Basic course for clinical investigators BROK®
E-learning for obtaining a BROK certificate and for extending the validity.
Only start with the re-registration procedure when your end date is approaching, which you can find in the BROK® registry.
read moreBasic course for clinical investigators BROK®
The Basic Course Regulations and Organization for Clinical Investigators (eBROK®) deals with laws and regulations when conducting clinical research and is compulsory for all researchers involved in human-based scientific research that falls under the scope of the WMO. For more information, see the national NFU BROK website. The eBROK also covers the Radboudumc policy regarding human-related research.
After you have obtained the BROK® certificate, your end date will be registered in the BROK® registry. Only start with the re-registration procedure when your end date is approaching.
Enroll
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Find more information and frequently asked questions about the new course and the updated re-registration process that will go live 1 September.
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New BROK® course live on 1 september 2024
New BROK® course: the external exam ceases to exist
On September 1, 2024, the new BROK® e-learning is open (ebrok.nl). The content of the e-learning consists of a basic part and several in-depth modules (non-WMO research, research with medicinal products, research with medical devices and other research subject to WMO).
The new course will no longer conclude with a formal external exam. Instead, your knowledge will be assessed online at various points during the course. The course consists of a basic part, followed by an in-course assessment. Upon successful completion of this assessment, a choice of in-depth module (e.g., medicinal products or medical devices) must be taken. This module is also concluded with an assessment. The Center Specific Meeting (CSB) is the e-learning “Human-related scientific research” and must also be completed. Upon completion, you will receive, as before, your BROK® certificate, which will also indicate which in-depth module you have completed. This will also be recorded in the BROK®-register.
Continuous certification: yearly recertification
The old 3-yearly re-registration period is changed. To remain certified, you must purchase the re-registration module annually. After obtaining the BROK® certificate, your knowledge will remain up to date by regularly reviewing small pieces of content in the eBROK. Every time you update the basic eBROK and the in depth module(s), the end dates will shift accordingly. You continuously keep your BROK® certificate up to date. The most recent end dates of your basic eBROK and the in depth module(s) can be found in the BROK®-register.
Frequently Asked Questions
What happens if I completed the old course (nfu-ebrok.nl) and passed the exam?
If you completed the old course and passed the exam, your certification will remain valid for 3 years. Only purchase the re-registration module when the end date is approaching (see the BROK®-register).What should course participants do who are currently in the old environment?
Participants who have purchased the old course (nfu-ebrok.nl) will continue to have access to the old course environment until December 31, 2024. They can still take exams or re-exams within the old environment until the last exam on 10 December 2024. Please note: everything must be completed by 31 December 2024, to complete the BROK® via the old environment. This applies to eLearning (modules at 100% and news articles read), completion of CSB, and passing the exam by 10 December 2024Can I choose to switch to the new BROK® course if I have not yet completed the old BROK® course?
Yes, if there are compelling reasons for not being able to complete the course on time (e.g. a failed exam, language problems, external circumstances etc.), participants can be transferred to the new environment. This applies only to the entire BROK®, not the re-registration module. Progress in the old course will not be transferred to the new course. So, you start over, but you do not have to take a formal BROK® exam. If you are unable to complete the full BROK course before December 31, please send an email to brok@radboudumc.nl explaining why you are not able to complete the course.Can I still purchase the current BROK® course after the launch of the new course on 1 September 2024?
It is no longer possible to purchase the old BROK® course. However, the old BROK® course will remain available until 31 December 2024, for participants who have already purchased it. The only product you can still purchase in the old environment from 1 September to 1 December 2024, is a re-examination for the BROK®.More information?
We hope this information provides clarity about the upcoming changes in the BROK® course. If you have any further questions, please do not hesitate to contact us via BROK@radboudumc.nl.
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Find step-by-step instructions regarding enrolling in the BROK course and the BROK recertification.
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Continuous certification Yearly recertification
To keep your certification valid, you must purchase the Recertification module via ebrok.nl every year.
read moreComplete everything in the old environment before 31 December 2024
Are you still busy with the BROK course or re-registration in the old environment (nfu-ebrok.nl)? This means you purchased a product before September 1, 2024. Everything must be completed before December 31, 2024!
read moreComplete everything in the old environment before 31 December 2024
The old environment will be online till December 31, 2024. Complete everything before December 31. This applies to the e-learning (set modules at 100% and read all news items), complete the CSB and pass the exam by December 10, 2024 at the latest.
For recertification you must complete the re-registration module before December 31.
If you are unable to complete the full BROK course before December 31, please send an email to brok@radboudumc.nl explaining why you are not able to complete the course.
In short
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The BROK course is mandatory for researchers involved in human-based scientific research that falls under the scope of the Medical Research Involving Human Subjects Act (WMO).
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Aimed at
For whom?
The BROK is mandatory for researchers who are involved in research subject to the WMO. Researchers must be BROK certified at the start of the study (or the moment their study activities start).
The BROK is recommended for researchers involved in research that is not subject to the WMO. These researchers are obligated to complete the Radboudumc specific e-learning on human-related scientific research.
For more information on training requirements, see the policy guideline on Training.
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The total course takes approximately 16 hours. Annual re-registration takes approximately 4 hours. Every three years, the Radboudumc-specific e-learning must be completed again, taking approximately 2 hours.
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The BROK course is ABAN / ABFE accredited for 16 credits, 5 credits for the re-registration. The BROK course applies to 1.5 EC (ECTS) points for (PhD-)students.