Substantial Modifications: CTD
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. NREC-CT advise submission of SM applications for assessment at least three (3) months ahead of the Sponsor’s intended timeframe for transition.
Applications for a substantial modification must be completed using the NREC Substantial Modification Form.
How to submit an application:
Substantial modifications to Clinical Trials of Investigational Medicinal Products are to be submitted to clinicaltrials@nrec.ie
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
Template Forms for CTD SMs:
Applications that do not include the relevant documentation or information will be deemed invalid and will require resubmission.
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.