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, including clinical trials in CRUs. In order to be allowed to (re)start clinical trials, requirements should be complied with. This document is restricted to clinical trials under the Medical Research Involving Human Subjects Act (WMO).
The above 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 by the IGJ (see below) remain in full force for all other aspects and restrictions not changed/reduced/elevated by this new updated document.