Vol 10: Clinical Trials

EudraLex - Volume 10 Clinical trials guidelines


Volume 10 of the publications "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.

General information (July 2006)

Chapter I - Application and application form

Chapter II - Safety reporting

Chapter III - Quality of the investigational medicinal product

Chapter IV - Inspections

Chapter V - Additional information

Chapter VI - Legislation