Commission Implementing Regulation (EU) 2017/556 Article 6

Subject matter of inspections

Article 6

Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of the rights and well-being of the clinical trial subjects, the quality and integrity of data generated in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the relevant national legislation.

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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 6 of Commission Implementing Regulation (EU) 2017/556 (LawPlayer, data as of 2026-07-04)

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