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 |