IMPStudy object

Yes

'a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial' (Regulation on Clinical Trials of Medicinal and Biological Products 2014).

Clinical Trial: 'any investigation in humans intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or to identify any adverse reactions to one or more investigational medicinal products or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal products with the object of ascertaining their safety and efficacy'

Observational drug study is defined as 'an epidemiological study to collect data on a medicinal product, spontaneously prescribed to patients undergoing treatment in the indications using the posology and route of administration, for which the product has been approved in Turkey according to the current diagnostic and therapeutic guidelines of the Ministry' (Regulation on Clinical Trials of Medicinal and Biological Products 2014).