Adhere to ICH GCP Guidelines for Ethical and Rigorous Clinical Trials
Sub Category
- Industry
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Objectives
- Articulate the definition, purpose, and historical context of GCP.
- Explain the importance of GCP in protecting human subjects and ensuring data integrity.
- Identify key international organizations involved in establishing GCP standards.
- Apply ethical principles and informed consent procedures in clinical research.
- Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
- Design and conduct clinical trials according to ICH E8 and E9 guidelines.
- Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
- Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
Pre Requisites
- A basic understanding of research methodology and medical terminology is recommended.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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