Risk Based Monitoring for GCP Compliance

Why Should You Attend:

It is essential to comply with the latest GCP requirements to have a risk based monitoring methodology for your clinical trials. It is also essential to have a quality risk management system in place to allow for risk based monitoring. The FDA and EU regulatory authorities’ supports 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.

This webinar will explain:

• The rationale for risk based monitoring
• The requirements for risk-based monitoring and targeted source data verification (sdv) risks identification
• Critical data and risk indicators analysis
• The monitoring plan including risk monitoring and centralized monitoring
• How to use risk based assessment for investigational sites and the protocol to implement risk based monitoring
• Risk based monitoring roles and responsibilities

Learning Objectives:

• Understand the new requirements for risk based monitoring in clinical trials
• Define the regulations and guidelines which cover risk based monitoring
• Review of risk based monitoring approaches and methodology for clinical trial projects
• Learn how to identify and evaluate risks for the investigator site and protocol for implementing risk based monitoring
• Learn how to identify critical data
• Evaluate the risk indicator and set thresholds
• Consider how to implement this new concept within your organization
• Hear best practice of these new risk requirements

Areas Covered in the Webinar:

• Define risk based monitoring for clinical trials
• 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
• Develop and apply risk monitoring in your clinical trials
• Learn how to document risk based monitoring in the monitoring plan

Who Will Benefit:

The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel such as:

• Clinical development managers and personnel
• Clinical operations personnel
• 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
• Laboratories analyzing samples from clinical trials
• Regulatory affairs personnel
• Legal and regulatory authorities

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

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