EU Clinical Trials Regulation (CTR 536/2014)
CTR - Start, End and Safety Reporting (Ch VI-VII)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.36_37: Start and end of trial notifications (Articles 36-37)

Article 36 requires the sponsor to notify, through CTIS, the start of a clinical trial, the start of recruitment of subjects, and the first visit of the first subject. Article 37 requires the sponsor to notify the end of the trial in each Member State concerned (within 15 days) and the end of the trial in all Member States (within 15 days), together with the summary of results within 1 year (or 6 months for paediatric trials, plus a lay summary). Article 37(4) requires the summary of results to be submitted within 30 days of trial termination/halt.

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