NREC-CT reviews clinical trials of investigational medicinal products (CTIMPs), as determined by the EU Clinical Trial Regulations in the area of clinical trials on medicinal products for human use (EU No. 536/2014).

The National Office, in consultation with the NRECs and external stakeholders, have developed a national template for Sponsors to use to demonstrate compliance with applicable data protection regulations/legislation, including national legislation. The template is designed to support Sponsors in notifying the relevant NRECs about their compliance with data protection and associated ethical considerations.

The Statement of Compliance and guidance on completing the Statement of Compliance may be found with the list of documents for submission.

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

NREC-CTs do not undertake expert assessment of the insurance policies pertaining to the research described in the application they review. Sponsors are responsible for ensuring that cover is sufficient and adequate.

The NREC-CTs request that sponsors submit an assurance that adequate insurance or indemnity arrangements will be 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. You can find more information on the fees section of our website.

The timelines for NREC decisions are consistent with those required by the EU Clinical Trial Regulation (EU No 536/2014).

Steps for the validation and assessment of clinical trial applications are as per the EU Clinical Trial Regulation (EU No 536/2014), and communication with the applicant is via the EU Clinical Trials Information System (CTIS).

Please refer to the reporting section of our website.

If a clinical trial involves exposure to ionising radiation where the exposure or intervention is experimental or beyond the standard of care, as determined by the applicant, please complete the relevant sections of the Site Suitability Template which can be found in the NREC-CT Apply section of our website.

Studies which include an investigational medicinal product (carried out under the EU Clinical Trials Regulation) and a medical device and/or an in vitro diagnostic medical device (carried out under the EU Medical Device Regulation /EU In Vitro Diagnostic Medical Device Regulation) require review and approval by both NREC-CT and NREC-MD.

Two separate applications are required for NREC-CT and NREC-MD. These applications can be submitted consecutively or concurrently. Applications to NREC-CT are submitted via the EU Clinical Trials Information System (CTIS) only.

The application documentation for NREC-CT should be completed as per the requirements of the EU Clinical Trial Regulation (CTR).

Following separate internal validation processes, each committee will conduct their own independent review within their respective remits, i.e.:

• NREC-CT will review and approve aspects and documents of the study pertaining to the clinical trial in question. Aspects of the clinical investigation/performance study which require ethical review will not be reviewed or approved by NREC-CT.
• Similarly, NREC-MD will review and approve aspects and documents of the study pertaining to the clinical investigation/performance study in question. Aspects of the clinical trial for investigative medicinal products (CTIMP) which require ethical review will not be reviewed or approved by NREC-MD.
• It is requested that the cover letter clearly states the aspects of the applications to be assessed by both NREC-CT and NREC-MD, as per their legislative remits.
• Substantial modifications for combination studies should also be submitted separately to either/both NREC-CT or NREC-MD based on the context of the SM.

For more information on the NREC-MD application process, please visit the NREC-MD website.

No; There will be no approval letters sent for studies reviewed under the EU Clinical Trial Regulation (CTR). A Final Assessment Report (FAR) is uploaded to the EU Clinical Trials Information System (CTIS) for the Part II dossier. The complete list of reviewed documents and their version numbers will not be stated on the FAR. This information will be accessible in the sponsor workspace of CTIS.