Conditions for (re)starting studies in clinical research units
CCMO has published a document on the conditions for the (re)start of studies in clinical research units.
UPDATE 10 June 2020
The conditions for (re)start studies in clinical research units have been adjusted on the following issue:
- The weekly testing of research staff has been abolished. Instead, research staff must keep a daily record of whether, and if so, what symptoms they have. They will be tested if they have one or more symptoms that may indicate a COVID-19 infection. The CCMO follows the testing policy of the RIVM.
News item 19 May 2020
Due to the corona crisis, phase I clinics in the Netherlands have been closed since 8 April 2020 for the majority of the research being conducted there. The government announced a step-by-step relaxation of the restrictive measures on 6 May. This enables a step-by-step restart of studies put on hold in phase I clinics or a start of new studies if the conditions described in the document are met. The conditions do not only apply to phase I clinics but are valid for all clinical research units (CRU).
By CRU is meant:
- 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 content of the document was drawn up in collaboration with the MREC of the Stichting Beoordeling Ethiek Biomedisch Onderzoek (BEBO) (Foundation for the Assessment of Ethics in Biomedical Research) and the Health and Youth Care Inspectorate.