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eBROK® course and monitoring course

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). 

The 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). 

The BROK® consists of 3 parts:

  • e-Learning (eBROK®), including a self-assessment
  • A site specific part at the UMC Utrecht (eModule in Ulearn for candidates of the UMC Utrecht or hand-outs for external candidates).
  • The national BROK® exam

More information about the BROK®-course is located at https://nfu-ebrok.nl/. 

If you successfully pass your BROK® exam you will obtain a BROK® certificate and you will be added to the public BROK-register. If you have any questions concerning the BROK® certificate please contact EMWO.

Accreditation uitklapper, klik om te openen

  1. The BROK course is 1.5 ECT for PhD students and students. 
  2. Per 25 August 2020 the accreditation by the ABFE/ABAN is 16 points after finishing the complete eBROK course.  

Course price uitklapper, klik om te openen

The course price of the eBROK® including the BROK® exam is for UMC employees €465,-. 

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

Aim & Content

To take part in the BROK® exam, the site specific part of the BROK® is mandatory. This part of the BROK® course focusses on local procedures and policies related to Clinical Research Involving Human Subjects within the UMC Utrecht. 

In the online study environment of the eBROK course (https://nfu-ebrok.nl) you can register for the site specific part of the eBROK. The site specific part of the eBROK consists of an eModule in Ulearn, the learn management system of the UMC Utrecht. For external candidates we have hand-outs and a set of related questions. A link to the eModule or the hand-outs and questions will be send to you the day the site specific part takes place together with an informative email.  If you have questions about the eModule or the hand-outs you can send an email to brok@umcutrecht.nl. The information in the eModule and hand-outs are not part of the eBROK exam, but consists of information about how to do your research in the UMC Utrecht. It is allowed to finish the exam before you finish the site specific part of the eBROK course.

Note

You can register for the site specific part at the UMC Utrecht via https://nfu-ebrok.nl/.

Questions? 

  • Do you have questions about the BROK® study environment or did you notice any errors in the study environment, please send an email to: servicedesk@elevatehealth.eu 
  • Do you have any other BROK course related questions, pleas send an email to: Mirte Scherpenisse| Research Office, UMC Utrecht|brok@umcutrecht.nl| mon-tue


BROK® exam and BROK® re-registration uitklapper, klik om te openen

BROK® (re) exam

You can register for the BROK® exam via https://nfu-ebrok.nl/.  

Candidates for the BROK® exam will have 2 hours to finish the exam. A BROK® exam-test is available here. If you need more time for your exam, please send an email at least 14 workdays before your exam to brok@umcutrecht.nl (keep in mind that your email will only be read on Monday and Tuesday).

After finishing your exam, you will see directly if you passed the exam or not. If you have an exam on location you will get the opportunity to look into the exam questions and answers (unfortunately this option is not available for proctoring/online exams). If you pass your exam with a score of 80% or higher, you finished the centrum specific part of the eBROK, read the news in the BROK study environment and finished the basic modules and one module of your choose in the BROK study environment, you will receive the BROK® certificate. Thereafter, you will be included in the national BROK register

For more information about the BROK® exam, click here. If you have any complaints or questions about the BROK® exam, please send an email to EMWO

The BROK exam can be taken at UMC Utrecht or at other locations (see the EMWO exam calender). It is also possible to participate in an online proctoring BROK exam or a Record & Review BROK exam (see for more information the study environment of the eBROK course). 

The proctoring online BROK exam:  In the study environment you can register for this online BROK exam on specific dates. Online proctoring makes it possible to participate in your BROK exam through remote surveillance. All that is required for this are a quiet room and a stable internet connection. This room can therefore also be at your home.  In the study environment of the BROK course you can plan your BROK exam and in the 'Agenda' you can see when an online BROK exam is planned. 

The Review & Record online BROK exam: These BROK exams can be planned whenever you want! The exam will be recorded and checked within 24-48 hours by a reviewer of the exam-organisation (EMWO). There is 24 hour techsupport available to help you.

Registration for (online) BROK exam: In the BROK study environment you can register for the different BROK exams.

BROK exam at the UMC Utrecht:

Registration for the BROK exam via the online BROK study environment. 

  • 11 March 2024; 15.15-17.15 hour, CLZ-1 UMC Utrecht. 
  • 10 June 2024; 15.15-17.15 hour, CLZ-1 UMC Utrecht.

BROK® re-registration

Re-registration within three years after the initial BROK® (or after the previous re-registration) is mandatory if you still set up or carry out WMO-projects. The re-registration at the UMC Utrecht consists of an online training without examination. For more information about the re-registration see: https://nfu-ebrok.nl/, -> [BROK re-registration] and follow instructions. Accreditation by the ABAN for re-registration BROK® for medical specialists is 5 points (from 14 September 2021) . More information is available on Connect (UMC Utrecht employees).

Important Note (English)

  • Your BROK®-registration expires after 3 years. The expiration date is mentioned on your certificate and in the online BROK®-register.
  • Re-registration is mandatory before the expiration date in order to retain your BROK®-registration. For employees of UMC Utrecht, please visit the intranet for more information on the BROK® re-registration course, or contact your BROK®-coordinator.
  • The responsibility for re-registration lies with the investigator himself/herself. No reminder will be sent.

Important Note (Dutch)

  • Uw BROK®-registratie verloopt na 3 jaar. De datum waarop uw registratie zijn geldigheid verliest staat op uw BROK®-certificaat en is ook te vinden in het BROK®-register.
  • Voordat uw BROK®-registratie is verlopen, moet u een herregistratiecursus volgen om uw BROK®-registratie te verlengen. Bezoek de website van uw UMC voor informatie over de herregistratiecursus, of neem hiervoor contact op met uw BROK®-coördinator.
  • U bent zelf verantwoordelijk om uw registratie voor die datum te verlengen. Er wordt geen herinnering verstuurd. 

Contact information and route information UMC Utrecht uitklapper, klik om te openen

Contact information BROK-coordinator:

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

Route information UMC-Utrecht

  • Exam room CLZ-1/2 UMCU (G01.601): From the head entrance turn left. Take the first door to the right after the restaurant (glass building with red doors). Walk past the black counter and turn right. The entrance to CLZ-1/2 is in front of you.
  • Parking information

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):

  • Thursday 6 June 2024: Monitor Training, Day 1, 9:00 -16:30h.
  • Tuesday 11 June 2024: Monitor Training, Day 2, 9:00- 16:30h.

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).

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