WG Quality Management

Whereas there are mandatory regulations for drug approval trials (e.g. law of drugs (AMG), MPG and the GCP guidelines) there still aren't such rules for quality assurance protocols. Quality assurance protocols only use drugs in therapies which are approved for the respective disease entity. They are a very important instrument, to test new combinations of approved drugs and to advance new methods of therapy. Their results have a direct consequence on the therapy of future generations of patients.

Working group Quality Management

Therefore it is very important to develope adequate quality standards - particularly with regard to the shortness of resources - also for quality assurance protocols, which are indebted to the declaration of Helsinki and the "Good Clinical Practise" and which account for the characteristics of the quality assurance. Because the study groups being involved in the competence network predominantly perform quality assurance protocols, the working group "Quality Management" was created to develope such quality standards among other things.

Furthermore the working group is developing computer-based tools for quality management to support the quality oriented strategy, development and evaluation of the clinical study. In the following the fields of functions will be introduced, which will develope the quality standards.

Diversified competences

In addition to the quality managers who are assigned to the three study groups GLSG, DSHNHL and DHSG there are also associates from other study groups. Moreover there are envolved extern quality management groups, e.g. someone from the KKS for clinical studies. In this way, there is a good base for quality arrangements.

Four Topics

The working group is engaged in the developement of quality standards with four topics:

Good Clinical Practise

The GCP guidelines should be concretised in compliance to the AMG and MPG. They should consider the special situation of quality assurance protocols and provide the efficiency and the evidence of clinical trials.This concretisation results from instructions - the Standard Operating Procedures (SOPs) -. Before becoming effective, the SOPs must pass an expert opinion in the study groups and the Competence Network Malignant Lymphomas. At the time the working group developes an internet based software, which should be established to update the SOP-system.

Study documents

In addition to the SOP system a master protocol for quality assurance protocols will be developed, which facilitate the elaboration of future study protocols by providing essentiel components of a study protocol which are defined in the SOPs. Furthermore the Case Report Forms of the study groups DHSG, DSHNHL and GLSG should be harmonised, to prepare and facilitate the computer based documentation. For that purpose the documentation features e.g. laboratory values and adverse reactions has been compared and adapted as far as possible together with the network assistents and the physicians of all participating central trial offices.

Term Definitions

Similary the adaption of terms is planned, because some of them were not defined in a standardised manner and were used different (e.g. bulk definition). For that purpose frequently used terms are collected and discussed with experts. Additionally the aim is to facilitate the activity of the physicians of the participating centers and to prepare the computer based documentation.

Evaluation

To evaluate the success of the quality procedures, the quality of documentation in the study centers must be evaluated before and after establishing these proceedings. In a first step the actual state of the quality of documentation in the study centers of the GLSG, DSHNHL and DHSG will be elevated.

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