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 eBROK® course is mandatory for all researchers who set up or carry out a WMO-project at the UMC Utrecht or at another location under the responsibility of UMC Utrecht such as the sponsor of the research (decision by the Executive Board of UMC Utrecht). 

From September 2 2024 you have to register for the eBROK course at www.ebrok.nl. 

The new eBROK® consists of 3 parts:

• e-Learning (eBROK®)
• A site specific part at the UMC Utrecht 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.

BROK® certificate uitklapper, klik om te openen

You will obtain a BROK® certificate after finishing the basic eBROK®, CSB and an in-dept module of your choice. Thereafter you will be included in the public BROK-register. Because of the go-live of the new eBROK course we have temporarily two BROK registers. In the coming months, these two BROK registers will be combined.

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.

BROK® site specific part at the UMC Utrecht uitklapper, klik om te openen

This part of the BROK® course focusses on local procedures and policies related to Clinical Research Involving Human Subjects within the UMC Utrecht. For UMC Utrecht employees we have a short eModule in Ulearn. In the BROK study environment you can register for this part of the eBROK® course and after registration for the BROK site specific part, you can find an link to the Ulearn eModule of the UMC Utrecht.

If you have questions about the BROK® site specific part of the UMC Utrecht (the Ulearn eModule), feel free to send and email to brok@umcutrecht.nl.

External BROK® candidates do not have to follow a BROK® site specific part.

BROK® continuous re-registration uitklapper, klik om te openen

If you still have a BROK® certificate from the old eBROK® course, you must first complete the in-dept module of your choice. Afterward, you will receive the BROK® re-registration certificate, which is valid for one year from that date. Then, you will enter the BROK® continuous re-registration with a score of 80%. The goal is to maintain this score at a minimum of 80% throughout the year. You can do this by logging into the BROK® continuous re-registration once a week, month, or year to answer the questions and read the short texts provided. After completing this information, the score will rise back to 80% or even higher. Automated monthly checks are conducted to see if the score is 80% or higher. If so, the validity of the BROK® certificate is extended by one month. 

It is up to the researcher to determine how often to engage in the BROK® continious re-registration training. However, if you save everything until the end of the year, you will need to invest more hours to regain the 80% score. It is more time-efficient to refresh your knowledge regularly!

A link to the BROK® register will be shared on www.ebrok.nl. 

Important Note

• Did you obtain your BROK® certificate before September 2 2024, in the old eBROK® environment? Then your BROK® certificate is valid for 3 years from the date of issue. Keep track of the expiration date yourself. Before your certificate expires, you must re-register at www.ebrok.nl. 
  • There is no more leniency/grace period! This means that if your BROK certificate has expired (even by just 1 day), you will need to retake the basic BROK® course.
  • Candidates who still wish to complete the old eBROK® basic course will receive a certificate valid for 3 years from the date of issue after passing their external BROK® exam. Exams are available up to 12 December 2024. 
  •  Missed the BROK® re-registration deadline? You can enroll in the BROK® course at www.ebrok.nl.
• Did you obtain your BROK® certificate or your BROK® re-registration after September 2 2024, in the new eBROK course? Then your BROK certificate is valid for 1 year from the date of issue.
  •  Participate actively in the continuous BROK® re-registration to continuously extend your BROK® certificate (keep your score on Green (80% or higher)!).

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-thu

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 07 Nov 2024 (9:00-16:30)
• Day II: Tuesday 12 Nov 2024 (9:00-16:30)
• 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).