This position paper reflects the current state of thinking of swissethics and Swissmedic on
decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their
respective areas of responsibility. The aim is to encourage and invite stakeholders to intensify the dialogue on this innovative way in conducting clinical trials and to find relevant information on the interpretation of the current legal situation in Switzerland. This paper describes a broad variety of topics starting from the recruitment, trail conduct, sponsor- and investigator responsibilities and how oversight should be ensured in decentralised clinical trials. Guidance is also provided on content requirements for drafting the trial protocol, conduct of monitoring visits and task delegation. As this type of clinical trial is relatively new, changes to existing laws and regulations may be required over time and will be included in this guidance on an ongoing basis.
In general, the developing practices associated with DCTs require careful scrutiny on a caseby-case basis for compatibility with applicable law…
