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Risk Based Monitoring and Targeted SDV - Online Academy

4 weeks - 2 hours per week

4 week online course beginning on Monday 1st October 2018

Online Academy

Implementing the most efficient strategies for monitoring is crucial to reduce the risks and costs associated with your clinical trial - it is estimated that sponsors can save 23% of trial costs with a risk-based approach.

This course will assess the practicalities of implementing a risk-based approach and will demonstrate how risk based monitoring can contribute to better oversight of your clinical studies.

Over 4 weeks you will explore the requirements for risk-based monitoring and targeted Source Data Verification (SDV) including which factors influence the scope of on-site SDV vs. remote SDV. Monitoring aspects will be assessed based on a standard risk assessment for investigational sites and how it can be applied.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

 

Over 4 weeks students will learn through:

  • 8 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 4 weeks the course is running
  • Additional content such as materials and white papers available to download

Dr. Schiemann is Managing Partner at Widler & Schiemann Ltd, a consulting firm working in the area of quality management in clinical trials and drug safety out of Zug, Switzerland. He is pharmacist by training and obtained his PhD in human biology from Philipps University in Marburg, Germany. He started his career in the pharmaceutical industry in 1996 by joining Roche in Switzerland. From 1999 to 2003 he worked with PricewaterhouseCoopers as a consultant in R&D Strategy in Switzerland and the US. During this time he obtained his postgraduate degree of Pharmaceutical Medicine from the University of Basel and a cMBA on International Marketing from Jones International University in Colorado, USA. He re-joined Roche in the US in 2003. In 2012 he co-founded Widler & Schiemann Ltd together with Beat Widler.

  • Fully understand the concept of a ‘risk-based approach’
  • Develop contingency plans and get practical advice for making decisions on acceptable levels of deviation
  • Explore the practicalities and impact of transitioning to a risk-based approach to monitoring without impacting deliverables
  • Examine how the protocol should be designed and the risk-based criteria set
  • Define the process, metrics and role of design in a targeted and remote monitoring approach
  • Understand the capabilities of automated approaches to assist monitoring clinical trials
  • Get practical advice for employing a risk-based approach in a global context

This course is relevant to anyone who would like to develop a better understanding of a risk-based approach, including (but not limited to) Heads/Directors/Managers/Specialists from the following departments:

  • Clinical Monitoring
  • Clinical Operations
  • Data Management
  • Study Management
  • Quality Assurance

What happens during an Online Academy course?

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This online academy course can be accessed from Monday 5th February 2018. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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