BROK® Course
The Basic course on Regulations and Organization of Clinical Trials (BROK®) deals with laws and regulations when conducting clinical research and it is mandatory for all clinical investigators setting up, conducting and/or completing research that falls under the scope of the WMO, CTR, MDR and/or IVDR to be BROK®- certified. Furthermore it is strongly advised for investigators involved in non WMO research.

For more information you can also check the eBROK site and the national NFU site

For training requirements regarding research in the UMCG you can check this link.
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BROK Certification

Researchers/ supporting staff can follow the BROK® course in Dutch or English. The course is developed by the NFU and is hosted by GCP Central.

  • Follow the link for more information and to register
  • Costs are €225,00 for researchers from the UMCs, including UMCG, and €350,00 for other institutions. For recertification the costs are €45,00
  • The certificate is valid for 2 years after completing the eBROK® course
  • You are only certified if you have a valid certification for the Basic Course as well as for one of the Advanced modules.

  • If you are taking the full BROK course:

    • Complete all 5 basic modules in the eLearning and pass the Test eBROK Basics.
    • Complete the Center Specific Meeting (CSB). For Groningen subscribe for a CSB and follow the UMCG center specific e-learning to learn about local UMCG procedures. The e-learning can be found here:

      UMCG: UMCG Internal link

      External: External link
       

    • Select one of the Advanced Modules (Medicines, nWMO, Medical Devices, or WMO Research) and complete it in the learning environment. Pass the (Advanced) Test associated with it. After this you should have your certificate: Please check if this is the case.

    Your certification is should also be visible in the NFU BROK Register.

    Important

    It is your own responsibility to make sure that your certificate does not expire and these are valid for 2 years! You have to make sure to put the expiry date in your own calendar and perform recertification before your certificate expires.

  • You have to make sure to do the BROK Recertification before your certificate(s) expires:

    • Follow the link for more information and to register
    • For recertification the costs are €45,00
    • Select the recertification Module and complete it in the learning environment. Pass the test associated with it.
    • After this you should have your certificate that is updated to be valid for 2 years: Please check if this is the case.
    • Your certification is should also be visible in the NFU BROK Register.

    If your certificate have expired (please check the NFU BROK Register for the dates), this means you have to do the complete course instead of the recertification. If you have further questions about this, please contact the BROK coordinator through [email protected].

    Important

    It is your own responsibility to make sure that your certificate does not expire and these are valid for 2 years! You have to make sure to put the expiry date in your own calendar and perform recertification before your certificate expires.

  • For questions related to the e-learning environment, please contact GCP Central. Contact Information and other information can be found here: GCP Central Contact.

    If you have questions about the BROK and policy in the UMCG you can contact the BROK coordinator of the UMCG: Denise Mailly (Senior Research Consultant at SD CRO) through [email protected]

Contact

Denise Mailly BROK coordinator of the UMCG