Legislation changes for clinical trials in the Netherlands

July 01, 2015

A revised Decree for the mandatory insurance for medical research with human subjects has been published in the Official Dutch Journal (Staatsblad) on 9 December 2014.

Effective 1st July 2015, the legal requirements for Netherlands clinical trials policies are changing.
The new limits are:
- EUR 650,000 per patient (instead of EUR 450,000)
- EUR 5,000,000 per protocol (instead of EUR 3,500,000)

These changes do not apply to clinical trials that have been approved by Ethics Committee prior to 1st July 2015.

For more information:
https://zoek.officielebekendmakingen.nl/stb-2014-477.html

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