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Meeting Background

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify core data elements that should be collected by all clinical trial sites to allow measurement and improvement of important timeframes for study start-up.

Meeting Objectives

• Review the results from retrospective analysis to describe the current state of study start-up at sites participating in multicenter clinical trials
• Review, discuss and agree on a proposed list of standard metrics for site start-up activities including a standard, specific, and measurable definition for each metric that will be utilized in a prospective data collection pilot coordinated by CTTI
• Discuss strategies for success and potential barriers for engaging sites to participate in the prospective data collection pilot that will be designed to facilitate and encourage sites to measure themselves against “sites like me” to identify opportunities for improving their internal processes and cycle times

Meeting Presentations*

• Intro to the Site Metrics Meeting
• Site Metrics for Study Start-Up
  Project Overview
• Bottlenecks of Study Start Up & Some Suggestions for Efficiencies by Christine Pierre
• Workstream 1 Retrospective Data Analysis by Diana Abbott
• Proposed Data Elements and Cycle Time Metrics for WS3 Prospective Data Collection by Soo Bang

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.