ECSubmissionOfApplication object

Responsible for study submission

Principal Investigator

Guidance on study submission available


Guidance on study submission

Further details are provided on the website in section: Notification of clinical trial of medicinal products.

The notification to the research ethics committee shall meet the requirements stated in „Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics., No 9154, 5 May 2011“

Applicable national legal framework/ Reference

Section 14 & 15 of the Committee Act