How we carry out inspections

The Health and Youth Care Inspectorate (HYCI) carries out inspections of clinical trials in the Netherlands. We also do this internationally upon request.

National inspections

We carry out inspections based on risk monitoring (inspections) and incident monitoring (reports). With risk monitoring, we proactively determine where the greatest risks lie. On this basis, we decide which organisations and studies will be inspected.

Incident monitoring is reactive monitoring and occurs based on reports or triggers we receive. For example, from citizens, professionals or other organisations, but also from chain partners such as the Central Committee on Research Involving Human Subjects (CCMO) or the Medicines Evaluation Board (MEB). Performing an inspection can be part of the IGJ report investigation.

We may conduct inspections that were not announced prior to the visit. When we announce inspections, these inspections always include unannounced elements. The duration of an inspection differs and may range from a day to a week. This depends, among other things, on the approach of the inspection (regular or certain focus) and the trigger(s). After the inspection visit, we prepare a report.

International inspections

We also conduct international inspections at the request of the European Medicines Agency (EMA), the Medicines Evaluation Board (MEB) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (see also involved agencies). These international inspections focus on the trials that have been conducted worldwide within the context of Marketing Authorisation Registration applications for the European Union (EU) and the European Economic Area (EEA).

In general, these international inspections are conducted together with an inspector from another EU Member State (MS). Inspections may be announced in advance for international inspections as well. For international inspections, the duration of the inspection may also vary, but an inspection usually takes 4 to 5 days at each inspection location. Generally, for this type of inspection, multiple locations that are involved in the implementation of the research are inspected. The sponsor of the study may also be inspected. Following these inspections, an inspection report will be written by an inspector from the HYCI.