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Quality Management

Ensure and managing quality

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CTCC understands clinical Research as backbone of patient care.

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 of the CTCC tends to ensure all quality relevant processes, arrangements and procedures. We are certified according to DIN ISO 9001. This signet stresses our ambition to fulfill expectations of clients, partners, providers and staff in order of legal requirements and our own approach.

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 centralised work processes in confirmation 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

  • Nov 2016: Routine Surveillance Visit: DIN ISO 9001
  • Apr 2016: FSN Service successfully inspected by the FDA
  • Nov 2015: Routine Surveillance Visit: DIN ISO 9001
  • Jan 2015: Partial Audit: Safety Management
  • Oct 2014: Re-Certification Audit: DIN ISO 9001
  • Nov 2013: Routine Surveillance Visit: DIN ISO 9001
  • Oct 2012: Routine Surveillance Visit: DIN ISO 9001
  • Nov 2011: Certification Audit: DIN ISO 9001
  • 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 2009: Partial Audit: Data Management
  • Nov 2008: Inspection of the Paediatric Module (located in CTCC)
  • Nov 2006: Partial Audit: Monitoring
  • Dec 2003: System Audit