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21st Dec 2016, 02:42 PM
#2
Moderator
It is important that if the SPC contains the reference safety information (RSI) for the trial, then ONLY the RSI in the SPC approved by the MHRA in the clinical trial authorisation should be used for expectedness assessment and not the latest one available. Any changes to the RSI would require approval as a substantial amendment prior to use for expedited reporting purposes. For more information see the MHRA inspectorate blog.
https://mhrainspectorate.blog.gov.uk...inical-trials/
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