Are you a clinical investigator in an umc working on medical-scientific research that falls under the scope of the Medical Research Involving Human Subjects Act (WMO)? Then you are required to take the Basic course on Regulations and Organisation for clinical investigators (Basiscourse Regelgeving en Organisatie voor Klinisch Onderzoekers; BROK®), which was developed at the initiative of the NFU.
During the course, part of which is offered as online e-learning, you will learn about the legislation, responsibilities and agreements associated with medical-scientific research. The BROK® prepares you for your role. Well-trained investigators produce better quality work and contribute to an attractive climate for clinical research in the Netherlands. The BROK® is accessible to staff of other institutions than umc’s, like top clinical hospitals. Only BROK®-certified clinical investigators are permitted to conduct WMO research.
Course and certificate
The BROK® consists of an e-learning part (eBROK®) in Dutch or English and a centre-specific meeting. You can work through the material at your own pace. The BROK® can be customised, to suit the type of research to be conducted and meet the needs of the individual investigator. The course concludes with a digital exam. You become BROK®-certified once you have completed the e-learning part, attended the centre-specific meeting, and passed the exam successfully. Here are a few more facts about the course and the certificate:
- The examination standards and learning objectives apply nationwide;
- The BROK® has fundamental and advanced modules;
- Graduates receive a certificate that is valid for three years and are recorded in the BROK®-register;
- The date on which the registration loses its validity is stated on the BROK®-certificate and can be found in the BROK®-register;
- Agreements about the exam and (re)certification are recorded in the Education and examination regulations (Opleidings- en examenreglement, OER);
- For students and doctoral candidates, the BROK® is worth 1.5 EC (ECTS) points (if passed successfully);
- From 25 August 2020, each passed BROK® exam is accredited with the ABFE/ABAN (16 points).
The investigator is responsible for extending his/her BROK®-registration before it expires. No reminders will be sent. Because the legislation concerning clinical research can change considerably in just a few years, you can extend your BROK®-certificate with a subscription. You will then receive alerts when legislation is modified explaining how it is modified. This keeps you up-to-date. If you reviewed these changes promptly, then your certificate will be automatically extended.
Did you obtain your BROK®-certificate before 2015 or in the previous digital learning environment (the BROK® from before August 2019)? Then you can follow a separate procedure for reregistration in the modernised BROK®-learning environment.
Do you have any questions about the content of the course, (re)certification or (re)registration? Or would you like to enrol directly in the course, resit or recertification?
If you have another question, for example about the centre-specific meeting, then talk to your own BROK®-coordinator.
BROK®-certified? Then you will be registered in the BROK®-register.