Pediatrics / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D011361:Professional Competence / Q000592:standards; D011785:Quality Assurance, Health Care / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D017749:Total Quality Management / Q000379:methods / Q000458:organization & administration* / Q000592:standards