The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of clinical trial data.
The guideline provides a unified framework to facilitate the mutual acceptance of clinical trial results by regulatory authorities across ICH member regions, supporting global collaboration in drug development and ensuring consistent regulatory standards.?