Overview
When you are involved in a clinical trial and intended to be submitted to regulatory authorities, you have to adhere to laws and regulations. These laws and regulations are internationally defined in the ICH-GCP Guideline for Good Clinical Practice (GCP).
In this course, you will learn the content of ICH-GCP and how to apply it in your daily practice as clinical trials site staff, such as research nurses, researchers, medical doctors, project managers and project/trial assistants. This course is suitable for both obtaining beginner knowledge as well as refreshing the basics of Good Clinical Practice.
Learning objectives
At the end of this GCP Fundamentals course at Utrecht University, you will be able to:
- Understand the framework of international laws and regulations which govern the set-up and conduct of a clinical trial
- Identify and explain the purpose of ICH-GCP
- Identify and explain the 13 principles of ICH-GCP
- Understand when the ICH-GCP guideline is applicable
- Identify the key roles in clinical trials according to ICH-GCP
- Identify three phases of a clinical trial: the preparation phase, the execution phase and the close-out phase
- Understand the requirements, responsibilities and tasks of the investigator in three phases of a clinical trial
Programme Structure
This course is divided in three different chapters:- Importance of Good Clinical Practice
- Three Phases of a Clinical Trial
- Course Exam and Evaluation
Key information
Duration
- Part-time
- 1 days
- Flexible
Start dates & application deadlines
Language
Delivered
- Self-paced
Disciplines
Health Sciences View 11 other Short Courses in Health Sciences in NetherlandsAcademic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
We are not aware of any English requirements for this programme.
Other requirements
General requirements
To enroll in this course, you need:
- An academic qualification in the medical field
- Sufficient proficiency in English reading and writing
Tuition Fee
-
International
125 EUR/fullTuition FeeBased on the tuition of 125 EUR for the full programme during 1 days. -
EU/EEA
125 EUR/fullTuition FeeBased on the tuition of 125 EUR for the full programme during 1 days.