In the late 1990s a funding program was set up by the federal German government to help keep stride with developments in the international research arena. Within this programme, Coordinating Centres for Clinical Trials ("Koordinierungszentren für Klinische Studien", KKS) were established at 12 German universities aiming at supporting all processes of academic clinical trials according to international standards. A close network infrastructure was chosen in order to reap maximum benefit from synergy effects and to promote the harmonisation of standards. Continuing to grow, the KKS Network currently has 16 research institutions as members. More than 400 employees within the KKS Network provide scientific services to clinical trials at universities, hospitals and in industry. In cooperation with study clinics, surgeries, study groups and competence networks in medicine within Europe and beyond, the KKS supports many different research projects covering all areas of medicine. The KKS Network contributes expertise to legislative processes within Germany and Europe through its work in professional committees and working groups. A wide range of education and training concepts supports clinical research as a scientific field in its own right. After nearly ten years the KKS Network has established itself as an indispensable partner in the field of clinical research.

Many healthcare providers digitize their paper-based patient records from routine care, destroying originals (replacing scanning). Current regulations are unclear as to which paper-based patient records may be destroyed after digitization if the respective patients participate in clinical trials. GCP-compliant destruction is possible if both sponsors and authorities recognize the digital copies as source documents. Recognition should be based on digitized paper-based patient records complying with the requirements for certified copies defined in 'Note for Guidance -CPMP/ ICH/135/95'. This paper describes principles by which digitized patient records can be recognized as GCP-compliant certified copies, allowing the paper-based originals to be destroyed. A prerequisite is written proof that the digitization process implemented is controlled and its outcome quality is permanently monitored. Keywords: certified copy • CPMP/ICH/135/95 • digital archiving system • digitization • GCP-compliant digitization • Good Clinical Practice • paper-based patient records • source documents

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Das Netzwerk der Koordinierungszentren für Klinische Studien (KKS) umfasst 17 Institutionen, die bundesweit als akademisch verankerter Wissenschaftsdienstleister für Universitäten, Studiengruppen, die pharmazeutische und medizintechnische Industrie sowie weitere Auftraggeber, die im Umfeld klinischer Forschung tätig sind. Die KKS sichern die Good Clinical Practice (GCP)-konforme Planung, Durchführung und Auswertung klinischer Studien mit einer breiten Palette an Studiensupport. Ein indikationsspezifischer Schwerpunkt ist die Krebsforschung. Expertise in der onkologischen Forschung kann bundesweit und standortübergreifend abgerufen werden. Das KKS-Netzwerk kooperiert mit medizinischen Fachgesellschaften und anderen, auch europäischen Zusammenschlüssen in derzeit 20 Ländern und hat sich als belastbare Plattform für onkologische Studien profiliert.