According to the GCP Guidelines, a clinical trial sponsor is responsible for implementing and maintaining quality assurance and quality control systems.
ZKS Münster has established an appropriate quality management system which ensures
- Compliance with GCP Guidelines, ethical and regulatory requirements
- Safeguarding of rights, safety and well-being of trial subjects
- Trial quality in terms of planning, organisation, conduct, documentation, analyses, reporting and archiving
- Early detection, correction and further prevention of problems and mistakes