Study-level Risk Management Back
This course to provides delegates with an understanding of a risk-based approach to clinical trials. By the end of this course delegates will be able to:
Review the basics principles of risk management and how to utilise them to take a risk-based approach
Plan a risk management workshop for a clinical trial
Identify the people to involve in a risk management workshop for a clinical trial
Document the risks identified during a risk management workshop
Prioritise risks and plan mitigation actions where necessary
Review of basic risk management methodology
Who should do what?
What aspects of a clinical trial may generate risks?
What should the risk documentation look like and how do you use it?
When should risk assessment take place?
How do you decide what actions to take?
Who should be involved in trial risk assessment?
How do you get started?
Who will benefit?
This course is designed for, clinical trial monitors, data managers, statisticians, study managers and supporting roles within the wider study team.
Enquire on website for more information.
Prior knowledge of basic FDA guidelines is a prerequisite of this course and therefore should be read prior to coming. A copy can be viewed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory.
Short courses (CPD) - Full time
- 1 Day
- Teaching method: