Vol 10: Clinical Trials

EudraLex - Volume 10 - Clinical trials guidelines


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

A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover new aspects introduced by the same Regulation.

In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website.

Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.

During the transitional period, which will last for a period of 3 years starting from when the Regulation becomes applicable, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.

At the end of the transitional period all clinical trials shall be conducted under the Regulation and should follow only the set of documents applicable to the Regulation.

Although it is not mandatory, stakeholders are encouraged to take already into consideration a number of aspects that are outlined in the new or updated documents published in the page dedicated to the Clinical Trial Regulation and apply them to those clinical trials authorised under the Directive, to the extent possible and in compatibility with the legal framework of the Directive.


Set of documents applicable to clinical trials authorised under Directive 2001/20/EC

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

Set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable

Chapter I

  • Guidance to be added at a later stage

Chapter II - Safety reporting 

For more guidance on safety reporting please refer to the Q&A document on the Clinical Trials Regulation in Chapter V

Chapter III – Quality

 Chapter IV – Inspections

Note: The revision of Annex V on inspections of phase I unit, has been put on hold until finalisation of the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products” now published on the EMA website. An updated version of the document will be provided in due course.

Chapter V - Additional documents

 Chapter VI – Legislation

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, and repealing Directive 2001/20/EC

Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council

Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)