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.
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 credit: 7h (3 months period to complete course)
Complete the course at anytime, anywhere!
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.
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
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.
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