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21st Mar 2014, 11:27 AM
#1
SUSARs at Investigational Sites
Please can someone give me some guidance on how quickly Principal Investigators (PIs) are expected to read, acknowledge and share updated safety information with their team? This is in relation to SUSAR reports.
A SUSAR report was sent to a site by the Sponsor in May 13 but was not read by the PI until July 13. My question being was this too long? I can't see anything in the regulations so any feedback would be greatly received.
Thanks
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