Submission of changes during the clinical trial and reporting

The guidelines below provide information about:

  • How to report changes to trial, which was already approved by Swissmedic,
  • the reports required during the course of a clinical trial,
  • the procedures to follow once the study is finished, or has been interrupted prematurely
  • the reports required after completion or termination of a clinical trial.

All substantial amendments to the quality and safety documentation must be reported to Swissmedic for approval, together with a justification from the sponsor. Substantial amendments that are subject to Swissmedic approval, according to ClinO (SR 810.305), art. 34 para. 3 letters a-c, include in particular:

  • changes to the medicinal product (IMP), the route of administration, dosage form or dose administered,
  • changes based on new preclinical or clinical data that may affect the safety of the product,
  • changes to the manufacturing of the medicinal product (IMP) that may affect the safety of the product.

All remaining substantial amendments (defined according to international standards) and all non-substantial amendments (incl. administrative changes) have to be provided to Swissmedic for information.