Risk Based Monitoring and Clinical Data Transparency
Online Training Id: GCP-003
Duration: 2 hrs
Under the current GCP umbrella, applying a risk-based approach to the monitoring and site management activities should be based on a given project’s risk profile. This course will outline the techniques of RISK BASED MONITORING methodology which describes the steps taken to assess risk, to determine Critical Data and Processes, and to mitigate those risks through the utilization of the Integrated Quality Risk Management Plan (IQRMP). Well-designed protocols and case report forms (CRFs) are considered important foundational influencers with an impact on quality and efficient monitoring.
Describe the concepts and activities of a Risk-Based Monitoring approach
Investigate the regulatory and industry rationales for Risk-Based Monitoring
Recognize where risk-based decision making fits into the clinical quality system
Identify risks for a project related to monitoring
Identify components to include in building the project profile risk score
Apply risk factors to various study decisions, i.e., monitoring plan, site assignments, and frequency
Who Should Enroll :
All those involved in Clinical Research – Sponsors / CROs (e.g. CRAs, PMs, CRA Managers)
Prior to founding Pi-CRIS, Ms. Casasco grew from key clinical research positions towards management functions within International Pharmaceutical and CRO companies. She developed functions on a regional basis, throughout Latin-America. Her last position before becoming an independent consultant was Latin-American Quality and Training Manager for a major European Pharmaceutical Company.
With more than 15 years of experience in clinical research, she contributes to education within the clinical research industry coordinating and delivering training programs for foundations and universities. Currently guess editor of Barnett GCP Question and Answers guide 2014 & 2015 Edition (chapter Latin America).
Ms. Casasco has conducted over 25 GCP audits within the last 3 years, as well as designed Quality Systems for Clinical Research Units and prepared sites for inspections.
She has a degree in Molecular Biology and a Master in Business Administration. Prior to enter the clinical research field, Ms. Casasco had a fellowship at the NIDR, National Institutes of Health, Bethesda, Maryland, USA.
Paula Valeria Casasco
EXECUTIVE DIRECTOR OF PICRIS