ECSubmissionOfApplication object
Entitled to study submission
Sponsor
Prerequisites for submission / approval
Application is limited to the institution
Additional Information
Application is done by the institution which is legally responsible for the study, called “promoteur” promotor. It can be a public institution (Hospitals, Inserm, Inra..) or industry. The submission is done by a sponsor only when this sponsor is the promotor
Of course the project is prepared by investigators. The main investigator must be MD.
