«Quality Assurance» Working Group
With the overall objective to improve the patient safety and integrity of the collected data in clinical trials, the working group has developed an overall concept to improve and harmonise the quality assurance within the CTU-Network.
The main cornerstones of the concept are:
- The Quality Policy, approved in 2010. With this policy the CTUs commit to implement a process-oriented and continuously improved quality management system respecting all applicable legal and regulatory requirements.
- The Guidelines for Good Operational Practice (GGOP), introduced in 2011. They represent jointly defined quality standards for the operational practice of the CTUs and affect their management systems as well as the conduct of clinical research projects.
- Audits: regular audits of the implemented quality management systems are planned for the future.
Quality Policy (pdf, 70.0 KB)