The duration of the course is 2 days with an additional 0,5 day session to reflect on lessons learned of the training versus the practical experience.

Within the course, theory will alternate with interactive exercises and discussions to ensure

implementation  of the learning in daily practice.

Preparation activities prior to the first 2 days of face to face training (e.g. reading of training materials) involve 1 hour of homework for each training day, thus 2 hours in total.

The following topics will be discussed:

• Update GCP
• WMO vs GCP
• Monitoring:
  • General
  • Tasks & Responsibilities
  • Visits: site selection, initiation, monitoring & close-out
• Sponsor
• Monitor (Investigator and Sponsor Initiated Trials)
• Monitor plan and visit preparations
• Investigator Site File
• Clinical Trial Protocol
• IRB/IEC
• Informed Consent procedure
• Source Data Verification
• Practice of a monitoring visit (including preparation, conduct and follow-up)

At the end of the course, the participant will be able to:

• Describe the tasks and responsibilities regarding the function of a monitor
• Describe and conduct the procedures, law and regulations regarding monitoring
• Perform a monitoring visit
• Recognize and name individual qualities and points of attention regarding monitoring related competences

Staff involved in management or conduct of monitoring (e.g. study coordinators, research nurses).

The course will be lead by an experienced trainer with significant and relevant experience in the field of clinical research.

There will be a minimum of 5 and a maximum of 15 participants for this training to ensure a maximum learning effect.

In case you have any questions or would like to schedule the training, please contact Gayle van Krevelen, trainer of Julius Clinical, at: +31 (0) 631644581 or email gayle.vankrevelen@juliusclinical.com.

We look forward to offer you our training services.