Apply to NREC-CT
The NREC-CT will review 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
- Where feasible, the National Office encourages 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 clinical trial applications can be made under the Clinical Trial Directive to the NREC-CT until January 2023.
- Substantial amendments can continue to be submitted to the NREC-CT under the Clinical Trial Directive until January 2025.
- Trials that continue to fall under the Directive can transition to the NREC system through the submission of a substantial amendment.
- Trials that have not yet transitioned to the CTR or the NREC-CT through the submission of a substantial amendment must continue to report to the relevant recognised local research ethics committee where they initially received approval.