eBROK® offers practically oriented and innovative training, when and where it suits you, customised to your needs and presented in an attractive manner.
NOTE: Re-certification is arranged differently at different UMCs. Go to the website of your own UMC for more information (for the link, see the contact page for your own centre).
Why an eBROK® training course?
In 2006 the Basic course on Regulations and Organisation for clinical investigators (BROK) was set up - a joint initiative of the eight university medical centres (UMCs) in the Netherlands. In accordance with national agreements, clinical investigators working for the UMCs are obliged to follow the BROK® course and obtain the corresponding certificate. The final qualifications for BROK® can be found here on the NFU website.
The eBROK® training course has been accredited by ABAN/ABFE and represents 15 credits. For students and promovendi the e-BROK® course (provided that the exam has passed satisfactory) is good for 1,5 EC (ECTS) points. All those who have passed the BROK® examination will be entered into the BROK® register which can be found here. The regulations stipulate that a BROK® certificate is valid for 4 years, after which a re-certification course must be followed to obtain an extension. Thousands of investigators are now listed in the BROK® register: professors, PhD students, project leaders, research coordinators and research nurses. Paramedics such as biomedical scientists, psychologists and epidemiologists do the training course as well. The BROK® training course is also open to staff of institutions which the UMCs collaborate with, and the Association of Top Clinical Teaching Hospitals (STZ) has been represented in the national BROK® committee for several years now as well.
What distinguishes BROK® from a GCP training course?
- BROK® is not limited to research involving medicinal products, but addresses all types of research involving human subjects.
- The regulations and procedures are discussed from the perspective of the investigator and of the sponsor. After all, most clinical research in university hospitals is investigator-initiated research.
- The BROK® training course also addresses regulations that apply to non-WMO research involving human subjects. For file studies, biobank studies or studies involving remaining samples, the codes on Good Conduct and Good Usage are particularly important. These codes offer clear guidelines for how to handle personal data, subject consent procedures or (un)expected findings, for instance.
- BROK® is accepted by many pharmaceutical companies and the Netherlands Healthcare Inspectorate (IGZ) as the standard training course on laws and regulations for research involving human subjects. BROK® has been recognised by TransCelerate Biopharma Inc as a ‘GCP training meeting the minimal criteria’ and has been added to the List of Training Providers.
The NFU’s desire to make BROK® more accessible, more flexible, more efficient and up-to-date resulted in the decision to give BROK® a makeover. BROK® was converted to an e-learning format and is now called eBROK®.
What are the costs of eBROK®?
UMC staff: EUR 400
STZ hospital staff: EUR 600