ACR634 - Clinical Risk Management and Safety

General

Prefix

ACR

Course Number

634

Course Level

Graduate

Instruction Mode

Lecture

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.

Course Outline

Dependencies