The following changes and documents are acknowledged by the Swiss cantonal ethics committees by means of a „Silent Approval“:
- Non-substantial amendment (ClinO Art.29 Abs. 6),
N.B. non-substantial amendments for HRO projects don’t need to be submitted at all)
- Annual Safety Report (ClinO Art.43)
- Clinical Investigator’s Brochure (IB) (ClinO Annex 3)
- Completion of the clinical trial (ClinO Art. 38 Abs. 1) and of the research project (HRO Art. 22 Abs. 2, Art 36 Abs. 2 and Art. 40 Abs. 2).
N.B. The “Silent Approval” does not apply to the discontinuation or interruption of the clinical trial or of the research project.
- Closing report (ClinO Art. 38 Abs. 3)
If the competent ethics committee has any comments or questions, it will contact the applicant. If there is no feedback within 30 days, the applicant can regard the documents as acknowledged by the ethics committee.