Good Clinical Practice

Clinical investigation with (newly discovered) drugs involving human subjects is a precarious action and could lead to ethical dilemmas. Therefore, laws and regulations apply. As an investigator in a clinical trial, knowledge of these (inter)national laws and regulations is needed. Next to that, it is important to know which parties are involved in clinical trials and what their responsibilities are. Directives for good clinical practice are recorded in the ICH-GCP guideline.

At the end of this course you should understand the general development process of a drug, understand the framework of international laws and regulations which govern the set-up of a clinical trial, identify and explain the purpose and the key aspects of ICH-GCP and understand when these are applicable. Also, you should be able to identify the key parties in a clinical trial and understand their requirements, responsibilities and tasks throughout the three phases of a trial.

You will gain this knowledge by reading, answering multiple choice and open questions, participating in polls and actively participating on discussion forums. Gained knowledge will be assessed in a one-hour multiple choice exam. Please note that this course will have a workload of approximately 5 hours per week.

Course fee:: € 75,-