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Basic course for clinical investigators BROK®
E-learning for obtaining a BROK certificate and for extending the validity.
read moreBasic course for clinical investigators BROK®
The Basic Course Regulations and Organization for Clinical Investigators (BROK) 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 and the eBROK e-learning.
The BROK course is an e-learning and can be done online in its entirety, including a national exam. While completing the national e-learning, you will follow a center-specific e-learning where the policy of the Radboudumc with regard to human-related research is discussed.
Please note The current e-learning is going to stop
The exam must be passed by 10 December 2024, at the latest. On 1 September 2024, registration for the new e-learning opens. If possible, wait until 1 September to register!
Enroll in the course!
Find step-by-step instructions regarding enrolling in the BROK course and the BROK re-registration.
click hereNew BROK® course live on 1 September 2024
Find more information and frequently asked questions about the new course and the updated re-registration process that will go live 1 September.
read moreNew BROK® course live on 1 September 2024
New BROK® course: the exam ceases to exist and a new re-registration procedure
The BROK course will change on 1 September 2024 because a new BROK® e-learning will go live. The content of the e-learning continues to consist of a basic part and various 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 centre specific meeting (CSB) must also be completed according to UMC procedures. Upon completion, you will receive, as before, your BROK® certificate, which will indicate which in-depth module you have completed. This will also be recorded in the BROK® register.
The current 3-year re-registration has been changed: After obtaining the BROK® certificate, your knowledge will be maintained through a so-called PowerApp. This web app offers small pieces of content. The various formats provide a varied, dynamic, and interesting learning experience. By regularly reviewing these small pieces of content, your BROK® certificate will always remain up to date. Even with a busy schedule, you can still learn with the PowerApp thanks to its short interactions.
Completion of current BROK® course
The launch of the new BROK® course is scheduled for 1 September 2024. From that moment on, it will no longer be possible to enrol in the current BROK® course. The learning environment of the current BROK® course remains available until 31 December 2024, allowing you to complete your BROK® course if you purchased it before 1 September 2024. A final online BROK® exam will take place on 10 December 2024. Please note: if you wish to file an objection based on your exams, this can be done until 17 December 2024, at the latest. We advise current BROK® course participants to complete the BROK® course as soon as possible.
Frequently Asked Questions
Can I still purchase the current BROK® course after the launch of the new course on 1 September 2024?
No, after the launch of the new course, it will no longer be possible to purchase the current BROK® course. However, the current 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®.
What happens to current participants after the launch of the new course?
After the launch of the new course, participants who have purchased the old course will have access to the current course environment until 31 December 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 current (old) environment. This applies to eLearning (modules at 100% and news articles read), completion of CSB, and passing the exam by 10 December 2024. If this is not possible, you will need to start over in the new BROK®.
Is the structure of the new course comparable to the old course?
No, the structure of the new course will be different from that of the old course. Additionally, the new course will not conclude with a formal external exam but will include an assessment within the BROK® environment that can be taken at no extra cost.
Can I transfer my progress from the old course to the new course?
No, progress within the course will not be transferred if you choose to access the new course environment.
What happens if I complete the old course and pass the exam?
If you complete the old course and pass the exam, your certification will remain valid for 3 years.
Can I choose to switch to the new BROK® course if I have not yet completed the old BROK® course?
Yes, participants who have already purchased a course can choose whether they want to complete their course, with an exam, in the old environment (last opportunity on 10 December 2024) or if they want to continue in the new environment without an exam, provided their purchased product has not expired. 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. More information on how to request access will follow. Please note: completing the BROK® course in the new environment later is only an option if, for example, you have not yet started your research (the requirements regarding BROK® certification in the UMCs remain in force).
My BROK® certificate is expired. Is it better to wait for the new course, or should I start the old BROK® course?
If the BROK® certificate expires before 1 September 2024, we advise you to complete the re-registration module in the current BROK® environment as soon as possible. If your BROK® certificate expires after 1 September 2024, you can enrol in the GCP-central PowerApp. This PowerApp will replace the current re-registration.
My BROK® certificate is expiring soon. Is it better to wait for the new course, or should I start the old BROK® course?
If your BROK® certificate is expiring before 1 September 2024, we recommend completing the re-registration module in the current BROK® environment as soon as possible. If your BROK® certificate expires after 1 September 2024, you can enrol in the GCP-central PowerApp. This PowerApp will replace the current re-registration.
How can I log in to the new BROK® environment?
There is currently no webpage set up for the new BROK® course. A message will follow as soon as possible with instructions on where participants can sign up for the new BROK® course. Keep an eye on the NFU website for more information.
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
Every 3 years Recertification
To renew your certification after 3 years, you must complete an online re-registration before the expiration date. Would you like to receive a timely reminder for this?
read moreIn 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 approx. 26 hours. A re-registration takes approximately 5 hours (including the Radboudumc-specific e-learning of 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.
