CLINICAL TRIALS OF MEDICINAL PRODUCTS
Beaumont Hospital Local Checklist - CTIMPS (updated September 2018)
The above checklist only applies for the ethical review of clinical trials of medicinal products
Department of Health Application FormLink to DoH website
The Department of Health Application Form only applies for the ethical review of clinical trials of medicinal products
Department of Health Site Specific Assessment Form Link to DoH Website
Health Research Regulations 2018Link to HRB Website
Article on Health Research Regulations 2018Link to Arthur Cox Website
STUDIES OTHER THAN CLINICAL TRIALS OF MEDICINAL PRODUCTS
Please obtain legal advice on the Health Research Regulations 2018 before making a submission to this committee.
Beaumont Hospital Local Checklist (updated September 2018)
Beaumont Hospital Local Signatory Page (updated August 2018)
Research Ethics Committee Standard Application Form (RECSAF) 5.6 (adapted 31 August 2018, copyright RCSI & Beaumont Hospital)
Always refer to the accompanying Instructions, the Health Research Regulations, and the HSE Consent Policy when completing this form
Instructions for Use 5.6 (adapted 31 August 2018, copyright RCSI & Beaumont Hospital)
Health Research Regulations 2018Link to HRB Website
Article on Health Research Regulations 2018Link to Arthur Cox Website
HSE National Consent Policy (2017)(Please note any references to Data Protection in his document pre-date GDPR 25th May 2018, and the Health Research Regulations 8th August 2018, and hence are no longer accurate.)Link to HSE Website
Frequently Made Mistakes (updated 30 September 2018)
Sample Answers J1 and J2 - Beaumont only
Recurring Review Themes
Sample Size - a rough guide (Prof. R. Conroy)