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.6_7: Part I and Part II assessment (Articles 6-7)

Article 6 governs the Part I scientific assessment (jointly assessed by the Member States concerned and led by the Reporting Member State): therapeutic and public-health relevance, design quality, risk-benefit balance, compliance with manufacturing/import provisions, compliance with labelling, completeness and adequacy of the investigator's brochure. Article 7 governs the Part II assessment (each Member State concerned individually): informed consent, recruitment arrangements, compensation, suitability of investigators/sites, damage compensation, data-protection rules, biological samples management, financial-flow disclosure.

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