Good Clinical Practice
ICH-GCP: a guideline for good clinical practice
Learning objectivesBy the end of the Good Clinical Practice course, you will be able to:
- Understand the general development process of a drug (pre-clinical development and phase 0–IV trials)
- 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 two pillars 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 the three phases of a clinical trial: the preparation phase, the execution phase and the close-out phase
- Understand which steps are included in each of the three
- Understand the requirements, responsibilities and tasks of the investigator in the three phases of a clinical trial
- 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.
The whole course will take place online. The following learning methods will be used:
- Individual assignments
- Group discussions
This course includes a one-hour multiple-choice online exam. The exam is not compulsory. However, if you want to receive the Course Certificate, it is obligatory to take the exam. You are allowed to redo the exam once.
Upon successful completion of this course, you will receive a recognized certificate from Elevate Health. The certificate will be valid for 4 years.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of Good Clinical Practice training among trial sponsors.
To enroll in this course, you need:
- An academic qualification in the medical field
- Sufficient proficiency in English reading and writing
This is an online course, so you need access to an internet connection in order to be able to complete assignments, communicate with fellow participants and take the final online exam.