Substantial Modifications

Applications for a substantial modification must be completed using the NREC Substantial Modification 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 Modification 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 modifications prior to transition to CTR via CTIS

A very high volume of substantial modifications (SMs) are submitted on a monthly basis to the National Office. SMs must be reviewed sequentially, and the National Office cannot prioritise applications based on chosen CTR transition date. The National Office team advise submission of SM applications for assessment at least three (3) months ahead of the Sponsor’s intended timeframe to transition under CTR. 

Substantial modifications to studies approved by local RECs

Submission of a substantial modification must be accompanied by the NREC Substantial Modification 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 modification. This documentation should include the original REC submission, cover letters and approval letters for any substantial modifications, 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For clinical investigations of medical devices approved by local RECs, historical documents from the study are to be provided along with the submission of the substantial modification. This documentation should include the original REC submission, cover letters and approval letters for any substantial modifications, and the most recent version of the documents.

To note

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

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

Substantial modifications 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 modification 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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