STUDIES OTHER THAN CTIMPS AND IMDS
(Trials of Medicines / Investigations of Medical Devices)
(previously approved by this committee) |
| Amendment Letter |
 |
| DPIA Review |
Link |
| Annual Progress Report | |
| Final Progress Report | |
| Amendments, Reports, Notifications and Letters may be submitted to beaumontethics@rcsi.ie until study completion | |
CTIMPS (Trials of Medicines)
(previously approved by this committee) |
| NREC Substantial Amendment Form | Link to NREC website |
| Review of all substantial amendments will transfer over to the new National REC for Medicines (NREC-CT) from June 1st 2021 | |
| NREC Reporting Forms | Link to NREC website |
| Reports may continue to be submitted to this committee at beaumontethics@rcsi.ie until such time as you submit a substantial amendment to the new national REC - clinicaltrials@nrec.ie | |
| The deadline for transfer of existing trials to the Clinical Trials Regulation (CTR) and thereby to the national REC is 31st January 2025 | |
| NREC Guide to Substantial Amendments | Link to NREC website |
IMDS (Investigations of Medical Devices)
requiring HPRA authorisation
(previously approved by this committee)
Post-Marketing Follow Up Studies of Medical Devices
(previously approved by this committee) |
| NREC Substantial Amendment Form | Link to NREC website |
| Review of all substantial amendments will transfer over to the new National REC for Devices (NREC-MD) from May 26th 2021 | |
| NREC Reporting Documents | Link to NREC website |
| All Reports (including safety reports, notifications re. device deficiency, annual and final reports) to be submitted to the new National REC for Devices (NREC-MD) from May 26th 2021 - devices@nrec.ie | |
| NREC Guide to Substantial Amendments | Link to NREC website |
