Please find below links to documents relating to regulations for Clinical Trials

Ethical Considerations for Clinical Trials on Medicinal Products conducted with the Paediatric Population
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
Article from The Lancet 2005
"A proposed charter for clinical trial data monitoring committees: helping them to do their job well"
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 April 2001
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.