[Quality standards and their assurance for study centers in the competence network malignant lymphoma].
BACKGROUND
The aim of most of the trials of the Competence Network Malignant Lymphoma is to optimize the standard treatment of lymphoma using only registered drugs in the case of medicinal therapies (quality assurance protocols). In contrast to regulatory trials, special regulations for quality assurance protocols are not given by the legislature. However, there is agreement that also for this type of studies the declaration of Helsinki and the Guidelines of the International Conference on Harmonisation (ICH) are relevant. The ICH Guidelines must be formulated to take into account the specific situation of quality assurance protocols and to ensure at the same time efficiency and transparency of these studies. This is the aim of the quality management of the study groups in the Competence Network Malignant Lymphoma.


METHODS
The quality assurance measures already established in the study groups are being expanded to a comprehensive quality management concept in agreement with the ICH Guidelines and allowing for the situation of quality assurance protocols. To this end, a working group for quality management (AG-QM) has been set up to define and establish general quality standards for all aspects of planning, executing and evaluating quality assurance protocols in study centers.


RESULTS
The AG-QM has developed a system of Standard Operating Procedures (SOPs) reflecting all working procedures of the study centers. Furthermore, evaluation parameters for the quality of trial execution have been identified and the harmonisation of documentation parameters has been initiated. Term definitions are collected and their harmonisation coordinated.


CONCLUSIONS
Development of quality standards is the first step of quality management. To ensure the realisation of these standards in practice, the AG-QM will establish quality assurance measures including continuous reevaluation of quality criteria and actualization of quality standards if necessary.
Pfistner
B
B
Studienzentrale der DHSG, Koordinierungszentrum für Klinische Studien Köln (KKSK), Klinikum der Universität zu Köln, Germany. beate.pfistner@biometrie.uni-koeln.de
Mehl
C
C
Klöss
M
M
Löffler
M
M
Herrmann-Frank
A
A
Diehl
V
V
D006381:Helsinki Declaration; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy / Q000628:therapy*; D008499:Medical Records; D017410:Practice Guidelines as Topic; D011364:Professional Practice / Q000592:standards; D011785:Quality Assurance, Health Care; D017749:Total Quality Management