Non-interventional study

A clinical study other than a clinical trial [Reg (EU) No 536/2014 Art 2(2)(4)].

Non-interventional studies do not fall in the scope of Regulation (EU) No 536/2014 [Reg (EU) No 536/2014 Art 1].

The table in Annex I of the Questions & Answers Document – Regulation (EU) 536/2014, Volume 10 of the Rules Governing Medicinal Products in the EU provides the difference between non-interventional studies and interventional trials.

See also Clinical study, Clinical trial, Normal clinical practice