¹ The investigator shall, within 7 days, notify the responsible ethics committee of the following:

a.

serious adverse events which occur in participants in Switzerland in the course of a Category C clinical trial of products under Article 2a paragraph 2 TPA and where it cannot be excluded that the events are attributable:

1.

to the product under investigation, or

2.

to an intervention undertaken in the clinical trial;

b.

deficiencies in the product under Article 2a paragraph 2 TPA under investigation that could have led to serious adverse events if suitable action had not been taken, intervention had not been made, or circumstances had been less fortunate.

² If, in the case of a multicentre clinical trial at one of the trial sites, serious adverse events or deficiencies occur deficiencies in the product under Article 2a paragraph 2 TPA under investigation, the coordinating investigator shall also notify the responsible ethics committee concerned.

³ For a Category C clinical trial, the notifications specified in paragraph 1 shall also be made to the Agency. This obligation rests on the sponsor. In addition, the sponsor shall notify the Agency of any events occurring or deficiencies in the product under Article 2a paragraph 2 TPA under investigation observed abroad. In the case of a Category A clinical trial, the sponsor is subject to the reporting requirements specified in Article 15 paragraph 1 MedDO³⁵ in its version of 1 January 2002³⁶ in application of Article 103 paragraph 2 MedDO.

⁴ The definition of serious adverse events and deficiencies in products under Article 2a paragraph 2 TPA is governed by the rules of Good Clinical Practice as specified in Annex 1.