SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
Definition pursuant to Regulation 4 SI 190/2004:
'the person who takes on responsibility for the initiation and management (or for arranging the initiation and management) of, and the financing (or arranging the financing) for that clinical trial“.
The sponsor or legal representative of the sponsor shall be established within the European Community.
Sponsorship mandatory
Yes
Co-Sponsor - Definition available in national law
No
Co-sponsorship allowed - Additional information
There is no provision for Co-Sponsorship at present, however, this will change when the rules of CT Regulation 536/2014 become applicable.
For non-commercial multi-centre clinical trials, it is possible to have a local sponsor in addition to an international sponsor.
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
