Good Clinical Practice
What is GCP?
According to the US Food and Drug Administration, GCP “…is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”
GCP is described in a European Union document E6 Good Clinical Practice: Consolidated Guidance which was published in 1996. EU Directives in 2005 (2005/28/EC) updated some aspects of the document, but the principles remained the same.
The principles of GCP
The ICH E6 document can be downloaded from:
Some abbreviations (from the E6 glossary)
IRB – Institutional Review Board
An independent body constituted of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and materials to be used in obtaining an documenting informed consent of the trial subjects.
IEC – Independent ethics committee
An independent body (a review board or a committee, institutional, regional, national or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
These materials are based on content originally provided by the WOMBAT collaboration. The WOMBAT Collaboration was formed to promote and support high quality randomised clinical trials in the perinatal area in order to improve the health and wellbeing of women and their children (2005 – 2010).
Prepared by Rebecca Tooher (WOMBAT) in 2008 and updated by Lucille Sebastian (NHMRC CTC) in 2015
Last revised: 24 June 2015