ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP) Narayana Raghava Ramesh*, Gowda KP Shivalinge, Ahamed Syed Mansoor, Badami S Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur, Karnataka *Corresponding Author: Raghava Ramesh Narayana, Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur. Karnataka. Email: ragpharma@gmail.com
Online published on 20 March, 2013. Abstract Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. Top Keywords ICH, Good clinical practices guidelines, Quality, Safety, Efficacy, Multidisciplinary. Top |