Quality assured training that gets results!
This course can be tailored to your specific requirements.
DELIVERY FORMAT : Live, interactive webinars or face-to-face skills development workshop.
The recent regulatory guidance on risk-based monitoring has prompted its increasing use to help speed the development of safe and effective treatments for patients. This course covers the purpose, principals and practice of using a risk-based approach so that clinical studies are monitored efficiently and effectively while clinical trial subjects are protected.
Who is this course for?
Risk-based monitoring is being used increasingly to help speed the development of safe and effective treatments for patients. This course is for anyone who is involved in monitoring clinical trials and needs to adopt a risk-based approach.
- The principles of risk management
- Background to risk-based monitoring – European and US perspectives
- Theory of risk management applied to study monitoring
- Developing and adapting monitoring plans
- Practical application of a risk-based approach to monitoring
By the end of the course the participants will be able to:
- Summarize the key aspects of risk management
- Analyze the risk factors involved in conducting various types of study
- Analyze the risk profile of investigator sites
- Apply techniques to adjust their level of monitoring according to risks
Learning Credits / Contact Hours / Continuing Education Points
The number of CPD / CME / CEP / CPE / contact hours awarded will be according to the length of the course delivered for your organizations i.e. whether the full course is run, or selected modules. A typical one day training program will carry 10 CPD / CME / CEP / CPE / contact hours.
Corporate Roll-OutWe are experienced at providing large scale solutions, including “train the trainer” programs. Please contact us to discuss your requirements and how we can work in partnership with you.
We believe that best practice in clinical research should be available to everyone. Contact us to discuss discounted rates for not-for-profit organizations, micro businesses and SMEs in developing regions.