ACR634 - Clinical Risk Management and Safety
Risk analysis, mitigation, assurance, and control in clinical trials. Clinical quality control. Corrective and Preventive Actions (CAPA), adverse events, protocol deviations, safety issues and advisory and safety committees.
Goals and Diversity
MN Goal Course
Implement clinical quality control measures.
Proactively anticipated and manage risks to study conduct and completion and subject safety, health and well-being.
Develop, implement, and evaluate corrective and preventive actions (CAPA).
Manage adverse events, protocol deviations, and safety issues.
Understand monitoring and auditing processes, how they differ, and how to use them to help assess and ensure clinical trial safety and compliance.
Demonstrate knowledge of the different types of advisory boards, including a Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC), and other advisory boards.
Demonstrate an ability to manage negative information, including communication to/from regulatory bodies, ethics review committees, investigators, subjects, and internal and external stakeholders.