A Risk-Based Approach to Clinical Audits
Book a session
Date | Product | Location | Price | |
---|---|---|---|---|
17/09/25 | A Risk-Based Approach to Clinical Audits | Brussels | EUR 1025 | Pre-Book |
If you would like to have this course as an in-house session click here |

About this course
Reasons to attend
This 1-day course on how to apply a risk-based approach to clinical audits will allow you to:- Understand your organisation’s approach to risk
- Develop a QA risk strategy
- Apply a risk-based approach to the development of your audit program
- Adopt a risk-based approach in the execution of individual audits
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions |
Course Description
Where you focus your valuable QA resource ultimately determines what you discover at audit. Therefore, to maximise the value of your QA resource, you must apply a robust risk-based approach to auditing by focusing on the areas that matter most and bring the greatest benefit to your company.In the new ICH GCP E6 R2 world, a risk-based approach to clinical trials, including audits is essential. Since companies manage risk at many different levels. The QA group must assess their company’s approach to risk, actively evaluating and visualising risks themselves to determine whether the approach is fit for purpose. However, the application of a risk-based approach to clinical audits can be challenging as it requires:- An understanding of the companies’ approach to risk
- An ability to identify and assess the potential compliance risks of the company's business strategy
- An ability to challenge the risk-based approach in the conduct of clinical trials
Programme highlight
- Risk management – what are the acceptable thresholds for risk
- How to assess the risk associated with your company's business strategy
- How to determine which risks matter in developing your QA risk strategy
- How to develop a risk-based audit program
- How to apply a risk-based approach to audits
- How to develop risk-based audit plans
- How to adapt audit plans based on risks identified at the audit
- What is risk-based monitoring versus adaptive monitoring
- How to audit risk-based monitoring trials
- How to develop an audit plan for risk-based monitoring trials
- Common challenges of auditing risk-based monitoring trials
Learning objectives
- Appreciate how a risk-based approach to the auditing can focus the QA resource and benefit your organisation
- Understand how to apply a risk-based approach to clinical audits
- Understand the challenges of auditing risk-based monitoring trials
Who should attend
Clinical auditors and other quality professionals with a professional interest in how to apply a risk-based approach to clinical audits. Individuals should have at least 1-2 years’ experience in clinical auditing or in the development of audit programs.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Benoit de Malglaive
IDDI