Appendix I - 207 if this did not result in trial subjects being put at “No, SAE reporting risk, and if it was not a systematic or persistent problem. (page 11) In some circumstances, failure to report a SUSAR could have a significant impact on trial subjects. Sufficient information and context should be provided for the impact to be assessed adequately. “ It is understood that if one SUSAR is not reported this is not a serious breach because it was single event. This implies that there first needs to be a trend. Please clarify in which cases this would be a serious breach. Appendix 1 investigator was not clear on the reporting requirements “The Category SAE reporting for the and was incorrectly classifying events as expected” and then: incorrect classification of “Yes, seriousness criteria”. Comment: is independent of “seriousness” “expectedness”. The example speaks about expectedness, the response speaks about seriousness which is inconsistent. Errors from investigator sites on the assessment of events may occur, however investigators are not responsible for assessing expectedness which is based on the RSI as specified in the IB or approved label (SmPC). The pharmacovigilance department of the sponsor is responsible to evaluate the expectedness of an event against the RSI, and will then classify events as SUSARs when appropriate. Proposal: Example to be corrected and modified. investigator was not documenting all the AEs associated “The with the trial.”
Appendix I - 207 SAE reporting (page 11) “No, if this did not result in trial subjects being put at risk, and if it was not a systematic or persistent problem. In some circumstances, failure to report a SUSAR could have a significant impact on trial subjects. Sufficient information and context should be provided for the impact to be assessed adequately. “ It is understood that if one SUSAR is not reported this is not a serious breach because it was single event. This implies that there first needs to be a trend. Please clarify in which cases this would be a serious breach. Appendix 1 Category SAE reporting “The investigator was not clear on the reporting requirements for the and was incorrectly classifying events as expected” and then: “Yes, incorrect classification of seriousness criteria”. Comment: “seriousness” is independent of “expectedness”. The example speaks about expectedness, the response speaks about seriousness which is inconsistent. Errors from investigator sites on the assessment of events may occur, however investigators are not responsible for assessing expectedness which is based on the RSI as specified in the IB or approved label (SmPC). The pharmacovigilance department of the sponsor is responsible to evaluate the expectedness of an event against the RSI, and will then classify events as SUSARs when appropriate. Proposal: Example to be corrected and modified. “The investigator was not documenting all the AEs associated with the trial.”
efpia-response_guideline-on-serious-breaches_300817final.docx