Submit under the Clinical Trial Directive

The NREC-CT will accept new applications related to Clinical Trials of Investigational Medicinal Products that come under the Clinical Trial Directive (S.I. No. 190/2004) until 25 January 2023. This includes interventional and low-interventional studies that include medicines for human use.

For further information regarding the transition period from CTD to CTR in January 2023, please see: Meetings & Cut-off Dates page.

Please use the templates below when submitting to the National Office under the Clinical Trial Directive.

For information on submitting substantial amendments under the Directive, please refer to the Substantial Amendments page. 

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

Please note that all documents must be submitted in original PDF format. Scanned copies will not be accepted. This is to ensure accessibility.

  • 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
  • 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.

How to submit an application

All applications should be sent as a zipped folder to

More information

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