History and Principles of ICH GCP: Good Clinical Practice
- Any individuals that are interested in acquiring knowledge about ICH GCP
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 : –
investigators and site staff
contract research organizations (CROs )
regulatory authorities regulatory authorities
Who this course is for:
- Pharmacy students
- Working Professionals in Clinical Research, Pharmacovigilance or Clinical Data Management
- Life science graduates
- Nursing graduates
- Paramedical staff
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.