The investigator must report any serious adverse events occurring during clinical trials with medicinal products, even if they are not necessarily in a direct causal relationship with the treatment, to the sponsor within 24 hours (art. 40 para.1 ClinO, SR 810.305).
All SUSARs (suspected unexpected serious adverse reactions) occurring during a clinical trial at a Swiss trial centre must be reported to the Agency by the sponsor within the legal deadlines described in art. 41 ClinO. N.B. ALL three criteria (serious + related + unexpected) must be met in such cases. Please note that only SUSARs from Swiss centres must be reported to Swissmedic immediately. In the case of clinical trials also conducted abroad according to the same protocol, the events or adverse reactions occurring abroad must be included in the Annual Safety Report.
The sponsor is also obliged to submit to Swissmedic, once a year, a list of all undesirable side-effects, SUSARs and a report on the safety of trial subjects, together with a re-evaluation of the risk-benefit ratio. You can find additional information in the instructions below.
Instructions and forms
Instruction for the notification of safety measures and SUSARs in clinical trials
CIOMS form for initial notification of SUSARs