eBROK® course and monitoring course

The BROK® is a basic course about regulations and organization for WMO-project research (Medical Research Involving Human Subjects Act, WMO, in Dutch). 

eBROK® course uitklapper, klik om te openen

The Basic Course Regulations and Organization for Clinical Investigators (eBROK®) deals with laws and regulations when conducting clinical research and is compulsory for all researchers involved in human-based scientific research that falls under the scope of the WMO. For more information, see the national NFU BROK website. The eBROK also covers the UMC Utrecht policy regarding human-related research.

After you have obtained the BROK® certificate, your end date will be registered in the BROK® registry. Only start with the re-registration procedure when your end date is approaching.

The eBROK® consists of 3 parts:

• e-Learning (eBROK®)
• A site specific part consisting of a short eModule in Ulearn for candidates of the UMC Utrecht.
• An in-dept eModule of your choice. 

You can find more information about the BROK®-course and registration at www.ebrok.nl. 

eBROK® course price uitklapper, klik om te openen

• €350,- for the complete eBROK® course.
• €225,- for UMC employees for the complete eBROK® course.
• €45,-/year for the eBROK® continuous re-registration, including access to the basic eBROK® course and in-dept eModule of your choice.

BROK® certificate uitklapper, klik om te openen

You will obtain a BROK® certificate after finishing the basic eBROK®, centrum specific part and an in-dept module of your choice. Thereafter you will be included in the public BROK-registry. 

The BROK® certificate (of the new eBROK course) is valid for 1 year. To extend your BROK certificate you have to follow the BROK® continuous re-registration. More information can be found on www.ebrok.nl or scroll down. 

If you have any questions concerning the BROK® certificate, please contact klantenservice@ebrok.nl.

It is permitted to use the BROK register 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 format. The site file can refer to the BROK register. For individuals who do not wish to register in the BROK register, a paper or digital version of the certificate remains mandatory.

The BROK® is accepted by many pharmaceutical companies and the Healthcare and Youth Inspectorate as the standard course on legislation of research involving human subjects. The BROK® is recognised by TransCelerate Biopharma Inc. as a ‘GCP training meeting the minimal criteria’ and has been added to the List of Training Providers.

Yearly recertification uitklapper, klik om te openen

Purchase the ‘Re-registration eBROK’ module on www.ebrok.nl every year and keep your certificate valid. When you purchase the re-registration module, you will receive one year of access to the eBROK learning environment. Your new BROK certificate will be active directly after the registration. Therefore, don't register to early for the BROK re-registration. You will have to complete the in-dept module of your choice. Without completing the in-dept module, your BROK certificate is not valid!  

After obtaining the BROK® certificate, your knowledge will remain up to date by regularly reviewing small pieces of content in the eBROK. Every time you update the basic eBROK and the in depth module(s), the end dates will shift accordingly. You continuously keep your BROK® certificate up to date. The most recent end dates of your basic eBROK and the in depth module(s) can be found in the BROK®-registry. You’ll receive reminders so that you do not forget to keep your eBROK valid. If you are late with the re-registration, you will have to take the entire course again! There is no period in which respite is granted.

Accreditation uitklapper, klik om te openen

It is not yet known how many accreditation points the new eBROK® will have. When there is more information about the accreditation, we will update the information. 

Questions? uitklapper, klik om te openen

• Do you have questions about the eBROK® study environment or did you notice any errors in the eBROK® study environment, please send an email to: klantenservice@ebrok.nl or use the chat function in the BROK® study environment.  
• Do you have any other BROK® course related questions, feel free to send an email to brok@umcutrecht.nl. 

Contact your BROK-coordinator:

Mirte Scherpenisse| Research Office, UMC Utrecht|brok@umcutrecht.nl| mon-wed

MONITORING COURSE OF WMO-RESEARCH uitklapper, klik om te openen

Monitoring of WMO-research with negligible risk at the UMC Utrecht can be carried out by an experienced research nurse of BROK certified researcher. Following a monitor training is mandatory. Up to date knowledge of GCP/WMO is necessary to follow the monitoring course (i.e. latest WMO/GCP course < 4 years).

Dates monitoring course organized by Julius Clinical B.V. (both dates together represent one training):

• Day I: Thursday 10 Apr 2025 (9:00-16:30)
• Day II: Tuesday 15 Apr 2025 (9:00-16:30)

Registration form:

• registration form.
• For more information please contact Eugenie Ram (E.Ram@umcutrecht.nl)

Course price

Course price for UMC Utrecht employees €495,- (costs may change)

Practical and theoretical aspects of monitoring will be provided during the first two days. In the return session practical experience will the discussed.

For questions regarding the monitoring course:

• Quality Coordinator Research of the Division
• Eugenie Ram | Research Office | UMC Utrecht: e.ram@umcutrecht.nl, (mon-thur).