Ordinance
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Art. 39 Documentation of adverse events (AE) in clinical trials of medicinal products
1 If, in the course of a Category C clinical trial of medicinal products, adverse events which are not to be classified as serious occur in participants, they must be documented by the investigator in a standardised manner. 2 Adverse events occurring in the course of a Category B clinical trial must be documented in a standardised manner, if this is envisaged in the protocol or was requested by the authorities responsible for authorisation. 3 For Category A clinical trials, there is no obligation to document adverse events. 4 The definition of adverse events is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2. |