NEW ACDM Webinar - Risk Based Monitoring - 12th July 2016


Course Introduction

This is a new webinar provided by the ACDM on Risk Based Monitoring in clinical research. In order to satisfy the regulatory requirements, companies nowadays have to utilise a risk based approach. To maximise the benefits of a risk based approach, the drug / device development companies, CROs and other institutions are actively looking into practical implementation of risk based monitoring. A risk based approach has to be applied at all stages of the clinical trial process as risk based monitoring cannot be employed in isolation. This webinar will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities.

Why should you attend?

This webinar provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring.   It allows opportunities to develop the skills necessary for implementation of a risk based monitoring approach.

Along with identification and evaluation of risks to critical study data and clinical trial operations it is imperative to ensure the necessary pieces are in place. This webinar will allow participants to appraise their current processes, people and technology with a view to improving monitoring efficiency and enhancing patient protection while maintaining high quality data.

The webinar has been designed to give a balance between trainer input and delegate interaction.

Learning Objectives

By the end of this course you will be able to:
• Review the basic principles of Risk Management
• Utilise the basic principles to take a 'risk-based approach'
• Document risks identified
• Prioritise risks and plan mitigation actions where necessary
• Outline the limitations of current monitoring practices
• Differentiate between different types of monitoring
• Describe the link between study level risk assessment and the monitoring plan
• Identify risk triggers during monitoring
• Share best practice

Who should attend?
Any clinical research professional embarking on a risk-based approach would benefit from attending this webinar. In order for a risk based approach to operate effectively all clinical trial disciplines e.g. monitors,  CRAs, data management, project management statisticians, outsourcing, drug suppliers etc., should provide their unique input to all steps in the process.

Training Course Details:

Date: Tuesday 12 July 2016
Time: 12:00 – 13:30 BST 
Duration: 90 minutes
Venue: WebEx
Instructor: Sue Fitzpatrick and Jane Tucker

Instructors Profiles

Sue Fitzpatrick has more than 30 years’ experience within clinical research.  She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas.  Sue was elected to the executive board of The Institute of Clinical Research in 1991 and is an honorary Fellow of The Institute. She was appointed as a Specialist Director of the Institute in 2010 and as Head of Education and Training she was responsible for the provision of training courses for the Institute and postgraduate courses in collaboration with Cranfield University, Edinburgh Napier University and was an honorary lecturer at Liverpool John Moore’s University.  She currently holds a recognised teaching certificate at Cranfield University.  As a Director of Redtree she continues her work on enhancing competencies and standards.

Jane Tucker - Having Path Lab experience on her CV proved an advantage when applying for a Data Management post in the pharmaceutical industry, as the manager concerned lacked Path Lab understanding in her team, thus started Jane’s latest career!  Over the past 30 years Jane has moved from routine data cleaning activities, via system validation on to training and quality activities, eventually specialising in Risk Assessment and Management, both facilitation of workshops and extensive training roles.  Jane also has experience of training in a range of clinical disciplines including Risk Management, Outsourcing and many aspects of computer system validation and was involved in many Regulatory Inspections.  During her career Jane has worked for a number of major Pharmaceutical companies and CROs, eventually retiring from the vagaries of company politics to become a freelance consultant.  Jane now operates as a Risk Management and Quality consultant, specialising in Study Level Risk Management and Risk-based Monitoring as well as facilitation of risk assessment workshops.

Click here for full course details and online booking

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