SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

Clinical trial sponsor is an individual or a legal entity that takes responsibility for
commencing, conducting, and/or financing a clinical trial (Art 2 Law on MP & MD 2010)
Clinical trial sponsor can be a manufacturer, legal or physical entity, who is responsible for the initiation, management, quality and financing of the clinical trial conduct. (Art 71 Law on MP & MD 2010)

Sponsorship mandatory

Yes

Sponsorship mandatory - Additional information

Mandatory in all investigations of Medical Devices.

Co-Sponsor - Definition available in national law

No

Co-sponsorship allowed

No

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