How to apply to NREC-CT

The NREC-CT reviews applications related to Clinical Trials of Investigational Medicinal Products (CTIMPs). All trials that come under the Clinical Trials Regulation (CTR) when Ireland is a Member State Concerned (MSC) will fall within the remit of the NREC-CT with support from the National Office. This includes ongoing trials that have now transitioned from the CTD to the CTR.

Applications for clinical trials come under the Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use (Clinical Trial Regulation or CTR) and are no longer submitted directly to the National Research Ethics Committee for Clinical Trials (NREC-CT) or to the Health Products Regulatory Authority (HPRA).

The regulation requires that all clinical trial applications and assessments must be submitted and managed through a unified online portal called the Clinical Trial Information System (CTIS): CTIS for sponsors - EMA (euclinicaltrials.eu).

For queries related to the CTIS, please contact the European Medicines Agency.

Submissions via CTIS

CTIS contains a 'Sponsor' workspace for clinical trial sponsors and the organisations that work with them; an 'Authority' workspace for EU Member States, EEA countries and the European Commission; as well as a public-facing website.

  • The 'Sponsor' secure workspace assists clinical trial sponsors in preparing for and compiling clinical trial applications and related documents to submit for assessment.
  • The 'Authority' secure workspace supports the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.

Roles and responsibilities

How to register for CTIS

To access CTIS, clinical trial sponsors must ensure their users have an EMA account.

  • Those that have an existing EMA account i.e. to use EudraVigilance or the substances, products, and organisations database (SPOR) do not need to create a new account.
  • Those that do not have an EMA account can register via EMA Account Management. Clinical trial sponsors may need to complete additional registration steps based on the user management approach they choose for CTIS. To use the organisation-centric approach, organisations must ensure they are registered in EMA’s Organisation Management System, and they must register a CTIS High Level Administrator via EMA Account Management.

Using CTIS as a sponsor

  • We recommend clinical trial sponsors consult the sponsor handbook for guidance on preparing for CTIS. Tailored specifically for the pharmaceutical industry, research organisations, SMEs and academic sponsors, it covers priority topics for clinical trial sponsors and links to supporting materials.
  • Become familiar with the workings of CTIS by completing the online training programme. It consists of several modules covering the full lifecycle of clinical trial submission.

Useful links to resources & training materials

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