Apply to NREC-CT
The NREC-CT reviews applications related to Clinical Trials of Investigational Medicinal Products. This includes interventional and low-interventional studies that include medicines for human use.
Submit under the Clinical Trials Regulation
- As of 31 January 2023, all new clinical trial applications to be submitted under the Clinical Trials Regulation.
- All submissions and notifications related to trials that fall under the Clinical Trials Regulation must be made through the Clinical Trials Information System.
- All trials that come under the Clinical Trials Regulation where Ireland is a Member State concerned will fall within the remit of the NREC-CTs with the support from the National Office. This includes ongoing trials that have now transitioned to the Regulation.
- Please see the NREC Operational Framework for further information.
- NREC CTIS Templates are available here: NREC CTIS Templates
Transition from the Clinical Trial Directive
- New applications under the Clinical Trials Directive (CTD) are no longer accepted by the National Office for Research Ethics Committees and must be submitted under the Clinical Trials Regulation (CTR) using the Clinical Trials Information System (CTIS)
- All trials authorised under the CTD ended or transitioned to the CTR by 30 January 2025.