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Clinical trials (GCP)

According to legislation and regulations for clinical trials, the Healthcare Inspectorate (IGZ) supervises clinical trials to determine whether trials involving subjects are conducted in accordance with these rules. The aim of the IGZ is to ensure that trials are carried out in a way that the rights, safety, and well-being of the trial subjects are protected and that the results from clinical trials are traceable, valid and reliable.

How the IGZ supervises clinical trials

Clinical trials (also defined as scientific medical research involving human subjects) focus on the treatment and prevention of diseases and disorders in human subjects. These clinical trials are carried out by testing (new) drugs, combinations of drugs, therapies or medical devices on patients or healthy volunteers under well-controlled conditions.

Each year, about 1800 clinical trial protocols are approved in the Netherlands by one of the accredited medical ethical reviewing committees (METC). The duration of each individual clinical trial can differ and may last several years. Since it is not possible to inspect all of these clinical trials, the IGZ mainly focuses on clinical trials where the greatest risks are expected. The IGZ uses a risk-based approach to determine which trials are potential candidates to be inspected. In addition, anyone can report incidents or other signals that a clinical trial is not being conducted according to the legislation and regulations. See the end of this page how incidents and signals can be reported.

The IGZ performs inspections and investigates reported incidents and signals based on a risk assessment. Therefore, various locations may be visited by the IGZ. There are also other agencies that may be involved in or may need to be informed about clinical trials conducted in the Netherlands.

Extra focus 2015-2016

In 2014, the IGZ started a project to conduct inspections at so-called investigator-initiated trials (abbreviated as IIT). For this type of trials, the investigator site (actually the Board of Directors) where the trial is conducted, should be seen as the sponsor and the researcher as the investigator. These inspections continued until 2016. In 2016 the IGZ also conducted inspections at STZ hospitals (this is a cooperation of top clinical training hospitals, not including the university medical centres).

Previous inspection results

In the period 2013-2014, the IGZ had a special focus regarding the role of contract research organisations (CROs). CROs are increasingly involved in the conduct of clinical research. CROs may be delegated some or all sponsor activities/tasks. The IGZ determined how this collaboration between CRO and sponsor was organised.

More information can be found in inspection results of clinical research.

Legislation and regulations

The rules for clinical research are outlined in national and international legislation and regulations including the Medical Research Involving Human Subjects Act (WMO), the ICH-GCP guidelines, Directives 2001/20/EC and 2005/28/EC and related legislation such as the Medicines Act.

More information about legislation and regulations can be found at ‘Rules for clinical research’.

Reporting incidents as calamities

Some incidents that occur during the conduct of clinical research may also be defined as calamities by the Healthcare quality, complaints and disputes Act (Wkkgz). These incidents should be reported by a healthcare provider or any other party or person involved in a clinical trial at the IGZ.