Author: Julia Hannemann, Irene Krämer, erstellt 2003/11/16, Editor: Dr. med. Ralf Herold, Last modification: 2004/06/16

Why?

The quality assurance program aims at improving both patient care and the doctors levels of experience by optimizing the work of trial coordination centers and hospitals. Fulfillment of certain quality criteria is also a legal requirement and that of our sponsors. Mapping of the work flow is a tool for on-the-job training of new employees. Standardized protocols and questionnaires for example, ease the work of participating hospitals.

How?

In order to establish a quality management system the trial coordination centers' work flows are systematically mapped and described (see 'Quality House'). Pros and Cons of it's organization are determined and mapped in process descriptions. Possible deficient procedures are eliminated by and by, and the work flow is adapted to emerging new requirements. This assures that the work flow is kept on an optimal level, a structured job profile of trial center employees is provided, and optimal use of available resources is made. An extensive phase of analysis shall make sure that energys are focused on the right spots and a lasting framework for improvements is set up.

The Working Committee 'Quality Assurance for GPOH Clinical Trial Centers' (AG QS), responsible for formulating quality control procedures was founded in February 2003 . This committee consists of documentation officers and medical doctors from different trail coordination centers. It’s led and organized by members of the Study Support Group. They develop templates and forms for the support and simplification of trial realizations that are afterwards discussed and reviewed by the committee. Initial main objective of this work is the standardization of trail protocols and an adequate implementation of GCP criteria.

The following objectives are to be met:

Easier, concise creation of protocols:

• Standardized tabel of contents for GPOH trial protocols (resolution about to be passed)
• Adaption of GCP checklists for study planning developed by the German Cancer Society (Deutsche Krebsgesellschaft) to the needs of GPOH studies (under way)
• Development of an adapted master protocol for pediatric oncology in reconcilement with the German Cancer Society (Deutsche Krebsgesellschaft) (expected summer 2004)
• Improved clarity through standardization (protocol, questionnaire)

Improved trial organization:

• Introduction of a trial master file (in use since March 2003)
• Provision of relevant information for creation of trial protocols, realization of trials, guidelines, regulations for employees of trial coordination centers
• Development of standard operating procedures (being planned)
• Faster and easier on-the-job training of new employees by use of training tools (being planned)

Conception of measures for improvement, such as the trial master file and the table of contents, began before the Working Committee was founded. Conceptional work is done parallel to the development of the systematic framework. Smaller improvements are realized on short notice.