BROK®
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, Clinical Trials Regulation (CTR), Medical Device Regulation (MDR) and/or the In Vitro Diagnostics Regulation (IVDR)? 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. Only clinical researchers who are BROK® certified are allowed to conduct this type of research.
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 (both the basic and an in-depth module of your choice), you have completed this part with a digital test in the BROK learning environment and you have attended the centre-specific meeting. The center-specific meeting is not mandatory for students who are nog affiliated with an umc. 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 one year 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. (Applicable to the nfu-ebrok.nl environment, which is available until the end of 2024. The regulations for the new environment (ebrok.nl), which has been available since September 2, will be published here soon).
Recertification?
The BROK® certificate is extended by following the re-registration course. It is the investigator's own responsibility to renew the BROK® registration before the expiration date.
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?
Can't find the answer to your question in the Frequently Asked Questions?
Questions regarding old eBrok (nfu-ebrok.nl)
Email: via contact button on the website or via servicedesk@elevatehealth.eu
T +31 85 488 53 81
Questions regarding new eBrok (ebrok.nl)
e-mail: klantenservice@ebrok.nl
T: +31 85 401 0008
Or via the chat button on the website
Questions about switching from old to new website:
Contact the BROK coordinator of your institution
BROK®-certified? Then you will be registered in the BROK®-register.
