SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
Sponsor is an individual, company, institution or organisation that takes responsibility for the initiation, management and/or financing of a clinical trial, and that signs the request for authorisation.
- Chapter 1, Section 1(5-8) Regulation 2009 (en)
Sponsorship mandatory
Yes
Sponsorship mandatory - Additional information
Investigator and sponsor may be one and the same person.
Co-Sponsor - Definition available in national law
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
