EU Clinical Trials Regulation (CTR 536/2014)
CTR - Sponsor, Damage Compensation and Supervision (Ch XI-XIII)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.71_72_73_74: Sponsor, co-sponsorship, principal investigator and legal representative (Articles 71-74)

Article 71 establishes that a clinical trial may have one or several sponsors, and that the sponsor may delegate any or all of its tasks (but remains responsible). Article 72 governs co-sponsorship (joint and several liability for compliance unless a written contract allocates obligations and the trial subjects are informed). Article 73 establishes the principal investigator role. Article 74 requires the sponsor (where established outside the Union) to be represented by a legal representative established in the Union.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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