In these challenging times and with the fast evolving situation due to COVID-19, KCE Trials understands that the priority is treating patients. We want to take this opportunity to stress that we will support you in all decisions you take regarding your clinical trials: whether putting a study on hold, stopping the recruitment, allowing protocol deviation for out of window assessments, or if you are able and wish, continuing recruitment etc.
In all trial activities, the priority remains to ensure ongoing subject safety and well-being. We advise a brief risk assessment and documentation of the impact of this situation, with consideration of prioritisation of critical activities such as safety reporting. Remote monitoring can be considered, however, this should not place an extra burden on trial site.
In case of temporary halt of the study do not forget to inform the ethic committee and the competent authorities (if applicable).
The FAMPH has sent out a circular letter for studies with Investigational Medicinal Product:
16.03.2020 - Directive sur la délivrance directe de médicaments aux patients dans le cadre d'essais cliniques
16.03.2020 - Richtlijn voor rechtstreekse aflevering van geneesmiddel aan patiënt in klinisch proef
You can inform us of measures that you are considering/or have put in place during the regular status meetings. In the meanwhile if you need any other information from KCE Trials do not hesitate to contact us.
We will wish you all much courage in order to deal with the challenging times ahead of us.
