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Correct end date of a Serious Adverse Event

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  • Nadine Roethling
    29/12/2020 13:35
    Repost my question from the RQA-Pharamcovigilance forum after consultation with Sarah Haig from RQA. Hopefully someone from the GCP forum has some thoughts about the question - thank you in advance. A question has currently arisen in our team: „What is the correct Serious Adverse Event end date on the SAE form?" Is this the date when the serious criteria are no longer met? Or is it the date the event disappear? Often the underlying event has not yet ended while e.g. the serious criterion (e.g. hospitalisation) has ended. For example: AE thromboytopenia, start date: 01-Nov-2020, date SAE became serious (hospitalisation): 05-Nov-2020, hospital discharge: 08-Nov-2020, AE end date: 15-Nov-2020). Is the SAE end date 08-Nov-2020 (hospital discharge) or 15-Nov-2020 (end of AE thromobcytopenia)? Our vigilance team say 15-Nov-2020 and explain this with the signal detection, so the end date of the event is relevant and not the end of the serious criterion. Wouldn't that also be contradictory in the way that SAEs artificially last longer than they actually do? The progress of the underlying adverse event can be derived from the clinical database. Thank you for any reply.
  • Anon
    29/12/2020 22:25
    Do you run an AE with start dates from when AE starts and end date when the AE stops, even if it becomes an SAE in between those dates (ie goes to hospital and comes out again)? So the AE would last longer than the SAE. Sounds logical to me but I don't know what I'm talking about. I hope the the RQA PV Commiitte could answer this one.
  • Colin Wilsher
    01/01/2021 12:50
    From one member of the GCP Com. >> The start and stop dates on which the event meets the seriousness criteria would be part of the narrative (if relevant) but the duration of the adverse event in itself, the contemporaneousness with study drug intake, and the evaluation of concurrent events are of greater relevance in the clinical assessment. With respect to the point about 'underlying adverse event', we need to remember that all SAEs are fundamentally AEs. Clinical trial protocols will specify the study duration for which AEs need to be followed up after the last clinic visit - this is often until resolution or stabilization. The same rules apply to SAEs as the SAE is not cut off from the AE. It is the AE - it lasts for as long as the AE does. With respect to the point about the clinical database, the start and stop dates of the AEs in the clinical database and the AEs in the safety database are often reconciled as part of the process of SAE Reconciliation at the end of the study. As per ICH E2A, the duration of the reaction is the significant data point. Hence, the stop date (and time) of the reaction (event) are required. Some guidance is also found in ICH E2B (R3) about how to report start and end dates of related events : 'If the events are thought to be related (i.e., if event1 is a sign or symptom of event2), it would be clinically reasonable to use the earliest start date or latest end date, as relevant, for both events. However, a sender should not infer dates unless there is a clear clinical rationale and this rationale should be stated in the case narrative'.
  • Nadine Roethling
    12/01/2021 19:27
    Thank you both for your reply to my question, this is helpful. Best regards.
  • Anon
    13/01/2021 09:11
    Did you put this question to the RQA OV Committee ??
  • Nadine Roethling
    13/01/2021 09:20
    Yes, but didn't receive an answer yet.
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