Are you planning to attend the SCOPE conference in Miami? I'm presenting:
Tuesday, February 4, 20141:35pm EST
Summary Level Clinical Site Data: A Method of Site Selection and Ranking Sites for Audits and Feasibility
Nadia Bracken, Clinical Program Manager and Lead Author of ClinOps Toolkit
This presentation will discuss best practices to improve site selection process and the development of a lean method to determine adequacy of a site during feasibility for a multicenter trial. I will explain how to track each site’s historical performance; identify top performers; weed out underperformers for future trials using retrospective data; evaluate, rank, and summarize site start-up metrics, recruitment and retention of participants, completeness and quality of data, individual subject outcomes, and other operational and administrative factors using descriptive statistics. Also discussed is how to identify, predict, and mitigate potential risks prior to inspection and conduct of future trials and a review of CDER’s Inspection Planning Draft Guidance for Industry: Summary Level Clinical Data published December 2012.