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SAE reporting in clinical trial

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  • Anon
    07/03/2018 09:21
    An AE is reported in a Clinical trial. IT is assessed as non-serious and related to the study drug. A surgery is advised by Investigator as treatment for the same. The patient is withdrawn from the clinical trial due the same. After 3 months patient is operated for same. Hospitalisation for surgery occurs. Does this meet the seriousness criteria and qualifies for reporting to RA. The protocol period for reporting AE/SAE is end of the study visits. After this only related SAEs are to be reported by Investigators to Sponsor`s. In this case it is related AE requiring surgery after 3 months of End of the trial for the patient. Is this event reportable as a SAE in the said clinical trial ?
  • RQA GPvP Committee
    18/03/2018 18:38
    Dear Anon without having the full details of this AE, it does sound as if it should have been reported as "serious", once the surgery occurred (we presume trial participant will be hospitalized, why the delay of 3 months is not clear). The event you describe is rather borderline, because the surgery decision was made, but the actual surgery (which then leads to the upgrade to serious AE) would be delayed until after the end of the trial participation for that patient. Most companies would take a conservative approach (i.e. report as serious, follow-up information) and update their clinical trial database (already enter a comment that hospitalization is planned due to the initial AE). Practically, most companies would only actually upgrade to serious, once the surgery then had actually happened (in case the patient recovered prior to the surgery).
  • D. Chesnais
    04/04/2018 13:35
    You can refer to the ICH Topic E2A, CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING, section 3. Post-study Events, adopted by the EMA as CPMP/ICH/377/95
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    23/06/2019 22:49
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