Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. From now on, the rules in force will be applied and any deviation must be requested by providing a clear description of the situation.
Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. The FAMHP had developed this guideline as a supplement to the new European guidelines, in cooperation with the Clinical Trial College, the Belgian Association of Research Ethics Committees (BAREC) and a number of research centres.
The exceptions that were linked to the guideline and that were allowed during the epidemiological emergency situation no longer apply. Direct delivery of medication to the patient (as described in section 4 of the Belgian guideline) is no longer allowed. The four-monthly report providing a listing or overview of the COVID-19 measures (as described in section 2.3 of the Belgian guideline) is no longer required. For outstanding issues, follow-up is still recommended.
We recommend sponsors to send a Dear Investigator Letter to the sites involved in the study in order to inform them of the changes and the fact that the exceptions no longer apply.
Contact
• Regulatory aspects such as deadlines and procedures: ct.rd@fagg-afmps.be
• Practical implementation of clinical trials: inspection@fagg-afmps.be