Foundational ICH-GCP E6 (R2) Training – eLearning
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Date | Product | Location | Price | |
---|---|---|---|---|
Foundational ICH-Good Clinical Practice (GCP) E6 (R2) Training | eLearning | EUR 500 | Book | |
If you would like to have this course as an in-house session click here |
About this course
Reasons to attend
Did you know that your clinical investigations need to comply with the Good Clinical Practice (GCP) guideline?This interactive eLearning is crucial for any professional in the field of clinical research. It will provide you with all elements of the International Council on Harmonization Good Clinical Practice (ICH GCP) guideline E6 (R2), as required by the majority of Regulatory Authorities.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been mutually recognised by TransCelerate BioPharma
- This course has been reviewed by the Belgian GCP Inspectorate.
Course schedule
- Course credit: 7h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
Through an innovative approach, this online 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 are included in our eLearning course that give you immediate feedback on your comprehension. This will help you to maximise your learning journey. You will be able to test your comprehension with a final grading test.Programme highlight
- 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
Learning objectives
- Identify the GCP requirements for conduct and documentation of clinical studies
- Distinguish the responsibilities of all involved parties
- Determine the regulatory conditions imposed by GCP
- Detect common problems and obtain insight to avoid errors
Who should attend
Any professional within clinical research; investigator; monitor; study coordinator or other staff that need to gain foundational knowledge about and comply with the current GCP standard.
No prior training or working experience in a GCP environment is required.Competencies
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)
Trainers
No trainer yet
Yemesrach Tessema Ayele
Cristina Donini
Medicines for Malaria Venture
Yemesrach Tessema Ayele
IDDI
Mathilde Tournay
IDDI