Journal of Clinical Research & Bioethics

Abstract

A Role of ICH- GCP in Clinical Trial Conduct

Pranali Wandile and Ravindra Ghooi

The Good Clinical Practice Guideline of the International Conference on Harmonization (ICH-GCP) is an international ethical, scientific and quality standard to harmonize technical procedures and standards, improve quality, speed time to market the drug. This standard is for designing, conducting, performing, monitoring, auditing, recording, analyzing and reporting clinical trials involving human subjects.
Mushrooming regulatory requirements of different countries made new drug research very expensive and time consuming, simply because different countries had different requirements. The ICH standardized the requirements so that a drug developed as per the GCP guidelines could be acceptable to any member country of the ICH. Past history of human research abuses led to the inclusion of ethical standards to make them uniform across the ICH region. The guideline lays emphasis on protecting rights, safety, and welfare of human study subjects who participate in studies. In last two decades, these standards have evolved and become pillars of successful global drug development, which we have today. These standards have been revised and updated in 2016, but the core principles remain the same.