A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.
The new version is the result of collaboration between the FAMHP, the Clinical Trial College, the BAREC (Belgian Association of Research Ethics Committees, Association belge des comités d'éthique de la recherche) and several research centres. The national directive applies from the moment of its publication and supplements the European guidelines.
These new guidelines should help sponsors of clinical trials manage:
- clinical trials for the prevention or treatment of COVID-19;
- clinical trials underway in Belgium.
The national directive now provides answers to frequently asked questions and will be updated depending on how the pandemic further develops.