Quality assurance in non-interventional studies

Karlheinz Theobald, Müge Capan, Marlis Herbold, Stefan Schinzel & Ferdinand Hundt
Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using...