title: Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model.
abstract: BACKGROUND
  With the amendment to the German Drug Law in 2004, the conduct of clinical trials changed by at least two main aspects: (1) The principles of Good Clinical Practice (GCP) were implemented in the national legislation, and (2) for the first time, the function of the sponsor of a clinical trial and the clinical trial itself have become legally binding definitions. By that, legal differences between industrial and academic clinical trials no longer exist. Clinical trials initiated by investigators have to fulfil the same requirements while the entire sponsor responsibility has to be carried out by the Coordinating Investigator or his institution including implementation of a quality management system according to the GCP.
  
  
  OBJECTIVE
  The Cologne Sponsor Model is an effective approach with settings, structures, basic features, action, and reporting lines, as well as funding for clinical trials initiated in an academic environment.
  
  
  RESULTS
  The University of Cologne assumes the sponsor responsibility for clinical trials organised by the university researchers according to law. Sponsor's duties are delegated to a central operational unit of the sponsor - the Clinical Trials Center Cologne - which further delegates duties to the Coordinating Investigator. Clinical Trials Center Cologne was established in 2002 to support the performance of clinical trials at the university by offering comprehensive advisory and practical services covering all aspects of study planning and conduct. Furthermore, a specialised division of its quality management department acts as an independent sponsor's Quality Assurance Unit. The Clinical Trials Center Cologne has established a quality management system consisting of different components (1) to enable a reasoned decision to subsequent delegation, (2) for risk-based surveillance of trial conduct (audits, monitoring-checks, and reports), and (3) support and training of the Coordinating Investigator.
  
  
  CONCLUSIONS
  Double functions of persons and departments in the university environment sometimes make it difficult to define roles in such a model. Therefore, it is necessary to establish clear reporting lines and moreover to monitor regularly and carefully the roles and responsibilities.
  
  
  CONCLUSIONS
  With the combination of central management and support, control and independence of the researchers, our model represents a 'risk-based' system that offers a sensible option that fulfils the requirements of legal regulations and GCP for trials organised within the university environment.
authors.affiliation: Clinical Trials Center Cologne, University of Cologne, Germany. christine.georgias@uk-koeln.de
authors.forename: Christine
authors.initials: C
authors.lastname: Georgias
authors.forename: Andrea
authors.initials: A
authors.lastname: Grunow
authors.forename: Miriam
authors.initials: M
authors.lastname: Olderog
authors.forename: Alexander
authors.initials: A
authors.lastname: May
authors.forename: Ursula
authors.initials: U
authors.lastname: Paulus
mesh_terms: D000046:Academic Medical Centers / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods; D005858:Germany; D006801:Humans; D016365:Liability, Legal; D017146:Models, Organizational; D024382:Professional Role; D011786:Quality Control; D012107:Research Design; D012109:Research Support as Topic / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D014495:Universities / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration*