Certification and Re-certification

The BROK® course is completed with a national digital examination. All those who pass, will receive a certificate. Only certified investigators are allowed to carry out research with human subjects.

In the BROK®-register you will find the names of the certified investigators.

The BROK®-registration expires after 4 years. The date on which the registration loses its validity, is indicated on the BROK® certificate and can also be found in the BROK®-register. Before the BROK®-registration has expired, a re-registration course has to be followed. Visit the website of your UMC for information on the re-registration course, or contact one of the BROK® coordinators of the UMCs.

The following course subjects have been set for 2018

  • Research on medical devices (Regulation 2018)
  • Safety reports
  • Reporting of AE/SAE/SUSAR by Toetsingonline
  • Public disclosure of study results
  • Subject insurance (Insurance Decree juli 2015)
  • EU Privacy legislation and directive on data leakages
  • WMO-modification 2016: extension research with minors and legally incapable adults
  • ICH-GCP 2016
  • EU Clinical Trial Regulation 536/2016
  • Monitoring and Auditing
  • Review of non-WMO research (data management, biobanking)

WMO/GCP re-registration courses of the following companies comply to all the above mentioned requirements and have been approved by the BROK®-committee of the NFU:

  • GCP Central
  • TAPAS Group B.V.

It is the investigator’s own responsibility to renew the BROK®-registration before the expiration date. A reminder will not be sent.

The arrangements regarding examinations, certification and re-certification have been stipulated in the BROK® Training and Examination Regulations.

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

NFU Nederlandse Federatie van Universitair Medische Centra / Oudlaan 4, 3515 GA / Postbus 9696, 3506 GR Utrecht / T 030 273 98 80 / nfu@nfu.nl / Disclaimer © 2019