Ethical Aspects of Clinical Research

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Package Price: € 3230 A massive saving of € 420,00 €€VSCR Vienna, 22 – 27 March 2010 Duration – 5 days + e-course module Clinical Research Diploma For the first time you can now gain a “VSCR Clinical Research Diploma” in one week long course. Introduction to Clinical Research 22 - 24 March 2010 Description This course has been designed to deliver a good basic foundation to all professionals interested in clinical research. Lectures are supplemented by workshops throughout the program giving participants the opportunity to apply knowledge learned in practical exercises and case studies. Introduction to Biostatistics 25 – 27 March 2010 Description This course has been designed to provide intensive, practice-oriented training for clinical research professionals. The objective of this course is to give participants a basic understanding of the more common statistical tests that are applied in surveys and clinical trials. The participants will be able to apply defined methods to simple, relevant situations. Topics • • • • types of data types of data distributions risk and rates hypothesis testing and confidence intervals • significance tests • correlation and regression Introduction to Good Clinical Practice E-course Description This course has been designed to provide intensive, practice-oriented training for clinical research professionals. The objective of this course is to give participants a basic understanding of the more common statistical tests that are applied in surveys and clinical trials. The participants will be able to apply defined methods to simple, relevant situations. Topics • historical background of ICH-GCP and clinical research rules, • regulations and guidelines • roles and responsibilities of sponsors, investigators and ethics committees • essential documents Topics • the drug development process • principles of toxicology and pharmacology • basics of biostatistics • clinical trial design and methodology • the study protocol • informed consent • patient protection • safety reporting • quality assurance • technical skills training Usual Price: € 2,350 Usual Price: € 1050 Usual Price: € 250 If you have already participated in and successfully passed the final examination for 1 or more of the components of this package please contact us to discuss your individual package price. Book early for further discounts: 10% off bookings made before December 22nd 2009 5% off bookings made before February 22nd 2010 Vienna School of Clinical Research Kölblgasse 10, 1030 Vienna, Austria www.vscr.at +43 (0) 1713 40 510 The Faculty The course faculty is drawn from a pool of leading international experts including university professors, clinical researchers, ethics committee members, industry representatives and representatives from other relevant areas. Faculty members are contracted in by the VSCR and are committed to provide independent teaching of state of the art principles. Application Criteria The following pre-requisites should be met by applicants: • fluency in the English language Pricing, Discounts and Scholarships Introduction to clinical Research Introduction to Biostatistics Introduction to Good Clinical Practice The package price: All prices indicated above include: • course fee • course material • lunch and refreshments • group dinners where applicable Early Booking Discounts are available for early booking and group bookings: • • Bookings made more than 3 mths in advance of course start date receive a 10% discount Bookings made more than 1 mth in advance of course start date receive a 5% discount € 2,350.00 € 1,050.00 € 250.00 € 3,230.00 Certificates Certificates will be provided to all participants subject to participation (minimum of 90%) and final exam result. Certificate Participation Pass Distinction Requirement Attendance of at least 90% of the total course duration. (Excluding breaks) 90% attendance plus 60% correct multiple choice responses in final exam 90% attendance plus 90% correct multiple choice responses in final exam This course has been submitted for CME credits to the following bodies: • • Österreichische Akademie der Ärzte (DFP) European Accreditation Council for Continuing Medical Education (EACCME) This certificate is acknowledged for: • • • • VSCR Junior Clinical Research Associate/Monitor Diploma VSCR Senior Clinical Research Associate/Monitor Diploma MUW Postgraduate Diploma in Clinical Research MUW Master of Science in Clinical Research Vienna School of Clinical Research Kölblgasse 10, 1030 Vienna, Austria www.vscr.at +43 (0) 1713 40 510

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