October 24, 2018, 12:00-1:00 PM ET – Increasing clinical trial complexity with leaner budgets demand the clinical trial site be more agile than ever. Sites must balance needs to effectively staff trials and distribute workload between team members or justify increasing staff to support growing demands.
November 1, 2018, 12:00-1:00 pm – This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance.
November 6, 2018, 11:00-1:00 pm – Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study.
November 8, 2018, 12:00-1:00 pm – The session will discuss the privacy and information security concerns that can occur from the time a protocol is drafted through the completion of the study.
November 13, 2018, 12:00-1:00 pm – This session will cover adverse event (AE) reporting for medical device clinical trials, including the following topics: the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on a study protocol, and a discussion on device AE reporting requirements from a monitoring and auditing mindset.