Author: Julia Hannemann, Irene Krämer, erstellt 2003/12/17, Editor: Dr. med. Ralf Herold, Last modification: 2004/06/16

The quality management system for GPOH trials is accessed through the Quality House. It is a comprehensive map of structures and processes for design and realization of a trials. The Quality House is where developmental results and tools are provided.

Steering processes form the houses roof. These processes are part of the management's (trial leaders) responisibilities (e.g. financing, study design and organization).

The foundation is made up of support processes. They are essential for all other parts of a trial (e.g. IT provision, accountancy, supply of material).

So called revenue processes form the houses middle part. Revenue processes describe the steps necessary for achieving the goal set for the trial. One goal of the trial coordination centers work for example is to assure an optimized treatment of the patient.

The Quality House's revenue processes take place in the trial coordination centers or the hospitals in which trial patients are treated.

The Quality House allows to access descriptions of the revenue processe's single steps in form of flow charts.

Elements of the process description:

• Headline: process title, person in charge, process number
• Footer: version number and date, clearance
• Left side: linked documents, templates, data bases, etc. necessary for the process step
• Right side:
• Interfaces: exchange with other processes or institutions (data, information, questionnaires, findings, etc.)
• Responsibilities: a person in charge is assigned to every process step (List of tasks/positions). If a trial coordination center lacks the respective specialist, another employee has to be assigned the defined tasks.)

Elements of the flow chart:

• Oval: defined starting and end point of a process
• Diamond: decision field (arrow down: yes, arrow sideways: no)
• Box: single steps
• Blue delta: quality condition needed to be fulfilled at the respective point
• Magenta delta: Difficulty within process, description of improvement suggestions and measuerements needed to be developed

Every field contains a link to detailed definitions, descriptions, and information about available job instructions. These descriptions can be accessed directly within the document by moving the mouse over the respective field. The complete content is also available for download as a PDF document (click the 'description' button in the upper left hand corner of the process description). A PDF document containing the flow charts can be downloaded by clicking on 'Diagram' in the upper right hand corner.

The Quality House is still under construction. Nevertheless would we like to grant the members insight into the processes. Some elements are still being discussed and are therefore marked yellow. These elements are being revised and adapted by and by.

Take a look into the Quality House find out more about the work of a trial coordination center (access restricted)

The Quality House is displayable with MS Internet Explorer only. We apologize for the inconvenience.