Ordinance
|
Art. 26 Procedure and deadlines
1 The ethics committee shall acknowledge receipt of the application within 7 days and notify the investigator of any formal deficiencies in the application documents. 2 It shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents. 3 If the ethics committee requests additional information in accordance with Article 24 paragraph 2, the clock shall be stopped until this information has been received. 4 It shall inform the Agency of its decision in the case of Category B and C clinical trials. |