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