Implementing Risk-Based Monitoring: The Essential Dos and Don'ts
May 02, 2012 |
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.