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 BROK. 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 BROK (CSB).

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

Who is the course intended for?

Please refer to the OER (Study and Examination Regulations) to see for whom BROK® certification is compulsory. Please also bear in mind that your UMC may have additional policies in place.

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 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.

Centre-specific BROK module

The CSB (Centre-specific BROK module) is a compulsory part of the BROK course for UMC employees involved in medical scientific research.

In addition to the national eBROK, the CSB focuses specifically on local regulations, procedures and working methods within the UMC itself.

Purpose and content

The purpose of the CSB is to provide researchers with insight into how the national rules and frameworks for medical scientific research are organised and applied within their own UMC.

Topics that may be covered in the CSB include:

• Local procedures for starting, conducting and completing research.
• Roles and responsibilities of researchers and support departments.
• Internal review and approval processes.
• Reporting procedures, for example in the event of (S)AEs and protocol deviations.
• Available support and facilities within the UMC.
• The exact content of the CSB may vary from one UMC to another and is tailored to the local organisation of research.