Legislation and Organization for Clinical Researchers (BROK)

Aim

This course is obligatory for all clinical researchers carrying out work covered by the Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO). It leads to a specific final quality level, which is assessed using a national testing procedure. 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.

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Location & Organization

Organizer

AMC - Graduate School Amsterdam Medical Centre

Course Director

Dr. M.D. Trip

Faculty / Teachers

AMC Graduate School

Location / venue

Amsterdam, AMC

Costs

No charge for registered AMC PhD students.

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Timing & Workload

Duration Three days and self study
ECTS points 1.1
Frequency Three times per year
 

Teaching methods used

Lectures

Examination yes

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Criteria

Is the course taught in English? no
Is documentation available? (book, syllabus)? yes
Is the course open for external researchers? no

Remarks

Course is given in Dutch.

The course ends with an official national examination for the certificate required by researchers covered by the WMO. That qualification incorporates the GCP certificate required under EU legislation and the laws of other countries.

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More Information

http://www.amc.nl/index.cfm?pid=2857