Face-to-face and blended
learning for corporate clients

Advanced Monitoring of Clinical Trials

Duration: 2 days

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