CTR National Collaboration Project

Clinical Trial Regulation

The way clinical trials are conducted across the European Union will undergo major changes under the Clinical Trials Regulation (CTR) – due to be applied in early 2022. The CTR will harmonise the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). This in turn will harmonise submission and assessment processes, improve collaboration and information-sharing, increase transparency, and further improve standards of safety for research participants – collectively fostering an environment that is more favourable for conducting clinical trials across the EU.

The CTR represents significant change to the way sponsors submit clinical trial documentation, and how the Health Products Regulatory Authority (HPRA) and the newly launched National Research Ethics Committees (NRECs) review and approve clinical trials in Ireland. The scope of the NREC for review of Clinical Trials of Medicinal Products (NREC-CT) will be based on the requirements of the EU CTR.

CTR National Collaboration Project

The National Collaboration Project is jointly run by the HPRA and the National Office over a six-month period. It aims to enable national readiness for and facilitate a smooth national transition to, the CTR by replicating in, so far as possible, the coordinated processes necessary to deliver a ‘single national opinion’ from the two authorities.

As part the collaborative project, the HPRA and the NREC-CT, supported by the National Office, will work closely with a small group of volunteer, academic and industry sponsors conducting trials in Ireland. Together, we will work through the CTR timelines and processes for review of a select number of clinical trials ahead of the application of the CTR later in 2021.

This project is due to commence in May 2021 and will run until December 2021.

Procedures and Guides

Documentation submission

Documents must be submitted in a Part I and II dossier structure, as required by the legislation. Dossier structure folders are available, and clinical trial documents can be added to the folders under the relevant headings.

For further information, please contact clinicaltrials@hpra.ie or clinicaltrials@nrec.ie.

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