What is Good Clinical Practice?
One part of Quality Assurance in Clinical Trials is adhering to Good Clinical Practice (GCP). GCP is defined by EU Directive 2001/20/EC, article 1, clause 2 as:
“a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
The International Conference on Harmonisation (ICH); a group consisting of the regulatory authorities of the European Union, Japan and the United States of America, produced a set of guidelines to ensure that:
Since being written in 1996 and used across the world as a set of guidelines, GCP has become law as of 2004 for all investigational medicinal product clinical trials in the European Union.
Address - UK HQ:
Address - US HQ: