Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned
As of 25 August 2020, the conditions for (re)starting clinical research in clinical research units (CRUs) are the same as those for healthcare institutions. This has been decided by the Health Care and Youth Inspectorate (IGJ) together with CCMO.
The conditions have been published on the IGJ website. These conditions state, among other things, that the research location is in charge of the clinical research (re)start, which will be based on the policy of the health care or research institution. The general measures taken due to the COVID-19 virus (RIVM guideline) and the obligation of a risk inventory remain in full force. If the risk inventory leads to substantial changes to the study, these changes must be submitted for assessment to the review committee and, in the case of research with a medicinal product, to the competent authority as well.
This means that the CCMO document ‘Conditions for (re)start studies in clinical research units’ is lapsed with immediate effect. The CCMO document Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus has been adapted.