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.
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: 24th May 2017
Time: 12:00 – 13:30 BST
Duration: 90 minutes
Instructor: Sue Fitzpatrick
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.
MEMBERS ONLY DISCOUNTS Available:
Multiple Course Discount - If you book another course within 24hours, you will receive 20% off each course
Academia / Public Sector Discount - You will receive 15% off this course
Discounted rates are also available for contractors / freelancers - email firstname.lastname@example.org for more information
How to Claim the discount: When booking, select Invoice (instead of credit card) and also email email@example.com to confirm your name, course you have booked on and the discount you are entitled to. The discounts will then be applied and shown on your invoice.
Group Size 1-15 people
Webinar participation is £150.00 + VAT for members and £250.00 + VAT for non-members.
This price is for one location with 1-15 people participating. All delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions. (Please note: you need to log in as a member for the members rates to show below when booking)
Click here to view the terms and conditions.
Group Size 16-50 people
Webinar participation is £200.00 + VAT for members and £300.00 + VAT for non-members.
This price is for one location with 16-50 people participating. All delegates must be in the same room and be sharing one telephone line to dial in. Proceeding to book a place on this course you are agreeing to our terms and conditions. (Please note: you need to log in as a member for the members rates to show below when booking)
Click here to view the terms and conditions.
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