Basic course for clinical investigators (BROK®)

Since 2006, all clinical investigators are obliged to follow the Basic course on Regulations and Organisation for clinical investigators (BROK®). Clinical investigators have to satisfy the stringent requirements set by the legislator for the implementation of medical scientific research. In addition, an increasing number of disciplines are involved in the implementation of research with human subjects.

Hence, clinical investigators should not only be experts in the area of medical scientific research, but should also know everything about the legislation and regulation and about the arrangements that should be made with the supporting departments in order to be able to carry out the research. All these aspects are addressed in the BROK®, which is an initiative of the NFU. Another important aspect of the course is that well-trained investigators will produce a better quality. This makes the Netherlands more attractive as a country in which clinical research can be carried out.

How does the BROK® course distinguish itself from a Good Clinical Practice (GCP) course?

  • The BROK® is not limited to research involving medicinal products, but discusses 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® course also discusses regulations that apply to non-WMO research involving human subjects, such as file studies, bio-bank studies or studies involving remaining samples.

The BROK® is accepted as the standard course about the legislation and regulations for research with human subjects by many pharmaceutical companies and the Health Care Inspectorate. The BROK course is recognised by TransCelerate Biopharma Inc. as a “GCP training meeting the minimal criteria” and has been added to the "list of Training Providers".

The final qualifications of the course are set nationally. The BROK® course is completed with an examination for which a certificate will be awarded in case of good results.

In the beginning of 2015, NFU converted the BROK® to an e-learning version, the eBROK®. Each investigator can therefore follow the exact same course at a time and at a pace that suits the individual. The eBROK® is also open for employees of other institutions.

The ABAN/ABFE has accredited 15 study points to the eBROK®.

For students and promovendi the e-BROK® course (provided that the exam has passed satisfactory) is good for 1,5 EC (ECTS) points.

From September 2016 the eBROK® is also available in the English language. You can register for the eBROK® at the site of the NFU BROK Academie.

Questions about entry in the BROK®-register? Please contact the EMWO, +31 (0)33 750 10 36, info@emwo.nl


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