Good Clinical Practice

“I like distance learning because of the interaction with a diverse, international student group of…”
Esther de Groot, Amsterdam - The Netherlands
“E-learning, as provided by Elevate, is a good opportunity to do part of the MIH on a distance.”
Tabitha Kievit, student, Tokyo - Japan

Clinical investigation (perhaps with newly discovered drugs) involving human subjects is a precarious activity and could lead to ethical dilemmas. Therefore, laws and regulations apply to ensure good clinical practice. As an investigator in a clinical trial, you need to know about the relevant national and international laws and regulations. What’s more, it’s 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.

 

ICH-GCP: a guideline for good clinical practice

ICH-GCP is the international ethical and scientific quality standard on how clinical trials should be set up, conducted and reported. It furthermore defines the responsibilities and tasks of people with key roles – such as investigators, sponsors and ethics committees (IRB/IEC) – and identifies documents essential for clinical trials. This online medical course explains the context of the ICH-GCP Guideline and is comprehensively structured to follow the various phases of a clinical trial: preparation, execution and close-out.

 

By the end of this course, you will understand the general development process of a drug, the framework of international laws and regulations governing clinical trials, and the applicability, purpose and key aspects of ICH-GCP. Also, you will be able to identify the key parties in a clinical trial and understand their requirements, responsibilities and tasks throughout the three phases of a clinical trial.

 

This course is suitable for medical professionals intending to be involved in a clinical trial in which a drug will be tested on human subjects. The focus will be on the responsibilities involved in clinical trials from a drug investigation perspective, rather than focusing on the scientific research itself.

 

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. 

 

The Good Clinical Practice course is also available in the Dutch language (Good Clinical Practice (GCP) and WMO in de eerstelijn).  This course is developed in close cooperation with our clinical research partner institute Julius Clinical and specifically aimed at Dutch General Practitioners and professionals working in Primary Care setting.
 

The Dutch course is offered free of charge to all members of the Julius Clinical Primary Care Research Network (PCRN). For non-members the course fee is €115. To learn more about PCRN and to become a member, please visit the website or call + 31 (0)30 6569955. For direct enrollment in the course (without membership), please click here. Please note: Payment via Creditcard or Ideal will enable you to start our online medical courses immediately. Payment via invoice may take a few processing days. 

 

Learning objectives

By 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

 

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.

Learning methods

The whole course will take place online. The following learning methods will be used:

  • Individual assignments
  • Group discussions
  • Self-tests

 

Examination

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.

Accreditation

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.

Entry requirements

To enroll in this course, you need:

  • An academic qualification in the medical field
  • Sufficient proficiency in English reading and writing


Please note
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.

Course staff

E-moderator

Enrollment

Pick a date for this course:
(Enrollment deadline: 4 November 2018 - 23:59 CET)
14 days left.

Quick overview

  • 5 Nov 2018 – 18 Nov 2018
  • 2 weeks
  • 5 hrs/wk
  • Certificate
  • EC
  • Online
  • Individual assignments, group discussions, self tests
  • Desktop, Laptop, Smartphone, Tablet
  • 115

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