1. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TMF – A Common Platform for Medical Research Networks in Germany Improving the Organisation and Infrastructure of Medical Research in Cooperative Structures TTeC 2006 – Tromsø – June 12, 2006 Antje Schütt Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. Berlin

2. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 2 Increase of cooperative structures Competitiveness of medical research needs  collaboration of research groups at diffenrent institutions and distrubuted locations  collecting, processing, and exchanging clinical data  building up clinical data banks and large patient cohorts  collaboration between research and health care  transfer of knowledge from research to health care  transfer of data from health care into research

3. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 3 Funding initiative of the German Federal Ministry of Education and Research since 1999  Competence Networks in Medicine  disease-oriented  innovation and transfer of results into health-care  17 networks: www.kompetenznetze-medizin.de  Coordinating Centres for Clinical Trials (KKS)  located at university hospitals  resources for planning, conducting and evaluating clinical trials  12 KKS: www.kks-netzwerk.de

4. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 4 Meta-organisation TMF  Networked research: common demands and problems (technical, legal, organisational)  founded in parallel to the Competence Networks and the KKS  central partner for issues of networked medical research  broad focus: technical platform and communication broker within the community  one of the few national central institutions for telematics in health care in Germany

5. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 5 Aims  to improve medical research in terms of quality, organisation and cooperation  to develop high-performance IT infrastructures, implementation in interconnected structures  to solve common questions of networked medical research (e.g. collecting, processing and exchanging research data)  to clarify the legal and ethical framework for conducting medical research  to contribute to sustainable and efficient health research by improved translation of research findings into health care

6. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 6 Members  national networks and institutions  Competence Networks in Medicine  Coordinating Centres for Clinical Trials  Networks for Rare Diseases  German National Genome Research Network  Fraunhofer Institute for Toxicology and Epidemiology  Paul-Ehrlich-Institute  and others  2006: 45 members (2003: 30 members)

7. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 7 Structure

8. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 8 Working groups  IT infrastructure and Quality management  Data protection  Biobanks  Management of clinical trials  Molecular Medicine (about to be initiated)  further 3 forums: Network speakers, CEOs, PR officers

9. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 9 Main topics  Legal and ethical framework conditions  IT infrastructure for clinical research  Interconnection of research and health care  Standards and terminology  Quality management

10. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 10 Legal and ethical frameworks conditions Projects  generic data protection strategies  patients‘ informed consent  biobanks  …

11. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 11 IT infrastructure for clinical research Projects:  pseudonymisation software  SAE management  MediGRID  …

12. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 12 Interconnection of research and health care Projects:  electronic health card /health professional card  IT support for clinical guidelines  interfaces between documentation systems in health care and research  …

13. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 13 Standards and terminology Projects:  evaluation of CDISC standards  CDISC based macros  harmonisation of documentation and ontologies, data dictionaries or clinical values  …

14. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 14 Quality management Projects:  validation of IT systems  Standard Operating Procedures  monitoring strategies for IITs  …

15. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 15 Perspective  considerable experience with networked medical research in a national context  vertical networks unique  „good practice“ for European level  European Commission increasingly addresses topics of networked medical research, e.g.:  Interoperability  Patient Safety  Translational research

16. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. TTeC, June 12, 2006 – Antje Schütt page 16 Functions of the TMF  central contact point for initiatives on a European level  with access to experts and potential partners (from medicine to methodology)  participates in initiatives of standardisation  promotes on a political level important topics in the field of health care and health research  members provide “good practice” in the area of Translational Research

17. Telematikplattform für Medizinische Forschungsnetze (TMF) e.V. Thank you! Further information & contact: Internet: www.tmf-ev.de/site/EN eMail: info@tmf-ev.de Phone: +49 – 30 – 31 01 19 50