Cut-off dates for submission:  

Applications to the NRECs for Clinical Trials of Investigational Medicinal Products (NREC-CT) can be submitted at any stage until the submission cut-off date for the next NREC meeting (see table below). All applications must be submitted to the National Office by 12 noon on the cut-off date to be considered at the next NREC-CT meeting. 

Please note, under the Clinical Trial Regulation (CTR), timelines will be dictated by the Clinical Trial Information System (CTIS), and the National Office will review and revise published cut-off dates in 2023 as required. 

Transition to CTR through the CTIS: 

From 31 January 2023, all new applications must be submitted under the CTR via the CTIS system: https://euclinicaltrials.eu/. 

Further guidance on the process can be found here:

• National Office: Submit under the Clinical Trial Regulation - NREC (nrecoffice.ie)
• HPRA: Clinical Trials (hpra.ie)

Meetings are filled on a first come first served basis. Trials submitted under the CTR will take precedence over those submitted under the CTD, to ensure Ireland can meet the legislative timelines for delivering an opinion under the CTR. Depending on the volume of applications received ahead of the cut-off date, the Chairperson of the NREC-CTs in consultation with the Programme Manager will limit the number of applications reviewed at any given meeting in order to manage workflow and ensure consistent high-quality ethics review. 

Apply to the NREC-CT.

Submission under the Clinical Trials Directive: 

Please note, the National Office can confirm that all valid applications submitted under the Clinical Trials Directive (CTD) by 25 January 2023, will be accepted by the National Office for NREC-CT review under the CTD.

We are currently experiencing a high volume of applications under the CTD as the final submission date for applications under this directive approaches. We cannot guarantee review timelines at this point, but all CTD submissions will be queued for validation and subsequent review by the NREC-CT in accordance with their submission date. The National Office will provide clear communication to applicants regarding validation and review timelines once available.

As a clinical trial cannot be commenced under the Clinical Trials Directive unless it has been authorised by both the HPRA and the National Office for Research Ethics Committees, please ensure that you make a simultaneous CTD application to the HPRA: Clinical Trials (hpra.ie).