SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

An individual, company, institution, organisation or enterprise whose role is to initiate, manage and/or finance a clinical trial of a medicinal product (Art 2(i) Regulation no 433/2004).

Sponsorship mandatory - Additional information

If no sponsor is connected to the study, the principal investigator shall perform this role.

Co-Sponsor - Definition available in national law

No

Additional Information

Related details to study responsibilities are specified in Art 4 Regulation no 443/2004.

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