COURSE PORTFOLIO
COURSE PORTFOLIO
Basic Courses
Basic Good Clinical Practice (eCourse)
(more details)
This course provides researchers who are new in the field of clinical research with basic information and covers elements of Good Clinical Practice (provides intensive and practice-oriented training for clinical research professionals (Duration: 5-8 hrs)). You can start the course conveniently from your home or even during your nightly shift at the hospital. No time is lost by travelling. You will receive a certificate showing you have a basic knowledge of GCP.
SOP Writing (eCourse)
(more details)
This practical and straightforward e-learning course will give you the basic skills necessary to start writing SOPs and details the process necessary to get ensure effective implementation within your organization. The course content will take approximately 2-3 hours to complete at the end of which participants are expected to create a SOP on SOPs for submission to the Vienna School of Clinical Research for evaluation.
Introduction to Good Clinical Practice
A two day course covering all elements of Good Clinical Practice (ICH GCP). Lectures will be supported by examples from real clinical studies and workshops. This course is suitable for beginners in clinical research as well as a refresher for more advanced researchers.
Introduction to Clinical Research
(more details) A two day course for beginners in clinical research. Experts in the field of clinical research will present the history of clinical research and will teach the principle concepts of the different phases of clinical research, including preclinical development, biometrics and study design, patient protection and safety reporting.
Introduction to Biostatistics
(more details)This course has been designed to provide practice-oriented training for clinical research professionals interested in biostatistics. The objective of this course is to give participants a basic understanding of the more common statistical tests that are applied in clinical trials. The participants will be trained to apply defined methods to simple and relevant situations.
Introduction to Good Clinical Laboratory Practice
This course has been designed to provide practice-orientated training for clinical researchers interested in laboratory work and to introduce the principles and basic concepts of Good Clinical Laboratory Practice. The overall objective of this course is to give participants an understanding of the principles of GCLP and the related international guidelines including OECD, FDA, ISO as well as other guidelines.
Biomarker and Personalized Medicine
(more details)This course will provide the opportunity for reinforcement of basic principles and concepts of biostatistics through hands-on exercises, followed by more advanced and complex biostatistical methods. This modular course consists of parts: a 3-day introduction, a 2 month period for exercises to be performed at home, and a 4-day advanced course. The target audience for this course will have knowledge of the basic principles of biostatistics and they can expect practice oriented training in more complex statistical methods.
Advanced Courses
Advanced Biostatistics
(more details) This course will provide the opportunity for reinforcement of basic principles and concepts of biostatistics through hands-on exercises, followed by more advanced and complex biostatistical methods.
Introduction to Clinical Epidemiology
(more details) Clinical trial design is the crucial backbone of a successful clinical trial. This advanced course provides an in-depth understanding of the various types of design and methodology and how to apply them most effectively. The participants of this course should have a basic knowledge of clinical trials and trial design and will receive information and training on study design for epidemiological and interventional studies with many real-life examples.
Applying Good Clinical Practice
This is a two day course for experienced professionals in clinical research. Supported by real-life examples the course will provide hands-on training for safety reporting, quality assurance/control and how to prepare an informed consent. In addition, participants will get insights into data management and information on how to become audit and inspection ready.
Project Management in Clinical Research
(more details)A well-designed study protocol is useless if the study is inadequately conducted. Well organized project management is an essential element for a successful study. In this three day course researchers and clinical trial associates will learn how tomanage and organize a clinical trial and a study team in accordance to international guidelines and requirements (GCP).
Publication Workshop: How to Write a Biomedical Research Paper
(more details) An appealing and adequate presentation of data from clinical trials is important for successful publication in internationally acknowledged medical journals. In this advanced course participants will learn how to critically appraise scientific articles and write abstracts and scientific articles according to international guidelines and recommendations (CONSORT, STROBE, etc.). Other learning objectives will include how to choose the right journal for publication and how to communicate with the editor. Basic knowledge in clinical research and trial design is a requirement for this course.
Publication Masterclass
This course provides intensive, practical training for clinical research professionals interested in publishing a variety of different types of research other than randomized clinical studies (such as abstracts for congresses, posters, meta-analysis & reviews, and observational studies). Building on the publication of randomized clinical trials (Publication workshop) the Advanced Publication Workshop focuses on other publication types and explores some topics in more detail. Knowledge in clinical research terminology, biostatistics and trial design is required from participants.
