Reference documents

• 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)
• Medical Devices Regulations (2002)
• Research Governance Framework for Health and Social Care (Second edition, April 2005)
• Universities UK and Department of Health joint statement on legal responsibilities in clinical trials

EU Commission Guidance

• Clinical Trials Directive (Directive 2001/20/EC) - 4 April 2001
• Good Manufacturing Practice (Directive 2003/94/EC)
• Good Clinical Practice Directive (Directive 2005/28/EC) - 8 April 2005

EU Commission Guidance

• Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial - Revision 2 (October 2005)
• Detailed guidance on the European Clinical Trials database (EudraCT Database) (April 2004 plus amendments of May 2004)
• Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use - Revision 2 (April 2006)
• European commission guidelines on Good Manufacturing Practice: Manufacture of Investigational Medicinal Products (Annex 13) - July 2003
• Detailed guidance on European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module) - Revision 1 (April 2004)
• Detailed guidelines on the Trial Master File and Archiving - Draft 12 June 2002
• Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use. Revision 1 (February 2006)
• International Conference on Harmonisation Guidance on Good Clinical Practice (Topic E6) (CPMP/ICH/135/95)
• International Conference on Harminositation Guidance on Clinical Investigation of Medicinal Product in the Paediatric Population (Topic E11) (CPMP/ICH/2711/99)