Master of Science in Clinical Research

Master of Science in Clinical Research

Master of Science in Clinical Research Clinical research competence to improve patient care. Programme Description Clinical research plays a major role in translating scientific advances into improvement of patient care and optimal health resource allocation. Clinical research has become a sophisticated science requiring researchers to obtain highly specific training in health research methodology to assure ethical conduct and generation of valid results of clinical studies. This master programme is intended for university graduates in natural sciences with professional experience who pursue a career in health care research. Its objective is to qualify participants for designing, conducting, analyzing, and presenting clinical studies. The programme provides students with a solid understanding of health research methodology and biostatistics, and confers practical skills, e.g. in project management. Students will also become familiar with international legal and ethical standards in clinical research. Graduates of the programme will acquire the competence to successfully lead research projects and compete on an international level. The programme comprises 90 ECTS (European Credit Transfer System). The curriculum is structured in 3 modules consisting of blocked workshops, and a final thesis. Optional workshops in module III allow the selection of individual tracks within the programme. This is a part-time programme allowing professionals to remain on their job and to potentially integrate the training with their professional activities. Workshops are offered several times per year and may be taken in flexible order within modules. Consequently, students have maximal flexibility regarding completion of workshops and the overall duration of their programme. The minimum duration is 2 years. All training and the whole programme material is in English. Faculty The programme has been developed and is delivered by the Medical University of Vienna (MUW) in co-operation with the Vienna School of Clinical Research (VSCR). The faculty members are drawn from the MUW academic staff and international experts in multiple disciplines. Participants of the programme will benefit from the national diversity and the different professional backgrounds of the faculty as well as of the other students.

Curriculum MODULE I: Basics of Clinical Research (25 ECTS) Introduction to Clinical Research 4,5 ECTS Introduction to Good Clinical Practice / e-learning 2,3 ECTS Advanced Good Clinical Practice 3,4 ECTS Introduction to Clinical Epidemiology 3,4 ECTS Introduction to Biostatistics 3,4 ECTS Publication Workshop 5,6 ECTS 2 Tutorials 2,4 ECTS Written exam for Module I MODULE II: Detailed Planning of Clinical Studies (20,5 ECTS) Ethical Aspects of Clinical Research 4,5 ECTS Systematic Reviews to Support Reimbursement Decisions 6,8 ECTS Protocol Development Workshop (in one of the therapeutic areas offered: cardiovascular medicine, oncology, psychiatry, endocrinology, infectious diseases) 6,8 ECTS 2 Tutorials (interpretation of clinical studies from the literature) 2,4 ECTS Written exam for Module II MODULE III: Master Module 29,5 ECTS MANDATORY: Publication Masterclass 5,6 ECTS Advanced Biostatistics (including homework) 9 ECTS 2 Tutorials 2,4 ECTS Written exam for Module III ELECTIVES: minimum 12,5 ECTS (2-4 courses required) Health Economics 6,8 ECTS Health Policy 6,8 ECTS Health Care and Social System 6,8 ECTS Project Management 3,4 ECTS Pharmacovigilance and Safety Reporting 3 ECTS Effective Patient Informed Consent 3 ECTS Essential Skills for Clinical Research Associates/Monitors 5,6 ECTS SOP Writing 3 ECTS further workshops in development MASTER THESIS: 15 ECTS - Written preparation of a study protocol - Written review of a study protocol - Oral presentation of the study protocol

Admission Criteria Successfully passed graduate degree in natural sciences (Master degree or equivalent with at least 300 ECTS) Fluency in English language (spoken and written) Successful admission interview with one of the programme directors Registration and Tuition Fees Programme office: Koordinierungszentrum für Klinische Studien Medical University of Vienna Vienna General Hospital Borschkegasse 8b, A-1090 Wien Level 06 Phone: +43-1-40400-2163, Fax: +43-1-40400-2372 clinical-research@meduniwien.ac.at http://www.meduniwien.ac.at/kks Tuition fee: 15.000,- Euro (1 st rate of 7500,- Euro due upon registration) Medical University of Vienna Reference (Verwendungszweck): LG 15019000 Account no.: 40410070700 Sort code: 20111 (ERSTE Bank) BIC (SWIFT): GIBAATWW / IBAN: AT36 2011 1404 1007 0700 Register as an external student at the Medical University of Vienna (außerordentlicher Hörer); registration fee of 150,- Euro (due upon registration) Vienna School of Clinical Research Reference (Verwendungszweck): [As reference please use your name] Account no.: 51262 398 702 Sort code: 12000 (Bank-Austria) BIC (SWIFT): BKAUATWW / IBAN: AT52 1200 0512 6239 8702 Please submit the following documents in either hard copy or electronic format to the programme office: o Curriculum vitae o University degree certificate o Application form, passport picture o Confirmation of payment (first rate of the tuition fee) Detailed information on workshops, course schedules, registration for individual workshops, course locations: Vienna School of Clinical Research Kölblgasse 10, A-1030 Vienna, Austria Phone: +43-1-7134051-0, Fax: +43-1-7134051-99 vscr@vscr.at www.vscr.at

Programme directors: Christoph Male, MD, MSc, Assoc. Prof. Department of Paediatrics, Medical University of Vienna and Johannes Pleiner-Duxneuner, MD, Assoc. Prof. Department of Clinical Pharmacology, Medical University of Vienna Master Degree Requirements for completion of the programme are: Successfully completion of all mandatory and the required number of elective courses (each including a written examination) and the tutorials Written examination after each module Final thesis (study protocol) and oral presentation Graduates of the programme will be awarded the degree: Master of Science in Clinical Research. All courses are submitted for accreditation to the following bodies: for CME credits to the European Accreditation Council for Continuing Medical Education (EACCME) an institution of the European Union of Medical Specialists (UEMS) for DFP credits to the Austrian Medical Chamber.