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