Trial Innovation Center Webinar

Tuesday, November 14 at 12:00 pm to 1:00 pm
Online webinar

Integrated Quality Management plan for an investigator-initiated multicenter trial

Speakers: Kate Marusina, PhD, MBA and Katrina Wheeler of UC Davis

This webinar will highlight practical implementation of published TransCelerate (TransCelerate BioPharma Inc.) methodology to create Integrated Quality Management Plan for a multicenter academic trial. The Plan describes the steps taken to assess and mitigate risk, and to determine critical data and processes. The resulting products include Risk Assessment Categorization Tool, Risk Indicators, SOPs and Functional Plans. The presenters will describe the overarching infrastructure and provide examples of documentation. In addition, we will describe implementation of the Electronic Trial Master File (Complion) to support off-site monitoring and quality control. Through this modernization, the coordinating center is able to reduce costs associated with monitoring, increase regulatory compliance and better assist sites with document management.