Clinical trials with trial participants can be gradually (re)started

Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures, there is room on the national level to gradually restart clinical trials that were put on hold or start new initiated clinical trials, not being clinical trials in CRUs. In order to be allowed to (re)start clinical trials, not being clinical trials in CRUs, requirements should be complied with. This document is restricted to clinical trials under  the Medical Research Involving Human Subjects Act (WMO).

The mentioned requirements are formulated by the IGJ in collaboration with the Central Committee on Research Involving Humans (CCMO) and taking into account input provided by relevant stakeholders.

The European Guidance, the advices and requirements of the CCMO and the document published previously by the IGJ (see below) remain in full force for all other aspects and restrictions not changed/reduced/elevated by this new document. Please refer the IGJ document mentioned above for links to all relevant documents and information.