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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 1 year 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 in-depth 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

      If you have finished the e-learning within 2 weeks this will be verified in the BROK e-learning. If this is not the case, please send an e-mail to [email protected]
    • 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 2 certificates. Please check if this is the case:

    • Login to NFU eBROK
    • Go to ‘Profile’
    • Check if, next to the EBROK passport, a certificate for the eBROK basic course and for the Advanced BROK is visible.
    • If you have 2 certificates, you are fully certified (and can consider this email as not sent to you).
    • If you are certified this 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 1 year! You have to make sure to put the expiry date in your own calendar and perform recertification before your certificate expires.

  • You are doing BROK Recertification before your certificate (s) expires:

    • Select one of the Advanced Modules (Drug Research, Research with medical deviced, WMO Research or non WMO research) and complete it in the learning environment. Pass the (Advanced) Test associated with it.
    • Click on the Recertification Module Basic and answer the questions that are provided for you. Once completed, you will receive a new certificate for the basic course.

    After this you should have 2 certificates. Please check if this is the case:

    • Login to NFU eBROK
    • Go to ‘Profile’
    • Check if, next to the EBROK passport, a certificate for the eBROK basic course and for the Advanced BROK is visible.
    • If you have 2 certificates, you are fully certified (and can consider this email as not sent to you).
    • If you are certified this should also be visible in the NFU BROK Register.

      To remain continuously certified, you can log in to the Recertification Module Basic and the Recertification Advanced Module to answer the questions there. Each time you ensure that you answer the questions and score 80%, your certificate will be extended for another year. So, make sure you do this at least annually (before your certificates expire).

    If your certificate (s) have expired. Please check the following link. 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 1 year! 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