Clinical Trial Directive

The NREC-CT will no longer accept new applications related to Clinical Trials of Investigational Medicinal Products that come under the Clinical Trial Directive (S.I. No. 190/2004) as of 31 January 2023. All new applications must instead be submitted under the Clinical Trial Regulation (CTR) - further details here.

Substantial amendments to trials authorised under the CTD are permitted until 30 January 2025. Please note however that all trials authorised under the CTD must either end or transition to the CTR by 30 January 2025. For information on submitting substantial modifications under the CTD, please refer to the Substantial Modifications 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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