Substantial Modifications
Applications for a substantial modification must be accompanied by the NREC Substantial Modification Form below and a cover letter outlining the documents submitted.
All applications should be sent as a zipped folder to devices@nrec.ie.
Substantial modifications must be reviewed and approved by NREC-MD prior to any study changes being actioned.
You can find the NREC-MD meeting and cut off dates here.
You can find more information about fees here.
For more information on the application and review process, please visit the NREC-MD FAQs and Resources page.
Requirements/Checklist
- Application documents should be numbered, and file names should include version number and date
- All documents must be submitted in original non-scanned PDF format. Scanned copies will not be accepted. This is to ensure accessibility.
- Table should be included in the cover letter outlining which documents are for review and which are for reference only
- Clear description of proposed change(s) in the NREC form and where applicable, the cover letter
- Clear indication of all changes to each submitted document e.g. tracked changes, highlights etc.
- 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
Non-substantial modifications
A non-substantial modification is any change to the research study, the protocol or any other supporting documentation, that does not meet the definition of a substantial modification.
It is the responsibility of the Sponsor to determine whether a modification is considered substantial, but if unsure, please contact the HPRA at devices@hpra.ie for advice.
Non-substantial modifications are not reviewed by the NREC-MD, but applicants may notify the National Office of any non-substantial changes to approved clinical investigations/ performance studies via email to devices@nrec.ie.