ECSubmissionFormat object

Format option(s)

Online portal

Online portal

DKMAnet: Only one application to the common submission portal.

(Currently the use of the DKMAnet is not mandatory, but in future it will be. Exact date is not yet decided)

Guidance on submission format

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“