Clinical trials with trial participants in clinical research units can be gradually (re)started
Due to the corona crisis Phase I clinics are closed for the majority of the clinical trials conducted at the clinics. Since the Government currently gradually reduces the restrictive measures, there is room to gradually restart clinical trials that were put on hold or start new initiated clinical trials.
In order to be able to (re)start clinical trials, requirements should be complied with. This document is restricted to clinical trials under the clinical trials under the Medical Research Involving Human Subjects Act (WMO).
These requirements are formulated by the Central Committee on Research Involving Humans (CCMO) in collaboration with the IGJ and input provided by the MREC, Foundation Beoordeling Ethiek Biomedisch Onderzoek (BEBO). The requirements are not only applicable for Phase I clinics, but apply to all clinical research units (CRU).
A CRU is defined to be:
- an independent research institution with its own legal form that is exclusively or almost exclusively set up for early phase research with medicinal products (mainly phase I),
- or a research department within a hospital set up exclusively or almost exclusively for early-stage research with medicinal products.
The European Guidance, the advices and requirements of the CCMO and the documents 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.