ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Guidance on study submission
Various guidance documents on application procedure, research plan, information for trial subjects as well as the English version of the application form are available in English on the Central EC website in Section Application.
Additional Information
An application is deemed complete when the application form has been filled in correctly, the required appendices are attached and the fee has been paid.
The sponsor ensures that a copy of the EC’s opinion is submitted to the MPA within 15 days after receipt.
NB! If ionising radiation or radiological methods are used:
Additional approval from Local Radiation Protection Committees is required!
