Transparency in Clinical Trials

This webpage refers to the electronic Registry of Non-Interventional Studies (RNIS) and is posted on the website of the Hellenic Association of Pharmaceutical Companies (SFEE). It is an integral part of the SFEE Code of Ethics (the “Code”) as amended by the SFEE General Assembly on 08.03.2013 and in effect as from 08.03.2013.

The Code aims to harmonise practices across the pharmaceutical industry in terms of transparency, ethics and professional conduct.

The Registry includes all registered Non-Interventional Studies (EMA annex March 2011) which are being conducted by SFEE member companies and admit subjects as from 1 January 2013. In these studies, a medicinal product is prescribed in accordance with usual clinical practice and its marketing authorisation. In addition, the Registry includes a second category of studies that do not involve medicinal products, i.e. epidemiologic observational studies.

Specifically, the following data are recorded in the Registry and made publicly available:

  • geographical distribution of research centres participating in the study;
  • envisaged number of participants;
  • compensation of subjects (rate per completed form);
  • implementation timetable; and
  • results after completion.

Access to the data is free.

For further details, please visit: https://www.dilon.sfee.gr