Conditions for (re)starting clinical research
The Health and Youth Care Inspectorate (IGJ) has published a document with the conditions for the (re)start of clinical research in the Netherlands. The conditions for the (re)start of clinical research in a clinical research unit (CRU) that had been shut down due to COVID-19 were previously published in a separate document. This document has been brought more in line with current developments regarding the relaxation of the COVID-19 measures.
As a result of the corona crisis, the majority of clinical research in the Netherlands has been put on hold. The latest relaxations of the restrictive measures in force make it possible to continue clinical research that was put on hold or to start new clinical research.
In order to (re)start clinical research, the conditions from the IGJ document must be met. If you have fulfilled the conditions, you must notify the review committee about the (re)start of the study - and, in the case of research with a medicinal product, to the competent authority as well. Please include the study-specific risk statement in the notification.
If (re)starting the study involves substantial changes to the research file (substantial amendment), you must first submit this to the review committee for approval in accordance with the applicable procedure - and, in the case of research with a medicinal product, to the competent authority as well.
The above information has been incorporated in the recommendations of the CCMO for the conduct of clinical research at the time of the restrictive measures imposed by the coronavirus and in the conditions for (re)starting clinical research in a CRU.