You are a clinical research professional; investigator, monitor or other staff active in the field of clinical research; then you need to comply with the Good Clinical Practice guideline, including the recently released ICH-GCP E6 (R2) Addendum 2016. This eLearning course will allow you to understand the responsibilities of everyone involved, which allows a direct implementation in your area of work. We will give you the needed training, required by the majority of European Regulators.
This course has been reviewed by the Belgian GCP Inspectorate.
Our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by “TransCelerate BioPharma” as necessary to enable mutual recognition of GCP training among trial sponsors.
Through an interactive approach, this eLearning course is designed for professionals who are active in clinical research. Without training on the International Council on Harmonization Good Clinical Practice (ICH-GCP) standard, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This eLearning course focuses on the requirements of Good Clinical Practice (GCP) in clinical studies with pharmaceuticals. The complete and most recent version of the ICH-GCP, up to the items added in 2016 is covered by this training.
Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.
All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it. Course Credits: 7 hours
Who should attend
Everyone who wants to understand the current regulations and Good Clinical Practice (GCP) in clinical studies. No prior training or working experience in a GCP environment is required.
- Clinical Research and Regulations
- Highlights of the Declaration of Helsinki
- ICH-GCP Definitions and Principles
- ICH-GCP Responsibilities of Ethics Committees/ Investigators/ Sponsors/Monitors
- The Protocol, Investigator’s Brochure and other Essential Trial Documents
- ICH-GCP non-compliance
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Fully grasp the GCP requirements for conduct and documentation of clinical studies
- Distinguish the responsibilities of all involved parties
- Understand the regulatory requirements imposed by GCP
- Be prepared to implement GCP requirements in your clinical research activities
- Understand the impact of the ICH-GCP E6 (R2) Addendum 2016
- Recognise common problems and obtain insight to avoid errors
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (3)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (5)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained