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Home / Submit under the Clinical Trial Regulation

  • Apply to NREC-CT
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Submit under the Clinical Trial Regulation

Applications for clinical trials that come under the Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use (Clinical Trial Regulation or CTR) will no longer be submitted directly to the National Research Ethics Committee for Clinical Trials (NREC-CT) or to the Health Products Regulatory Authority (HPRA). Instead, they must be submitted using the Clinical Trial Information System (CTIS).

NREC-CT operational framework under the CTR

In line with the CTR, the National Office and the NREC-CT have adapted their processes and requirements to meet the legislative changes. Please download the Appendix below for further information.

 

Appendix 1: NREC-CT Operational Framework under CTR

Part II dossier templates

The National Office has adapted templates developed and endorsed by the EU Clinical Trials Expert Group to comply with the CTR. The completion and submission of the templates below are a mandatory requirement for any Part II dossier submission where Ireland is a Member State concerned.

 

Investigator Cirriculum Vitae
Investigator Declaration of Interest
Site Suitability Form
Recruitment and Informed Consent Procedure
Compensation for Trial Participants
Collection, Storage and Future Use of Human Biological Samples

Fee payment

In line with the CTR, there will be one single national fee payment applicable for all clinical trial applications and substantial modifications. This payment will be managed by the HPRA. Please see the links below for further information:

  • Guide to Fees for Human Products
  • Human Products Fees

 

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