CROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance: "A Risk-Based Approach to Monitoring." From a practical level, how do you start your program and gain the full advantages of RBM? This course will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities. This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

Course Objectives:

By the end of this course you will be able to:

• Review the basic principles of Risk Management
• Utilize the basic principles to take a 'risk-based approach'
• Document risks identified
• Prioritize 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
• Leveraging risk insights to increase the quality of trial design
• Share best practices

Why Should You Attend:

In order to satisfy the regulatory requirements companies have to utilize a risk based approach. To maximize 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.

Any clinical research professional embarking on a risk based approach would benefit from attending this course. 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. The FDA and EU regulatory authorities also support clinical trial sponsors to use risk-based site monitoring. For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.

Course Outline:

• Define risk based monitoring for clinical trials
• Define the regulations and guidelines which cover risk based monitoring
• Understand risk based monitoring tools and methodology used in clinical research projects
• Explore the roles and responsibilities of those involved in risk based monitoring
• How to plan risk based monitoring approaches for clinical trials
• Understand how to identify and evaluate study site and protocol risks for targeted SDV
• Learn how to identify critical data
• Develop and apply risk monitoring in your clinical trials
• Evaluate the risk indicator and set thresholds
• Learn how to document risk based monitoring in the monitoring plan
• Hear best practices of these new risk requirements
• Evaluate industry think tank trends (TransCelerate, CTTI)

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Clinical Operations Personal/Managers
• Project Managers
• CRA's
• Data Managers
• Statistical Personnel
• Stakeholders in introducing a risk based approach within a company or institution e.g. outsourcing, clinical supplies
• Clinical Development Managers and Personnel
• Clinical Investigators and Staff
• Clinical Research Associates
• Clinical Research Archiving and Document Management Personnel
• Quality Assurance Managers and Auditors
• CROs using Laboratories to Analyze Clinical Trial Samples
• Project Management
• Sponsors and Non-Commercial Sponsors
• Consultants
• Sponsors/CROs Clinical Operations
• Clinical Quality Compliance and Quality Assurance Professionals