ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Principal Investigator
Guidance on study submission available
Yes
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“