Training

CTCM offers various training options, including GCP-WMO and eBROK, or customized training. On request, some training courses can also be offered in English.

  • In the Netherlands, medical research in which participants are subjected to interventions or required to follow rules of conduct is regulated in the Medical Research involving Human Subjects Act (WMO; Wet Medisch-wetenschappelijk Onderzoek met mensen). CTCM offers various GCP-WMO training courses that are intended for everyone involved in the design and implementation of WMO-required research. The GCP-WMO exam is a national exam organized by the Medical Researcher Examination Office (EMWO). After passing this exam, you will be registered in the GCP-WMO registry; the GCP-WMO certificate is valid for 3 years.  The GCP-WMO exam can be taken online or at various locations in the Netherlands. Check the EMWO website for the current exam dates and locations. If you would like to take the GCP-WMO exam at Maastricht UMC+, please contact training.ctcm@mumc.nl.

    Complete GCP-WMO training 

    The complete GCP-WMO training lasts a whole day (approximately 7 hours) and provides all the information needed to prepare for participation in the national GCP-WMO exam.  
    The training covers the following topics, among others:

    • International ICH E6 (R2) Good Clinical Practice guideline
    • Medical Research Involving Human Subjects Act (WMO)
    • European legislation including the Clinical Trials Regulation and Medical Devices Regulation
    • General Data Protection Regulation (GDPR)
    • Re-registration GCP-WMO

    In addition to the full GCP-WMO training, CTCM also offers a GCP-WMO re-registration training that lasts approximately half a day. By following this re-registration training, the validity of the GCP certificate is extended by 3 years. If necessary, the full GCP-WMO training and the re-registration training can be combined, with the students joining the group that follows the full GCP-WMO training for the re-registration in the afternoon. 

    Basic introduction GCP-WMO

    Is a full GCP-WMO training not necessary? Then a brief introduction to GCP-WMO may be more suitable for you and we can offer the Basic Introduction to GCP-WMO training. 

  • A BROK© certificate (Basic course on Regulations and Organisation for Clinical Investigators) is mandatory within University Medical Centers (UMCs) in order to conduct research subject to the WMO. In preparation for the national BROK© exam, a blended course (e-learning and center-specific meeting) is offered in the field of legislation and regulations regarding clinical research (eBROK©). The BROK© certificate is valid for 3 years. The BROK© exam takes place at Maastricht UMC+ four times a year. In addition, online exams are continuously available. Click here to register.

  • In addition to GCP-WMO training, CTCM also offers training on a specific subject, such as research with medical devices and drug research.

    The Medical Devices Regulation (MDR) came into effect on May 26, 2021 and applies to all medical devices sold within the European Union. The European Clinical Trials Regulation (CTR) came into effect for drug research on January 31, 2022, replacing the Clinical Trials Directive (CTD).

    It is also possible to offer tailor-made MDR and CTR training courses with a focus on a specific topic (e.g. submissions, implementation, etc.). 

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