Ordinance
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Art. 29 Changes
1 Significant changes to an authorised clinical trial must be authorised by the ethics committee before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants. 2 The investigator shall submit to the ethics committee any application documents specified in Annex 3 which are affected by the change. At the same time, the investigator shall provide information on the reasons for the change. 3 The following are considered to be significant changes:
4 The ethics committee shall reach a decision on significant changes within 30 days. Article 26 applies mutatis mutandis. 5 If a site at which a clinical trial is to be additionally conducted does not lie within the responsibility of the ethics committee which granted authorisation, the procedure is governed by Article 27mutatis mutandis. 6 Other changes must be notified to the ethics committee in the annual safety report specified in Article 43. |