Dit rapport bevat zowel de vierde evaluatie van de Wet medisch-wetenschappelijk onderzoek met mensen (WMO) (Deel A) als de daarmee samenhangende evaluatie van de Centrale Commissie Mensgebonden Onderzoek (CCMO) als zelfstandig bestuursorgaan (zbo) (Deel B). Tot slot hebben wij ons uitgelaten over de …

The complexity of regulations governing investigator-initiated trials (IITs) places a great burden on hospitals. Consequently, many hospitals seek to alleviate regulatory pressures by seeking an alternative quality management system (QMS). This paper takes the Netherlands as a case. To investigate how QMSs …

National regulatory regimes for supervising ongoing clinical trials are affected by external challenges, both international, such as harmonization of EU legislation, and national, such as critical reviews of incidents. This study examines how supervisory bodies dealing with ongoing trials respond to …

This paper analyzes how endeavours to implement the EUCTD set in motion a dynamic process of institutional change and institutional work. This process lead to substantial differences between policy and actual practice; therefore, it is important to learn more about the implementation of harmonization policies …