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.
In collaboration with experts from Julius Clinical, in this course you will learn more about the ICH-GCP guideline. ICH-GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible*.
* This course focuses on the international regulatory requirements, not (specifically) on the Dutch situation.
**Do you want to follow this course in Dutch? Click here for the Dutch GCP course.
This course is divided in three different chapters:
Importance of Good Clinical Practice. This chapter explains 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. 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 13 principles. Finally, you will learn about how ICH-GCP is legalized in the laws and regulations.
Three Phases of a Clinical Trial. This chapter introduces the three phases of a clinical trial: the preparation phase, the execution phase and the close-out phase. In addition, we will also cover the three main players in a clinical trial: the investigator, the sponsor and the monitor. You will learn about the phases separately and mostly from the perspective of the investigator.
Course Exam and Evaluation. The final chapter contains an extensive overview and summary of all the previous materials in the course. In addition, it provides you with practical information regarding the exam. You need to get a score of 80% or higher to pass the exam. If you fail the exam, one re-examination attempt is included. Completion of the course exam** is compulsory in order to receive an official certificate, acknowledged by TransCelerate Biopharma inc.
** For Julius Clinical investigational site staff the exam is to be taken after the GCP-in-Practice Day covering practical GCP aspects for conducting clinical trials
At the end of this course, 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
There are no set deadlines in this course.
You will receive a certificate upon completion of all required learning activities. Access to the course in the online learning environment will be granted for up to 1 year after enrollment into the course.
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