Education and training of research staff
The WMO (section 2, article 3rd) requires that research involving human subjects be carried out in organizations suited for that purpose and by or under the supervision of persons with appropriate training in scientific clinical research, at least one of whom is an expert in the research procedures/activities which must be carried out in relation to the human subject. According to the Dutch Federation of University Medical Centers (NFU) a certificate of the Basic course on Regulations and Organisation for clinical investigators (Dutch acronym: BROK®) is mandatory for all clinical researchers involved in setting up and conducting clinical research to which the WMO applies.
Other employees, not being clinical researchers, whom are involved in clinical research (such as research nurses and study coordinators, students, data managers, etc) must be trained in WMO/GCP as benefits their research duties. See below for further details.
The aim of this course is to provide clinical researchers with knowledge of the laws and regulations covering clinical research and their practical consequences
The BROK consists of three parts: (1) the e-learning module eBROK, (2) a centre-specific meeting (CSB) for further information about local procedures and details, and (3) a final exam.
You can find all information about the BROK on the website of the Dutch Federation of University Medical Centers (NFU). On the website you will also find the BROK® register, in which all certified persons are registered. To obtain and/or keep your BROK® certificate, you can register for one of the courses via https://nfu-ebrok.nl/.
For substantive questions about the BROK course, the exam and the recertification, please contact our Amsterdam UMC BROK coordinator. Logistical and/or administrative questions can be addressed to our BROK administration via BROKfirstname.lastname@example.org.
Recertify your BROK® course
BROK registration expires after 3 years. Before your BROK registration expires, you will need to complete a re-registration course.
Note: You will not receive a notification from the BROK-register that your registration has expired. It is important to take the re-registration course before the registration expires otherwise you will have to follow the entire course again including passing the final exam.
WMO/GCP (light) training
Research staff, other than clinical researchers, such as research nurses and programme coordinators may but are not required to take the BROK course, but do have to complete an accredited WMO/GCP course. GCP central offers, among other useful courses, an expert WMP/GCP training for clinical trials in the Netherlands.
Other research support staff (including scientific trainees) who will conduct one specific or limited activities for the research project, such as specific measurements, data processing, sample processing or analysing, must be trained in WMO/GCP as benefits their duties. The Clinical Monitoring Center (CMC) offers an in house training WMO/GCP light course at Amsterdam UMC (€35,- p.p) mainly intended for investigator initiated research. For location, dates and regitration form check their website.
GCP Central offers online learning and has several courses to choose from for specific target groups and roles such as 'The Inductory WMO GCP course to conduct clincial trials in the Netherlands (€65,- p.p)'.
GCP Central offers Amsterdam UMC a discount of 10%. The discountcode is: AUMC-2023
There's also an e-learing available in basic WMO/GCP light training via GCP Central.
Amsterdam UMC Doctoral School
It is good to know that the Doctoral School offers various courses and training activities that might be helpful in supporting your research project. Unless indicated otherwise, the courses are free for PhD candidates. Amsterdam UMC employees can register, group size permitting. Courses are planned for the year, so remember that some modules may already be fully enrolled.