Quality Management

CTCC is obligated by the University of Cologne (UoC), by national law (i.e. AMG, MPG) and international regulatory bodies (i.e. ICH-GCP, DIN ISO 14155, DIN ISO 9001) to uphold quality standards. The quality management mandate of CTCC contains the following components:

Continuous management and updating of a comprehensive system of Standard Operating Procedures (SOP).

Verification that centralized work processes are conform with SOPs.

Continued training of staff through regular courses as well as internal and external advanced education.

Participation in national and international specialty committees, i.e. in the Network of the Coordination Centers for Clinical Studies (KKS Network) and in the European Clinical Research Infrastructure Network (ECRIN). 

Successful audits are the following 

  • Dec 2003: System Audit
  • Nov 2006: Partial Audit: Monitoring
  • Nov 2008: Inspection of the Paediatric Module (located in CTCC)
  • Nov 2009: Partial Audit: Data Management
  • Jun 2010:  BMBF (Federal Ministry of Education and Research) – System Audit of  implementation and operation of CTCC and its associated clinical trial Units (CTUs)
  • Nov 2011: Certification Audit: DIN ISO 9001
  • Oct 2012: Routine Surveillance Visit: DIN ISO 9001
  • Nov 2013: Routine Surveillance Visit: DIN ISO 9001
  • Oct 2014: Re-Certification Audit: DIN ISO 9001
  • Jan 2015: Partial Audit: Safety Management
  • Nov 2015: Routine Surveillance Visit: DIN ISO 9001
  • In addition the FSN Service was successfully inspected by the FDA in April 2016.
  • Nov 2016: Routine Surveillance Visit: DIN ISO 9001

For more specific information please contact:
Drita Meta
CTCC Quality Management
Phone: +49 221 478 88148