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.

• ICHGCP 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