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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 have been 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 and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents are listed in two separate pages on the Eudralex Volume 10 website.

During the transitional period, which will last until 30 January 2025, 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.

Set of documents applicable to clinical trials authorised under Regulation EU No 536/2014

Recommendation paper on decentralised elements in clinical trials

This recommendation paper (December 2022) was created as part of the priority action 8 ‘Methodology guidances’ of the ACT EU initiative of the Heads of Medicines Agencies, the European Commission and the European Medicines Agency.

Recommendations to sponsors on managing the impact of the war in Ukraine on clinical trials

The Clinical Trials Coordination Group (an HMA working group of experts in the classification, assessment and oversight of clinical trials from National Agencies) has published a set of recommendations focusing on the transfer of trial participants from centres in Ukraine to centres in the EU/EEA within the same multinational clinical trial.

Chapter I - Application and application documents

  • Templates documents for FORM section of the CTIS
    • Template statement on compliance Regulation (EU) 2016/679: PDF/Word
  • Part II application document templates
    • Compensation for trial participants - Template: PDF/Word
    • Harmonisation guidance: PDF
    • Investigator Curriculum Vitae template: PDF/Word
    • Declaration of interest template: PDF/Word
    • Site suitability form: PDF/Word
    • Informed consent and patient recruitment procedure template: PDF/Word
    • Compliance with applicable rules for biological samples: PDF/Word

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

Chapter V - Additional documents

Chapter VI – Legislation

Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use

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)

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

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

Joint EC/EMA/HMA technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU

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