This presentation will go through a methodology used to produce a site risk analysis for a clinical study site from agency inspection and other publicly available data, including some obvious factors and some that are less so. It will discuss how to determine the risk factors, how to categorize them as critical (red), major (orange), or minor (yellow), and how to evaluate the signals over time. Included will be case studies that illustrate the methodology used. The intent is to provide a method that enables sponsor companies to minimize the risk of issues with clinical trials that could impact the submission package and ultimately drug approval.
Learning Objectives:
Understand why quality risk factors at clinical study sites are important.
Determine the quality risk factors for a clinical study site.
Combine the risk factors discovered to produce a compliance and risk picture of a clinical study site.
Understand how to use that information to inform improvement efforts and perform due diligence for current and potential partners.
