PTI - international

Agenda: Day Two

• Identify categories of scoreboard metrics 
  • study start 
  • study management 
  • study close
• Analyze examples of related balanced scorecard metrics
  

Exercise: Develop Financial Metrics
Exercise: Develop Customer/Satisfaction Metrics
Exercise: Develop Organizational/Learning and Growth Metrics

VIII. Integrate Data Collection and Display Systems

• Clarify data collection and display system goals
  
• Identify common data collection and display system pitfalls
  
• Establish ideal data collection and display systems
• Implement everyday data collection tools to improve data quality
  
• Identify advantages and disadvantages of using computerized vs. paper processes

Exercise: Analyze an Example Tracking System Display

IX. Integrate Metrics with Clinical Project Management

• Translate expectations from senior management to operational departments and project sites
  
• Organizational behavior: Manage a "why should I care attitude"
  
• Use metrics to identify performance improvements and problems in both active and in future studies
• Apply on-going data analysis to identify and make changes to a trial in progress
  
• Complement performance reports with root cause analysis and corrective and preventive actions (RCA and CAPA)

Exercise: Identify Key Process Owners and Responsibilities

X. Develop a Viable Metrics System

• Set up a metric system and normalize your metrics
  
• Summarize and evaluate steps in creating useful metrics
  
• Identify implementation challenges: What can go wrong?
  
• Prepare strategies for alternatives and solutions to a failed metric
  
• Respond to protocol deviations

Exercise: Using the Provided Example, Prepare an Approach to a Normalized Metrics System

XI. Course Summary and Other Considerations

• Parallel metrics implementation with regulatory requirements
  
• Summarize the use of surrogate endpoints and biomarkers