Risk Based Monitoring for GCP Compliance 2019

Topics

• Understand risk based monitoring tools and methodology used in clinical research projects
• Define risk based monitoring for clinical trials
• How to plan risk based monitoring approaches for clinical trials
• Explore the roles and responsibilities of those involved in risk based monitoring
• Develop and apply risk monitoring in your clinical trials
• Understand how to identify and evaluate study site and protocol risks for targeted SDV
• Learn how to document risk based monitoring in the monitoring plan

Who should Attend

• Clinical operations personnel
• Clinical development managers and personnel
• Clinical research archiving and document management personnel
• Clinical research associates
• CROs using laboratories to analyze clinical trial samples
• Quality assurance managers and auditors
• Sponsors and non-commercial sponsors
• Project management
• Laboratories analyzing samples from clinical trials
• Consultants
• Legal and regulatory authorities
• Regulatory affairs personnel