BROK®

• Researchers

• Education and Training

During the BROK course, researchers involved in research covered by the WMO, CTR, MDR and IVDR learn about the laws and regulations regarding medical scientific research.

BROK certification

The BROK® consists of an e-learning part (eBROK®) in Dutch or English and a centre-specific meeting. You can work through the material at your own pace. The BROK® can be customised, to suit the type of research to be conducted and meet the needs of the individual investigator. The course concludes with a digital exam.

• The assessment criteria and learning outcomes are set at national level.
• Agreements regarding the examination and (re)certification are laid down in the Training and Examination Regulations (OER).
• Successful candidates receive a certificate that is valid for one year and are included in the BROK® register.
• The date on which the registration expires is stated on the BROK® certificate and can also be found in the BROK® register.

You are BROK® certified once the following requirements have been met:

• You have completed the entire e-learning programme (i.e. the basic module and at least one advanced module of your choice).
• You have completed these modules with a digital test in the BROK learning environment.
• For students affiliated with a university medical centre: You have completed or attended a centre-specific meeting (CSB).

BROK® certified? Then you will be registered in the BROK® register.

Who is the course intended for?

For clinical researchers at a university medical centre who are involved in medical scientific research that falls under:

• The Medical Research Involving Human Subjects Act (WMO)
• The Clinical Trials Regulation (CTR)
• Medical Device Regulation (MDR)
• In Vitro Diagnostics Regulation (IVDR)

About recertification

The BROK® certificate is renewed by completing the re-registration course. It is the researcher’s responsibility to renew their BROK® registration before the expiry date.

Distinction between BROK® and GCP course

How does BROK® differ from a Good Clinical Practice (GCP) course?

• BROK® is not limited to pharmaceutical research, but covers all types of human-related research.
• Most clinical research in university medical centres is initiated by the researcher. The BROK® covers regulations and procedures from the perspective of both the researcher and the investigator.
• The BROK® also covers legislation and regulations that apply to human-related research that is not subject to the Social Support Act (WMO), such as file research or biobank research.

The BROK® is accepted by many pharmaceutical companies and the Health and Youth Care Inspectorate as the standard course on legislation and regulations governing human research. The BROK® has been recognised by TransCelerate Biopharma Inc. as a “GCP training meeting the minimal criteria” and added to the List of Training Providers.

About the BROK® register

The BROK register may be used as a source to verify or demonstrate that a person is BROK certified. This eliminates the obligation to store a BROK certificate in paper or digital form. The site file may refer to the BROK register. For persons who do not wish to register in the BROK register, a paper or digital version of the certificate remains mandatory.

The register is managed and maintained by UMCNL.

Questions about your entry in the BROK® register? Please contact klantenservice@ebrok.nl.

For the GCP-WMO register, please contact EMWO.

If you have obtained your certificate, you can find your BROK registration here.

If that does not work, try the old BROK registration here.