Implementing Risk-Based Monitoring: The Essential Dos and Don’ts

Now formally backed by the FDA, risk-based monitoring opens the door to more efficient techniques for ensuring subject safety and data quality. However, risk-based monitoring also increases the complexity of study planning and startup while placing new demands on technology, especially during the transition from traditional monitoring techniques.

A successful transition requires understanding the keys to implementing a risk-based monitoring program from the start. What are the greatest challenges? Where are the potential missteps?

Other topics covered in Health Decisions white paper are:

  • The different approaches and techniques covered under FDA Guidance
  • Key strategies to implement from study startup forward
  • Safeguards to prevent compromising data quality
  • Benefits once the process is in place

Read the white paper.