NREC-CT reviews clinical trials of investigational medicinal products, as determined by EU Regulations in the area of clinical trials of investigational medicinal products (CTIMP) (EU No. 536/2014).

Only the modification; the reach of the NREC’s decision on a substantial modification relates only to the ‘question‘ before it (ie, the change proposed in the amendment application). Substantial modifications are reviewed in line with NREC processes and  may require  access to documentation that supported the original REC approval for context, which may inform the NREC decision on the modification; however the ongoing study itself is not subject to NREC approval..

The National Office, in consultation with the NRECs and external stakeholders, have developed a national template for Sponsors to demonstrate compliance with all applicable data protection legislation, including national legislation. The template aims to assist Sponsors with informing the respective NRECs of data protection compliance and associated ethical considerations.

Applicants now have the following options regarding demonstrating compliance with data protection legislation:

1. Submission of national ‘Statement of Compliance’ template [Please see ‘Guidance on Statement of Compliance’] to ensure a free form Statement of Compliance is comprehensive and addresses the requirement to demonstrate compliance with data protection legislation,
2. Or submission of a study-specific Data Protection Impact Assessment (DPIA) DPIAs can be submitted instead of.

NOTE: Where the NRECs believe the Statement of Compliance (or DPIA) is insufficient, such that there are ethical concerns, they reserve the right to request further information, as appropriate.

NRECs are not expected to undertake detailed expert scrutiny of the insurance policies pertaining to the research described in the application they review. The responsibility for ensuring that cover is sufficient and adequate lies with Applicants .

The NREC should receive an assurance from the Applicants that there are adequate insurance or indemnity arrangements in place for the potential legal liability arising from the research, and consider provision in proportion to the risk for compensation or treatment in the event of injury, disability or death attributable to participation.

In particular, this information must evidence that:

1. the insurance arrangements cover the research study concerned;
2. the sponsor and, except for Phase 1 trials, all protocol authors, investigators / collaborators and, where applicable, Site Management Organisations will all be protected by insurance or indemnity arrangements;
3. the arrangements will provide adequate cover to meet the potential liability assessed by the sponsor.

Where a site, sponsor or Investigator come under the Clinical Indemnity Scheme, the sponsor and / or Investigator is responsible for notifying the State Claims Agency of the research study.

Yes, Applicants must pay the relevant fee in advance of submission to the National Office for Research Ethics Committees. For NREC-CT, in the first instance, the fees for ethics review are aligned with those currently in place for the local REC system. It is anticipated that in January 2022 a new fee structure will be required for the NREC-CT with application of the EU CTR. These fees will be determined in consultation with the relevant Government departments including the Department of Health and Department of Business, Enterprise & Innovation. Fees due under the EU CTR will represent a combined fee for both ethics and regulatory approval.  You can find out more about our fees at https://www.nrecoffice.ie/apply-2/fees/

The timelines for NREC decisions will be consistent with those required by the pending EU Regulation for clinical trials (EU No 536/2014). In the first instance, the National Office has established an NREC meeting schedule that facilitates clinical trials of investigational medicinal product applications to be considered twice per month.

The National Office is currently collaborating with the HPRA to run a CTR National Collaboration Project with select volunteer Applicants to prepare for a ‘single national opinion’ by testing the processes and timelines required for the EU CTR; in this regard, the timing of an NREC decision will be coordinated with the regulatory decision of the HPRA. When the EU CTR is applicable (anticipated January 2022), the NREC-CT will work to the timelines set out in the EU CTR. Currently, Applicants submitting to the NREC-CT may expect a decision on a valid application within 60 days.

Following the submission deadline, the National Office validates all applications.  This means we check if the application falls within the scope of NREC-CT, if all necessary documentation is included, can be accessed and marked with version numbers and dates.

Applicants should normally receive notification of whether their application is ‘Valid’ or ‘Invalid’ within seven calendar days of validation, in line with the operational requirements of the particular NREC review process. Invalid applications will require resubmission if ethics review is to proceed. Typically, the NREC-CT will review all valid applications at full meeting and the National Office will inform the Applicant of the outcome of an ethics review within five working days of a meeting being held. The outcome for validation is not issued until the cut-off date has passed.

Under the CTR, all safety reporting is carried out through the CTIS system and reports are no longer sent to the NREC-CT.

Under the CTD, applicants must notify the relevant NREC about urgent safety measures, suspected serious unexpected adverse reactions, and submit annual safety reports for notification, related to studies approved by the NREC. Relevant forms and templates can be found here: Reporting Forms & Templates - NREC (nrecoffice.ie)

If your study involves the exposure to ionising radiation where the exposure or intervention is experimental or beyond the standard of care, please complete the relevant sections of the Site Suitability template.

It's up to the applicant to determine whether the use of ionising radiation in conjunction with a CTIMP is beyond the standard of care or for experimental purposes.

If your study involves a medicinal device in combination with a medicinal product, an an additional appendix must be submitted with the application - https://www.nrecoffice.ie/nrec-ct-combination-studies/.

Please note, certain combination studies are a subject to both NREC-CT and NREC-MD review, for example studies carried out under both CTD/ CTR and MDR or IVDR, particularly if the study is subject to review by both CT and MD team of the HPRA. In such cases, a separate application to NREC-MD is necessary. For more information on the NREC-MD application process, please visit the NREC-MD website.