ECAmendment object
Ethical review mandatory for
Any substantial amendments
Responsible for notification of SA
Sponsor
Standard notification form available
Yes
Standard notification form
The standard form to be used (Form 4) is available on the Department of Health website in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products > Application Forms
Timeline Ethical review of SA (max nr days)
35
From date of receipt of valid application
Guidance on submission of SA
Further details on the submission procedure of amendments are provided in the Guidance booklet on applications to Recognised Ethics Committees (RECs), available on the website of the Department of Health in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products.
