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The aim of this course is to provide PhD candidates with the knowledge of the laws and regulations covering clinical research and their practical consequences. It leads to a specific final quality level, which is assessed using a national exam. Included in the course is coverage of ICH-GCP, the harmonized international guidelines for good clinical practice set by the International Conference on Harmonization. These apply to research in Europe, the USA and Japan.

The course is offered as blended learning. It runs five times a year in the AMC and consists of a Self-Assessment and a Study Arrangement by e-learning, a center-specific meeting (CSB) with lectures, and the official national examination.
The e-BROK is organized under the auspices of the NFU BROK Academy.

Participants are advised to plan sufficient additional time to prepare for the examination.

Scheduled dates:


  • Centre Specific Meeting: April 11, 2017. Examination on May 2, 2017
  • Centre Specific Meeting: June 22, 2017. Examination on July 11, 2017
  • Centre Specific Meeting: September 19, 2017. Examination on October 3, 2017
  • Centre Specific Meeting: November 28, 2017. Examination on December 19, 2017


  • Centre Specific Meeting: January 30, 2018. Examination on February 13, 2018
  • Centre Specific Meeting: April 10, 2018. Examination on April 24, 2018
  • Centre Specific Meeting: June 21, 2018. Examination on July 10, 2018

The Self-Assessment leads to an individual study advise.
In the Study Arrangement, four cases are offered: research with a medicinal product, research with a medical device, biobank research with a surgical intervention, and vaccine research.
The AMC center-specific meeting discusses scientific integrity, quality assurance, logistics in the AMC, medical ethical testing, legal aspects, and exam instructions.
The exam provides a qualification that also incorporates the GCP certificate required under EU legislation and the laws of other countries.

Target audience:
This course is obligatory for all AMC PhD candidates and AMC researchers carrying out work covered under the Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO).

The course is given in Dutch.

To qualify for the certificate, a participant must finish the e-learning, attend the centre-specific meeting and pass the national exam. Attendance is registered.

Certification is valid for 4 years. After 4 years you have to renew your knowledge by following a life e-learning course at a location in VUmc. More information: website.

Study load:
28 hours, which is comparable to 1.0 ECTS points.

Number of participants:
Maximum 45 per course (for CSB).

No charge for PhD candidates registered with the AMC Graduate School, after application through the AMC Graduate School. All other participants are charged a fee of 400 euro. They can apply directly at https://nfubrokacademie.nl .

Course coordinator:
Dr. J.J.W. van Dalen / j.j.vandalen@amc.uva.nl / tel. +31 (0)20 566 1871

More information:
From the coordinator or AMC Graduate School / graduateschool@amc.uva.nl / room J1A-112 / tel. +31 (0)20 566 63108 or 4618.

For information about e-BROK courses for all other researchers (non AMC PhD candidates), research nurses and research coordinators, please contact brok-cursus@amc.uva.nl / tel. + 31 (0)20 566 4618.


AMC Graduate School
Tel: +31 (0)20 - 5663108