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Course information

Elementary course Regulation and Organization for clinical researchers ('BROK')

BROK® 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 (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

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 course price of the eBROK® including the BROK®exam is for UMC employees €435,-.

BROK® SITE SPECIFIC PART AT 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. 

NOTE

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

These are the upcoming dates for the site specific part at the UMC Utrecht. You can follow the BROK® site specific part of the UMC Utrecht in Dutch or in English:
  • 25 November 2019, 9am - 1pm, location: HvdB 3.70-3.71
CSB data reserved for the new eBROK course:
  • 28 January 2020, 9am - 1pm, location: STRAT-Geel
  • 30 March 2020, 9am - 1pm, location: STRAT-Geel
  • 9 June 2020, 9am - 1pm, location: HvdB 2.70-2.71

For questions regarding the BROK® course or the BROK® site specific part contact:

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

BROK® exam and BROK® re-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 info@emwo.nl. If you would like an exam in English, send an email to info@emwo.nl 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

For more information about the BROK® exam, click here. If you have any complaints 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).

Dates UMC Utrecht (location: Computerleerzaal-3 (CLZ-3), G01.601, a route description can be found below):

  •  
  • 10 December 2019; 15.15-17.15 hrs
  • 11 February 2020; 15.15-17.15 hrs
  • 14 April 2020; 15.15-17.15 hrs
  • 22 June 2020; 15.15-17.15 hrs

BROK® re-registration

Re-registration within four years (after December 2019, 3 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.

Untill 31 December 2019 it is also possible to register for the BROK® re-registration online training via GCP Central. UMC Utrecht employees get a discount on the course price (regular course price is €125 excl. BTW). Please visit the intranet of UMC Utrecht for more information on the BROK® re-registration online training (e-learning).

Accreditation by the ABAN for re-registration BROK® for medical specialists is 6 points.

For questions regarding the BROK® re-registration contact the BROK-coordinator:

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

IMPORTANT NOTE

  • Your BROK®-registration expires after 4 years (after December 2019 new re-registration certificates are valid for 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 (in Dutch)

  • Uw BROK®-registratie verloopt na 4 jaar (vanaf eind december zijn nieuwe herregistratie certificaten 3 jaar geldig). 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

Contact information BROK-coordinator:

Mirte Elferink-Scherpenisse|Reserach Office, UMC Utrecht|brok@umcutrecht.nl| 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):

  • 2 and 9 April 2020

Registration form

 

Course price

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.

For questions regarding the monitoring course:

  • Quality Coordinator Research of the Division
  • Eugenie Ram | Research Office | UMC Utrecht: e.ram@umcutrecht.nl, 088-75 69 092 (mon-thur).
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