Risk Management and Risk Based Monitoring in a Clinical Research Setting

Understand risk management principles and the links between study level risk management and the implementation of risk based monitoring

  • 23. May 2018

1 day course

English

5.500,- DKK ex VAT
(app. 739,- EUR ex VAT)

Summary

The scale, complexity and cost of clinical trials have increased over time. In addition there is a permanent pressure on resources for clinical trials and it is vital that those precious resources are utilized where they deliver the greatest benefit. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities both within companies and on sites. Regulatory agencies have recognized this fact and are now actively promoting the implementation of risk based approaches to management of clinical trials.

This course will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities. We will review the principles of risk management and how to apply them within a clinical research or monitoring setting. The impact of introducing a risk based approach on site processes is also considered. Along with identification and evaluation of risks to critical study data and clinical trial operations it is imperative to ensure the necessary processes are in place.

This course will allow you to appraise your current processes, people and technology with a view to improve monitoring and site efficiency and enhancing patient protection while maintaining high quality data.

The course has been designed to give a balance between trainer input, exercises and delegate interaction.
 

Keywords

Risk management
Risk based monitoring
Critical study data

What you will learn

  1. How to review the basic principles of risk management and utilize the basic principles to take a 'risk-based approach'
  2. How to document, prioritize risks and plan mitigation activities and their measurement
  3. How to differentiate between different types of monitoring and outline the limitations of current monitoring practices
  4. How to identify risk triggers during monitoring
  5. How to discuss the impact of a RBM approach on sites
  6. How to share best practice

What your company will get

  1. A clinical research professional who understands the principles of risk management and their application within a clinical research setting
  2. An individual who will be able to utilize a risk based approach to all stages of the clinical trial process from study design, study conduct through to study reporting
  3. A professional who can identify and evaluate risks to critical study data and clinical trial operations and employ mitigation and corrective and preventative action where indicated
  4. A professional who can provide valuable input towards implementation of a risk based approach across all disciplines within a clinical research unit
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@atriumcph.com.

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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