EU Clinical Trials Regulation (CTR 536/2014)
CTR - Authorisation Procedure and Substantial Modifications (Ch II-III)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.15_16_17: Substantial modification procedure (Articles 15-17)

Article 15 establishes that substantial modifications require prior authorisation. Article 16 sets the application requirements (submission via CTIS). Article 17 sets the 6-day validation period for substantial-modification applications. Articles 18-24 cover the Part I / Part II / combined assessment, decision, and persons-assessing-the-application provisions for substantial modifications.

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

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