EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation

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(Regulation (EU) No. 536/2014). Although the regulation has not yet taken effect, the template—developed and endorsed by the EU Clinical Trials Expert Group on 9 October—can already be used under the currently applicable Directive 2001/20/EC.

Purpose of the Site Suitability Template

The template is designed to help sponsors clearly demonstrate that a proposed trial site is suitable for conducting the planned clinical trial. It includes five key sections allowing sponsors to describe:

how the site’s characteristics align with the nature and use of the investigational medicinal product
the adequacy of site facilities and equipment
trial-specific procedures that will be performed at the site
human resource arrangements, including staff qualifications and expertise
any other relevant operational considerations

Additional EC Documents

Alongside the template, the EC has made available a collection of documents relevant to clinical trials that will fall under the new regulation once it becomes applicable. These include forms and guidance issued between 2013 and 2019, as well as the most recent draft of a question‑and‑answer document published in June.

These resources aim to support sponsors in preparing for a smooth transition to the new clinical trial regulatory framework across the EU.

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