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 responsibilitiesAreas 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
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 responsibilitiesAreas 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
Speakers
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).
