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.
Format for submitting amendments, responses to the conditions and reports required during or after the completion or termination of a clinical trial
Would you like to help protect our environment? Please comply with the submission format specified below. We regret that we will be obliged to dispose of any stationery, etc. that we did not specifically request.
Please submit all documents on paper and CD (including the form) in accordance with our requirements.
- If submitting individual documents:
One copy of each document on punched A4 paper, collated in a transparent folder. Please do not use loose-leaf binders.
- If making an extensive submission:
One copy of each document (A4), punched and placed in a ring binder (2 perforations, spine width 7 cm) with a file divider or divider strips (see below for binder colour).
Please do not submit individual documents in pocket folders or loose-leaf binders.
When making your submission, please ensure you use a binder in the colour that corresponds to the Swissmedic reference number of your clinical trial.
There is no specified binder colour for earlier clinical trials or for collective submissions.