WEBINAR

Focusing Investigational Sites Risks in RBM

Speaker: Sandra ‘Sam’ Sather

Sponsor’s performance of investigational site risk assessment is essential for effective planning and implementation of clinical trial project. Risk identification starts at the sponsor/CRO system and project level, and also risks are assessed and controlled at site level at pre-study and during the trial. The monitoring approach and content of the study monitoring plan must be based on this risk identification and assessment. This webinar will review site risk identification, assessment steps and how to integrate them into site qualification and into the study monitoring plan. This webinar will also focus on how to coordinate the sponsor quality systems to support risk-based approaches for monitoring and oversight.

Objectives:

• Identify key investigational site risk categories per project and integration into site qualification and monitoring plan development
• Recognize risk management factors to coordinate for investigational site oversight: risk assessment, tracking and controlling
• Importance of centralized monitoring in monitoring investigational site risks
• Role & responsibilities of central monitor in tracking and managing investigational site risks