Substantial modifications to an approved clinical trial must be approved by the FOPH before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants.
The sponsor must submit to the FOPH any application documents specified in Annex 4 which are affected by the modification. At the same time, the sponsor shall provide information on the reasons for the modification.
The following are considered to be substantial modifications:
modifications due to new scientific knowledge, based in particular on new preclinical or clinical data, which affects the assessment of the safety of the organs, tissues or cells used;
modifications relating to the origin, the tests to be performed or the storage of the organs, tissues or cells used;
in the case of clinical trials of the transplantation of embryonic or foetal tissues and cells: modifications which may affect the safety of the participants; or
the extension of a deadline in accordance with Articles 23a and 50; in the application to the FOPH, the sponsor shall indicate whether the application documents are still up-to-date, particularly with regard to questions of the origin, safety and quality of the organs, tissues or cells used; if this is not the case, the sponsor shall submit updated application documents.
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The FOPH shall reach a decision within 30 days of receipt of the complete set of application documents affected by the modification. Article 33 applies mutatis mutandis.
Other modifications which affect documents submitted to the FOPH must be notified to the FOPH as quickly as possible.