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24th Jan 2012, 05:53 PM
#1
SAE seriousness criteria - hospice admission
Is a hospice admission (for pallative care) covered by the SAE criterion hospitalisation?
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22nd Feb 2012, 05:28 PM
#2
With SAE reporting I would always err on the side of caution and say yes. But if you know this is likely to be a possible scenario for your study (e.g. in oncology) then it is easier to specify the requirement (yes/no) for reporting these specific type of admissions in the protocol at study start, and then you can just report as per protocol.
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2nd Jul 2015, 10:25 AM
#3
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