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This is a quick guide on the main rules and procedures of the Clinical Trials Regulation (EU) No 536/2014 (CTR) [1] for sponsors who wish to conduct clinical trials (national and multinational) in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region. The list of documents applicable to clinical trials authorised under Regulation (EU) No 536/2014, are published at the Eudralex Volume 10 website [2]. The first document recommended for reading is the Questions and answers document – Regulation 536/2014 (Q&A –CTR) [3] in chapter V. Additional documents (guidelines, guidances, recommendation papers, Q&As) to be considered are given in chapter 6.


To find out if a particular clinical study is a clinical trial on a medicinal product or not, see decision tree in Annex I of the Q&A – CTR [3].

A clinical trial may be conducted only if:

a. the rights, safety, dignity and well-being of participants are protected and prevail over all other interests; and
b. it is designed to generate reliable and robust data.


The design and conduct of the clinical trial should comply with the CTR and General Data Protection Regulation (EU) No 2016/679 (GDPR) [4] together with the complementary national legislation

. The following guidelines are also applicable:
– Investigational Medicinal Product (IMP) manufacture and distribution should comply with Good Manufacturing Practice (GMP) [5] and Good Distribution Practice (GDP) principles 
– The clinical trial should be conducted under the principles of good clinical practice (GCP) 

In case the provisions of CTR and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP guidelines differ, rules defined in the CTR prevail.