Apply to NREC-CT

The NREC-CT will review applications related to Clinical Trials of Investigational Medicinal Products. This includes interventional and low-interventional studies that include medicines for human use.

The NREC-CT will continue to accept the templates dedicated to ethics review for Clinical Trials of Investigational Medicinal Products specified by the Department of Health during the transition period (until January 2022). However, we strongly encourage the community to use the templates below for the Application Form, the Site Suitability Template and the Application Checklist when submitting an application to the NREC-CT.

Please ensure all relevant documentation is included as part of your application:

  • Application Form
  • Checklist
  • Evidence of Fee Payment
  • Clinical Trial Protocol
  • Summary CV for Principal Investigator
  • Research Participant Information Leaflet
  • Research Participant Consent Form
  • Insurance / Indemnity Certificate (for each site)
  • Site Suitability Form or Site-Specific Assessment Form (for each site)
  • Letter of Invitation for participant
  • Investigator’s Brochure
  • Data Protection Impact Assessment (or statement why not required)
  • Cover letter on headed paper
  • Details of any Data Monitoring Committee
  • Case Report Form
  • Validated Questionnaire
  • Non-validated Questionnaire
  • Copies of Advertisement Material for Research Participants, e.g. posters, newspaper adverts, website. For video or audio recordings, please also provide the printed script.

Applications that do not include the relevant documentation or information will be deemed invalid and will require resubmission.

All applications should be sent as a zipped folder to clinicaltrials@nrec.ie.

You can find more information about fees here.

You can find more information about submission processes in our Operational Framework.

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