With the publication of the guidance for industry “Oversight of Clinical Investigations – A risk based approach to monitoring”, many researches felt thatin order to apply a risk based approach we just had to do less SDV! But the realisation is that a risk'based approach isn't just about changing roles and responsibilities it is more about a change in the whole philosophy of companies and it is having an impact on the way clinical studies are managed, particularly with regard to outsourcing which is fast becoming an inspection target.As more and more work is contracted out it is becoming increasingly important to employ efficient and risk based strategies for managing outsourced activities.Risk management principles will need to be applied to the selection of vendors, content of contracts and ongoing management of the selected vendor. The selection and oversight of vendors has to be based on risk management principles to ensure that regulatory expectations are met.
The course is designed to integrate a risk based approach into vendor selection and management. The
course will discuss the reasons why a risk based approach is necessary and the methodologies for
achieving this objective.It will cover the requirements for vendor management including contracts. The
role of vendor management personnel will be discussed along with tools to facilitate efficient working
practices. This practical course allows opportunities to develop the skills necessary for implementation
of a risk based approach to outsourcing. The webinar has been designed to give a balance between trainer
input, practicale exercises and delegate interaction.
Jane Tucker and Sue Fitzpatrick
Over the past 3 years Sue and Jane have become an established team delivering Risk-based Monitoring training. They have trained as a team to staff within pharmaceutical companies and CROs as well as attendees at commercial trainings operated by a variety of different organisations. The material they have developed together, relies upon Sue’s vast experience as a trainer and auditor of CRAs plus Jane’s background in practical Risk Management and training. Sue and Jane have also worked with competent authorities in the area of Risk-based Monitoring. They interact very effectively during training sessions and presentations merge seamlessly from one to the other.
- Review the different models of outsourcing
- Outline why a /risk'based approach/ is necessary in vendor management and the five steps of risk management
- Discuss strategies for outsourcing
- Review the process of vendor management and apply a risk based approach
- 0rioritise risks and plan mitigation actions during the vendor selection process
- Drafting an effective communication plan and identify other potential plans that may add value
- Draft contracts applying risk based strategy
- Identify strategies for effective vendor oversight and management of non'compliance
- Any clinical research professional currently involved in the selection and management of vendors who intend to adopt a risk based approach would benefit from attending this course
- Equally any CRO, ARO or vendor who wishes to observe the strategies applied by sponsors could also benefit.
- In order for a risk based approach to operate effectively all clinical trial disciplines e.g. monitors, CRAs, data management, project management statisticians, outsourcing, etc), should be qualified to provide their unique input to all steps in the risk based outsourcing process