Learning Areas:
- How to identify key, study specific risks and key risk indicators
- Develop the threshold values that will trigger the examination of a finding
- Create and maintain the Quality Risk Management Process (QRMP)
- Develop the study’s quality and monitoring plans
- Communicate and coordinate activities with the study team on study and site-specific risks
- How to interpret the metrics, performance indicators, and trends that emerge from centralized monitoring within and between programs
- How to develop and recommend risk mitigation strategies
- How to conduct root cause analysis to institute corrective and preventive action plans