ICH-GCP R3 Transition course
Develop an understanding of the ICH GCP E6(R3) principles and Annex I, focusing on the critical updates and revisions from E6(R2) to E6(R3).
Designed to effectively guide clinical research professionals through the transition from ICH-GCP E6(R2) to (R3)
LEARNING OBJECTIVES
You’ll specifically learn about:
- Explore the purpose of the revision, it’s impact on clinical trials, and understand the differences in the structure of E6(R2) and E6(R3);
- Explore the updated Principles;
- Gain insights into the requirements for fit for purpose trial designs and protocols,
- Understand the revised ethical considerations (including Declaration of Helsinki 2024) and their impact on participant recruitment, and informed consent;
- Master key changes in the updated responsibilities and oversight requirements for investigators, sponsors and service providers.
- Gain insights into data governance and the definition of essential records, new terminology such as metadata, data acquisition tools and the data life cycle.
- Understand the key changes to the appendices of ICH-GCP: the Investigator’s Brochure (IB), Protocol and Essential Records.
DESCRIPTION
The ICH GCP R3 Transition course is the self-paced online training solution for all professionals who are involved in the setup and conduct of clinical trials with medicinal products in ICH regions, and need to be aware of the changes to the Good Clinical Practice guideline (ICH E6(R3)) that will be applicable as of 2025.
This training is applicable for professionals working for pharmaceutical and biotech companies and for investigators and site staff and is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the changes in ICH-GCP Guideline to clinical practice and gives you the tools to start implementing the changes in your daily practice and procedures.
- Duration 2 hours
- Language – English
- With practical Insights from experts
- Easy access on desktop, tablet and mobile
- Online Exam & Certificate of Completion
- Highly interactive due to our question-based learning method
- Flexible: Access the course anytime, anywhere
The course consists of 6 online training modules in a logical order: from the design to close-out of a clinical trial. It represents a total workload of 2 hours. The modules are divided into chapters of 15 minutes to allow flexible learning.
After you have completed the modules of the ICH GCP Transition course, you will receive a printable GCP Certificate. This course complements the ICH-GCP for Sponsors and ICH-GCP for Investigators course, which fulfil TransCelerate Biopharma’s minimum requirements for the mutual recognition of GCP training for investigators.
All training courses include one-year access to our online training. With our continuous learning model, we will keep you up to date with changing regulations and guidelines, including Annex 2.
Enroll now to get started with the online learning modules on your smartphone, tablet or desktop
COURSE CONTENTS
Module: Introduction
- 1.1 The Evolution from E6(R2) to E6(R3)
- 1.2 New or updated terminology
- 1.3 Updated GCP Principles
Module: Preparation
- 2.1 Quality by Design
Module: Submission
- Submitting for Ethical Review
- Continued Review
Module: Roles & Responsibilities
- 3.1 Roles & Responsibilities: Investigator
- 3.2 Roles & Responsibilities: Sponsor
- 3.3 Data Governance in Clinical Trials
Module: Review by ethics committee
- 4.1 IRB/IEC Requirements
Module: Start of the trial
- 5.1 Informed Consent in ICH-GCP R3
Module: Conduct & Close-out
- 6.1 Essential Records
- 6.2 Monitoring and end-of-trial
Reviews