SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

The sponsor who is an individual, company or organisation takes responsibility for the initiation, management and/or financing (or arranging the financing) of a clinical trial (see Section 3 of the Clinical Trial Regulations 2004)

Sponsorship mandatory

Yes

Co-Sponsor - Definition available in national law

Yes

Co-Sponsor - Definition (pursuant to national law)

There is a peculiarity in the UK because co-sponsorship is allowed under UK law according to section 3 paragraph 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004:
"(2) If two or more persons take responsibility for the matters specified in paragraph (1) in relation to a clinical trial, those persons may—
(a)take joint responsibility for carrying out the functions of the sponsor of that trial under these Regulations; or
(b)allocate responsibility for carrying out the functions of the sponsor of that trial in accordance with paragraphs (4) to (10)."

Co-sponsorship allowed

Yes

Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:

Yes

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395