Research Roadmap

The WMO (Section 2, Article 3) requires that research involving human subjects is carried out within organizations suited for that purpose and by/under the supervision of professionals with appropriate training in scientific clinical research. At least one these professionals must be an expert in the research procedures/activities carried out in relation to the human subject.

The Dutch Federation of University Medical Centers (NFU) mandates that all clinical investigators involved in setting up and conducting clinical research subject to the WMO must obtain a certificate of the Basic course on Regulations and Organisation for Clinical Investigators (Dutch acronym: BROK®).

Other research staff, who are not clinical investigators - such as research nurses, study coordinators, students, and data managers - must be trained in WMO/GCP as benefits their research duties. More details are provided below.

BROK® course

The BROK course aims to provide clinical investigators with knowledge of the laws and regulations covering clinical research and its practical implications.

The course consists of three parts: (1) an online learning module: eBROK, (2) a centre-specific meeting (CSB) focusing on local procedures and details, and (3) a final exam.

For comprehensive information the BROK course, visit the NFU-website, where you can also find the BROK® register listing all certified professionals. To obtain or retain your BROK® certificate, you can register for one of the courses via the NFU-website.

For content-related questions about the BROK course, the exam or recertification, please contact the Amsterdam UMC BROK coordinator. Logistical and/or administrative questions can be addressed to the BROK administration via BROK-cursus@amsterdamumc.nl.

BROK® recertification

BROK certification is valid for 3 years. Before it expires, you will need to complete a re-registration course to maintain your certification.

Note: You will not receive a notification from the BROK-register that your certification will expire. Therefore, make sure you have a reminder in your personal calendar for the re-registration course. Once your certification is expired, you will need to retake the entire course, including the final exam.

WMO/GCP (light) training

Research staff who are not clinical investigators - such as research nurses and programme coordinators - can, but are not required to complete the BROK course. However, they must complete an accredited WMO/GCP course. GCP central offers, among other useful courses, an expert WMP/GCP training for clinical trials in the Netherlands.

Scientific trainees and other research support staff who conduct one specific or limited research activities (e.g. specific measurements, data processing, sample processing or analysing), must be trained in WMO/GCP basics as benefits their duties.

The Clinical Monitoring Center (CMC) at Amsterdam UMC offers an in house training WMO/GCP light course (free of charge for Amsterdam UMC employees and €50,- p.p for external participants) mainly intended for investigator initiated research. Location, dates and the registration form are available on their website.

GCP Central also offers online learning, including several courses for specific target groups and roles, such as the 'Introductory WMO/GCP course to conduct clincial trials in the Netherlands' (€65,- p.p). A basic WMO/GCP light training is also available via GCP Central.

Amsterdam UMC receives a 10% discount on GCP Central courses with the discountcode: AUMC-2024.

The registry for national WMO/GCP-certified professionals is available on the EMWO website.

Amsterdam UMC Doctoral School

The Amsterdam UMC Doctoral School offers various courses and training activities that may support your research project. Unless indicated otherwise, the courses are free for PhD candidates. Amsterdam UMC employees can also register, subject to availability.
Courses are scheduled for the year, so early registration is recommended as some modules may reach full capacity.