SSSponsor object
Sponsorship mandatory - Additional information
It is mandatory to have a sponsor in all clinical investigations of MD (CE-marked MD use outside label , non-CE-marked MD, respective combination studies with IMP).
It is not obligatory to have a sponsor for Non-Interventional Trials; they can be “unsponsored”, inicialized and conducted by the healthcare provider.
However the fee should be payed prior to the process, regardless of sponsorship, if the study results can be used for marketing purposes!