What is GCP and Which GCP should we be following?
Fact: Clinical Trials with investigational medicinal products should be conducted to Good Clinical Practice standards (the law since May 2004). There are many courses advertising ICH GCP for investigators and site staff but if these are just ICH GCP courses and are not structured to include both UK and European Regulations they do not fulfil the obligation to inform investigators of all their legal responsibilities. In the UK and other European member states we do not just follow ICH GCP we are committed to ‘European GCP’ which is a higher standard than ICH GCP. Therefore, the GCP standards we should be following within the EU are: • GCP Directive 2001/20 • GCP Directive 2005/28 • The local Laws of each member state for sites set up in that country (in the UK this will be the Medicines for Human Use (Clinical Trial) Regulations 2004 and the Amendment Regulations 2006 which transposes Directive 2005/28 into UK Law. • ICH E6 must be “taken into account”. So, if you are conducting clinica
