CHAPTER XISPONSOR AND INVESTIGATOR

Article 72Co-sponsorship

1.

Without prejudice to Article 74, where a clinical trial has more than one sponsor, all sponsors shall have the responsibilities of a sponsor set out in this Regulation, unless the sponsors decide otherwise in a written contract setting out their respective responsibilities. Where the contract does not specify to which sponsor a given responsibility is attributed, that responsibility shall lie with all sponsors.

2.

By way of derogation from paragraph 1, the sponsors shall be jointly responsible for establishing:

(a)

a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III;

(b)

a sponsor responsible for being a contact point for receiving all questions from subjects, investigators or any Member State concerned regarding the clinical trial and providing answers to them;

(c)

a sponsor responsible for implementing the measures taken in accordance with Article 77.