Good Clinical Practice

Overview

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. GCP provides assurance for trial subjects' safety and data integrity. It is of utmost importance that this standard is upheld at all times. In so doing, all those who are involved in clinical trials will provide the assurance that the rights, safety and well-being of the study subjects are safeguarded; in keeping with the principles that have their origin in the Declaration of Helsinki. 

In Malaysia, the implementation of GCP is within the purview of the National Committee for Clinical Research (NCCR), formed in 1997, the committee comprises of members from the Ministry of Health (MOH), public universities, pharmaceutical associations, and other Non-Governmental Organizations. It is chaired by the Director General of Health.