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 (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 by the ABAN for BROK® for medical specialists is 15 points (12 points eBROK® course and 3 points for the site specific part at the UMC Utrecht).
The BROK course is 1.5 ECT for PhD students.
The course price of the eBROK® including the BROK®exam is for UMC employees €435,-.
The BROK site specific part (CSB) at the UMC Utrecht will not take place in the UMC Utrecht until at least the end of December 2020. However, in the online study environment of the BROK course (www.nfu-ebrok.nl) you can registrate for the CSB on 27 October or 15 December. On the day the CSB takes place, you will receive the hand-outs of all the presentations. Take your time to read the hand-outs. If you have questions about the hand-outs send an email to email@example.com. The information in the hand-outs will not be a part of the BROK exam but consists of information about doing research in the UMC Utrecht. So you can do your BROK exam, before you attend a CSB.
The BROK exam: an online proctoring BROK exam is now available (not in July/August, but is available from September onwards). In the study environment you can registrate 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.
Due to the Corona precautions and lack of space in the UMC Utrecht we will not have any exams until at least the end of 2020. We advice you to registrate for an online proctoring BROK exam. In the study environment of the BROK course you can see when an online BROK exam is planned. Check the website of www.emwo.nl for more information about the online BROK exams and/or other locations where it is maybe possible to do your BROK exam. If you have any questions about the BROK exam please send an email to firstname.lastname@example.org.
Registration for (online) BROK exam: It is possible to register for the BROK exam via online proctoring in the BROK study environment of the BROK course or choose a date for your BROK exam at a location of your choice. The online proctoring BROK exam is offered to those who cannot go to their own location or who wish to retake the exam short-term.
BROK® Site Specific part at the UMC Utrecht
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 within this session, however, you are welcome to ask any questions regarding the study material.
You can register for the site specific part at the UMC Utrecht via https://nfu-ebrok.nl/. Due to the Corona virus measures, at least until the end of 2020 you will receive the hand-outs of the site specific part of the BROK. No live meetings are available at the moment. For more information and dates check the BROK-study environment, www.nfu-ebrok.nl.
- Questions about the BROK® study environment, planning your exam, CSB or any errors in the study environment send an email to: email@example.com
- Any other questions about the eBROK® course: Mirte Elferink-Scherpenisse|Research Office, UMC Utrechtfirstname.lastname@example.org| mon-thu
BROK® exam and BROK® continuous registration
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 one week before your exam to email@example.com. If you would like an exam in English, send an email to firstname.lastname@example.org at least one week 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. 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.
The BROK exam can be taken at UMC Utrecht or at other locations (see the EMWO exam calender). It is possible to participate in an online proctoring BROK exam (see for more information the study environment of the eBROK course).
BROK® continuous registration (previously 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 6 points. More information is available on Connect (UMC Utrecht employees).
- 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).
Important Note (in 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).
Contact information and route information UMC Utrecht
Contact information BROK-coordinator:
Mirte Elferink-Scherpenisse|Reserach Office, UMC Utrechtemail@example.com| mon-thu
Route information UMC-Utrecht
- Exam room CLZ-3 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 left. On your right is the entrance to CLZ-3.
- Location Hijmans van de Bergh building (HvdB): via main enterance follow J Hijmans van den Berghgebouw, mentioned as HvdB.
- Parking information
MONITORING COURSE OF WMO-RESEARCH
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):
- 8 and 15 June 2020
- 18 and 25 June 2020
- Not available at the moment, please email Eugenie Ram for the registration form).
Course price for UMC Utrecht employees €375,-.
Practical and theoretical aspects of monitoring will be provided during the first two days. In the return session practical experience will the discussed.