Substantial Amendments

Applications for a substantial amendment must be completed using the NREC Substantial Amendment Form.

Requirements

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

  • Cover letter outlining documents submitted
  • NREC Substantial Amendment Form signed by the lead study Principal Investigator
  • Clear description of proposed change(s) in the NREC form
  • Clear indication of all changes to each submitted document
  • Submission of CV to support changes to the Principal Investigator
  • Submission of Site Suitability form to support addition of a new site
  • Submission of evidence of fee payment with each application

Substantial amendments to studies approved by local RECs

Submission of a substantial amendment must be accompanied by the NREC Substantial Amendment Form, relevant documentation as designated by the form, and evidence of fee payment.

For clinical trials approved by local RECs, previous documents from the trial are to be submitted within one month of submission of the substantial amendment. This documentation should include the original REC submission, cover letters and approval letters for any substantial amendments, and the most recent version of the documents.

For clinical investigations of medical devices approved by local RECs, historical documents from the study are to be provided along with the submission of the substantial amendment. This documentation should include the original REC submission, cover letters and approval letters for any substantial amendments, and the most recent version of the documents.

To note

  • It is the responsibility of the Principal Investigator or Sponsor to determine whether an amendment should be considered ‘substantial’ or ‘non-substantial’
  • Substantial amendments must be reviewed and approved by the relevant NREC prior to any study changes being actioned.
  • Applicants who intend to request a substantial amendment to their study must pay the appropriate fee in advance of submitting their application. See Fees for more information.
  • Read further details on substantial amendment classification.
  • See our Operational Framework for more details on the review process of substantial amendments.

All application documents should be numbered, and file names should include version number and date.

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

Substantial amendments to Clinical Trials of Investigational Medicinal Products are to be submitted to clinicaltrials@nrec.ie.

Substantial amendments to Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices are be submitted (preferably as a zipped folder) to devices@nrec.ie.

Queries relating to the substantial amendment process can be addressed to the National Office team at clinicaltrials@nrec.ie for Clinical Trials of Investigational Medicinal Products (NREC-CT), and devices@nrec.ie for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD).

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