Apply to NREC-CT
New/initial 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).
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 Trial Regulation
- As of 31 January 2023, all new clinical trial applications to be submitted under the Clinical Trial Regulation.
- All submissions and notifications related to trials that fall under the Clinical Trial Regulation must be made through the Clinical Trial Information System.
- All trials that come under the Clinical Trial 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 Appendix 1 NREC-CT Operational Framework - Clinical Trial Regulation for further information.
Submission under the Clinical Trial Directive
- The Clinical Trial Directive was transposed into national law under the S.I. No. 190/2004.
- New applications under the Clinical Trials Directive (CTD) are no longer accepted by the National Office for Research Ethics Committees.
- Substantial amendments to trials authorised under the CTD are permitted until 30 January 2025.
- All trials authorised under the CTD must end or transition to the CTR by 30 January 2025.
- Trials that continue to fall under the Directive can transition to the NREC system through the submission of a substantial modification.
- Trials that have not yet transitioned to the CTR or the NREC-CT through the submission of a substantial modification must continue to report to the relevant recognised local research ethics committee where they initially received approval.