Reference Documents

Research Governance Frameworks

• Cardiff University Research Governance Framework v0.4 [223.0 Kb]
• Research Governance Framework for Health and Social Care in Wales (Second edition, 2009) [616.8 Kb]

European Commission Legislation

• Clinical Trials Directive (Directive 2001/20/EC) - 4 April 2001 [151.7 Kb]
• Good Clinical Practice Directive (Directive 2005/28/EC) - 8 April 2005 [67.2 Kb]

Medicines for Human Use (Clinical Trials) Regulations

• The Medicines for Human Use (Clinical Trials) Regulations 2004
• MHRA short description of the Medicines for Human Use (Clinical Trials) Regulations 2004
• The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928)
• The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations SI (2006/2984)
• The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 SI (2008/941)
• The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 SI (2009/1164)
• Universities UK and Department of Health joint statement on legal responsibilities in clinical trials [88.9 Kb]

Medical Devices Regulations

• Medical Devices Regulations (2002)

European Commission Clinical Trials Guidelines

For up to date European Commission guidance documents on Clinical Trials, including information on clinical trial authorisation, monitoring and pharmacovigilance, the quality of the investigational medicinal product and GCP inspections please visit the European Commission website 

International Conference on Harmonisation Guidance

• International Conference on Harmonisation Guidance on Good Clinical Practice (Topic E6) (CPMP/ICH/135/95) [396.9 Kb]
• International Conference on Harminositation Guidance on Clinical Investigation of Medicinal Product in the Paediatric Population (Topic E11) (CPMP/ICH/2711/99) [156.9 Kb]

University Public Statement