- Evolution of GCP
- Introduction to ICH GCP
- Investigator's Responsibilities
- Sponsor's Responsibilities
- Clinical Trial Protocol
- Investigator's Brochure
- Essential Documents
- Case Study
What you'll learn
- Principles of ICH Good Clinical Practice (GCP)
- History and Evolution of ICH Good Clinical Practice (GCP)
- Key facts about the Declaration of Helsinki
- Importance of GCP and its 13 Core Principles
Description
ICH GCP certification is essential for all those working in the field of clinical research. This module introduces GCP and helps you understand the role and goals of the International Council for Harmonization (ICH) and the principles of Good Clinical Practice (GCP). We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
International Conference on Harmonization -Good Clinical Practice (Food and Drug Administration guideline)
ICH GCP is a unified standard to facilitate the mutual acceptance of clinical data by the mutual acceptance of clinical data by the regulatory authorities.
ICH GCP is an international standard for designing, conducting, recording and reporting trials that involve participation of human subjects.
This standard provides public assurance that the rights, safety, and well-being of trial subjects are protected Consistent with the Consistent with the Declaration of Helsinki Declaration of Helsinki
The responsibility for GCP is shared by all of the parties involved, including : –
sponsors
investigators and site staff
contract research organizations (CROs )
ethics committees
regulatory authorities regulatory authorities
research subjects
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About the instructors
- 4.17 Calificación
- 5005 Estudiantes
- 4 Cursos
Jehangir Centre for Learning
Leading training Centre in Healthcare
Jehangir Centre for Learning (JCL) is a division of Jehangir Clinical Development Centre (JCDC) which is a leading clinical research centre in India.
JCL is a leading healthcare education and training institute since 2008. JCL with a vision of spreading quality education in healthcare offers a wide range of educational and training programs.
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detailed content.
Yes,the course was very helpful with proper explanation.