CLINICAL TRIALS OF MEDICINAL PRODUCTS (until Dec 31st 2021 only)
Beaumont Hospital Local Checklist - CTIMPS (updated March 2021)
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 Form	Link 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 2018	Link to HRB Website
Template Data Protection Impact Assessment (Beaumont)	Link
Template Information Leaflets and Consent Forms (Beaumont)	Link
Standard Form of Indemnity	Link
Radiation Declaration Form
Invoice Details Form
Fee Structure	Link
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? If yes, the radiation declaration form will apply. Is it a gene therapy trial?
A new national research ethics committee will commence accepting applications for the conduct of CTIMPs from May 2021. Beaumont Ethics (Medical Research) Committee is permitted to review CTIMPs for a transition period until 31 December 2021 only - link to national office of research ethics committees here