Good Clinical Practice

Course topics

Introduction to ICH-GCP

We will start by explaining the motives behind the development of international laws and regulations, using historical facts as a basis. A number of different laws and regulations will illustrate these motives, including the Nuremberg Code, the Declaration of Helsinki and ICH-GCP. In addition, you will learn about differences that exist between international and national laws and regulations. We will also present a definition of a clinical trial, followed by an explanation of the different phases of a drug’s development and testing.

Importance of Good Clinical Practice

You will then go on to explore more detailed information about ICH-GCP. The key aspects of ICH-GCP will be explained by presenting its two pillars and 13 principles. We will also cover the three main players in a clinical trial: the investigator, the sponsor and the monitor.

Preparation Phase

Now it’s time to learn about the first phase of a clinical trial: the preparation phase. You will find out about the first steps to be taken before a clinical trial can be conducted. Topics covered include the pre-study visit, the collection of essential documents, the submission and approval of the trial proposal, and the initiation visit. You will learn about the responsibility of the investigator and the sponsor within these steps as well.

Execution Phase

After this you will explore the second phase of a clinical trial: the execution phase. A distinction will be made between subject management and trial management. For subject management, the topics of subject selection and inclusion will be presented, as well as informed consent, subject visits, source documents and safety reporting. In addition, insights will be provided into the tasks which are part of trial management: delegation and training, drug accountability, non-compliance and monitoring and auditing. Again, the responsibilities of the investigator and the sponsor will be presented for discussion.

Close-out Phase

The last phase of a clinical trial is the close-out phase. You will learn about the steps to be taken in this phase, starting with the close-out visit and archiving, before moving on to reporting and publishing. The responsibilities of the investigator and the sponsor during the activities in the close-out phase will also be set out.