GCP Legislation in Europe
EU Directive 2001/20/EC
Requirements for the conduct of clinical trials in the EU are provided for in “EU Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use”
Download EU Directive 2001/20/EC in PDF format
Directive 2001/20/EC is further concretised in “EU Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.”
Download EU Directive 2005/28/EC in PDF format
The Medicines for Human Use (Clinical Trials) Regulations 2004
In the UK the EU Directive 2001/20/EC is implemented in the form of The Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations apply specifically to Clinical Trials of Investigational Medicinal Products (CTIMP) studies taking place in the UK and compliance with the princilples of GCP is now a legal requirement for staff involved in clinical research in the UK.
A GCP Framework for Scotland
In Scotland the principles, requirements and standards for GCP are laid out in The Research Governance Framework for Health and Community Care. The framework sets standards, details the responsibilities of key people involved in research and outlines the process for achieving governance.
Download The Research Governance Framework for Health and Community Care in PDF format
GCP Training & Resources in Scotland
In the UK each local health authority is responsible for implementing its own GCP training. Clinical Research Training Scotland provides a comprehensive online list of clinical training courses currently running locally in Scotland including GCP.
The University of Aberdeen also has highly informative Research Governance pages.
They also provide a list of Research Governance SOPs which are available for download in PDF format.
GCP training for Lothian NHS staff is accessed through the Welcome Trust CRF Education Programme. The Welcome Trust Clinical Research Facility (WTCRF) Education Programme was launched in 2003 and provides an extensive multi-professional programme of education in clinical research skills. Their website provides a list of courses running in Lothian.
Clyde and Greater Glasgow NHS
A list of GCP training courses and online booking can be accessed through the Glasgow CRF website.
Other Useful GCP Resources
A List of GCP resources including downloadable reference documents and templates can be found ion the NIHR website
The UK MCRN has an extensive collection of online GCP related resources which can be accessed from their wesite.