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Course: Regulation and Organization for clinical researchers (BROK)

Online elementary course Regulation and Organization for clinical researchers (eBROK®)

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 (hand-outs or a 1/2 day course)
  • 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. The practical application of the study material provided within the eBROK® is discussed by people involved at UMC Utrecht as well as practical information concerning the BROK®-exam. The study material of the eBROK® itself is NOT the focus, however, you are welcome to email any questions regarding the study material. 

In the online study environment of the eBROK course (www.nfu-ebrok.nl) you can register for the site specific part of the eBROK. The site specific part of the eBROK consists of hand-outs and a set of related questions. These hand-outs and questions will be send to you the day the site specific part takes place together with an informative email. Take your time to read the hand-outs. If you have questions about the hand-outs you can send an email to brok@umcutrecht.nl. The information in the hand-outs are not part of the eBROK exam, but consists of information about doing research in the UMC Utrecht. It is aloud 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/. You will receive the hand-outs of the site specific part of the eBROK and related questions on the day the site specific part takes place. For more information please check the BROK-study environment: www.nfu-ebrok.nl.

Questions? 

  • Questions about the BROK® study environment or any errors in the study environment, you can send an email to: servicedesk@elevatehealth.eu 
  • Any other questions about the eBROK® course: Mirte Elferink-Scherpenisse|Research Office, UMC Utrecht|brok@umcutrecht.nl| mon-tue


BROK® exam and BROK® continuous registration uitklapper, klik om te openen

BROK® (re) exam

You can register for the BROK® exam via https://nfu-ebrok.nl/.  The exam consists of three cases in which different kind of studies will be discussed.

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 10 workdays before your exam to brok@umcutrecht.nl (keep in mind that email will only be read on Monday and Tuesday).  If you would like an exam in English, send an email to info@emwo.nl at least 10 workdays before your exam.

After finishing your exam, you will see directly if you passed the exam or not. After the exam you get the opportunity to look into the exam questions and answers (this option is only for exams on location and not for the online BROK exams). If you pass your exam with a score of 80% or higher, you will receive the BROK® certificate and 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 and even in 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 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® continuous registration (or 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/, option 2: "I followed the old eBROK course") 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. If you take part in the continuous registration, you will receive a notification when your eBROK account expires. If you extend your registration also your BROK certificate will be extended with 1 year extra (this costs 25 euro per year (costs may change over the year). 

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. Als u deelneemt aan de Continu registratie, dan krijgt u wel een notificatie wanneer uw toegang tot de eBROK omgeving verloopt. Door acties uit te voeren voordat de toegang eindigt kunt u uw BROK certificaat steeds weer met een jaar verlengen (25 euro per jaar, kosten kunnen veranderen). 

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

Contact information BROK-coordinator:

Mirte Elferink-Scherpenisse|Reserach 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):

  • xxx
  • xxx

Registration form:

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

Course price

Course price for UMC Utrecht employees €375,- (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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