Face-to-face and blended
learning for corporate clients

Improve your expertise as an Advanced/Senior Monitor/CRA
Work more efficiently and understand the benefits of more effective planning of
monitoring activities
Gain expertise in how to manage monitoring issues more effectively
The course is designed for advanced Monitors/CRAs who wish to expand their skills and
learn about the more complex aspects of clinical trial management.
1. Introduction and Objectives
2. Discussion of monitoring issues experienced and how to manage them
3. Introduction to project planning and management to apply to monitoring clinical
trials including risk assessment
• How to apply project planning principles to monitoring to improve efficiency
4. Discussion of Developing and adapting monitoring plans
• inc. Adhering to the monitoring plan (going to site when planned) and identifying when
there is a deviation from the monitoring plans
5. Discuss optimising Investigator oversight - to help ensure expectations and
responsibilities are clear (role play)
6. Discuss how to review monitoring visit reports to ensuring reports and submitted
on time, the content provides appropriate level of detail and action points are
implemented
7. Current technology trends in clinical research monitoring
8. Managing patient recruitment issues
• inc. ensuring patients meet the entry criteria and patient retention, and monitoring
recruitment issues in International Studies
9. Effective communication with the study site (the investigator, pharmacy, nurses)
and managing issues with difficult people (role play)
10. Preparing a site for audit/inspection
11. How to motivate the investigator site
12. Fraud prevention and detection
13. GCP Inspection Findings
• Root causes and CAPAs (Corrective and Preventative Action)
14. Maximising time management and efficiency
• inc. identifying and how to manage common time wasting activities in monitoring
sites, improving how to prioritise what is important during monitoring visits