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DCRIN, Copenhagen Trial Unit and Danish clinical research Christian Gluud,

DCRIN, Copenhagen Trial Unit and Danish clinical research Christian Gluud, DCRIN, National Coordinator CTU, Head of Department. DCRIN - Danish Clinical Research Infrastructures Network Jens Sandahl Christiansen, Torben Lauersen, Aarhus University

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DCRIN, Copenhagen Trial Unit and Danish clinical research Christian Gluud,

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  1. DCRIN, Copenhagen Trial Unit and Danish clinical research Christian Gluud, DCRIN, National Coordinator CTU, Head of Department

  2. DCRIN - Danish Clinical Research Infrastructures Network Jens Sandahl Christiansen, Torben Lauersen, Aarhus University Ove Andersen, The Research Unit, Hvidovre Hospital Arne Astrup, Depart. Human Nutrition, Copenhagen University Hans Jørn Kolmos, Per Damkier, and Kim Brøsen, Odense University Gedske Daugaard, Department of Oncology, Rigshospitalet Peter Gimsing, Depart. of Haematology, Rigshospitalet Karin Friis-Back, The GCP Unit, Copenhagen University Annette Jørgensen, The GCP Unit, Odense University Charlotte Calov, The GCP Unit, Aarhus University Jørn Wetterslev, and Christian Gluud Copenhagen Trial Unit (CTU), Rigshospitalet, Copenhagen University

  3. GCP units: Unique in Europe • Established to comply with the EU • Directive • Planning • Monitoring • 30 full time positions • 2 million Euro

  4. GCP units • discussion of the trial protocol • guidance in patient information • case report forms • notification of regulatory authorities • initiation visits • GCP monitoring • adverse event reporting • correct archiving • closure visits • standard operating procedures

  5. Monitoring data in clinical trials Source data Case record forms Data entry into computers Data cleaning Data analyses Report plus publications

  6. Data flow - future need for monitorering - the ’custom’ model Source data Publication • IN DEPT MONITORING OF TRIALS ACCORDING TO • RISK ASSESSMENT AND • RANDOM SELECTION

  7. Copenhagen Trial Unit (CTU) • Centre for Clinical intervention Research • Objectives • Conduct scientifically valid randomised trials • Conduct scientifically valid systematic reviews • with meta-analyses of randomised trials • Develop these two areas • Educate postgraduatedly on these two areas

  8. Copenhagen Trial Unit (CTU) • Centre for Clinical intervention Research • Established 1995 • 15 clinical researchers and research • assistants • Yearly budget 700,000 Euro • A trial service unit, not a control • organisation

  9. Copenhagen Trial Unit (CTU) • Centre for Clinical intervention Research • Conduct scientifically valid randomised trials • 40 randomised clinical trials • psychiatry to foot warts • total of 15,000 randomised

  10. Copenhagen Trial Unit (CTU) • Conduct scientifically valid systematic reviews • with meta-analyses of randomised trials • The Cochrane Hepato-Biliary Group since 1996 • More than 1400 members • More than 330 registered titles • More than 279 protocols • More than 121 systematic reviews • Fifth most productive Cochrane Review Group

  11. Copenhagen Trial Unit (CTU) • Develop these two areas • Randomisation systems • Data management systems • Trial sequential analyses

  12. Copenhagen Trial Unit (CTU) • Educate postgraduatedly on these two areas • Numerous train-the-trainer courses and • workshops • Biannual CHBG meetings during • EASL/AASLD meetings • Digestive Disease Week meetings

  13. Thank you !

  14. D W E A D N F A Regulatory framework Proposal Authorised D M A R E C D D P A

  15. D W E A D N F A Regulatory framework Proposal Authorised D M A R E C D D P A CT on MP CT using gene therapy /GMOs

  16. D W E A D N F A Regulatory framework Proposal Authorised D M A R E C D D P A CT on MP CT using gene therapy /GMOs CT using herbal, vitamin, mineral CT on MD

  17. D W E A D N F A Regulatory framework Proposal Authorised D M A R E C D D P A CT on MP CT using gene therapy /GMOs CT using herbal, vitamin, mineral CT on MD No MP (nutrition, diagnistic, OTT, non-interventional) No MP retro, obs, non-interventional, no bio samples

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