Risk Management from an ICH-GCP E6 (R2) perspective

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

  • 8. May 2019

1 day course

English

5.400,- DKK ex VAT
(app. 726,- EUR ex VAT)

Summary

In this course you will get the basic tools to apply a risk-based approach when managing your clinical trial. We will review the principles of risk management and how to apply them within a clinical trial setting according to ICH GCP E6(R2).

You will also get the opportunity to practice the necessary skills when we look at examples from actual inspections and discuss how to apply a risk-based approach on areas where change is needed.

Along with identification and evaluation of risks in critical processes, study data and clinical trial operations, it is imperative to ensure that the necessary processes are in place. This course will allow you to appraise your current processes, people and technology with a view to improve oversight and enhance patient protection while maintaining high quality data.

We aim to provide a balance between trainer input, exercises and participant interaction.

Keywords

Risk management
Risk based approaches
Critical processes and study data
Key risk indicators

What you will learn

  1. How to review the basic principles of risk management and utilize them to take a ‘risk-based approach’
  2. How authorities interpret the ICH GCP E6(R2) through review of inspection/audit findings
  3. How to document, prioritize risks and plan mitigation activities and their measurements
  4. How to develop descriptive metrics for your risks
  5. How to identify acceptance criteria and actions
  6. How to review and document your approach
  7. How to discuss methods to communicate and report the approach taken and share best practice

What your company will get

  1. A clinical research professional who understands the principles of risk management and application in a clinical research setting
  2. An employee who will be able to utilize a risk-based approach and define measurable metrics to report on the actual progress for all stages of the clinical trial process from study design, study conduct to study reporting
  3. A professional who can identify and evaluate risks to critical study processes and data and employ mitigation and corrective and preventive 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 us at + 45 39 27 60 60, or send us an email at contact@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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