Essential Skills for Clinical Research Associates/Monitors
(more details) Controlling the quality in clinical trials is essential. Monitoring of clinical trial data and investigational sites is therefore a prerequisite for all clinical trials and is also outlined in international guidelines for clinical research (ICH). This five-day course has been designed to prepare personnel new to the role and responsibilities of a Clinical Research Associate/Monitor. The course also incorporates some soft skills training appropriate for this role.
Ethical Aspects in Clinical Research
Protection and safety of study participants is of utmost importance in all clinical research projects. Review of all clinical research projects by independent ethics committees is therefore required. In this course the participants will explore the ethical aspects of clinical research, study participant protection and the work and processes of ethics committees. Research in vulnerable populations, such as children and incapacitated adults as well as cross cultural considerations will also be covered. This course is suitable for ethics committees ’members, researchers and all other staff involved in clinical research.
Scientific Aspects of Clinical Trials - Protocol Development Workshop
(more details)A well designed study protocol is the basis for all clinical research projects. This 5 day course is a hands on training program covering the creation and assessment of clinical trial protocols. The following disease areas are covered by this course: Cardiovascular, Diabetes, Oncology & Psychiatry. The first part of this course will cover the basics needed for developing a protocol and during the second part the participants will work on their own protocol. Experienced specialists for the specific disease areas as well as biometricians are available during the course to facilitate protocol development. Proofed basic knowledge in Good Clinical Practice (e.g. VSCR eCourse "Basic GCP") is a prerequisite for this course.
The Scientific Approach to Modern Oncology - Clinical and Translational Oncology
(more details)This course provides an overview of the actual approaches to detection and treatment of malignant diseases. The take-home message is: Science is the key, starting from experimental investigations to be implemented in the oncology wards. Integrating translational research and clinical state-of-the-art interventions, this course addresses the open issues of today and tomorrow. Basic knowledge of oncology - either from the academic or the non-academic background - will help the participants to fully appreciate the expertise of distinguished lecturers from the Medical University of Vienna.
Health Outcomes Research Courses
Evidence Based Decision Making for Pricing and Reimbursement: from Theory to Practice (Core Module)
(more details) This course is designed for professionals working in the industry or in the public health sector and involved in negotiations and decision making for pricing and reimbursement. Those who have a need to understand how evidence based decision making is being used to direct reimbursement and market access decisions will also benefit from this course.
Evidence Based Medicine and Implementation Science (Elective Module)
(more details)This course is designed for personnel working in the pharmaceutical industry, in the public healthcare sector and/or being involved in decision and policy making. The primary course objective is to understand the principles and concepts of evidence-based medicine and implementation science to apply them to decision making and improving health care practice.
Systematic Reviews for HTA and Reimbursement Decisions (Elective Module)
(more details) This course is designed for personnel working in the pharmaceutical industry, in the public health sector, those involved in commissioning health care and research organisations. The course provides intensive, highly practiceoriented training in order to foster the application of systematic reviews and meta-analysis to reimbursement decisions, health technology assessments, treatment decisions in clinical practice and as well as to the formulation of new research questions.
Principles of Pharmacoeconomics (Elective Module)
(more details) This course is designed for personnel working in the public healthcare sector, in pharmaceutical industries or for those involved in negotiations related to the evaluation, pricing and marketing of drugs.
From Licensing to Reimbursement - How to Design your Studies (Elective Module)
(more details) This newly developed course offers its students the opportunity to learn about the key elements and critical factors on the way from discovery and drug development to successful introduction and commercialization of new medicines. The course is practically oriented and focuses mainly on how to modify and implement early clinical plans with maximum efficiency on a long run towards licensing and reimbursement. Particular focus will be on the different requirements for licensing and reimbursement, and the consequences for planning of phase 3 studies. The course is aimed at those employed in pharma or biotech industry (discovery, clinical development, access managers, regulatory, marketing and management), as well as members of regulatory or drug reimbursement agencies together with anyone who is interested in getting more knowledge and expertise about this important part of the overall drug development period.