ACR634 - Clinical Risk Management and Safety
General
Prefix
ACR
Course Number
634
Description
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.
Prerequisites
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Implement clinical quality control measures.
Outcome
Proactively anticipated and manage risks to study conduct and completion and subject safety, health and well-being.
Outcome
Develop, implement, and evaluate corrective and preventive actions (CAPA).
Outcome
Manage adverse events, protocol deviations, and safety issues.
Outcome
Understand monitoring and auditing processes, how they differ, and how to use them to help assess and ensure clinical trial safety and compliance.
Outcome
Demonstrate knowledge of the different types of advisory boards, including a Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC), and other advisory boards.
Outcome
Demonstrate an ability to manage negative information, including communication to/from regulatory bodies, ethics review committees, investigators, subjects, and internal and external stakeholders.