Investigator

---

Investigator Training
Guidelines for conducting clinical trials with
particular reference to ICH/GCP

Contents:

• Introduction to clinical research
• Guidelines
• Clinical trials and the German Drug Law (AMG)
• Responsibilities (ICH-GCP)
• Study protocol
• Patient information
• Site selection
• Approval procedure
• Site initiation
• Monitoring visits
• Clinical trial logistics

Aim:

In just 1 day this course provides you with the knowledge you need to work as an investigator.  Special emphasis is placed on meeting the requirements of the Ethics Committee and conducting clinical trials ICH-GCP quality standards and in accordance with the German Drug Law (AMG).
The training comprises 9 hours (à 45 minutes) including a written assessment.

Booking Form