What is GCP?

GCP (Good Clinical Practice) is an international ethical and scientific quality standard for the performance of a clinical trial on medicinal products involving humans. GCP includes all aspects of a clinical trial, i.e. from the trial is planned and carried out until the trial results are reported. GCP describes the ethical and scientific aspects of a clinical trial, and expressed in popular terms, GCP is the clinical trial's "ISO standard". 

The purpose of this quality standard is to ensure that the trial subject's rights, safety, and well-being are protected as described in the Declaration of Helsinki. By following GCP it is ensured that the data collected is valid, complete, and well documented. 

The guideline is described in ICH's Harmonised Tripartite Guideline for Good Clinical Practice. This guideline states the common standard for EU, USA and Japan and has been developed in consideration of the applicable standards in Australia, Canada and within the WHO. This means that trials, which are compliant with GCP, will be accepted by regulatory authorities in most countries.

Previously, GCP was only a requirement in commercial studies, where the results should be used to have a new medicinal product approved by the authorities, but on May 1st, 2004 a European Union Directive became applicable in Danish law, meaning that GCP is no longer just a recommendation but a legal requirement when doing clinical trials on medicinal products. 

Clinical trials with medical devices should comply with ISO standard: DS/EN 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice" which is the equivalent to GCP for medical devices.

Addendum til ICH-GCP:

Addendum for ICH-GCP, Guideline for Good Clinical Practice E6(R2), is approved on 15 December 2016 by CHMP, a committee in EMA (European Medicines Agency) and is entered officially into force on 14 June 2017.