EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

Regulatory NewsRegulatory News | 15 October 2019 |  By 

The European Commission (EC) on Tuesday 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.

Although the EU’s new clinical trial regulation was adopted and entered into force in 2014, its application is contingent on a functional Clinical Trials Information System (CTIS), which is determined via an independent audit. The CTIS is where trial information will be submitted, and some of that information will become publicly available.

According to a European Medicines Agency (EMA) update earlier this month, an operational assessment of the system “to identify critical business blockers” still needs to be carried out in order to enable EMA's Management Board to consider the timing of the audit.

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 form also explains: “When completing this form, any national guidelines should also be referred to with regards to which sections must be completed. Where no national guidelines exist, the form should be completed in full.”

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.

“Please note that certain Q&As and a section of this document are still being discussed within the expert group on clinical trials and are therefore not yet included. Updated versions of the document will be published progressively,” the EC says about the June document.

Other updates that are currently ongoing involve detailed guidelines on good clinical practice specific to advanced therapy medicinal products, and recommendations on the content of the trial master file and archiving.

European Commission


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