European Legislation
Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
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.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated version: 16/11/2012).
Directive 2003/94/CE, of 8 October laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Directive 2005/28/EC, of 8 April laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use.
ICH Guidelines
E3 - Note for Guidance on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95)
E6 - Good Clinical Practice (CPMP/ICH/135/95)
E8 - General Considerations for Clinical Trials (CPMP/ICH/291/95)
E11 - Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99)
On the website of the European Commission and the European Medicines Agency (EMA) are available all ICH guidelines and relevant scientific guidelines for conducting clinical trials.
European Commission Guidelines
EudraLex - Volume X
Chapter I: Application and Application Form
Chapter II: Monitoring and Pharmacovigilance
Chapter III: Quality of the Investigational Medicinal Product
Chapter IV: Inspections
Chapter V: Additional Information
Chapter VI: Legislation
