Regulation (EU) No 536/2014 Article 49

Suitability of individuals involved in conducting the clinical trial

Article 49

The investigator shall be a medical doctor as defined in national law, or a person following a profession which is recognised in the Member State concerned as qualifying for an investigator because of the necessary scientific knowledge and experience in patient care. Other individuals involved in conducting a clinical trial shall be suitably qualified by education, training and experience to perform their tasks.

Read the full instrument → · Read this in context: CHAPTER VIII — CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS →

Other provisions in CHAPTER VIII — CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS

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 49 of Regulation (EU) No 536/2014 (LawPlayer, data as of 2026-07-04)

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