Inspection results of clinical research
Here you will find inspection results from the Health and Youth Care Inspectorate (HYCI) by theme.
2017: clinical trials in mental healthcare institutions and addiction care clinics
In 2017, the HYCI asked about 50 mental healthcare institutions and addiction clinics to supply information regarding the conduct of clinical trials in the hospital. Based on the information provided, the HYCI determined which mental health institutions and addiction clinics were eligible for an inspection of investigator-initiated research. The HYCI has carried out an inspection of clinical trials at 6 mental health institutions and addiction clinics. A summary of the main results from these inspections can be found in this presentation (in Dutch).
2016 clinical research in STZ hospitals
In 2016, the Inspectorate was involved in the conduct of a series of inspections of clinical trials at STZ hospitals (this is a cooperation of top clinical training hospitals, not including the university medical centres). Specific information related to clinical trials in the STZ hospitals was requested prior to the inspections by the Inspectorate. Based on the information provided, 8 STZ hospitals were selected for inspection. A summary of the main results from these inspections (in a non-organisation identifiable form) is published on this website (in Dutch).
2015-2016 Investigator-initiated research
During 2014 and 2016, inspections were carried out in hospitals, mainly large university hospitals, which were involved in the conduct of various investigator-initiated trials (IITs). A summary of the main results from these inspections can be found in this presentation (in Dutch).
2013-2014: Research of Contract Research Organisations
In 2013-2014, HYCI had a special focus on the tasks and responsibilities of contract research organisations (CROs) in clinical trials as these companies have been increasingly involved in the conduct of clinical drug research in the Netherlands. The main results in Dutch can be found here.