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 informationpdf(375 KB) (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