This course gives you 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.

Format

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

Scheduled dates

  • CSB: 18 February 2021; Exam: proctoring exam dates in e-learning
  • CSB: 13 April 2021; Exam: proctoring exam dates in e-learning
  • CSB: 24 June 2021; Exam: proctoring exam dates in e-learning.

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).

Study load

The NFU eBROK® course (provided that the exam has also been passed) is valid for 1.5 ECTS.

The NFU eBROK® is ABAN / ABFE accredited for 16 credits.

    Content

    Continuous learning

    Because laws and regulations concerning clinical research can change a lot in a few years, this new NFU eBROK® course offers the possibility to purchase a subscription after you have obtained your certificate. This way you receive reminders when there are changes in legislation and regulations. That way you stay up-to-date. If you have reviewed these changes in time, your certificate will be automatically extended: recertification will now be continuous learning.

      In general registering to the new NFU eBROK®2.0 provides of:

      • 1 year access to the new eBROK e-learning modlue
      • Unlimited access to all course content
      • A center specific meeting
      • One exam submission
      • Continous updates on laws and regulations during the subscription period
      • Entry in the NFU BROK register after successfully passing the exam

      Number of participants

      Maximum 45 per course (for the CSB).

      Certificate

      The certificate will be issued by EMWO (the exam desk) after having finished the e-learning modules, attended the CSB, passed the exam (> 80%) and having read all news items in the e-learning environment.

      Language

      The e-learning and exam are available in Dutch and English. The CSB is given in Dutch.

      Course Coordinator

      Dr. Selma Camic / brok-coordinator@amsterdamumc.nl.

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

      More information

      For more information go to the NFU website.

      Registration

      Go to the application form.

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