e-BROK

Go to application form.

Goal:
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.

Format:
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:

2017

  • 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

2018

  • 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

Content:
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).

Language:
The course is given in Dutch.

Certificate:
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).

Costs:
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.

Contact

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