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


The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect.

The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this template is also relevant under Directive 2001/20/EC and may be used in advance of the Regulation applying,” the EC says.

Site Suitability Template:

The new template features five areas where sponsors can explain “the suitability of the site adapted to the nature and use of the investigational medicinal product,” the suitability of facilities and equipment, a description of trial procedures that will take place at the site and “a description of Human Resources arrangements and expertise at the site.”

The EC also has posted a series of other documents applicable to clinical trials that will be authorized under the new regulation once it becomes applicable. Most of the forms are from 2013 to 2019, with the most recent one being a draft question and answer document on the regulation from June.