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.77_78_79: Corrective measures, Member State inspections and Union controls (Articles 77-79)

Article 77 empowers Member States to take corrective measures: revoke the authorisation, suspend the trial, require the sponsor to modify any aspect of the trial. Article 78 requires Member States to perform inspections to monitor compliance with the Regulation. Article 79 enables Union-level controls by the Agency and the Commission in third countries and within the Union.

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

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