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 must end or transition to the CTR by 30 January 2025.
- The National Office recommends that sponsors submit transitions by 16 October 2024 at the latest to permit review and authorisation.
- Sponsors are advised to submit any necessary outstanding substantial modifications to studies authorised under the CTD to the National Office for NREC review at their earliest convenience, in order to submit their trial for transition to the CTR by the 16 October 2024
- Sponsors can use the guidance available to assist with the transition.
- National Office FAQ: CTR and CTIS FAQs - NREC (nrecoffice.ie)
- The European Commission have published a guidance document for the transition of clinical trials under EudraLex volume 10.
- The Clinical Trials Coordination Group (CTCG) adopted a best practice guide for multinational sponsors of transitional trials.
- Training materials available on the EMA CTIS website under the Transitioning Trials section.
- Trials which have not yet transitioned to the NREC-CT system from the authorising REC under the CTD can transition directly to CTR. Until the transition is initiated, safety and other applicable reporting should continue to be made to the authorising REC