CLINICAL TRIALS OF MEDICINAL PRODUCTS
Beaumont Hospital Local Checklist - CTIMPS (updated January 2019)
The above checklist only applies for the ethical review of clinical trials of medicinal products
The checklist outlines this committee's requirements, the documents for submission, and the method of submission
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
Section E2 (drafted 31 August 2018, copyright RCSI & Beaumont Hospital)
Instructions to complete Section E2 (drafted 31 August 2018, copyright RCSI & Beaumont Hospital)
Health Research Regulations 2018Link to HRB Website
Article on Health Research Regulations 2018Link to Arthur Cox Website
Contact the administrator before making any submission in respect of a clinical trial of a medicine to this committee. The following information is required: Single site or Multi-site? Name of PI at Beaumont site? Speciality? Phase of Trial? Will all participants be adults? Will all adult participants have capacity? Does the trial involve exposure to medical ionising radiation? Is it a gene therapy trial?
STUDIES OTHER THAN CLINICAL TRIALS OF MEDICINAL PRODUCTS
Please obtain expert advice on the Health Research Regulations 2018 before making a submission to this committee.
Beaumont Hospital Local Checklist (updated July 2019)
The checklist outlines this committee's requirements, the documents for submission, and the method of submission
Beaumont Hospital Local Signatory Page (updated January 2019)
The signatory page contains declarations to be signed by Investigators and Academic Supervisors
Research Ethics Committee Standard Application Form (RECSAF) 5.6 (adapted 31 August 2018, copyright RCSI & Beaumont Hospital)
Only forms downloaded from this website will be accepted for review. The application form and templates in use in the SJH/AMNCH Research Ethics Committee, although similar, differs from those on this site, and are not accepted for review by this committee.
Always refer to the accompanying Instructions, the Health Research Regulations, and the HSE Consent Policy when completing the application form on this site
The application form on this site is also used by the RCPI REC, and the ICGP REC.
Instructions 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
Health Research Consent Declaration CommitteeLink to CDC 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
European Commission Ethics and Data Protection (November 2018)Link to EC website
Frequently Made Mistakes (updated January 2019)
Sample Answers J1 and J2 - Beaumont only
Recurring Review Themes
Sample Size - a rough guide (Prof. R. Conroy)