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, firstname.lastname@example.org
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