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Focus on Regulation

European Commission publishes new documents regarding the Clinical Trials Regulation

1.            Introduction

Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.

2.            Recruitment and Informed consent procedure template

This draft template was developed and endorsed by the EU Clinical Trials Expert Group. It is part of Volume 10 of EudraLex which contains guidance documents that apply to clinical trials. The template was developed to provide compliance with the Clinical Trials Regulation. The document provides, however, that the template is also relevant to compliance with the existing Clinical Trials Directive, Directive 2001/20/EC. The template may, therefore, be used in advance of the entry into application of the Regulation.

Section K.59 of Annex I to the Clinical Trials Regulation provides that “unless described in the protocol, a separate document shall describe in detail the procedures for inclusion of subjects and shall provide a clear indication of what the first act of recruitment is”.

The informed consent and patient recruitment template provides that while not being obliged to use the template, sponsors of clinical trials may use the template to describe their recruitment arrangements and/or informed consent procedures. The document provides, however, that if the template is not used for these purposes, all the relevant information contained in the template should, at a minimum, be included in the protocol.

The first section of the template should be completed for all clinical trials. The template provides several questions to be answered by clinical trials sponsors. These relate to the procedures for identification of potential participants, recruitment and informed consent among others.

The other sections of the template relate to specific types of clinical trials such as:

  • Clinical trials which will recruit incapacitated adults;
  • Clinical trials which will involve minors;
  • Clinical trials where consent witnessed by an impartial witness will likely be used;
  • Clinical trials in an emergency situation;
  • ‘Cluster’ clinical trials.

3.            Clinical trial Application Form

In addition to the template, the European Commission has published an updated form regarding requests for authorisation of clinical trials to the competent authorities and for opinion of the Ethics Committees in the European Union.